Only five African countries have completed the necessary requirements to receive some of the 400 million doses of Johnson and Johnson vaccine through a special funding deal.

IBADAN – A deal to supply 400 million doses of Johnson & Johnson COVID-19 vaccines to African countries hangs in the balance as most countries are reluctant to make upfront deposits and borrow money to get the supplies.

With a looming deadline to express interest and complete the funding applications, Africa CDC John Nkengasong on Thursday appealed to countries to make use of the facility as it will ramp up vaccinations and help achieve herd immunity to curb the spread of the deadly virus. 

While Morocco has administered over 10 million doses of vaccines, countries like Burkina Faso, Tanzania, Eritrea, Chad, Burundi, and the Central African Republic are yet to officially administer a single dose—according to Africa CDC’s COVID-19 vaccination tracker, implying that many African countries are lagging behind the set vaccination goal even as the continent is heading towards the winter season and a possible third wave.

Thus far, only five countries have completed the process required towards accessing funds through African Export-Import Bank (Afreximbank) to pay for the doses they are getting through an arrangement involving key parties including J&J and Africa CDC.

Benedict Oramah, Afreximbank president , said only Botswana, Cameroon, Tunisia, Togo, and Mauritius have completed orders and submitted a 15% deposit as a down-payment for the vaccine supplies.

Thirteen more countries have signed commitment letters, but have not paid any deposits, according to Oramah. Whereas 17 have expressed interests in pre-orders without taking any action.  A total of 21 countries have not expressed any interest in securing the doses. 

The lack of finalisation of paperwork and funding requirements will result in only a fraction of the 400 million doses being delivered.

Oramah did not give a specific deadline date, but said the order book would be closing in the coming weeks in order to move forward with finalising deliveries.

The J&J vaccine is seen as an ideal option for the continent because it’s one shot, which reduces logistics and administration costs, Oramah said.

In March Health Policy Watch reported details of the deal between J&J and the African Union’s African Vaccine Acquisition Trust (AVAT) aimed at equitable access to new COVID-19 vaccines. AVAT would order up to 220-million doses this year and an additional 180 million doses in 2022.

Most of the supplies will be produced at Aspen Pharma’s pharmaceutical manufacturing plant in South Africa and will be made available to African countries through the African Medical Supplies Platform (AMSP), over a period of 18 months.

The transaction was made possible through the US$2 billion facility approved by Afreximbank, who also acted as Financial and Transaction Advisers, Guarantors, Instalment Payment Advisers and Payment Agents.

Prior to the conclusion of the Agreement with J&J, African Member States were asked to make pre-orders for the vaccines and several countries showed strong preference for this particular vaccine. The countries will be able to purchase the vaccines either using cash, or a facility from Afreximbank. 

African countries are reluctant to sign loan agreements to buy much needed vaccines. Only five countries have completed the process that will see them benefit from 400-million doses.

More Vaccinations Needed to Achieve Herd Immunity

Speaking at a press briefing on 13 May,  Nkengasong said his organisation would continue to encourage member states to use the funding opportunity as countries needed more vaccine doses to achieve herd immunity by 2022.

“I think that we will continue to encourage our countries to go to the AMSP platform to acquire their vaccines. You can only count on your own efforts by investing in health security,” he said.

According to Nkengasong, even if the COVAX-facility is able to deliver all the doses it had promised African countries, it will only be able to meet 30% of the continent’s vaccine needs.

“We have all agreed that if we do not vaccinate up to 60% of the population, we may not be able to get rid of the pandemic on the continent. The fact that the United States is further expanding its vaccination to lower age groups, and China is aiming to vaccinate 80% of its population, speak to the fact that we as a continent cannot say we will only vaccinate less than 30% of our population,” he said.

Africa CDC Director Dr John Nkengasong has urged African countries to make use of a loan facility that will enable them to get a share of 400 million doses of COVID-19 vaccines.

He however assured that J&J was on course to start the delivery as planned – the first shipment is expected from late July or early August.

“We are working very hard with Johnson and Johnson every day. We are expecting deliveries beginning from the third quarter of the year. We are still pressing hard to see if we can actually have any early deliveries because of shortage and challenging situations. So, yes, we are still on course for delivery,” he affirmed.

Africa’s Overstretched Wallet

Only one African country, South Africa,  has recorded more than one million cases of COVID-19,  but the continent has largely been unable to cope with the pandemic which has had severe impacts on the fragile health systems, including emergency spending on COVID-19 prevention and control measures.

Even as the world battles new COVID-19 variants and supply and roll-out of vaccines remains critically low in Africa, new research from the Partnership for Evidence-Based Response to COVID-19 (PERC) indicates 81% of survey respondents reported challenges in accessing food, 77% reported experiencing income loss and 42% reported missing medical visits since the start of the pandemic. 

Beyond acquiring vaccines, African countries are also spending limited resources on expanding testing and genomic surveillance capacities, public health measures including expanding water and sanitation hygiene measures, acquiring medical oxygen capacities and several others. 

Countries are also trying to restore normalcy to other health issues that have been negatively impacted by COVID-19 thus making them reluctant to further pile up loans while their economies are yet to return to growth.

Two weeks ago, the Nigerian government announced its plans to get 29.6 million doses of the vaccine through AVAT with the support of Afreximbank. The country’s finance Minister Zainab Ahmed, said just over  US $70-million has been released for the deployment of vaccines, which is 52% of what is required from 2021 to 2022.

“Nigeria has set a target of vaccinating 70% of its citizens who are 18 years and above between this year and next,”  Ahmed said.

Window Closing Soon

At the March 2021 announcement of the deal, Oramah said Afreximbank, was proud to be associated with this historic and collective effort. 

“In the midst of a very tight COVID-19 vaccine market, we are highly honoured to have been given the opportunity by the African Union to facilitate this impactful transaction…towards assisting the continent to begin to rid itself of the pandemic and rebuild its economy,” he said at the time.

But during an emergency summit of health ministers on  8 May, he said the window period for African countries to express interest and complete the process is closing soon (no date announced). 

“We want to make an appeal to all of you, especially those who have not made the orders, to please make your orders,” he said..

For Nkengasong, the deal is an opportunity for Africa to meet nearly 50% of its vaccination target.

“The Africa CDC recommended to the African Union that a minimum of 750 million Africans (60%) must be immunised if we are to contain the spread of COVID-19. This transaction enables Africa to meet almost 50% of that target. The key to this particular vaccine is that it is a single-shot vaccine which makes it easier to roll out quickly and effectively, thus saving lives,” he said.

Image Credits: Paul ADEPOJU.

The real challenge is manufacturing the vaccines, not the patents for them, say industry figures such as IFPMA’s Thomas Cueni.

In preparation for the next pandemic, the COVAX global vaccine facility “needs a pot of money, where they can be early movers” in competing for, and securing, vaccine doses. That could help scenarios like the ones seen recently, in which rich countries cornered the market on the first available COVID-19 vaccines, leading to severe shortages in low- and middle-income countries “because COVAX didn’t have money in the bank” at the time the first big contracts were being made.

That is just one key lesson learned from the COVID pandemic, says Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations. Cueni spoke to Health Policy Watch in the wake of the US decision to support a World Trade Organization waiver on vaccine IP. 

Whether or not the waiver initiative is ultimately approved, having the patent “recipe” without the knowledge or tools for “baking” could leave the cake flat, Cueni argues in this exclusive interview. What’s more, he contends that a waiver could have unintended consequences – intensifying the competition over already scarce raw inputs. Rather, the world should focus short-term on dose- sharing by rich countries and the removal of trade and export restrictions on vaccines’ scarce raw ingredients. Longer-term, industry is well-positioned to support more equitable redistribution of vaccine manufacturing capacity –  “an increase in more agile, flexible, ever-warm vaccine facilities in more continents” to combat vaccine inequity.

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

Health Policy Watch: What’s the upshot of the IP waiver. Despite industry resistance, couldn’t it still help expand supplies more rapidly? 

Thomas Cueni: As Stéphane Bancel said, the IP for the Moderna vaccine is available online.  And on top of that, Moderna said they would not enforce their patents during the pandemic.  However, he did also say that [just] having the patent, the technical blueprint …- well….good luck. 

We’ve seen compulsory licenses used for example in hepatitis, it happened in HIV/AIDS, but there has not been a compulsory license on vaccines.  As Sai Prasad, from Baharat Biotech [Indian developer of COVAXIN®, the first indigenous COVID vaccine], and a top expert on quality assurance has said, just waiving patents would create more problems than it solves.   

Right now you have tech transfer happening on a very large scale. Within 12 months, you have 275 contracts between vaccine manufacturers to help each other scale production. More than 200 include technology transfer.  That involves sharing know-how, sharing expertise, sending teams to make sure that you not only have the machinery and the equipment, but also know how to use it. Training of skilled workers. 

In Geneva, I’m sure you followed with as much interest as I did the debate about the delays in the delivery of the Moderna vaccine. Stéphane Bancel called this out very openly and said they have the equipment, machinery, but they don’t have sufficient numbers of skilled workers to scale up as fast as one would hope. 

Lonza, Moderna’s manufacturing partner for active COVID vaccine ingredient, nestled in the Swiss town of Visp, has faced an uphill road to rapidly scale up manufacturing capacity.

HP-Watch: Given all of that, doesn’t the industry still risk being on the wrong side of this issue, at least rhetorically – as per the debate over Africa’s access to HIV/AIDS anti-retroviral drugs two decades ago?    

Cueni: You know when you look at it, it is more an issue of political symbolism.  What is really interesting, and not much talked about, is that when you talk to, say, Indian vaccine manufacturers, they invoke our language. They say that tech transfer is a complex process, which is built up over the years, which involves much more than patents.  As for IP standing in the way of vaccines getting to the patients – this was the debate 20 years ago on HIV AIDS but it is not the same [today].

Because when you look at the HIV/AIDS debate, the first effective anti-virals were approved by the US FDA in 1995. And literally, it took almost 10 years for them to reach patients in Sub Saharan Africa.  It also needed the establishment of the Global Fund. In COVID-19 you had the industry responding on a large scale from Day 1. Few people would have expected, not one but several vaccines, within less than a year. 

You know mRNA technology goes back thirty years to 1990. But only now, we have seen the first products, vaccines, reaching the market, and not just from one company BioNTech, but also CureVac and Moderna.  And therefore, industry from Day 1 has acted very differently from what you had in the HIV/AIDS crisis.

But three of the four largest vaccine manufacturers in the world (Sanofi, GSK, Merck/MSD) don’t have a COVID vaccine yet.  And it’s not for want of trying. But this shows that this is high risk.  Pfizer, so far, is among the lucky ones; they succeeded by teaming up with the right partner. And when you look at Moderna or Pfizer, they do basically sell at cost, not for profit, to COVAX.

Not only with COVAX but also in striking partnerships –  Johnson & Johnson with BioE in India for a billion doses, AstraZeneca [with the Serum Institute of India] on a large scale, they have behaved responsibly. And I think that’s something which people also underestimate.

AstraZeneca vaccine production. As with most other COVID vaccine manufacturers, there have been setbacks and delays in scaling up manufacturing capacity.

And when you look at the partnerships, by and large these partnerships happened between organizations with proven expertise for large scale manufacturing. That’s why you do have in India, the Serum Institute or BioE. Also, you do have now Bayer, Sanofi, GSK, and Novartis coming in [as partners with vaccine developers] – because there is little doubt that they do know how to manufacture on a large scale.

What’s behind the call for the patent waiver is the impatience for scaling up.  It’s the lack of understanding that, moving from zero to 10 billion doses – trebling global vaccine capacity in a complex manufacturing process – that’s really challenging. 

HP-Watch: Did industry make a mistake, perhaps, by agreeing to sell too many doses to high income countries. Could manufacturers have put a cap on those sales whereby some countries, like Canada, pre-ordered 5-10 times the number of doses that they need? 

Cueni:  We could put it the other way around. What went wrong, or why is COVAX [the global vaccine facility] struggling?  I’ve heard some say they don’t have the money; that’s not true. COVAX actually more or less met its investment needs with cash injections for this year. Where COVAX was really handicapped was that they couldn’t sign contracts, before they had the money in the bank. 

When you look at when most of the MOUs/contracts [were signed] – that was in December 2020 – at the time when it was clear that the mRNA vaccines Madonna, Pfizer/BioNTech as well as AstraZeneca would make it. But COVAX was not able to sign these – in contrast to the US, where BARDA, (Biomedical Advanced Research & Development Authority) put in money at risk, for scaling up, and they immediately secured a huge number of doses. And you had the same with the UK, you had with a little delay the same in the EU, you had Canada.. 

If COVAX would have been able to sign up with the companies, but [GAVI head] Seth Berkley probably would have been challenged by his board. 

Which means that if you walk about what needs to be done, when you look at vaccine rollouts now, the benchmark is not When you look at the rollout.. The benchmark is not HIV AIDS – that disaster, it’s H1N1 [2009 flu pandemic], which was also a disaster. 

And I’ve looked at some numbers comparing roll-out of H1N1, where the rich countries basically bought up all of the antivirals and all of the vaccines, until they found out that H1N1 was not so traumatic, and then they tried to get rid of them. 

Ghana’s WHO representative, Francis Kasolo, on left, with UNICEF’s Anne-Claire Dufay, as first COVAX vaccine doses arrive on 24 February in Accra,

The COVAX situation is different because in COVAX, we did get a rollout within 100 days, or less. In 88 days after the granting of the first emergency use license by WHO, you had vaccines in quite significant numbers reaching Accra, Nairobi, Kigali – and on the same day as Tokyo. Therefore, the problem was that manufacturers who did invest, also at risk, in addition to getting some quite significant co-funding, in particular from BARDA – in return secured [contracts for] doses.  Then the companies would not have been in liberty to release these doses. 

And therefore, when I look in terms of future pandemic preparedness, COVAX needs a pot of money, where they can be early movers. 

It’s also a question for CEPI  (Coalition for Epidemic Preparedness Innovation).  Because when you look at the big manufacturers they, by and large, teamed up with BARDA early on. The  smaller biotech companies, such as Novavax, they got quite significant sums from CEPI.  But CEPI is a relatively small organization. Therefore, I think one needs to talk about how can we improve pandemic preparedness for the future; we need to make sure that COVAX and CEPI are equipped to have a level playing field for the deliveries to the poorer countries. 

Novavax, a smaller biotech firm that received significant support from CEPI, the Coalition for Epidemic Preparedness and Innovation, showed robust results for its COVID vaccine in clinical trials, but still faced an uphill battle to scale up manufacturing.

“I don’t think that you can fault the companies for signing up [orderes].  The companies took risks, and when you look at MSD/Merck & Co., two projects, nothing came out of it, and they invested at risk. When you look at Sanofi, delayed by at least a year, and nobody knows whether, by the time they reach market, there’s a surplus. All of them are now teaming up with somebody else to help in fill and finishing, or even active substance producing. 

HP-Watch:  You have talked about the need to have a pot of money available, so COVAX can move more quickly.  But where do you go from here in terms of industry interests, the broader well-being and this waiver, which is a big debate now?  

Cueni: Even if the waiver would pass, which is still a question mark notwithstanding the US, I would expect that it would create a huge frustration because people will realize that we were right.  

Short-term, what do we need?  We need a willingness of rich countries to start dose-sharing now, and not as President Biden said, once we have every single American vaccinated. We need some significant gestures of solidarity now.  We have seen early signals: New Zealand announced, France announced, but you know these are  in the hundreds of thousands, not in the millions.  I think (WHO Director General) Tedros has mentioned we need 20 million doses now.  And that can only happen if the rich countries that bought up these doses are willing to give priority to COVAX, and that needs to happen now. 

Also, in terms of the supply chain and manufacturing bottlenecks – for which COVAX set up a Manufacturing Task Force. One of the short-term priorities is to tackle trade barriers. (WTO Director General) Ngozi Okonjo-Iweala, has called out to world leaders to stop export bans, export restrictions. When you look, for example, at  the Pfizer/BioNTech vaccine, you have 280 ingredients from 86 different suppliers from 19 countries. If you have trade restrictions, these are usually disruptive.  You’ve seen [Adar] Poonawalla from the Serum Institute in a tweet calling out to President Biden to ‘please help; we are stuck because you don’t allow [export of] critical ingredients.’ [Addressing] that is something that would be immediately impactful.  

HP-Watch: OK, but if indeed the waiver passes, why indeed would it be disruptive? 

Cueni: Short-term it would be disruptive because we have identified a number of critical ingredients, like the giant plastic bags, the single use bioreactors, filters, lipids – that are in huge demand and in short supply. I’ve heard some people say that for some of these ingredients you have to wait for three-six months. 

Under normal circumstances, when you have bottlenecks, the normal reaction of human beings, and you saw it with hoarding of toilet paper last year, is that you have compensatory actions, and that leads to additional bottlenecks.

Therefore, what we identified in this joint Task Force effort with CEPI, the DCVMN, our developing country colleagues, BIO and IFPMA, we do believe that if we set up a matchmaking place where companies can submit information on [items] for which they in desperate need, or may have excess stocks, you could improve the efficiency and address some of these bottlenecks.   

Rajinder Suri, CEO, Developing Country Vaccine Manufacturers Network, with Pfizer, GSK and Bharat Biotech execs at 23 April IFPMA session.

HP-Watch: So how does the IP waiver have an effect on this mission? 

Cueni: The IP waiver potentially would mean that you get 100 more companies that want to participate, and have access to these scarce raw materials, scarce ingredients.  Unknown whether they would be able to manufacture, but they would compete on the ingredients.  And in that context, in the case of a waiver, you will have more players coming in trying to tap into the same scarce resources, irrespective of whether they can make good use of them or not. 

The other element is that the waiver, as such, is that it wouldn’t really give you the tools to manufacture. You would need teams of engineers or scientists or experts from Moderna or others to be willing to visit you, and share, and teach you how to use your know-how. 

That is happening now on a large scale. But it’s happening based on voluntary, established trust, established confidence – where you have a contract and a process for doing this. Can you imagine companies confronted with ‘your patent is no longer valid. You cannot enforce it; there is no contract it’s a free for all?’ The guy who takes your bike, basically comes to you and says, ‘now you need to give me the PIN code to unlock the bike so they can run away with it.’ 

This would be a huge distraction, when the skilled workforce is so limited, when a serious bottleneck is the lack of a skilled workforce. Therefore, short term we would likely see more disruption and distraction from the efforts that are really needed. 

Because we need to expand further.  If we can reach 10 billion doses this year, then I think the the world is pretty much vaccinated by March 2022. Of course, everyone would love the world to be vaccinated by July 2021. 

HP-Watch:  So long-term you are optimistic? 

Cueni: For next year, I’m very optimistic.  We will not only have the capacity, but we will also have the adaptive vaccines for new variants. In terms of the waiver, there is a willingness, and needs to be a willingness, among industry to …get a better geographic diversity of manufacturing hubs. 

“I was five weeks ago at the African Manufacturing Summit. The basis for that Summit was an absolutely excellent study, which was I think commissioned by the UK’s Foreign Commonwealth & Development Office, and the conclusion was short term, there isn’t really the capacity or the skill sets in Africa to add hundreds of millions of doses for Africa. It’s much more likely to come from the 500 million dose [COVAX] contract with J&J or AstraZeneca, and also Novavax will come in certainly. 

Medium term, I think we will see a much more constructive discussion on how can we make sure that we help to establish infrastructure capacity. BMGF [Gates Foundation] is interested, Germany, France, and the UK are all talking, and manufacturers are involved. But that, I think realistically, is not for this pandemic, that’s for the next one.

HP-Watch: Just to recap, you said that if there was an IP waiver, then in the immediate future, more players would come in and tap into the same vaccine inputs that you’re so short on already. But wouldn’t that also drive more production of those same items? 

Cueni: I expect that we will continue to see significant expansion of capacity, it will primarily come from those with expertise in scaling up, and the partnerships they signed with others that also have that expertise, whether it’s in India or within Europe and the US. Short term, I could expect that we may see some additional fill and finish. But even on fill and finish, don’t underestimate the requirements of standardized, manufacturing, quality control, and quality assurance. 

Pfizer’s COVID-19 vaccine manufacturing. Quality assurance is key.

HP-Watch: And what about patents on the many other vaccine manufacturing inputs required, from filters and bioreactors to vials? What if the waiver helps remove bottlenecks on those components, as advocates inputs and open up their production more widely?

Cueni: It is simplistic to think that a blunt tool like an IP waiver would be an appropriate solution for the scarcity of raw ingredients. There are different technologies and market circumstances in the production of each ingredient, and each case needs to be taken into account individually. In the very rare case that one may find an IP-related bottleneck on a pharmaceutical ingredient, there are already mechanisms in place available to governments to address them. Just like with finished pharmaceuticals, the waiver would only send a major disincentive for investments in technologies related to COVID-19, without any measurable impact on production. 

HP-Watch: You spoke about the COVAX Manufacturing Task Force, in which industry is participating actively. What about the WHO’s new initiative to create an mRNA vaccine hub? 

Cueni: WHO, in my view, should focus on norm-setting functions. When it comes to operational execution, WHO is probably not the best equipped organization. That is one of the reasons you have organizations like the Global Fund, GAVI and CEPI springing up over the last 20 years – all of them have a track record, and the willingness and ability to work with the private sector.  I haven’t really seen this in WHO. 

HP-Watch: Going back again to the text-based negotiations on this IP-waiver one more time – what are your final conclusions? 

Cueni: Basically companies have the responsibility for the quality of their products. You cannot coerce the sharing of what is here in your brain.. Companies really need to have the ability to pick their partners on the basis of checklists, which is really about quality, quality, quality.  It can’t be coercion, either in a pandemic treaty, or in the WTO. 

I think what you could do, in my view, is to get a pretty strong commitment from the Industry to be more engaged in tech transfer. You can have a strong commitment from industry to be constructively engaged in more tech transfer, as such, on mRNA and other [technologies], for the future. The discussion is ongoing right now on regional hubs, with BMGF, CEPI, and others –  and the industry is really interested to engage. 

That I see a little bit in the sense of the Third Way, that Dr Ngozi is talking about now. Because we need to address the bottlenecks now, the capacity expansion, dose-sharing.  But we need to look at what we can do to be better prepared for the future.  That’s where I mentioned the pot, you know, COVAX, being well-funded before the pandemic and not just starting to fundraise during the pandemic.

And the second element is what can we do to make sure there is an increase in bioresearch, an increase in more agile, flexible, ever-warm vaccine facilities in more continents, because that is one of the issues which did lead to vaccine inequity, which we’ve seen now.  But all that has to take place with industry at the table. 

Image Credits: Marco Verch/Flickr, World Health Summit, Lonza.com, AstraZeneca, Novavax, Pfizer.

COVID-19 has spread to rural India where many are dying of COVID-like symptoms. Experts are certain India’s already high official numbers do not reflect the true extent of the spread of the virus.

PUNE: India’s second wave is devastating the country’s rural areas where health infrastructure is rickety and a lack of trained healthcare workers, government support and access to healthcare is likely to worsen the spread of the COVID-19 pandemic.

Health experts believe the number of new COVID-19 cases and deaths are vastly underreported and that strict lockdown regulations and amping up vaccinations will be the key to help curb a possible third wave.

Rabeena Manral, a young mother of two boys who lives in the Champawat region of the picturesque Himalayan state of Uttarakhand, is certain that she was infected with the virus this year, but due to a lack of testing in her village, could not confirm her status. 

While the COVID-19 surge last year left her hilly village of roughly 200 people untouched, this time around there are dozens of known cases and three confirmed COVID deaths so far. 

To get tested Manral will have to hire a private vehicle and travel 15 to 20 km away – a distance too expensive to cover. Public buses are no longer plying as the state is currently under a lockdown to stop the spread of the virus. 

For weeks Indians have been turning to social media with pleas for help and finding help from fellow citizens, instead of the government, as Health Policy Watch reported earlier. Those living in rural areas like Manral are not on Twitter. Even if they were, there is no nearby hospital a sick patient can be taken to in an emergency. 

India has been consistently recording over 3,50,000 new daily cases and over 4,000 deaths for around two weeks now. Experts like Ashish K Jha, dean of the Brown University School of Public Health, believes that both the number of new cases, and the deaths are vastly underreported in India’s vast rural areas. 

Doctors working in rural areas confirm this assumption. Yogesh Jain, a physician and founding member of the Jan Swasthya Sahyog, a health non-profit that runs low-cost health programs in the central Indian state of Chhattisgarh, said that during the first wave of COVID-19 in 2020 he saw only a handful of cases and no deaths in the villages of the state. “It is now 50-50 (urban-rural case spread). There have been several, several deaths. The disease is well spread everywhere.”

Jain worries that the situation will worsen in the coming weeks and that the problem might neither be documented, nor acknowledged.

Indian government has consistently downplayed the toll the pandemic has taken on the country. The government has also pushed the task of procuring the vaccines on to the states, who are now trying desperately to arrange vaccines for their residents and failing.

In rural India people are simply dropping dead without access to tests or treatment. “There was a time most people in my village were sick and had symptoms like fever and cough, including me. None of us got tested,” Manral said speaking over the phone. Some tests were done sometime in April following a death in the village after a wedding party and so Manral knows that dozens are currently positive.

In Rabeena Manral’s rural Himalayan village there are dozens of COVID-19 cases. She suspects she herself might have had the virus but without access to tests there is no sure way to know.

But weddings have continued. Manral says there were a dozen or so in the past month, but now instead of hundreds of attendees only a handful family members are present. 

Jha has consistently communicated that large gatherings like weddings and election rallies are out of the question but Uttarakhand was one of the states that allowed thousands of devotees to gather for Kumbh, a religious event where devotees pray at the banks of the river Ganges that is considered sacred by the Hindus. The event ended up being a super spreader.

In recent days dozens of dead bodies of suspected COVID patients have washed ashore in villages downstream. Petitioners have approached India’s Supreme Court seeking its intervention in the deteriorating health and administrative situation. 

India’s High Positivity Rate

India is reporting a high positivity rate, leading experts to believe that a large number of cases are unreported.

Currently of every five samples tested for COVID in India, one comes back positive. 

The World Health Organization (WHO) recommends that this rate be below 5% for at least two weeks before countries consider easing their restrictions. At 20% test positivity rate, India is likely missing many COVID-19 cases.

Women have been hit particularly hard. Husbands who work as migrant workers outside are back home and without incomes. Anecdotal evidence suggests a rise in cases of domestic violence and stress for the women.  

“The burden on women has increased tremendously,” said Arvind Malik, CEO of Udyogini, an NGO that works with women enterprises across five states in central and northern India. “All these areas we work with are remote. The economy is run by migrant workers. All that has been disrupted. Many households are on the verge of not having food.”

Vaccinations Will be the Key in India

Along with restrictions that many states in India are now resorting to, ramping up vaccinations will be the key, according to experts. In Manral’s village all those above the age of 45 have received vaccinations.

Overall, around 2.5% of Indians are currently fully vaccinated against COVID and a tenth of the population has received at least one dose. If India has to avoid a third wave this number will have to be scaled up quickly. 

As authorities come under fire for not doing enough to pre-empt and handle the second wave, they are pointing out that India’s large size makes vaccinating its roughly 1,391,716,282 population a challenge. India’s health ministry has said that more indigenous vaccines could be available in the market in the coming months, a claim experts in India have called misleading and exaggerated. 

With the situation in urban India dire, those in rural areas are not receiving any media or aid attention this time around, according to Malik. The large digital divide has affected every aspect of life in rural India as children lose learning hours in the absence of mobile and internet connectivity.

Jain points to some urgent measures that need to be taken. “We should stop counting infected people now,” he said, adding that the focus now ought to be on mitigation. “Have a clinical diagnostic criteria. Those who can be managed at home should get high-quality home care and the health workers need to be given adequate protective gear. Those who require hospitalization, the government has to ensure transportation and have a helpline to tell people where to go. Everyone should be able to reach a hospital within one hour.”

Disha Shetty is an independent journalist based in Pune, India

Image Credits: Udyogini, Rabeena Manral.

Researchers have quickly developed an outstanding arsenal of vaccines, treatments and diagnostics to counter COVID-19. But closer global coordination of diverse clinical trials testing the same or similar treatments, extending even to a global platform to pool anonymized patient data, could strengthen and accelerate research findings – especially as emerging variants threaten to unwind gains.

These were among the key points made during a two-day COVID-19 Global Research and Innovation Forum hosted by the World Health Organization (WHO), which brought together two dozen leading figures across academia, civil society, and ministries of health.

There was also growing recognition that equity needs to be built into global health funding –  mainly by redirecting resources to the global south and embedding access provisions into funding agreements.

“The lesson is clear. A collaborative approach to research and innovation is essential to responding to COVID-19 and to the epidemics and pandemics of the future,” said WHO Director-General Dr Tedros Adhanom Ghebreyusus on Thursday. 

“There is a need for us to look at how we organise not just individual pieces of research, but how each individual research initiative or innovation is linked to each other, and how we can drive a coherent strategy for the world,” stressed WHO’s Executive Director of Emergencies Mike Ryan.  

“The issue has not been that science has not delivered,” added WHO’s Chief Scientist Soumya Swaminathan. “We haven’t been able to [work together] as a global community to really achieve the equity that we would have liked to have seen in the availability and access to these absolutely life-saving interventions.”

COVID-19 Research Has Boomed – But More Collaboration Needed

Despite astonishing progress in R&D since the novel coronavirus first emerged – from the development of mRNA vaccines to the use of lifesaving steroids for severe COVID-19 – the findings of many studies remain limited, warned panelists on Thursday. The most common flaws were methodological weaknesses and a lack of comparability, they added.

“There is so much diversity in studies with a lack of standardization across the board that it’s really difficult to reach conclusive evidence for many of the questions that are still outstanding,” said Marion Koopmans from Rotterdam’s Erasmus University Medical Centre Rotterdam, who is a member of the WHO-convened group to investigate the origins of SARS-CoV-2.  

Sylvie Briand, WHO’s Director of Infectious Diseases, explained that coronavirus variants have been particularly difficult to study because a wide range of data from diverse world regions is needed, including genetic sequencing data, epidemiological data, and clinical data. 

All of these data streams are crucial to investigate whether variants are becoming more contagious, virulent, and resistant to existing vaccines, she said. Yet in many regions comprehensive data is scarce and mechanisms to pool all of those streams together are still lacking.

“We need some more new research but particularly we may need different coordination mechanisms because the key challenges that are outstanding really require a multidisciplinary endeavor,” added Briand.

And if existing vaccines turn out to require an update as a result of new variants, that will also require active involvement from the pharmaceutical industry, added Philip Krause from the US FDA’s Office of Vaccines Research and Review. 

“Because vaccination is an international enterprise, you can’t modify vaccines in just a few countries as developers and manufacturers are making vaccines for the world,” he added.

“Some of the companies that hold the critical supplies, reagents and groups, like Illumina, need to contribute and participate,” added Trevor Mundel, President of Global Health at the Bill and Melinda Gates Foundation. 

“We need to be sure that our ability to sequence the virus as it spreads is much better distributed according to where we may anticipate problems [but] so far we haven’t seen at a certain level,” said Mundel.

The Future? A Portfolio of Coordinated Clinical Trials

Going forward, a portfolio of coordinated clinical trials could represent a fruitful strategy that would yield more robust data faster, while also avoiding duplication of research efforts, the panelists suggested.

While such a portfolio has not yet been developed, there are signs that large-scale clinical trials are being increasingly harmonized. Examples including the WHO’s Solidarity Trials to test possible therapeutics, the UK’s Recovery Trials, as well as three large-scale clinical trials investigating antithrombotic treatments  – ATTACC, ACTIV, and REMAP-CAP.

“Something quite remarkable that happened was that three of the large-scale platform trials [anti-thrombotics] were able to collaborate and to agree on common protocols in order to address some of the key questions in the fastest way possible,” emphasized Professor Michael Jacobs, the Clinical Director of Infection at London’s Royal Free Hospital.

“This is an incredibly important achievement for three trials that evolved independently to be able to come together to use common approaches to address key questions as quickly as possible for the benefit of patients.”

Antithrombotics have the potential to broaden the COVID-19 treatment menu, which remains limited to treating severe cases with dexamethasone or through expensive monoclonal antibodies, thus leaving few effective options to treat mild cases, said Jacobs.

Randomisation of Vaccine Distribution

There is also an increasing appetite for a global platform to pool anonymized patient data from large-scale trials. This could shed light on a range of questions about vaccine effectiveness, safety, and dosage regimens in populations after they are approved.

Ideally, those large-scale trials of vaccines following their approval would be randomized to yield more robust results, emphasized Krause, adding that randomization would be ethical in contexts where vaccine supplies are scarce – which seems to be the case across many low- and middle-income countries worldwide.

“You can address important questions by embedding randomised studies within normal vaccine deployment,” said Krause.

“Instead of usual procedures for allocating vaccines, researchers use randomisation to define who and how to vaccinate. And randomization is considered a fair means of allocation, especially when vaccine supplies are limited.”

Importantly, a randomised vaccine distribution strategy would not affect participants nor healthcare personnel as the logistics would be managed by researchers, who would inform vaccinators which participants are eligible for their doses.

“The person who gets vaccinated sees nothing different from what they would otherwise see in registering for a vaccine, and the vaccination personnel doesn’t do anything different from what they would otherwise do if they were administering a vaccine.

“And that’s [randomization of vaccine distribution] a simple thing to do where vaccine supplies are limited. It doesn’t mean that you will get vaccinated while other people don’t get vaccinated.”

Those studies would be particularly useful to understand the impacts of delayed second doses, the efficacy of single doses, and mixing doses, he emphasized. 

“We can use that randomisation to answer very important questions about these vaccines,” explained Krause. Studies could understand the impact of a delayed second dose, the efficacy of a single dose, especially when vaccine supplies are limited.”

But in the long run, a stronger incentive system will need to be developed to encourage such collaborative research efforts, as coordination is easy to recommend, but difficult to implement, warned Jacobs.

Building Access Into Funding Agreements 

Meanwhile, a proposal to integrate explicit access-to-medicines provisions into funding agreements drew widespread support, including from CEPI CEO Richard Hatchett,  Executive Director of Drugs for Neglected Diseases Initiative (DNDi) Bernard Pecoul, the Gates Foundation’s Mundel and the  WHO’s Swaminathan. 

“The great missed opportunity of 2020 is that the funders of vaccine development did not include access provisions in their funding agreements,” said Hatchett. “The major funders could develop and adopt common approaches to achieving equitable access including in their grant and contract provisions.”

“Innovation and access should be combined and should be linked from the start. We do not have to wait until we have innovation to start thinking about access,” added Pecoul.

“Why not have in place clear and transparent terms and conditions in contractual agreements so from the start you include those criteria or incentives to be sure that all knowledge will be shared.”

For that to happen, however, global health funders will have to work together, as most global health initiatives are funded by multiple bodies rather than having one funder from end-to-end.

Tipping Global Health Funding To Global South 

There is also growing recognition that, for equity to be achieved, global health funding will have to be redirected to the global south to leverage untapped research capacity and reduce dependency on rich countries for vaccines, treatments, and diagnostics. 

“There is research capacity available around the globe that has not yet been sufficiently utilized in the pandemic response, particularly in the Global South,” said Dr Tedros.

“Today, the opportunity to carry out research at the highest level is not equally distributed around the world,” said Australian philosopher Peter Singer, who is a professor of bioethics at the University of Princeton. “Talent, without the opportunity to use it, is a shocking waste.”

Of the 9,500 coronavirus-related research projects that are funded to the tune of more than $4 billion, less than 1,000 were funded in the global south, including Asia, Africa, and South America, stressed Charu Kaushic, Chair of the Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R).

“When we track that funding to see where exactly that funding has gone and where most of the dollars are invested, it is unfortunately primarily in the global north. And if you look at the global south, there’s not a lot of investment that has gone in there,” she added.

Image Credits: National Institutes of Health (NIH) , Twitter: @WHO.

Healthcare workers vaccinating at risk patients with the Pfizer-BioNTech COVID-19 vaccine in Lima, Peru.

Delaying the second dose of the Pfizer/BioNTech COVID-19 vaccine by 12 weeks could generate antibody responses in those over the age of 80 more than threefold, found a pre-print study published on Friday.

The study, conducted by the University of Birmingham and Public Health England, is the first to directly compare the immune response derived from the recommended three-week dosing interval with the extended 12-week interval.

Some 175 participants over 80 years of age were included in the study, 99 of whom received the second dose after three weeks and 73 had the second jab at 12 weeks. 

The peak antibody levels were 3.5 times higher in those who waited 12 weeks for their second shot, compared to those who waited three weeks. 

“The enhanced antibody responses seen after an extended interval may help to sustain immunity against COVID-19 over the longer term and further improve the clinical efficacy of this powerful vaccine platform,” said Paul Moss, Professor of Haematology at the University of Birmingham, in a press release. 

The peak T cell immune response, which plays a role in maintaining antibody production, was lower in those with the extended interval, but the responses were comparable between the two groups when measured at the same interval after the first dose. 

In addition, T cell levels rose two weeks following the second dose. Further research is required to understand the different T cell immune responses, said the authors. 

“This research is crucial, particularly in older people, as immune responses to vaccination deteriorate with age. Understanding how to optimise COVID-19 vaccine schedules and maximise immune responses within this age group is vitally important,” said Dr Helen Parry, lead author of the study, in a press release. 

“Individuals need to really complete their second dose when it’s offered to them because it not only provides additional protection but potentially longer lasting protection against COVID-19,” said Dr Gayatri Amirthalingam, Consultant Epidemiologist at Public Health England.

The “extension of interval of the second vaccine dose in older people may potentially reduce the need for subsequent booster vaccines,” said Moss, highlighting the use of the findings to develop global vaccination strategies.

Findings Useful in Optimizing Vaccinations, But Pfizer Vaccine not Available to Many Countries

While the findings are reassuring and could be useful in optimizing vaccination protocols and strategies, the results are specific to the Pfizer vaccine, which is largely not available to many low- and middle-income countries. In addition, in several countries where variants are spreading rapidly, the risk of infection may be higher after only one vaccine dose. 

In the United Kingdom, however, the study findings are supportive of the controversial approach taken by the government in late December to delay the second dose up to 12 weeks.The decision was made amid rising cases in an effort to expand partial immunity to more of the population. 

The study “provides further supportive evidence of the benefits of the UK approach to prioritise the first dose of vaccine,” said Dr Amirthalingam.

Experts Study Link Between COVID-19 Vaccines and Rare Blood Clots

The AstraZeneca vaccine being administered in Catalonia, Spain in mid-February.

In other vaccine news, scientists are investigating the possible connection between the AstraZeneca and Johnson & Johnson COVID-19 vaccines and rare blood clots, which have been reported across numerous countries in recent months. 

Both the AstraZeneca and Johnson & Johnson COVID-19 vaccines have been investigated by regulatory agencies for links to rare blood clots, known as cerebral venous thrombosis (CVT). Several countries, including the United States, the European Union, and South Africa, paused or limited the rollout of both vaccines due to reports of CVT.  

“Understanding the cause is of highest importance for the next-generation vaccines, because [the novel] coronavirus will stay with us and vaccination will likely become seasonal,” Eric van Gorp, Professor of Infectious Diseases at Erasmus University in the Netherlands, told the Wall Street Journal. 

A German research team, led by Andreas Greinacher, a transfusion medicine expert at the University of Greifswald, found that certain proteins and molecules in viral vector vaccines – which the AstraZeneca and J&J vaccines both are – could cause an autoimmune response that leads to blood clots. 

In a peer reviewed study published in the New England Journal of Medicine in April, the researchers proposed naming this type of clotting ‘vaccine-induced immune thrombotic thrombocytopenia’ (VITT).

According to Greinacher, it might be possible to reduce the risk of blood clots by removing proteins and reducing the level of the EDTA preservative in the jabs after the manufacturing process. Data would have to be collected on how this may impact the safety and efficacy of the vaccines. 

Although this is only one possible explanation for the cases of rare blood clotting and experts disagree on the exact mechanism at work, Greinacher is reportedly in communication with AstraZeneca and J&J to conduct more research on the vaccines and VITT.

“We strongly support raising awareness of the signs and symptoms of this very rare event, and we are currently exploring a potential collaboration with Dr. Greinacher,” said a J&J spokesperson. 

Image Credits: Flickr – Province of British Columbia, International Monetary Fund/Ernesto Benavides, Flickr.

WHO Director General Dr Tedros Adhanom Ghebreyusus

Being vaccinated against COVID-19 this week was a “bittersweet” moment, reflecting both a “triumph of science” and a “gross distortion” in vaccine access, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyusus told the body’s media briefing on Friday.

Thanking health workers at the Geneva Emergency Hospital for vaccinating him on Wednesday, Dr Tedros said that his thoughts “were very much with the health workers around the world who have been fighting this pandemic for more than a year” but still could not get protected. 

“At present, only 0.3% of vaccine supply is going to low income countries. Trickle-down vaccination is not an effective strategy for fighting a deadly respiratory virus,” noted Tedros.

He described India’s COVID-19 surge as “hugely concerning”, but added that Nepal, Sri Lanka, Vietnam, Cambodia, Thailand and Egypt, were also dealing with spikes in cases and hospitalisations. 

“Some countries in the Americas still have high numbers of cases and as a region, the Americas accounted for 40% of all COVID-19 cases last week. There are also some spikes in some countries in Africa,” added Tedros.

However, he highlighted three developments that gave him hope. The first was that countries were sharing vaccines with COVAX, following Sweden’s announcement last week to share one million doses with the global vaccine platform. Norway, France and New Zealand have also pledged doses.

The second was “new deals on technology transfer, and sharing of know-how between international manufacturers to scale up vaccine production”, said Tedros.

A new WHO vaccine mRNA manufacturing training facility aims to train and develop more vaccine manufacturing professionals – who could help kickstart new vaccine facilities in LMICs.

Earlier this week, Health Policy Watch reported that WHO has already received some 42 expressions of interest from countries, institutions and biotech partners to create the hub to train professionals in vaccine manufacturing to help to jumpstart manufacturing LMICs.

The 42 expressions of interest from countries, institutions and biotech partners to create the mRNA vaccine technology transfer hub.

In addition, in the past week, COVAX unveiled a three-stage plan to enhance existing vaccine production capacity, developed by its new Supply Chain and Manufacturing Task Force as well as a new “vaccine manufacturing group” to further expand production long-term.   

The third reason for hope, said Tedros,  is the fact that more leaders, including Spanish Prime Minister Pedro Sanchez have called for the lifting of all trade barriers to address the pandemic. This follows last week’s announcement by the US that it supported text-based negotiations on the proposed TRIPS waiver, which has resulted in countries previously opposed to this to reconsider their position, including the European Union and the UK.

India Clamours for Remdesivir Despite WHO Research

WHO Chief Scientist Soumya Swaminathan

 

Amid India’s surge, the country has seen growing demand for the antiviral medicine, remdesivir – resulting in the government banning the export of the medicine or any of its active ingredients.

However, the WHO reiterated that large studies found that remdesivir had no effect on the SARS-CoV2 virus.

WHO Chief Scientist Soumya Swaminathan said that the development of therapeutics had fallen behind vaccine development, but corticosteroids showed the most promise of reducing mortality in severe COVID-19 cases.

On the other hand, the large Solidarity trial that had tested remdesivir had found that it had no impact on mortality when compared with the control group, said Swaminathan.

The Solidarity Trial, which published interim results last October, found that all four treatments evaluated – remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon – had “little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients”.

However, India had already registered remdesivir for emergency use last July and continues to insist on its efficacy despite the WHO’s position. Meanwhile, the drug’s manufacturer, Gilead has been quoted in the Indian media as saying that the WHO research is potentially  “biased”.

Remdesivir is being produced by seven Indian companies and retails at over $37 per 100mg.

Swaminathan said it was important that Indian doctors were aware of the WHO recommendations, but that member states were free to make their own policies.

“Oxygen is probably the most essential and the most life-saving right now of all the drugs and all countries need to be prepared now with the oxygen supplies,” she stressed.

US Mask-Wearing Decision: ‘Very Contextual’

Maria Van Kerkhove, WHO COVID-19 Technical Lead

While wearing masks is part of the WHO’s comprehensive strategy to address the pandemic, this was “very contextual”, said Maria van Kerkhove, the WHO’s COVID-19 Technical Lead, when asked about the decision by the US Centers for Disease Control (CDC) to allow fully vaccinated people to forgo masks outdoors and in many indoor settings.

“Fully vaccinated people can resume activities without wearing a mask or physically distancing, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance,” the CDC announced on Thursday.

“It’s about how much virus is circulating around in the country. It’s about the amount of vaccines and vaccinations that are rolling out, it’s about the variants of interest and the variants of concern that are circulating,” said Van Kerkhove.

“We have to keep all of this in mind when thinking about how to adjust the policies associated with the use of masks, so it is contextual and all of these considerations need to be taken into account.”

While highlighting that Australia and New Zealand had been able to control the pandemic without vaccines, Van Kerkhove also cautioned that there were “uncertainties ahead because of these virus variants”. 

Mike Ryan, WHO’s executive director of health emergencies, added that any country that wanted to reduce or remove mask mandates had to consider both “the intensity of transmission and the level of vaccination coverage”.

Some countries were in a “strange period” of transition, where transmission hasn’t completely ended and people aren’t completely vaccinated. 

“And as long as we can sustain the public health measures, as long as we can keep the distance and as long as we can reduce exposure while we get vaccination levels to the highest level, then countries will be in a much stronger position when they do get to high vaccine coverage levels to start saying to people, you don’t have to wear a mask anymore,” said Ryan.

 

Image Credits: WHO.

The Wuhan Institute of Virology, guarded by police officers during the visit of the WHO team in early February, 2021. Critics say WIV officials did not cough up the laboratory’s secrets.

A group of 18 prominent scientists, primarily based in the United States, have called for further investigations into the origins of the SARS-CoV2 virus, including that it could have been created in the Wuhan Institute of Virology lab, in a letter published on Thursday in the journal Science. 

The letter, organised by David Relman, Professor of Microbiology and Immunology at Stanford University, and Jesse Bloom, virologist at the University of Washington, is seen as giving weight to calls to include all hypotheses about natural and laboratory spillovers.

They believe that previous “theories of accidental release from a lab and zoonotic spillover both remain viable” and were not “given balanced consideration” by an earlier joint WHO-China report.

In the letter, they demand that the two hypotheses “be taken seriously…until we have sufficient data.”

As of Thursday, the COVID-19 pandemic has claimed 3.3 million lives globally, and the scientists point out that: “Knowing how COVID-19 emerged is critical for informing global strategies to mitigate the risk of future outbreak.”

Among the signatories is Ralph Baric, a virologist at the University of North Carolina and one of the world’s leading experts on coronaviruses, who has collaborated with scientists at the Wuhan Institute of Virology, the institution at the center of the lab spillover hypothesis. 

Lack of Sufficient Evidence to Rule Out Lab Leak Hypothesis

The letter echoed the statements made by the US government, the EU, several other countries, and Dr Tedros Adhanom Ghebreyesus, Director General of WHO, who said: “I do not believe that this assessment was extensive enough. Further data and studies will be needed to reach more robust conclusions.”

The scientists said: “A proper investigation should be transparent, objective, data-driven, inclusive of broad expertise, subject to independent oversight, and responsibly managed to minimise the impact of conflicts of interest.”

“Public health agencies and research laboratories alike need to open their records to the public,” the authors stated, pushing for greater scientific rigour. “Investigators should document the veracity and provenance of data from which analyses are conducted and conclusions drawn, so that analyses are reproducible by independent experts.”

Efforts to Depoliticize Origins Investigation – But Topic will be Central to Political Debates at Next WHA

The letter is the first to be published in a scientific journal. Previous letters from other scientists requesting further investigations into the origin of the virus were published in news outlets.

“Our goal in putting out a letter that was signed solely by practising scientists…and published in a scientific journal was to emphasise that this is a scientific question and it needs to be addressed in the same way we address all scientific questions,” Bloom told Seattle Times in an interview. 

“I wanted this to be addressed to my fellow colleagues, the working scientists, and use a venue they respect and see as a place for scientists to talk about science and the importance of science,” Relman told the Wall Street Journal. 

“Our message here is wherever the data takes us, thou shalt go, and only go to the degree that the data allow,” he added.

A separate group of international scientists released three letters in recent months. The latest charted a political and technical way forward, calling for more explicit language in a draft World Health Assembly (WHA) resolution, a broader mandate for the origins investigation team, and an overhaul of the methods and protocols used in the virus origins research.

The appeals for further investigations are growing, coinciding with the upcoming (WHA), set to convene from 24 May to 1 June. The 74th WHA will likely feature contentious debates among member states over how the virus origins investigation should proceed. 

Image Credits: WHO, CNN.

Ursula von der Leyen, President of the European Commission, giving the opening remarks at the civil society consultation ahead of the Global Health Summit.

A draft “Rome Declaration” to be issued at next Friday’s G-20’s Global Health Summit, co-hosted by Italy and the European Commission (21 May), makes a series of 10 sweeping commitments to ensure equitable access to vaccines; expand medicines manufacturing capacity; assure WHO access to sites posing an outbreak risk; and invest in global health systems. 

But the draft manifesto seen by Health Policy Watch, framed as a “statement of principles,” also lacks any concrete targets for COVID vaccine dose-sharing, or medicines and vaccines finance. 

WHO and other global health officials have repeatedly said that COVAX and the other ACT-Accelerator initiatives urgently need some US$18.5 billion from the world’s most industrialised nations to fund purchases of medicines and tests, as well as vaccines. WHO and other global health officials have also begged for more vaccine donations. 

That means that if any such concrete commitments are to be made, they will have to be negotiated up until, and on, the day of the meeting of G-20 leaders. Meanwhile, a placeholder text for “announcements and actions” suggests a mere mention of: “Global dose sharing through COVAX?”  

A weak outcome document would be a major setback to the very immediate concerns around getting needed COVID vaccines and medicines to areas of need in low- and middle-income countries as fast as possible, say observers, with whom the draft declaration was shared.

Key events leading up to the G20 Global Health Summit.

Sidesteps mention of WTO Waiver 

The draft declaration so far also sidesteps mention of another thorny issue – the proposed World Trade Organization (WTO) waiver on intellectual property rights for COVID products, that the United States recently said it would support, in the case of vaccine IP.  

A placeholder text, however, leaves open “{…possible references to ACT-A, WTO activity, WHO, the MPP, C-TAP, and through bilateral arrangements}.” C-TAP is the WHO-sponsored patent pool for COVID technologies – which so far has failed to garner significant support from industry. ACT-A is the still desperately underfunded initiative.

The declaration affirms the importance of supporting developing and least developed countries to “build expertise” and increasing “global, regional, and local manufacturing … and the potential for voluntary and mutually agreed knowledge and technology transfer and licensing partnerships.”

That language, as well, represents code words for encouraging voluntary measures to share COVID-related medicines and vaccines IP and technologies – which pharma voices would find reassuring and access advocates disappointing.

Draft resolution sidesteps mention of the WTO waiver to expand the manufacturing capacity of low- and middle-income countries and improve vaccine equity.

No Pandemic Treaty – Extra Investigative Powers for WHO  

The draft language takes a relatively tough line on the investigation of the origins of SARS-CoV2 and other emerging pathogen threats, saying that countries need to ensure: “international cooperation for WHO-led teams’ access to sites of potential and actual outbreak origin, in full compliance with the IHR and relevant national regulations.”

It stops short, however, of calling for a new Pandemic Treaty, as had been recommended recently by WHO, some two dozen global leaders, and the recent Independent Panel Report for Pandemic Preparedness and Response  – saying rather that countries should “support and enhance the existing international health framework for early warning, preparedness and response, prevention and detection, and recovery capacities.”

Countries also need to invest in stronger “early warning information, surveillance and trigger systems at all geographic levels, as well as laboratory capacity, for human and animal health, “including genomic sequencing capacity…rapid data and sample sharing.”

The declaration also highlights the underlying environmental drivers of pandemics and climate change, calling for a “One Health approach…to address threats emerging at the human-animal-ecosystems interface, and anti-microbial resistance.”

This “should include action to address ecosystem and biodiversity loss, habitat encroachment, illegal wildlife trade and climate change as contributing factors increasing these threats,” the statement adds. 

Fully Funded-Independent WHO 

Finally, the draft Rome declaration also calls for a stronger global health architecture with a “fully funded, independent and effective WHO at its centre”. 

That includes advancing Universal Health Coverage, stronger systems for combatting long-standing infectious diseases like HIV/TB and malaria, as well as “education and promotion of healthy lifestyles in addressing among others non-communicable diseases as factors enhancing resilience.”

That, the declaration acknowledges, requires countries to “invest in the global health workforce, in health systems strengthening to achieve resilient, high quality health systems and public health capacities in all countries, in multilateral mechanisms to facilitate capacity building and the transfer of knowledge, data and expertise, and for dedicated assistance and response capacity building, especially in fragile settings.”

Rome Declaration – Statement of Principles not Actions?

The Rome Declaration is being pitched primarily as a general statement of principles, according to the summit’s advance statement: 

“The Summit is an opportunity for G20 and invited leaders, heads of international and regional organisations, and representatives of global health bodies, to share lessons learned from the COVID-19 pandemic, and develop and endorse a ‘Rome Declaration’ of principles. 

“Principles can be a powerful guide for further multilateral cooperation and joint action to prevent future global health crises, and for a joint commitment to build a healthier, safer, fairer and more sustainable world.”  

Italy, as co-chair of the G20, is hosting the Global Health Summit on 21 May. 

“It will provide a timely opportunity to share the lessons learned during the COVID-19 pandemic. We will discuss how to improve health security, strengthen our health systems and enhance our ability to deal with future crises in a spirit of solidarity,” Italy’s Prime Minister, Mario Draghi, is quoted as saying. 

Mario Draghi, Italy’s Prime Minister, speaking at the G20 Tourism Ministers’ Meeting in early May.

The summit will include G-20 members along with Spain, Singapore and the Netherlands as guests; leaders of WHO and other related UN agencies, as well as global health actors such as Gavi, The Vaccine Alliance, the Global Fund and the Coalition for Epidemic Preparedness Innovations (CEPI), which has been investing in key aspects of COVID vaccine R&D. 

According to the statement, the preparation of the Rome Declaration’s summit principles is supposed to involve civil society consultation and debate. Indeed, a public consultation with key civil society stakeholders was held on 20 April. 

But just a week before the meeting, the draft declaration has not yet been widely circulated among civil society groups.

G20 Global Health Summit, set to commence on the 21 May.

Image Credits: European Commission, European Union, Flickr, Governo Italiano.

americas
COVID vaccination in Brazil

Though more than 114 million people have been vaccinated against COVID-19 in the Americas, the WHO Pan American Health Organization (PAHO) has warned that the pandemic is far from over. 

Last week, the region reported more than 1.2 million new COVID-19 cases and nearly 34,000 COVID related deaths – nearly 40% of all global deaths reported.

“This is a clear sign that transmission is far from being controlled here in the Americas,” said PAHO Regional Director Carissa Etienne at a briefing on Wednesday. 

She noted that while countries such as the United States and Brazil were reporting a reduction in cases, other countries such as Canada, Cuba, and Trinidad and Tobago, are seeing higher rates of infections.  

The WHO’s approval of Chinese Sinopharm vaccine offers ‘fresh confidence’ to countries in the Americas who currently use the vaccine, and ‘brings hope for expanding access to vaccines’ in the region. But Etienne stressed the dire toll the pandemic has taken on health systems – rising hospitalization rates have impacted both oxygen supplies and the health workforce. 

“Until we have enough vaccines to protect everyone, our health systems and the patients that rely on them remain in danger.” 

Countries that have begun their vaccination programmes may also have a ‘false sense of security and safety that things are improving, when in reality this is not the case at all right now’, added PAHO Director of Health Emergencies Ciro Ugarte, citing the lack of oxygen supply and increased transmission of the virus in the region. 

Vaccine Donations Urgently Needed to Supplement COVAX 

Assistant Director of PAHO Jarbas Barbosa

In light of the growing spread of COVID in the region, prompting Latin America and the  Caribbean to be labeled an epicenter of the current pandemic wave, PAHO continues seek out donations from countries that ‘already have vaccines for their own needs’, said Assistant Director of PAHO Jarbas Barbosa.

Such donations, he added, will be used to supplement vaccines offered through COVAX, in addition to the Sinopharm vaccines, which will take time to arrive in the region.  

Barbosa emphasized that in the meantime, vulnerable groups must continue to be prioritized. 

“We need to continue using vaccines in a rational fashion for the most vulnerable groups.” 

Spain has already announced that they will make donations to Latin America and the Caribbean through the WHO co-sponsored global COVAX facility, and negotiations are ongoing with the United States. 

Healthcare Capacity Needs to Expand 

PAHO Regional Director Carissa Etienne

The pandemic also has underlined the need to expand healthcare capacity, scale up oxygen production, and make needed investments in equipment, maintenance, and human resources. 

“Countries are being forced to act quickly to make up for years of underinvestment,” said Etienne. 

Across the Americas, nearly 80% of intensive care units (ICU) are filled with COVID-19 patients, with the numbers ‘even more dire’ in countries such as Chile – with 95% of ICU beds occupied by COVID patients – and Brazil, which has waiting lists for ICU beds. 

Etienne estimates that based on the increasing spread of COVID-19, 20,000 doctors and more than 30,000 nurses will be needed to manage the ICU needs of ‘just half’ of the countries in Latin America and the Caribbean. 

In response, PAHO has deployed 26 emergency medical teams across 23 countries in the Americas to provide specialized care. More than 400 emergency medical teams and alternative medical care sites have been set up to expand hospital capacity.  

Oxygen Supply Challenge in the Americas

Rising hospitalizations rates leads to lack of oxygen for COVID patients

The rise in hospitalizations has triggered an ‘unprecedented oxygen supply challenge throughout the Americas, forcing countries and governments to find urgent solutions to the supply problem. 

While hospitalized COVID patients typically require up to 300,000 liters of oxygen during a 20-day hospital stay, patients in critical care often require double that.

In response, PAHO has donated more than several thousand pulse oximeters and nearly 2000 oxygen concentrators to aid health workers in identifying when a patient needs oxygen, and to ensure that workers are equipped with the supplies to help recovery. PAHO is also working alongside Ministries of Health to ensure the availability of oxygen now and for future emergencies. 

Protecting Health Workers Through Vaccinations 

Healthcare worker in Peru preparing COVID-19 vaccines. Healthcare workers in the Americas have been hard hit by COVID.

Since the start of the pandemic, at the least 1.8 million health workers have become infected with COVID in the Americas – 12% of the estimated regional health workforce – and over 9000 have died, the majority of them women and nurses.  

Etienne urged countries to protect the 8.4 million nurses in the Americas, honoring their work, sacrifice, and contribution in commemoration of International Nurses Day, celebrated 12 May.

“Let’s invest in the nurses and ensure that they have the tools and resources that they need to do their job.” 

Quarterly reports from 18 countries in Latin America and the Caribbean show that 1.5 million health workers are vaccinated, but countries are urged to make the most of limited doses and prioritize health workers first.

Image Credits: Flickr: IMF/ Raphael Alves, PAHO, Flickr: UNICEF Ethiopia/2015/Mersha, Andres Montesinos Malpartida/Flickr.

Faisal Shuaib, Executive Director and CEO of Nigeria’s National Primary Health Care Development Agency

IBADAN – The Nigerian government has decided to move ahead with a second dose of the AstraZeneca vaccine for the nearly 2 million citizens who already received the vaccine – despite advice from Africa CDC and the World Health Organization (WHO), that vaccine-strapped African countries could also choose to administer just one vaccine dose  – so as to reach as many citizens as possible very quickly. 

The decision to shun the Africa CDC and WHO advice comes at a critical moment. On the one hand, cases in Nigeria seem to be plateauing right now. On the other, national and regional officials are eyeing nervously India’s crisis – and ramping up oxygen supplies in the event of a third wave here and imposing a lockdown for the Muslim Eid al-Fitr holiday taking place this week. 

But insofar as the country is planning to shift to the one-shot Johnson & Johnson vaccine, with deliveries, hopefully to begin by September, officials seem prepared to take a calculated risk and finish off the remaining supply of AstraZeneca doses among those who have already received the jab.  

Speaking at a press briefing on Thursday, Dr Faisal Shuaib, Executive Director and CEO of Nigeria’s National Primary Health Care Development Agency (NPHCDA), said the country would much rather ensure the full vaccination(two doses) of those who had already received the first dose of the vaccine as recommended by its manufacturer, AstraZeneca.

This means that the four million doses Nigeria received via the COVAX Facility will only reach two million people – half of what it could have reached if health authorities used the available doses to vaccinate up to four million Nigerians as recommended by the WHO and the Africa CDC.

“Nigeria’s presidential steering committee made a strategic choice to utilise our current COVID-19 vaccine supply to administer double doses rather than single doses. This will ensure that every Nigerian who receives a vaccine from our present supply receives their second dose within the recommended time frame.”

Shuaib said that administration of the two doses on time – even to a more limited group of people: “ is very important to ensure the population benefits from the vaccine.” 

A Nigerian health worker receiving a COVID-19 vaccine jab.

In April this year, Health Policy Watch reported that the Africa CDC warned that the administration of the second jab was threatened in many African countries – citing then the case of Rwanda, which had already used up all of its vaccine doses.

The shipment delivery plans of vaccines were disrupted by the government of India’s decision  to direct the Serum Institute of India (SII) to halt the export of vaccine doses as a result of the country’s burgeoning COVID-19 pandemic. 

At that point, Africa CDC recommended that countries vaccinate as many citizens as possible with their initial shipments of doses – without holding back reserves for a second dose. While Dr John Nkengasong, Director of the Africa CDC said implications of the delay in receiving the second vaccine dose was unknown, he assured recipients of the first dose that they already would have acquired some form of immune protection against the virus.

“We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said.

The WHO’s position on maximising vaccinations with available doses is similar to that of Africa CDC. Dr Richard Mihigo, Immunisation and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, said: “African countries, I must say, took the right decision with the limited supply, to use most of their doses as the first dose with the expectation that the second dose will come quite soon.”

To date, 1,748,242 Nigerians, out of a population of 200 million, have been vaccinated with one dose of the AstraZeneca vaccine. But even though the total proportions are small, they still represent 86.9% of the high risk groups of frontline health workers and older people, particularly those with underlying conditions who were targeted first, according to Shuaib. The successful roll out of the COVID-19 vaccine could play a major role “in helping the country to better cope with the pandemic”, he said.

“We have rolled out a digitised registration and immunisation data system. This is the first of its kind in Nigeria. This is to help ensure efficiency and accountability in our initial rollout. We are continuing to optimise the system, and we are seeing its benefits,” Shuaib said.

A percentage share of people who have received at least one dose of a COVID-19 vaccine.

Steady Decline and Plateauing of the COVID Pandemic

After peaking in mid-January at around 1,400 reported cases a day, new COVID-19 infections  in Nigeria have been in a slow decline, plateauing at a few dozen new cases daily in May, with just 38 cases reported on May 10. 

Official data released by the Nigeria Centre for Disease Control (NCDC), show that 165,515 cases of COVID-19 have been confirmed in Nigeria, Africa’s most populous country, with 2,065 deaths. However, recent global estimates have documented how many cases in African countries also go under-reported, escaping  the radar of official data. 

Daily new COVID-19 cases per million people.

Risk of Imcomplete Immunisation “Too High”

Despite the reassuring statistics, Nigeria is not taking any risks, Shuaib told Health Policy Watch.

And incomplete immunisation of highly vulnerable groups that already got the first AstraZeneca vaccine dose, is one such risk that was “too high”, and which the country wants to avoid, he said. 

“What we did in Nigeria was to actually divide the four million doses we got into two compartments. We have around two million doses that we plan to give exactly the same people that have gotten their first doses.” he said.

Moreover, Nigeria had already started administering the second dose of the vaccine to those who have received the first dose – before the latest Africa CDC advance, as well as information about vaccine supplies was available, he said. Continuing one course with the plan will reinforce confidence in the overall vaccination programme, he added:  

“Nigerians have shown incredible interest in receiving the vaccine and cooperating with our health teams to have the system succeed. This is incredibly important because, to move beyond COVID-19, this must be a national effort.” 

Preparing for a Third Wave  

With a case fatality ratio of 1.3%, Shuaib said Nigeria is taking other key  measures to improve its health system’s ability to withstand a third wave of the COVID-19 pandemic, should one occur, and this includes expanding the country’s medical oxygen capacity nationwide. 

In Lagos state, which has been the epicentre of the pandemic in Nigeria, accounting for over 35% of all confirmed cases in the country, Shuaib announced up to four oxygen producing plants are being established to enable the country to combat oxygen shortage.

“There’s no doubt about the fact that we need to ramp up our capacity to provide oxygen, because this is something that can happen anytime, oxygen shortage can happen in any country,” he said.

Also speaking at Thursday’s briefing, hosted by the WHO’s African Regional Office, Nkengasong said the Africa CDC is supporting African countries to expand their oxygen supply chain as a key component of the continent’s response strategy to combating COVID-19 and ensuring that African countries do not get complacent with their disease response.

“This is part of the adaptive strategy which calls for enhanced prevention, enhanced monitoring and enhanced treatment—especially making sure that oxygen is available, and that we do not get complacent with where we are with the pandemic. We saw what happened in India,” he added.

While Shuaib was addressing journalists from his office in Nigeria’s capital city of Abuja, a development of public health importance was ongoing across the country – which was observing a public holiday to commemorate Eid al-Fitr at the end of the Ramadan fast—in a country that is home to the world’s fifth-largest Muslim population – and where Muslim’s make up about one-half of Nigeria’s population.

To avert a possible surge in the number of COVID-19 cases as a result of the Ramadan festivities, the Nigerian government reintroduced nationwide curfews and other movement and public gathering restriction measures this week. 

“We shall maintain restrictions on mass gatherings in and outside work settings with a maximum number of 50 people in any enclosed space, approved gatherings must be held, maintaining physical distancing and other non-pharmaceutical measures,” said Nigeria’s National COVID-19 Incident Manager, Mukhtar Mohammed.