Vials of Johnson & Johnson’s vaccine that was granted emergency use authorization by the FDA on Saturday.

The United States Food and Drug Administration (FDA) granted Johnson & Johnson’s single-dose COVID-19 vaccine emergency use authorization on Saturday, clearing the way for it to become the third COVID vaccine to be administered in the US starting on Tuesday. 

Initial supplies to the US market, however, are likely to be limited for at least the first few weeks due to issues with scaling up manufacturing, officials warned. Meanwhile, there was no clear timetable yet for the provision of the vaccine to the WHO co-sponsored global COVAX facility – which is supposed to receive some 500 million doses. 

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Janet Woodcock, Acting FDA Commissioner, in a press release.

The vaccine was 66% effective overall in preventing moderate to severe infection and 85% effective in preventing severe disease, according to results of Phase 3 trials with 43,783 participants. 

The level of protection against moderate to severe infection provided by the vaccine varied by country and region, with the US recording an efficacy rate of 72%, Latin America reporting 66%, and South Africa recording 57%. This suggests that the vaccine is slightly less effective against the B.1.351 variant, first identified in South Africa. 

Although lower than the 90%-plus efficacy ratings of the Moderna and Pfizer/BioNTech vaccines, as well as trial results obtained by Novavax and AstraZeneca, J&J’s vaccine offers dosing and handling advantages. 

Early Supply of J&J Vaccine Could Be Scarce

US hospitals are expecting to begin receiving the initial 3.9 million doses of the J&J vaccine on Tuesday, but officials from the Biden administration have warned that the supply could be uneven for the next few weeks. 

J&J signed a US$1 billion agreement with the US for 100 million doses, with the option to purchase an additional 200 million doses. The company is planning to deliver 16 million doses to US markets by the end of March and 100 million doses during the first half of 2021. 

Initially, the plan had been to deliver 37 million doses by the end of March, but the pharma company is facing difficulties scaling up its production, specifically at its manufacturing plant in Baltimore. The first round of 3.9 million doses are being delivered from the company’s factory in the Netherlands. The rest will be produced in the US. 

“We do not expect any additional deliveries next week and we expect deliveries to be uneven during the weeks of March,” said a senior Biden administration official at a press briefing on Sunday. “We’re getting doses out the door as soon as they’re available to ensure vaccines get into the arms as quickly as possible.” 

J&J Vaccine Under Review By EMA and WHO

The European Union has a purchase agreement with J&J, securing 200 million doses, with the option to order another 200 million. 

“We stand ready to begin distributing our vaccine within the European Union in the second quarter of 2021,” said Stoffels, Chief Scientific Officer of J&J, in a statement. 

Meanwhile, much to the dismay of medicines advocates, the promised distribution of J&J vaccines to the global COVAX facility may start even later.  J&J and GAVI, The Global Vaccine Alliance, recently announced an agreement to supply some 500 million doses of the vaccine to the global COVAX facility by 2022. 

“Johnson & Johnson is ready to join the fight on the ground against COVID-19 and eager to help bring this pandemic to an end – not just in the United States, but throughout the world,” said Alex Gorsky, CEO of J&J, in a statement. 

But it remains unclear how soon rollout of the vaccine through COVAX might begin,  particularly in light of the demands in the United States and Europe. And medicines advocates have already complained that poorer countries risk being pushed to the back of the bus in terms of getting access to a vaccine that is much easier for many countries to manage.  J&J’s modest temperature requirements, one-shot regimen, and demonstrated efficacy against the B.1351 variant that is spreading across southern Africa have all made it an attractive candidate to LMICs. 

J&J submitted applications in mid-February to the European Medicines Agency (EMA) for a “conditional marketing authorization” and to the WHO for an emergency use listing (EUL) – which would clear the way for distribution through COVAX. The EMA plans to meet in mid March to issue a decision.

Benefits of J&J Vaccine

The J&J vaccine only requires a single dose and can be stored for up to three months at standard refrigeration temperatures (2 to 8°C) and transported using existing cold chain technologies and standard vaccine distribution channels.

In contrast, the Moderna vaccine can only be stored at refrigeration temperatures for 30 days and Pfizer’s vaccine can be stored for two weeks. If the vaccines need to be stored longer, they have to be kept between -80ºC to -60ºC for Pfizer’s vaccine and between -25°C and -15°C for Moderna’s. 

Johnson & Johnson will ship the vaccine using existing cold chain technologies because the temperature requirements are not as strict as for Pfizer’s and Moderna’s vaccines.

J&J’s vaccine uses a more widely tested method than the Pfizer and Moderna mRNA vaccines. It uses an adenovirus to provide the cells with the genetic material to make the “spike” protein of SARS-CoV2. This triggers an immune response against the virus.

“We believe Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, Chief Scientific Officer of J&J, in a press release. “A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”

Following the FDA’s decision, the US Centers for Disease Control and Prevention (CDC) endorsed the J&J vaccine for use in people aged 18 and older, including the vaccine in the national immunisation program. 

“This vaccine is also another important tool in our toolbox to equitably vaccinate as many people as possible, as quickly as possible,” said Rochelle P. Walensky, CDC Director, in a statement released on Sunday. 

“Having different types of vaccines available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers,” Walensky added.

Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, described the three vaccines as “highly efficacious in many ways, including, importantly, preventing severe or critical disease” in an interview with CBS News on Sunday. 

“People should take the one that’s most available to them,” said Fauci in an interview with NBC News. “If you go to a place and you have J&J and that’s the one that’s available, I would take it. I personally would do the same thing. I think people need to get vaccinated as quickly and expeditiously as possible.”

In a video release by the White House on Monday, Dr. Fauci explained the method used by the vaccine and attempted to settle fears that the J&J vaccine is less effective than the other COVID-19 vaccines available.

South Africa Removes ‘Remaining Restrictions on Economic Activity’

With COVID-19 cases – and its economy – in decline, South Africa has moved to a more relaxed COVID Alert Level 1 from Monday in the hope that this will stimulate economic activity.

South African President Cyril Ramaphosa made the announcement on national television on Sunday night but stressed that the mandatory wearing of masks in public was even more important as the country opens up.

The country’s curfew is now between midnight and 4am, alcohol sales are permitted over weekends and indoor gatherings of up to 100 people and outdoor gatherings of up to 250 people will be allowed, depending on the size of the venue. Five airports have been opened for international flights, although 33 land border posts will remain closed.

Night clubs and night vigils are still not allowed.

“The return to alert level 1 means that most of the remaining restrictions on economic activity have been removed. We expect this to lead to higher consumption spending, bolstered by the steady recovery in employment,” said Ramaphosa.

By Sunday,  67,000 health workers had been vaccinated with the Johnson & Johnson vaccine in the 10 days since the vaccine had landed in the country. A new batch of 80,000 J&J vaccines arrived in the country on Saturday. 

Ramaphosa said that the number of vaccination sites “will increase from 17 to 49 sites next week.  Of these, 32 will be in public hospitals, and 17 in private hospitals”. 

Ramaphosa also reported that a further 11million J&J vaccines had been secured along with 20 million Pfizer vaccine doses with delivery expected in the second quarter, as the country rushes to vaccinate health workers, frontline workers and the elderly before the southern hemisphere winter and an anticipated third wave of the pandemic.

South Africa recorded around 10,000 new COVID-19 cases in the past week, a quarter of the case load it recorded a month ago.

Image Credits: Johnson & Johnson, NBC News.

Angela Merkel, Chancellor of Germany, at the European Council’s virtual meeting on Thursday.

Leaders of the 27 European Union member states are moving closer to a consensus on an EU-wide system of vaccine certificates for travel between countries in the bloc. Within three months a system will be introduced, EU officials announced on Thursday, the first day of the two-day virtual summit of the European Council.

Several EU member states that rely heavily on tourism believe that a system of digital vaccine passports or certificates could revitalize air travel and ease the pressure on economies. Many, including Greece, Spain and Italy, are urging other countries to support a common European approach.

“Of course more work needs to be done on digitalization and on cooperation with the World Health Organization, but we felt tonight more and more convergence among us about this important topic,” said Charles Michel, President of the European Council, at a press conference on Thursday. “The European Council will resolve this matter.”

WHO has been reluctant to move forward on creating an international framework for vaccine passports so far, until it becomes clear that vaccination inhibits COVID-19 transmission and vaccines become more available globally – beyond the high-income countries that currently dominate in the number of doses administered. 

WHO officials have made clear, however, that requiring proof of vaccination could be a good idea in the future – and based on an existing clause allowing for countries to demand proof of yellow fever vaccination – embedded in the WHO International Health Regulations. 

Hesitancy From Some EU Leaders Won’t Stop Plans To Establish An EU-Wide System

The leaders of France, Germany, and Belgium have, however, expressed concerns that more evidence on vaccines inhibiting SARS-CoV2 transmission needs to be amassed before such a system is put in place. 

“First, it must actually be clearly resolved that vaccinated people are no longer infectious,” Angela Merkel, Chancellor of Germany, told the Frankfurter Allgemeine Zeitung. 

However, “we all agree that we need [a digital vaccination certificate],” Merkel said at a press conference Thursday following the virtual meeting. 

Angela Merkel, Chancellor of Germany, at a press conference following the meeting of the European Coucil on Thursday.

Despite concerns about the current low level of vaccinations, particularly in Germany where people have been hesitat about accepting the Oxford/AstraZeneca jab, Merkel announced that the EU member states will have developed digital vaccine certificates and the technical framework required for their introduction within three months.

“That will make travel within the European Union possible by having more information,” and could open up the opportunity for third-country nationals to enter the EU, said Merkel. 

COVID-19 tests could also be part of the new system, she added.

Both political and scientific questions remain to be answered, said Ursula von der Leyen, President of the European Commission, at a press conference on Thursday. The issue of what the certificates will be used for will ultimately be decided upon at the national level.

“But at the EU level, I believe we should use them to ensure the functioning of the single market,” Von der Leyen said. 

The content of the certificates will be uniform and will contain minimal medical information. Beyond providing proof of vaccination and specifying which vaccine was administered, the  system would also allow for the certification of immunity from a previous COVID-19 infection, or a negative PCR test.

The certificates will provide individuals with a unique identifier – similar to an IBAN code. 

Each country will need to integrate this into their health systems and the European Commission will provide a “gateway for interoperability” between nations, said Von der Leyen. 

“Member states will need to move fast with the implementation if we want such a green certificate to be in place by summer,” said Von der Leyen. “Beyond bringing on the principles and the technology, they will have to ensure a quick and complete rollout in their national health systems and in their border systems.”

Ursula von der Leyen, President of the European Commission, at a press conference on Thursday.
Some European Countries and Others Already Moving Ahead with Systems 

Some EU countries already have created systems or have advanced plans for digital systems that document individuals’ vaccination status, both for the purposes of travel as well as to facilitate entrance to crowded venues or attendance of large in-person events. Many others are likely to move forward even without an EU-wide system – such as Denmark, Greece, Iceland, Hungary, and Poland.

The African Union, in partnership with the African Centers for Disease Control and Prevention (CDC), is developing a “My COVID Pass” tool to verify vaccine certificates, COVID test records and other documents, to facilitate travel across Africa. 

Thailand plans to ease restrictions for vaccinated individuals and shorten the mandatory quarantine from two weeks to three days. Lebanon is reportedly allowing those who have received the COVID-19 vaccine to be exempt from quarantine if they also take a PCR test upon arrival. 

Bahrain incorporated vaccine certificates into its “BeAware” contact tracing app, allowing authorities to scan a QR code linking to the national vaccine register.

Israel’s  “green pass” programme was launched last week –  and is intended to provide access to gyms, theatres, hotels, concerts and synagogues. Israel has also created bilateral agreements with Greece and Cyprus – and is in talks with Seychelles and Romania to establish a similar agreement – to permit the free flow of vaccinated travellers back and forth. 

However, at the country’s Ben Gurion Airport, current reality is almost the diametric opposite of any “green passport” vision. International flights have all but halted with thousands of Israelis left stranded overseas – and those wishing to return forced to submit requests to a “Exceptions” Committee – which critics say is politically stacked. The travel bottleneck has led to widespread allegations of corruption and bias in the issuing of the precious “exceptions” permits largely for ultra-Orthodox travelers and politically well-connected individvuals. And this is happening just week’s before a national election.  More fundamentally, COVID test forgeries and inconsistent quarantine enforcement also plague the system – with bureaucrats so far unable to come up with solutions for either.

Israel’s vaccination “Green Pass” that can be used to access in-person events and gatherings.
Experts Raise Scientific & Technical Questions About Vaccine Passport Plans

The experiences illustrate just a few of the technical, scientific, and ethical dilemmas yet to be faced from a region-wide or international system of vaccine certifications. 

Others include questions such as: Will two doses of the vaccine be needed? For how long will immunity – and thus the passport – be recognized?   And which vaccines would qualify? For instance, would individuals who have been vaccinated by China’s Sinopharm and Sinovac vaccines or Russia’s Sputnik V vaccine –  that have not been approved by an internationally recognized regulatory agency or the WHO have problems travelling? 

Along with those issues, experts wonder about the ability of vaccines to actually halt the transmissibility of SARS-CoV2, and the effectiveness of vaccines against the virus variants that continue to evolve and mutate, are yet to be faced.  

“If we can still get infected but remain asymptomatic, a vaccine passport may make the situation worse if it is not supported by testing and social distancing, so it may not be a real way out,” Gian Luca Burci, Professor of International Law at the Graduate Institute of International and Development Studies, told Health Policy Watch. 

“The science doesn’t support COVID Passports b/c vaccines can’t guarantee immunity,” wrote Lawrence Gostin, Professor of Global Health Law at Georgetown University, on Twitter. “Vaccines are really good, but passports are premature.”

Validation of Vaccine Status – Requires Cooperation Across Complex Systems

Beyond the scientific considerations, there are also worries about validating the certificates, preventing forgery and hacking, protecting medical privacy and assuring digital data security.

“The ability to identify an individual and validate vaccination status requires international cooperation, orchestration across complex systems and widespread adoption of open interoperability standards to support secure data access or exchange,” said a WHO statement released in early February. 

While a WHO standard does exist for providing proof of vaccination for international travellers, with the requirement of vaccination against yellow fever for entry into countries where yellow fever is endemic, implementing such a system for SARS-CoV2 would bring countless more considerations. 

International Certificate of Vaccination or Prophylaxis (ICVP) booklet. Yellow fever is the only disease in the International Health Regulations (2005) for which proof of vaccination may be required for entry to a country.

“Disease passports have rarely been tried. The only parallel is @WHO’s Yellow Fever certificates. That program is small & doesn’t face near[ly] the same logistical, scientific, legal & ethical hurdles of #COVIDVaccine Passports,” Gostin tweeted. “COVID Passports are tempting, but too many hard problems.”

Others say that the bigger challenge may very well be how to use vaccine passports domestically – outside of the travel industry.

“Being certified for being vaccinated is not a new or recent issue. If you want to travel internationally, it is expected that you have been vaccinated against some of the major diseases,” Dr. Sridhar Venkatapuram, Senior Lecturer in Global Health and Philosophy at King’s College London, told Health Policy Watch. “This seems to be like that for international travel during this pandemic.” 

“The difficult and new thing is that vaccination is not just for travel, but to carry on with daily activities like work, socializing, sports et cetera,” said Venkatapuram. “You can’t create benefits to being vaccinated if you can’t assure everyone who wants a vaccine has access.” 

Human Rights and Ethical Questions

In line with those challenges, the prospects that a system of vaccine certificates could create new forms of discrimination, exacerbate existing inequality, and even amplifying vaccine hesitancy are another source of expert concern. 

The use of vaccine passports could “create a two-speed society with potential for marginalization and demonization of the non-vaccinated,” said Burci. 

“Another criticism is that it would make vaccination practically compulsory, which is an extremely sensitive point given the widespread vaccine hesitancy and [may] even generate pushback against vaccination programmes,” Burci added. 

COVID vaccine hesitancy is widespread in many European countries, with Italy (53.7%), Poland (56.3%), and France (58.9%) having among the lowest rates of vaccine acceptance, found a study reviewing the results from 31 peer-reviewed studies on COVID-19 vaccine acceptance. Ecuador, Malaysia, Indonesia and China had the highest rates of vaccine acceptance, among members of the public, the study found – while the lowest was in Kuwait, at only 23.6%. Meanwhile, in the Democratic Republic of Congo, another study found that less than 30% of health care workers would readily take up a COVID vaccine. 

Such low rates of vaccine acceptance also could pose a challenge for the widespread implementation of vaccine certificate programmes. 

“There is distrust of vaccines and pharma companies. So certifications will make people choose between their beliefs and distrust vs the benefits of getting vaccines,” said Venkatapuram.

In addition, vaccine certificates could lead to the gathering of “data that places marginalized and stigmatized people at risk, and could create a two-tier system that jeopardizes all our human right to work and to freedom of movement,” Dr. Sara Meg Davis, Senior Researcher at the Global Health Center at the Graduate Institute of International and Development Studies, told Health Policy Watch. 

National and Global Vaccine Equity

But one of the biggest barriers to the international rollout of a vaccine passport may be the small and disproportionate numbers of people to be vaccinated so far. Only about 8% of the adult population in Europe have received jabs: 

“Do we want to confer even more privilege on people who have so much privilege? Do we want to deny people a normal life if they can’t access vaccines?” Gostin tweeted. 

Beyond national equity, global equity is another concern, with vaccination campaigns in low- and middle-income countries only beginning recently and the first COVAX delivery of vaccines taking place on Wednesday. 

“Would we prevent travel & other joys of life primarily to rich country residents, when poorer nations can’t afford vaccines – especially when rich states hoard scarce vaccines,” Gostin tweeted. 

“One can also imagine that given extremely limited quantities of vaccines, if you add further benefits to getting vaccines, then they become even more valuable and people may start to distribute them even more unfairly or unjustly,” Venkatapuram said. 

“Despite the problems, there are policy makers and others who are interested in the big picture…The suffering of disadvantages of the few will be seen as acceptable, or will be ironed out as time goes on,” said Venkatapuram. 

Under Pressure from Travel Industry 

Whatever the the issues may be, EU politicians are also under pressure to act from the airline and travel industry. Ahead of the European Council meeting, the International Air Transport Association (IATA), a trade association representing 290 airlines globally, had urged EU leaders to implement a standardised travel solution. 

The IATA has already issued its own proposal for  a digital travel pass to verify and store details of travellers’ vaccination status and COVID-19 tests, sharing the results with government authorities before entry into the country. 

An overview of the IATA Travel Pass system presented at a media briefing this week.

According to Venkatapuram, it would be technically feasible for the EU to establish a vaccine certificate system within three months, as announced by EU officials on Thursday. 

“Policies can be made quite quickly…Different countries, or groups of countries may implement them. Like the EU,” said Venkatapuram. “The airline and travel industry is likely putting a lot of pressure on governments and summer is when people will want to travel. So yes, a policy could be put in place.” 

“The policy is easy to draft and enact. [Setting up] the actual infrastructure is a different story,” he added.

Image Credits: Twitter – EU Council Press, Press Office of the Federal Government, Deutsche Welle, Twitter, WHO, IATA.

COVID-19 vaccine administered in mid January at the Jacob K. Javits Center in New York City, which has been converted into a vaccination site.

A new COVID-19 virus variant recently detected in New York is “surging alarmingly,” according to the authors of two new pre-print studies by two teams of US researchers, from Columbia University and the California Institute of Technology. 

Even worse, the new variant, dubbed B.1.526, shares some key mutations in its “spike” protein structure with several other major variants of concern – which may enhance the SARS-CoV2 virus’ ability to evade the immune system and reduce vaccine efficacy.

The studies also predict that the variant is already on its way to becoming the predominant viral variant in New York and in the broader Northeast region of the United States. 

The most recent study – published by the Columbia University team on Thursday – which tested 1,142 samples from patients at the University’s Irving Medical Center, found that those infected with the new variant were on average six years older – and more frequently hospitalized than those infected with the original strain of SARS-CoV2. 

The B.1.526 variant first emerged in November 2020 and a steady increase in the detection rate was noted in the study – with an “alarming rise” of 12.3% in the past two weeks.

Mutations Can Give Variants ‘Evolutionary Fitness Advantage’

“As mutations develop, one of those variants may have an evolutionary fitness advantage allowing it to predominate over its ancestral virus and outcompete other variants,” Stephen Morse, Professor of Epidemiology at the Mailman School of Public Health at Columbia University, told Health Policy Watch.

Notably, the new variant identified in New York contains a key mutation in its spike protein, called the E484K mutation, which is also present in the B.1.1.7 and B1.351 variants, first detected in the United Kingdom and South Africa respectively. 

This mutation has been linked to reduced activity of neutralizing antibodies; studies have thus reported lower protective efficacy of vaccines against the variants with the E484K mutation. 

E484K has emerged in at least 59 lineages of SARS-CoV2, which is evident of convergent evolution – meaning it appeared in variants that evolved independently from each other. This may signal that the mutation is advantageous for the virus. 

According to the Columbia researchers, the B.1.526 variant “could threaten the efficacy of current antibody therapies and vaccines.”

“We find the rate of detection of this new variant is going up over the past few weeks. A concern is that it might be beginning to overtake other strains, just like the UK and South African variant,” David Ho, head of the Columbia University study, told CNN. 

“However, we don’t have enough data to firm up this point now,” he added.

Another Worrying Mutation Detected By Researchers

A separate pre-print study, led by researchers at the California Institute of Technology and published on Tuesday, used a variant database to detect the same emerging B.1.526 virus variant. The study found that as of February, the variant accounted for 25% of the COVID-19 genomes sequences in the state of New York. 

Among the other mutations identified in this B.1.526 variant, the CIT researchers detected another, the S477N mutation, which occurs near the binding site of multiple antibodies and has been associated with increased viral infectivity in previous virus lineages. 

“Given the involvement of E484K or S477N, combined with the fact that the New York region has a lot of standing immunity from the spring wave, this is definitely one to watch,” Kristian Andersen, a virologist at the Scripps Research Institute in San Diego, told the New York Times. 

Basic Public Health Measures Critical To Curb Variant Evolution 

“As long as the virus continues to circulate, variants will continue to emerge, and we don’t know what future variants may do,” said Morse. “We can reduce this risk by preventing viral transmission.”

This can be done by maintaining compliance with public health measures – masks, distancing, ventilation and hand hygiene – “at very least until everyone in the world is effectively vaccinated,” Morse said. 

Several experts, including the researchers involved with the Columbia University study, agree that systematic national and global genomic surveillance is needed to detect the variants in a more coordinated and consistent manner.

The UK, where the B.1.1.7 variant is widespread, has a program to sequence 10% of its positive SARS-CoV2 samples, which has assisted with the tracking of the variant. The United States, by contrast, is sequencing less than 1% of samples.

“There are probably far more variants already out there than we know about,” said Morse. “Luckily for us, they haven’t taken over the world yet, but we really do need systematic and meaningful global genomic surveillance.” 

Image Credits: Flickr – New York National Guard, Flickr – Metropolitan Transport Authority.

Mariângela Simão WHO Assistant Director-General on access to medicines

WHO Director General Dr Tedros Adhanom Gheyebresus on Friday issued his strongest call to date for a waiver on intellectual property related to COVID vaccines, medicines and other health products – which is due to be considered next week by the World Trade Organization’s General Council.

While welcoming a new UN Security Council resolution also approved on Friday, which calls for broader access to COVID vaccines in conflict zones and poor countries, Dr Tedros stressed that the UN resolution needed to be accompanied by concrete global actions of the kind that the WTO was positioned to take – by relaxing rules that restrict the generic manufacture and trade in patented COVID vaccines and health products. 

“I’m glad the UN Security Council has voted in favour of vaccine equity. And at the same time, if we’re going to take practical solutions, then the waiver of intellectual property should be taken seriously,” Tedros told the media at the body’s bi-weekly COVID-19 briefing.

“Voting for vaccine equity is important and we appreciate that. But concrete steps should be taken to waive intellectual property to increase production, increase coverage of immunisation and get rid of this virus as soon as possible.”

Referring to joint South African/India proposed TRIPS [Trade-Related aspects of Intellectual Property Rights] waiver to be discussed at the WTO, Tedros said that the pandemic was a “once-in-100-years occurrence”, so if the waiver “can’t be used now, when will it be used?”

The UN Security Council resolution, which was passed unanimously, calls for “the strengthening of national and multilateral approaches and international cooperation.. to facilitate equitable and affordable access to Covid-19 vaccines in armed conflict situations, post-conflict situations and complex humanitarian emergencies.”

It also calls on developed economies to donate vaccines to low- and middle-income countries and other countries in need.

Voluntary Licenses Could Also Be Tool For Increasing Manufacturing Capacity & Tech Transfer

WHO special adviser Bruce Aylward stressed that pharma should also issue more ‘voluntary licenses’ to firms in other countries for the generic manufacture of life-saving vaccines as a means of increasing vaccine manufacturing capacity and ease supplies. .

Mariângela Simão, WHO’s Assistant Director-General for Access to Medicines & Health Products, added that the WHO-managed COVID Technology Access Pool (C-TAP) offers a way to “share technology and issue voluntary licenses”.  However, so far there have been few, if any, industry takers in the COVID patent pooling plan. 

As a result, the WHO is “very interested in the outcomes ” of the upcoming WTO discussions, said Simão, saying: “Intellectual property is always a very sensitive topic in anything that’s related to access to medicines… Countries are looking for alternatives to increase production capacity and of course, this includes how to manage the intellectual property rights.

“We welcome any movement from countries to decrease and address current barriers to access as well as barriers to access that could be seen mid- and long-term. So this is quite an important discussion.”

Nigeria expects COVAX Vaccines Next Week

Also addressing the press conference were Chikwe Ihekweazu, Director General of the Nigeria Centre for Disease Control (NCDC) and Walter Kazadi Mulombo, WHO Representative in Nigeria

Chikwe Ihekweazu, Director General of the Nigeria Centre for Disease Control

Nigeria, which has a population of over 200 million, has secured close to 14 million doses of AstraZeneca vaccine through COVAX, and expects 4 million of these doses to be delivered next week, according to Mulombo.

Ihekweazu said that Nigeria had chosen not to do any bilateral deals with pharma suppliers, but rather to work only in a multilateral fashion through COVAX and the African Union.

“We will prioritise our health care workers, absolutely first,” said Ihekweazu. “We’re making some very hard decisions. I think at the end of the day, the key thing is we all recognise that we can only impact on transmission and reduce the burden in our hospitals if we target the right people, initially at the right pace, and at the right distribution.”

“Everything will come into play, not only the priority population groups but geography as well.  We have a very uneven outbreak in Nigeria. Lagos State, for instance, has 40% of all the cases in Nigeria, so it wouldn’t be a surprise if they are prioritised to a certain extent. But at the same time, we need to get some vaccines to every state in Nigeria. It’s a big country and a complex country, a lot of detailed planning is going into ensuring that the vaccines get to the right people as quickly as possible, so that we can get the outbreak under control.”

 

Italy launched its COVID-19 vaccine drive on Sunday, 27 December, 2020.  Two months later vaccines are only just being delivered to Africa.  Access groups say patent restrictions will constrain supplies and hamper rollouts in low- and middle-income countries throughout 2021.

Over 400 US organisations and 115 Members of the European Parliament declared their support this week for a waiver on intellectual property rights for COVID-19 products, due to be discussed by the World Trade Organisation (WTO) General Council.

Even so, WTO insiders said that consensus was more likely to build around a “third way” approach for voluntarily relaxing patent rights advocated by new WTO Director General Ngozi Okonjo-Iweala – in light of stiff opposition from other countries in Europe and Asia to the formal waiver plan. 

Informed observers also predicted that as a first step, the WTO was more likely to approve a much softer proposal by the “Ottawa Group” of 13 developed and emerging economies calling upon countries to voluntarily relax export restrictions and tariffs on key COVID-19 health products. 

At a high profile media briefing on Friday in Washington DC, US consumer, faith, health, development, labour, human rights, and other civil society groups urged the White House to reverse the Trump administration’s opposition to an emergency COVID-19 waiver of World Trade Organization (WTO) intellectual property rules so that more generic supplies of vaccines, treatments, and diagnostic tests can be produced in as many places as possible as quickly as possible. 

“The pandemic cannot be stopped anywhere unless vaccines, tests, and treatments are available everywhere so variants that evade current vaccines do not develop,” said the group in its appeal. 

Congresswoman Jan Schakowsky said she and 29 other congress members had signed a letter alongside 400 faith-based, labour and human rights urging US President Joe Biden to support the waiver.

“We have vaccine apartheid. Pharmaceutical companies and some rich countries are standing in the way of poorer countries getting access to vaccines,” said Schakowsky, a Democrat from Illinois and chair of the Consumer Protection and Commerce Subcommittee.

Sara Nelson, head of the US Association of Flight Attendants

Sara Nelson, head of the Association of Flight Attendants, told the media briefing that her members support the waiver because they “know first hand the impact of the pandemic on our health and our livelihoods”.

“I get choked up to think that some people might only get access to vaccines in 2024,” said a tearful Nelson. “I can’t imagine this going on until 2024, and the threat this poses to our livelihoods, lives and jobs. People must always be before profit.” 

Meanwhile,  a cross-party group of 115 Members of the European Parliament (MEPs)  also issued a declaration urging the European Commission and European Council to drop their opposition to the TRIPS waiver.

‘Third Way’ Approach More Likely To Gain Acceptance Than TRIPS Waiver  
Ngozi Okonjo-Iweala, new WTO Director General, at a press conference after her election, speaks about a “Third Way” to expand access to vaccines..

The waiver on certain Trade-Related aspects of Intellectual Property Rights (TRIPS) being championed by South Africa and India, would remove IP barriers on COVID-related medicines, vaccines and other health products. The TRIPS Council has been unable to reach consensus on the waiver and is expected to submit an oral report to the General Council.

Access groups have championed the waiver proposal, saying that would enable greater access to affordable COVID-19 health technologies, including vaccines, in particular for developing and middle-income countries. It is supported by the African Union and most of Latin America.

Geneva trade and diplomatic sources have said, however, that it is extremely doubtful that the WTO General Council would actually act, at least in this session, to approve such an initiative. 

There has been staunch opposition from the United States, United Kingdom, and other G-7 countries to the waiver measure, which opponents say would harm intellectual property rights, and thereby dampen pharma R&D investments. 

New WTO Director General Dr Ngozi Okonjo-Iweala, elected just last week, has talked about a “third way” to break the deadlock between rich countries and poorer ones over the issue – focusing on the issuance of more voluntary licenses by pharma companies to low- and middle-income countries for generic manufacture of their patented products. 

Ottawa Group’s Trade & Health Draft Initiative Could Get Support  

As a more likely initial WTO gesture on the pandemic, the General Council could next week approve a draft decision on Trade and Health around which more consensus may be building. This could pre-empt the waiver negotiations due to resume in the TRIPS Council on 10 and 11 March.

The draft decision, based on a Trade and Health initiative launched last year by the “Ottawa Group” of 13 countries, urges countries to review and “promptly eliminate unnecessary restrictions” on export of essential COVID health products,  temporarily remove or reduce tariffs; streamline customs processes; strengthen supply chains, display transparency in trade-related monitoring, and step up cooperation with the WTO and other international agencies in trade-related aspects of pandemic response. 

The measure, based on a joint statement from June 2020, has been backed by the Ottawa Group’s mix of high-income countries, which includes Norway, Switzerland, the EU and Canada, as well as emerging economies such as Kenya, Mexico and Chile, could at least send a signal of greater multi-lateral cooperation in pandemic related trade issues, sources say. 

Latin American countries are, meanwhile, expected to make a statement calling for relaxation of export restrictions, in the wake of recent European Union moves to restrict the export of vaccines manufactured in the EU region after supply shortages emerged. 

EU Parliamentarians Charge: EU Bloc’s “Open Opposition to TRIPS Waiver” Exacerbates North-South Divide  

In their declaration on the TRIPS waiver, European members of parliament (MEPs) stressed that “the EU’s open opposition to the TRIPS waiver risks exacerbating a dangerous North-South divide when it comes to affordable access to COVID-19 diagnostics, personal protective equipment, treatments and vaccines. 

“The WTO decision on a potential waiver offers a crucial and much-needed act of effective solidarity, as it is an important step towards increasing local production in partner countries and, ultimately, suppressing this pandemic on a global scale. As the Commission President has repeatedly stated, no one is safe until everyone is safe.”

Earlier in the week, Archbishop Ivan Jurkovic, Holy See representative to the United Nations, said that “the principles of justice, solidarity and inclusiveness, must be the basis of any specific and concrete intervention in response to the pandemic”, and the TRIPS waiver “would be a strong signal demonstrating real commitment and engagement and thus moving from declaration to action in favor of the entire human family”. 

WHO’s Director General Dr Tedros Adhanom Ghebreyesus also reaffirmed his support for the WTO IP waiver initiative on Friday. Speaking at a WHO press conference, he and other senior WHO officials said that the IP waiver offers a “practical solutions” for scaling up access, as compared to Friday’s Security Council Resolution on the issue, which remains largely symbolic.

“I’m glad the UN Security Council has voted in favour of vaccine equity. And at the same time, if we’re going to take practical solutions, then the waiver of intellectual property should be taken seriously,” Tedros told the media at the body’s bi-weekly COVID-19 briefing.

“We are very interested in the outcome of this discussion at the TRIPS Council,” said Mariangela Simao, head of the WHO’s Access to Medicines and Health Products. “We welcome any movement from countries to decrease and to address current barriers to access.”,

https://twitter.com/abinader/status/1365386652961619970

Image Credits: Tadeau Andre/MSF , Euoropean Commission , WTO.

A Pakistani healthcare worker listens to a child’s lungs for signs of pulmonary tuberculosis; Pakistan ranks fifth worldwide in TB burden.

ISLAMABAD, PAKISTAN –  EXCLUSIVE – The Global Fund to fight HIV/AIDS, Tuberculosis and Malaria and Pakistan’s Health Ministry are investigating a private sector hospital in Karachi for alleged mismanagement of some  US$ 4.2 million in Global Fund funds allocated to the country for tuberculosis elimination (TB) activities. 

The Indus Hospital (TIH), the principal recipient of the Global Fund’s TB grant to Pakistan, is alleged to have mis-spent US$ 4,196,938 of the country’s TB programme grant of  US$ 39.7 million for the years 2016-2018 in “fraudulent” awards to a service provider.

The funds provided to TIH were intended to be used  to provide TB outreach services in Karachi and the surrounding rural areas of Sindh province – both of which are high-TB burden areas in Pakistan.

The Indus Hospital, Karachi, Pakistan

The hospital was accused of embezzling the money in the December 2020 draft of a report by the Global Fund’s Geneva Office of Inspector General (OIG), obtained by this team from a Pakistani source in the Ministry of National Health Services – Regulations & Coordination  (NHSR&C).  The same allegations were repeated in an official NHSR&C committee report – subsequently obtained by these reporters. 

According to the World Health Organization (WHO), Pakistan is ranked fifth amongst high-burden countries of TB worldwide and it accounts 61 percent of the communicable disease in WHO’s Eastern Mediterranean Region (EMRO).

The GF’s OIG report covers the period of two years i.e January 01,2016 to December 31, 2018.  It found that some 4,196,938 USD in non-compliant expenses – related to “irregular payments” to suppliers or related conflicts of interests. 

Out of the total amount of mis-spent funds, some US$ 1,172689 USD is ‘potentially’ recoverable, the OIG report states.

TIH Failed To Conduct Competitive Tender For Services – And Was Overcharged

The report says that the TIH pre-selected a firm called Interactive Research and Development (IRD) as a long-term technical assistance supplier in connection to the GF grant, instead of conducting a competitive tender.  Then, IRD significantly overcharged for its services. 

“The Indus Hospital fraudulently awarded four projects to IRD. IRD then overcharged the Global Fund for these projects through non-delivery, fabricating and inflating programmatic achievements, and through unsupported expenses,” said the early investigation draft of the OIG.

An IT provider on the project, also misrepresented and overcharged for its services to the Indus Hospital, the OIG report states. The Indus Hospital engaged Interactive Health Solutions Private Limited (IHS) to provide IT services, but paid out double what IHS actually spent to  delivering the services.

Unmitigated conflicts of interest between the hospital and its providers were enablers for the alleged fraud, the OIG report states. 

But the Global Fund Pakistan Country Team also failed to provide adequate oversight, the OIG report concludes. The country team breached budget procedures in the process of approving The Indus Hospital’s selection of IRD and IHS.

“Conflicts of interest and irregular procurements contributed to US$4,196,9381 of non-compliant expenses, of which US$1,172,6892 is potentially recoverable,” states the OIG  report.  The report also contains a detailed diagram illustrating the complex conflict of interest patterns that emerged between TIH and its suppliers – as well as the failed oversight channels between the country’s Global Fund programme management team and the hospital.

That diagram, published in the original online version of the Health Policy Watch story, was later removed at the request of Global Fund’s OIG, pending the Global Fund’s publication of it’s full and final report on the investigation, scheduled for mid-March.

Global Fund Responses 

The Global Fund’s OIG Office in Geneva confirmed, however, to us the authenticity of the report, saying that an  “early draft version” had been leaked. GF Communications Specialist Dougal Thomson  said that a detailed report will be released around 16 March.  

The Global Fund Pakistan Country Team, approached by us for comment, through the Global Fund local funding agent, Amir Chaudry, declined to respond. 

The Global Fund has invested US$697 million in Pakistan since 2003; the GF is the country’s biggest donor for programmes related to HIV/AIDS and TB.

Pakistan’s Health Ministry Formed Inquiry Committee

Following their receipt of the draft  GF report on 1 December 2020, Pakistan’s Ministry of NHSR&C formed an inquiry committee to probe the charges against TIH. A committee report issued on 14 December 2020, validated the financial allegations leveled by the GF’s OIG against the Karachi hospital. 

The four-member inquiry committee concluded that the wrongdoing occurred because individuals violated health ministry and GF Standard Operating Procedures (SOPs), causing ‘triple damage’ to the cause of ending TB efforts in the country.

The committee also reported that the wrongdoing resulted had damaged donor trust – as well as causing national dishonor.  As a result of the episode, the Global Fund has now applied an  Additional Safeguard Policy (ASP) to Pakistan, to monitor future GF investments more closely.

The Health Ministry committee also concluded that it agrees with the OIG findings that the GF  portfolio manager in charge of the monies, had failed to provide adequate oversight, and when conflicts of interest became apparent, had not adequately flagged the issues to the Senior Recoveries Officer which is the GF standard procedure.

The Health Ministry committee report further added that “TIH responses are too generic and not responding satisfactorily to the documented facts and figures of OIG report.”The

The Indus Hospital (TIH) Responds To Charges 

TIH Chief Executive Officer (CEO),  Dr. Abdul Bari Khan, when asked by our team about the GF’s allegations on TIH,  said that “we have submitted our reply and are waiting for the final version of the report.”

A subsequent TIH media statement, signed by Khan, stated,  “the OIG carries out audits to ensure compliance in relation to good practices. At times there are certain procedures and related expenses which may require necessary explanation based on ground realities.”

The statement added that these observations about procedures or expenses are ‘not to be interpreted as fraud’.

Pakistan Committed To Battling TB – A Major Public Health Challenge  
WHO Global Tubercullosis Report, 2020

According to the National Program Manager of TB Control Program Pakistan, Dr. Naseem Akhtar, TB is one of the major public health problems in Pakistan, with the country ranking fifth among 30 TB high-burden countries worldwide.

She said that the estimated burden is 570,000 TB cases and 25,000 DRTB cases annually while 42000 people die of TB every year.

“In 2020, 330,000 TB cases were put on treatment and 93% of those were successfully treated while 3004 cases of DR TB [drug resistant TB] were also enrolled,” said Dr. Naseem.

In a response to queries by our team, Dr. Faisal Sultan, special assistant to the Prime Minister on National Health Services (NHS) stressed that TIH was contracted directly by the Global Fund – and not through Pakistan’s national ministry.  He said that the inquiry, as well, was conducted by GF inspectors. 

Irregardless of the issues that have emerged in relation to the GF, he pledged that the TB elimination remains a high national priority: “Our own [government] TB programme will continue, and we plan to fund it much better this coming year.”

___________________________________________________

  • Rahul Basharat Rajput is a Pakistan based journalist and a US Education Foundation – International Center for Journalist fellow. Muhammad Nadeem Chaudhry is a Pakistan based journalist reporting on health, social and poltical issues. 
  • Updated on 3 March 2021

Image Credits: Rahul Basharat Rajput , Stop TB Partnership, WHO .

The Medical Association of Tanzania (MAT) has started a massive awareness campaign on the prevention of COVID-19 following last Sunday’s admission by President John Magufuli and the Ministry of Health that the disease exists in the country.  

“We have started an advocacy strategy through the media and communities on prevention of COVID-19,” Dr. Elisha Osati, the immediate past president of the Medical Association of Tanzania told Health Policy Watch in an exclusive interview.  

“We have a lot of patients in our wards so we are also dealing with their treatment and management,” Dr. Osati said. “We of course have been taking precaution on our side, for our patients and their relations.” 

The medical profession has been stressing wearing masks, washing hands, using hand sanitizers, social distancing and generally seeking medical help for those that may feel unwell.  

For months, the Tanzania president, who has a doctorate in chemistry, cast doubt over the existence of coronavirus and said it was the work of the devil. Since April, Tanzania has not reported a single case of the virus to the WHO and no public measures have been implemented to contain the virus. 

High-Profile Deaths, WHO prompting

A source within the Tanzania government said that the  president’s recent change of heart could be due to the deaths of two prominent politicians, the vice-president Zanzibar Seif Sharif Hamad, died on Wednesday of COVID-19, and the head of civil service, John Kijazi who died on the same day although the reason for his death has not been given.   

However, another source said it was due to the WHO Director-General’s statement on Tanzania and COVID-19 issued on 20 February, in which he urged the government to scale public health measures against COVID-19 and to prepare for vaccination – a highly usual step for the global body that does not usually involve itself in the internal affairs of member states.

“This situation remains very concerning. I renew my call for Tanzania to start reporting COVID-19 cases and share data. I also call on Tanzania to implement the public health measures that we know work in breaking the chains of transmission, and to prepare for vaccination,” said Dr. Tedros Adhanom Ghebreyesus. 

Use Knowledge and Science, Says Moeti

Dr Matshidiso Moeti, the WHO Regional Director for Africa, said the WHO encourages countries to use knowledge, science and evidence for implementations they ask them to undertake.

The change to a medical approach from a faith-based approach comes amidst a pandemic that the Tanzania government may slowly be admitting to. 

However, a number of religious leaders have challenged Magufuli’s stance as being ‘not completely right’ and have been trying to encourage COVID-19 preventive measures within their communities. 

Catholic Bishop Siverine Niwemugizi of Rulenge-Ngara Diocese, which borders Rwanda and Burundi, suspended the celebration of public mass and community prayers. Instead, he resorted to using Radio Kwizera, established by the Jesuit Refugee Service (JRS) in partnership with the United Nations High Commission for Refugees (UNHCR) to broadcast Mass. 

Last Sunday, Magufuli acknowledged that there was a problem and called on people to wear face masks. On Wednesday, the Ministry of Health issued a statement urging the public to guard against contagious and non contagious diseases in the country, avoid crowds and wear safe masks approved by the ministry.

The Partnership of Evidence Based Response to COVID-19 (PERC) Weekly Update: COVID-19 Epidemiology and Policy in Africa observed that in February alone, there were 293 social media posts mentioning pneumonia in Tanzania. One Twitter user commented, “My timeline and groups are inundated with obituaries, deaths caused by ‘severe pneumonia”.

The Tanzania Ministry of Health stopped releasing Covid-19 updates last April, blaming “fake” COVID-19 test kits and fear mongering. The last update indicating 509 confirmed cases and 21 deaths.

Tanzania stopped sending COVID-19 to the WHO in April.

Osati also told Health Policy Watch that the medical fraternity will also start advocating for the use of  vaccines in once they have been approved by the national drug regulatory bodies. 

“As scientists, we know that vaccines are game changers. But we are still waiting for the relevant bodies to test and approve them,” he said. “ We want a vaccine that is safe, effective and cost-effective. 

The Tanzanian government officials had dismissed COVID-19 vaccines and were instead promoting herbal remedies. The Health Minister Dorothy Gwajima said they were not satisfied that the vaccines were clinically proven.

Osati said scientists in his country would continue to dialogue with the authorities in government until the management of COVID-19 pandemic is medically managed.  

“We are pleased about the Tanzanian government actions. A gap that has been created since last year. We await an appropriate strategy to engage with Tanzania,” said Dr. John Nkengasong, director of the Africa Centres for Disease Control and Prevention, during a weekly press briefing.

 

Ghana’s President, Nana Akufo-Addo, will be publicly vaccinated with the Oxford/AstraZeneca SARS-CoV2 vaccine on 2 March, signifying the start of the West African country’s vaccine rollout.

On Wednesday, Ghana became the first country in the world to receive vaccines via the global vaccine access platform, COVAX, according to Health Policy Watch. The Ivory Coast is expected to receive its COVAX vaccine delivery on Friday.

According to the COVAX Interim Distribution Forecast, Ghana – with a population of 31 million – will get a total of 2,412,000 doses of the Oxford/AstraZeneca vaccine. 

Ghana is the10th most affected country in Africa with over 81,000 confirmed cases and 584 deaths as at Thursday, a case fatality ratio of about 0.7% – far lower than the continent’s average of 2.7%.

Ghana has been prepared since early December 

On Thursday, Dr Franklin Asiedu-Bekoe, Ghana’s Director of Public Health, suggested that his country’s level of preparedness could be a major reason why it was able to get the vaccine ahead of several other countries.

Ghana submitted its COVAX application on 4 December, 13 days ahead of the deadline, with support from the World Bank and the World Health Organization (WHO), said Bekoe. 

The Ghana Health Service and partners also worked with the justice ministry to sort out the controversial indemnity request by the pharmaceutical companies as a pre-qualifying condition for countries to access the vaccines.

Dr Franklin Asiedu-Bekoe, Director of Public Health, Ghana Health Service

Every country receiving the COVAX vaccines is required to indemnify manufacturers and those that would administer the vaccine against liabilities arising out from the vaccine, as it has been  approved for emergency use and its safety profile is not yet fully known.

This is a global requirement and the United Kingdom passed a similar law recently.

Ghana’s plan for COVID-19 and the vaccine doses

Bekoe added that multi sectoral representation on Ghana’s COVID-19 working group had helped to develop its national plan on the pandemic.

Ghana aims to vaccinate 20 million Ghanaians. To achieve this, health officials will be deploying segmentation by population and by geography approaches.

“We looked at where are hotspots and which people are at most risk of contracting COVID in Ghana,” Bekoe said. 

For the first 600,000 doses received this week, the focus is on high-burden regions of Greater Accra, and Ashanti region. Bekoe said these are the key areas that will receive the vaccine. 

Regarding population segmentation, the government will be prioritising individuals above 60 years of age, and those that are needed to keep the government running.

“The executive, judiciary, and the parliament are also able to receive a portion of the 600,000 doses of the AstraZeneca vaccine. Then we are looking at the front line of security. So these are the persons that will form the first line—the first group of persons to receive doses of the vaccines,” he added.

Beyond allocating doses of the vaccine, he said the country admits that it has some challenges regarding vaccine hesitancy and as such, it has included communication plans in its COVID-19 agenda.

“Ghana also has a logistics and waste management committee, we have data, safety and a number of other committees that are embedded in the national development plan for COVID-19,” he added.

Emerging as the first country to get the COVID-19 vaccine through COVAX suggests that Ghana is very much reliant on the dose. Bekoe added that the country expects to receive subsequent doses but is also looking elsewhere to get sufficient doses that will enable it to reach the national goal. 

“We are very much reliant on the COVID facility and we’re also looking at other bilateral and multilateral facilities, to ensure that 20 million Ghanaians get vaccinated,” he said.

Johnson and Johnson vaccine in the mix

As Ghana was receiving the Oxford/AstraZeneca COVID-19 vaccines delivered by the Serum Institute in India, the US Food and Drug Administration (FDA) affirmed the efficacy of Johnson & Johnson’s single dose COVID-19 vaccine. 

According to the FDA, the vaccine is also efficacious against the dominant variant in South Africa. The vaccine which is already listed on the Africa CDC-supported platform for African countries to procure doses of various vaccines for their citizens.

Earlier in the day, Africa CDC director Dr John Nkengasong welcomed the Johnson & Johnson decision, but told a media briefing that the vaccine alone would not mark the end of the COVID-19 pandemic.

 

Africa CDC Director Dr John Nkengasong

“By using a combination of vaccines early on, we can begin to achieve our goals,” Nkengasong told Health Policy Watch “The vaccine landscape will continue to improve. We now have a menu of vaccines coming months as clinical trials are completed. The menu of vaccines will improve and countries will have a choice or choices of which vaccines to use for their vaccination programme.” 

Médecins Sans Frontières/Doctors Without Borders (MSF) has called on Johnson & Johnson to send its first shipments to COVAX for low- and middle-income countries, rather than high-income countries, should it get FDA approval at its meeting on Friday.

MSF said the vaccine could be an important tool in low-resource settings as, unlike the other COVID-19 vaccines being used today, it requires only one dose and can be stored at normal refrigerator temperatures. 

Preliminary data from a phase 3 trial testing the vaccine also suggests that the vaccine is effective against the 501Y.V2 COVID-19 variant, first identified in South Africa.

“J&J should supply low- and middle-income countries and immediately fulfil its pledge to the COVAX Facility,” said Dana Gill, US Policy Advisor, MSF Access Campaign.

“It is simply unfair that most of J&J’s vaccine doses are pledged to wealthy countries with already significant stockpiles of the other approved vaccines, where immunisations have been underway for nearly three months, while low- and middle-income countries where barely any vaccination has taken place are left at the back of the queue.” 

 

Israel has seen sharp declines serious COVID cases among people 60+ (yellow line) since the vaccine campaign began – but a parallel rise in cases among younger people (black line).

The largest peer reviewed study to date of some 1.193 million Israelis – half of whom received the Pfizer COVID-19 vaccine – confirms the vaccine’s efficacy in preventing symptomatic COVID-19 as well as serious cases and deaths – even after the first dose is administered.

The study, published in the New England Journal of Medicine, used data from Israel’s largest healthcare organization, Clalit Health Services (CHS), to evaluate the effectiveness of Pfizer’s BNT162b2 mRNA vaccine in a nationwide mass vaccination setting. 

Estimated vaccine effectiveness during the follow-up period, beginning 7 days after the second dose, was 92% for a documented infection, 94% in preventing a symptomatic COVID-19 case, 87% effective in preventing hospitalization and 92% in preventing severe disease. 

Even after the first dose, the vaccine was 72% effective in preventing serious illness or death, the study found.  

The study, led by researchers from Ben Gurion University of the Negev, matched, on a 1:1 basis Israeli’s diverse subpopulations of Israeli Jewish and Arab citizens, including people from a wide range of ethnic and religious backgrounds, in order to compare outcomes among those who had received the vaccines – and those who had not. 

“This is immensely reassuring … better than I would have guessed,” the Mayo Clinic’s Gregory Poland was quoted as saying in one local press report.

Just One Dose Highly Effective  
Drop-in testing clinic outside a health clinic in the ultra-orthodox city of Bnei Brak – one of Israel’s virus hotspots

The research may, however, provide an unintended incentive to countries struggling with vaccine supply shortages to delay the second Pfizer dose – despite the fact that the two vaccine jabs are recommended to be administered just 3 weeks apart.

“Even after one dose we can see very high effectiveness in prevention of death,” said Dr Buddy Creech of Vanderbilt University.  “I would rather see 100 million people have one dose than to see 50 million people have two doses,” Creech said.

With just 9 million people, half of them already vaccinated with at least one dose of the Pfizer vaccine, Israel has become a living laboratory for the efficacy of the brand new mRNA vaccine preparations being rolled out by Pfizer as well as Moderna.

The successful campaign has led to a sharp drop in serious cases and hospitalizations among people over the age over the age of 60 since a peak in the current COVID wave of mid-January. 

But Vaccines Alone Aren’t Enough 
Arrivals at “closed” Ben Gurion Airport – reported use of forged COVID tests by some ultra-Orthodox passengers to board “rescue” flights has provoked outrage among other Israelis, as thousands of people remain stranded abroad .

However, cases among under-50 Israelis have sharply risen – as the so-called British variant of the virus, B.117 takes over among younger age groups –  so that overall declines in new infections and hospitalizations has been much slower. In addition, the highly successful vaccine campaign has now met with resistance among some pockets of younger Israelis, ultra Orthodox Israelis and Arab Israeli citizens who tend to be more vaccine hesitant and suspicious of the government. 

In addition, despite closing its airport to all but 200 incoming passengers a day, Israel has been struggling with a wave of people returning on “rescue” flights with forged COVID-test documents- some even bragging about it.

Thousands of Israelis meanwhile remain stranded abroad – due to the inability of the government to both effectively prevent sick passengers from getting onto planes and enforce quarantines on arrivals – who routinely ignore mandatory quarantine requirements. 

“A jarring story this week of people forging documents to return to Israel, despite the closure, raises alarm bells…. Israel bills itself as the Start-Up Nation – but the country can’t even affirm if a document is forged prior to boarding people on a plane?” opined the English-language  Jerusalem Post. “The country that supposedly has the best security against terrorism in the world can’t spot a forged document? How can it be sure then that other people arriving are not forging their documents? Meanwhile, real Israelis with real-life problems are still stuck abroad without the option of getting home.”

Israeli health officials also are issuing sharp warnings that new infections could rise again if Israelis gather for traditionally raucous parties and celebrations during this weekend’s Jewish holiday of Purim.  

In addition, Israel’s campaign has come in for sharp criticism by local and international human rights groups for the lack of vacccine-sharing with some 5 million neighboring Palestinians in the occupied West Bank and Hamas-controlled Gaza, which has been under a longstanding Israeli security barricade. 

Vaccine-Sharing Plan To Latin America & Europe Halted Over Sharp Criticism at Home & Abroad 
Israeli Prime Minister Benjamin Netanyahu kicked off the mssave vaccine campaign in December.

Prime Minister Benjamin Netanyahu meanwhile had announced plans to share “symbolic” doses with countries with which Israel maintains close ties. 

On Thursday, Israel’s Attorney General halted the plan, which had not been fully disclosed – but was said to include the sharing of about 80,000 Pfizer vaccine doses with about 20 friendly nations in Europe, Latin America and Africa, including ones that have recognized Jerusalem as Israel’s capital – while Palestinians only received about 5,000 doses.  The plan was halted, but not before some countries, such as Honduras, had already received a shipment.  

In a statement, published on Twitter Thursday,the centrist Defense Minister Benny Gant decried Netanyahu’s moves as “undemocratic”, saying it was an arbitrary decision by the prime minister – who is also seeking re-election next month.   

”While the supply of vaccines to medical staff in the Palestinian Authority was transferred in an orderly fashion, paired with the need for the vaccines here in Israel, supplying vaccines to other countries around the world has never been brought up for discussion in the relevant forums,” Gantz said in a letter to Netanyahu and the Attorney General.   

Netanyahu’s moves, coming after a month in which Israel shared only a few thousand doses, at most, with the Palestinian Authority, was also decried abroad.

“It’s understandable to vaccinate one’s own citizens – but only to a point. After that, failure to share is ethically grotesque. Vaccines have become more scarce & valuable than the dollar. It is the new currency of influence & diplomacy. Wield it ethically,” said Lawrence Gostin, a global health professor at Georgetown University and head of a WHO collaborating centre on health and human rights,” in a series of tweets criticizing Netanyahu and Israel’s policies.

“It’s one thing for the Israeli gov to argue that it must prioritize vaccinating Israeli citizens over Palestinians living under Israeli occupation. But it’s morally indefensible to give surplus vaccines to Guatemalans, Hondurans, Hungarians and Czechs over Palestinians,” tweeted Dov Waxman, UCLA’s chair of Israel studies, in a post on Thursday. 

“Not only does Israel have a legal responsibility to help vaccinate Palestinians living under Israeli military rule (according to the Geneva Conventions, and notwithstanding the Oslo Accords), but Israel also has a moral responsibility to them.

“And, as if that’s not sufficient, Israel also has a pragmatic self-interest in preventing widespread transmission of COVID among Palestinians in the West Bank and Gaza.”

Sharing Epidemiological Space &  ‘Symbolic’ Quantities of Vaccines 
Palestinian health worker administers COVID test to young child – as the SARS CoV2 virus infects more young people on both sides of the poltiical divide

In a brief comment, the Prime Minister’s office stated that at the moment only “symbolic”: vaccine quantities were being offered to anyone for the moment: “no ability to render significant assistance is anticipated at least until the vaccines campaign in Israel will have ended. 

“Nevertheless, over the past month, a limited quantity of unused vaccines was accumulated; therefore, it has been decided to assist Palestinian Authority medical teams and several of the countries that contacted Israel with a symbolic quantity of vaccines.” 

With less fanfare, Israel has set up mobile posts along the borders of east Jerusalem and the West Bank – in an effort to vaccinate more Palestinian residents of the city and its environs  – which Israelis and Arabs share de-facto – regardless of political claims. 

On the other side of the political divide more nationalistic Israelis have sharply opposed delivering vaccines to Gaza, until two Israelis, one mentally ill, who are being held hostage are released, along with the remains of two deceased soldiers. 

However, Israel did finally permit the PA, headquartered in the West Bank, to transfer some 2,000 Russian supplied vaccine doses to Gaza – followed by another 20,000 Sputnik doses donated by the United Arab Emirates, which entered from Egypt.   

Along with purchasing supplies of Russia’s Sputnik vaccine, the Palestinian Authority is also expecting some 300,000 COVID vaccine doses from the WHO co-sponsored COVAX facility in coming weeks.

But those will only begin to cover some of the highest-risk groups among the estimated 5 million people living in the West Bank and Gaza. 

Per capita, Palestinian COVID cases and deaths have in fact been somewhat lower than those in Israel – but Palestinians are now reporting a recent surge  – possibly  driven by the same variants to have infected Israel, and where over 5,685 people have now died.  According to Palestinian authorities, some 2,261 Palestinians have died from COVID-19 –  but those deaths also include several hundred Palestinians living in East Jerusalem – which Israel also claims and counts as its own COVID cases too. 

 

Image Credits: HPW , Israel Ministry of Health, Uri Misgav/Twitter , Youtube – Israeli PM, Alia Ameen/Twitter .

Essential COVID-19 supplies like oxygen remain in short supply in many others,

A new COVID-19 Oxygen Emergency Taskforce has been created in response to the dearth of sustainable oxygen supplies in low- and middle-income countries (LMICs) – and its critical importance for treatment of COVID-19. 

Co-created by Unitaid and Wellcome Trust in partnership with the WHO and a range of other global public health agencies, the taskforce, launched Thursday, is taking a new role to coordinate and advocate for increased supply of oxygen in LMICs. 

The oxygen supply in most LMIC’s was already constrained prior to COVID-19, and needs have only been exacerbated by the pandemic. 

According to an oxygen tracker tool created by the Geneva-based PATH, LMIC countries need about 7.8 million cubic meters of oxygen per day to treat the more than half a million hospitalized patients. That translates into a supply of about 1.46 million cylinders of oxygen per day, with 25 countries currently reporting surges in demand, especially in Africa. 

PATH COVID oxygen tracker tool

Paul Schreier, Chief Operating Officer at Wellcome, said: “We have made critical advances in providing lifesaving clinical care and treatments to COVID-19 patients over the last year. The impact of the combination of oxygen and dexamethasone to treat severely ill patients has, in particular, been incredible.”

“But global access to advances remains unequal. We need to urgently increase access to medical oxygen to ensure patients are benefiting regardless of where they live and ability to pay. International solidarity is the quickest – and only – way out of this pandemic. It is a public health, scientific, economic and moral imperative that all tools are made available globally.”

PATH COVID oxygen tracker shows needs for oxygen by country,
US 1.6 billion Needed – US$90 Million Immediately  

The Taskforce says that some US$ 90 million in immediate funding is needed to address key challenges in oxygen access in delivery in up to 20 countries, including Malawi, Nigeria, and Afghanistan.  Unitaid and Wellcome will make an immediate contribution of up to US $20 million in total for emergency response. Urgent, short-term requirements of additional countries will be measured in the coming weeks, with the overall estimated funding needed to be US $1.6 billion. 

Philippe Duneton, Executive Director of Unitaid, said: “This is a global emergency that needs a truly global response, both from international organisations and donors. Many of the countries seeing this demand struggled before the pandemic to meet their daily oxygen needs. 

“Now it’s more vital than ever that we come together to build on the work that has already been done, with a firm commitment to helping the worst-affected countries as quickly as possible.”

The COVID-19 Oxygen Emergency Taskforce also brings together a long list of other organizations that have been working to improve access to oxygen since the start of the pandemic – WHO, UNICEF, the Global Fund, World Bank, Save the Children, the Clinton Health Access Initiative (CHAI), PATH, and the Every Breath Counts coalition to end pneumonia.

‘Double-Burden’ of Pneumonia and COVID-19 Places Strain on Global Health Systems 

Even before COVID-19, pneumonia was the world’s biggest infectious killer of adults and children, claiming the lives of 2.5 million people in 2019. 

COVID-19 has put increased strain on health systems, especially in ‘double-burden’ countries with both high levels of pneumonia and COVID-19. Many hospitals in LMICs are running out of oxygen, resulting in preventable deaths and families of hospitalized patients paying a premium for scarce oxygen supplies. 

Oxygen has long been regarded as an essential medicine, and despite being vital for the effective treatment of hospitalized COVID-19 patients, LMICs cannot access crucial oxygen supply due to costs, infrastructure constraints, and logistical barriers.  

The Taskforce recognizes the central importance of oxygen in treatment, and partners will focus on four key objectives as part of an emergency response plan: measuring acute and longer-term oxygen needs in LMICs; connecting countries to financing partners for their assessed oxygen requirements; and supporting the procurement and supply of oxygen, along with related products and services.

They will also address the need  for innovation market-shaping interventions and reinforce advocacy efforts to highlight the importance of oxygen access in the COVID-19 response. As well as meeting immediate needs of the pandemic, the taskforce will also look to aid in long-term pneumonia control.  

 

Image Credits: Independent Panel for Pandemic Preparedness – Second Progress Report. , PATH .