The CoronaVac vaccine, developed by the Chinese pharma firm, Sinovac.

CoronaVac, the Chinese vaccine developed by Sinovac, offers 83.5% protection against symptomatic COVID-19, according to interim data from a Phase 3 trial in Turkey published in the Lancet on Friday. 

Meanwhile, a large study of the efficacy of the vaccine on 10.2 million Chileans found that it was 65.9% effective in preventing infection, 87,5% effective in preventing hospitalisation and 86% effective in preventing death after two doses, according to a report published in the New England Journal of Medicine on Thursday.

CoronaVac – which can be stored and transported at normal fridge temperature – has been approved for emergency use in 22 countries, and by the World Health Organization (WHO).

The Turkish trial involved over 10,000 people, 6,650 of whom received two doses of the vaccine 14 days apart, while 3,568 received a placebo.

During the trial, 150 COVID-19 cases were confirmed – nine in the vaccine group (an incidence rate of 32 cases per 1,000 people per year) and 32 in the placebo group (an incidence rate of 192 cases per 1,000 people). Following analysis, the authors estimate that this is equivalent to a vaccine efficacy of 83.5%. 

CoronaVac induced an antibody response among 90% of those who received the vaccine, but the response decreased with age. 

No Freezing Necessary

No severe adverse events or deaths were reported and most adverse events were mild and occurred within seven days of an injection, according to the data.

“In order to bring the COVID-19 pandemic under control, the world needs every single dose of safe and effective vaccines, and our results add important evidence of the safety and effectiveness of inactivated-virus vaccines,” said lead author Professor Murat Akova, from Hacettepe University Medical School in Turkey. 

“One of the advantages of CoronaVac is that it does not need to be frozen, making it easier to transport and distribute. This could be particularly important for global distribution, as some countries may struggle to store large amounts of vaccine at very low temperatures.”

However, the Lancet noted that “more research is needed to confirm vaccine efficacy in the long term, in a more diverse group of participants, and against emerging variants of concern”. The majority of Turkish participants (58%) were men, the average age was 45 and all participants were between 18 and 59.

Earlier, Health Policy Watch reported on worrying indications that the Chinese Sinopharm and Sinovac COVID vaccines used by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected.

Earlier in the week, news outlet CNBC reported that five of the six highly vaccinated countries experiencing surges had used CoronaVac.

The Chilean observational study is the first to consider data from a mass vaccination rollout of CoronaVac.

“Estimates of vaccine effectiveness in the prevention of Covid-19 are essential because they reflect real-world challenges, such as logistics, cold chains, vaccination schedules, and follow-up, and also involve more diverse populations than those selected in randomized clinical trials, such as older or immunocompromised persons or those with coexisting conditions,” according to the NEJM.

“Despite being the standard for assessing vaccine efficacy, phase 3 clinical trials have some limitations, such as restrictive inclusion criteria and implementation under strict experimental conditions that may not resemble a mass vaccination rollout,” it added.

Using data from the national health system, which treats 80% of the population, the Chilean study estimated vaccine effectiveness based on laboratory-confirmed COVID-19, hospitalization, admission to the ICU, and death. 

 

Image Credits: Twitter – Chinese Embassy Manila.

The European Medicines Agency (EMA) does not recognize Covishield – the India-produced AstraZeneca vaccine

Nearly half of the 31 European nations using the European Union’s new digital COVID travel certificate have recognized the India-made version of the AstraZeneca vaccine, Covishield, alongside its European-made counterpart, Vaxzevria, an analysis by Health Policy Watch has revealed. 

But other major countries, including France, Poland, and Italy, seem to be holding out, authorizing only those vaccines recognized by the European Medicines Agency (EMA).  

The 15 countries that have adoped more progressive policies include: Austria, Bulgaria, Finland, Germany, Greece, Hungary, Ireland, Latvia, the Netherlands, Slovenia, Spain, Sweden.  Belgium also announced Wednesday that it would recognize the Covishield vaccine – good news for vaccine advocates in the Democratic Republic of Congo – which has been one of the most vaccine-hesitant countries to date.  Iceland and Switzerland, among the four members of the European Free Trade Association (EFTA) that align with EU policies, also are accepting Covishield vaccines for travel. 

But only 10 out of the 31 EU/EFTA countries have fully followed World Health Assembly recommendations, recognizing all eight vaccines that have been granted a WHO Emergency Use Listing, as valid for the entry of non-European visitors on “non-essential” visits, the Health Policy Watch analysis also found. 

They include: Finland, Germany, Latvia, Netherlands, Hungary, Spain, Sweden – as well as Iceland and Switzerland, according to a country-by-country analysis of the latest travel policies.

Rather than a unified response, the EU COVID pass has thus triggered a cacophony of different policies, by country.  

In the case of  “vaccination with a vaccine that does not correspond to one centrally authorised in the EU, each Member State has the option to recognise it,” EU spokesperson Stefan de Keersmaecker told Health Policy Watch, in remarks last week. 

Asked whether the EU might at sometime in the future consider a region-wide policy for Covishield, or the other 3 WHO-approved vaccines, the spokesperson declined to comment.  

Only fifteen EU/EFTA nations have recognized Covishield, the India-made version of the AstraZeneca vaccine as of 8 July, 2021. Legend: green – approved; purple – unapproved (HPW/Svet Lustig Vijay).  

Lack of Recognition Spurred Diplomatic Uproar 

Health Policy Watch inventoried all 27 EU country policies, as well as those of the four EFTA countries, via online sites or direct emails, to examine European responses to the new travel pass systems.   

This followed a wave of protest across South Asia and Africa late last month over the lack of EU recognition for the Covishield vaccine, as part of the new EU-wide COVID digital pass, which is being adopted by the 27-member bloc of countries, along with its four EFTA neighbors. 

The protests began after France and other European embassies in Africa posted guidance for would-be travelers about the new COVID digital pass, launched 1 July.  That information failed to include Covishield – the jab most widely distributed by the WHO-supported COVAX global vaccine facility – as a valid vaccine for the travel certificates.

In comments to Health Policy Watch last week, European Union officials said that the AstraZeneca vaccine produced by the Serum Institute of India could not be automatically included in the COVID digital certificate because the Indian version had never been formally approved by the European Medicines Agency (EMA). 

“Unlike Vaxzevria [the EU-produced AstraZeneca vaccine], Covishield never received European Medicines Agency marketing approval since it is not being manufactured on the European continent,” EU spokesperson Stefan de Keersmaecker told Health Policy Watch.

Rather than taking a EU-wide approach, Keersmaecker said that it would be left up to each “individual country” to determine whether to recognize Covishield – as well as three other vaccines that were approved for Emergency use by the WHO but not by the EMA. 

Those three other WHO-approved vaccines include yet another AstraZeneca jab, produced by SK Bio in the Republic of Korea and two vaccines manufactured by China’s Sinopharm and Sinovac.  

Vaccines recognized by the EMA, as well as the WHO, include those by Pfizer/BioNTech, Moderna, Johnson & Johnson, and Vaxzevria, the EU-manufactured version of the AstraZeneca vaccine.

Only 10 EU/EFTA nations have recognized all eight vaccines that have been granted WHO Emergency Use Listing. Legend: red – EMA-approved vaccines only; blue – WHO-approved vaccines (HPW/Svet Lustig Vijay).  

EU Is “Utterly Irresponsible”

“I think it is utterly irresponsible for the EU not to accept Covishield in its Green Pass system, and leave decisions to a patchwork of different European countries,” Lawrence Gostin, Director of the O’Neill Institute for National and Global Health Law, told Health Policy Watch.

“Covishield is a safe and effective vaccine, and has been authorized by a number of rigorous regulatory agencies. It is a highly discriminatory decision, given that Covishield is a major vaccine used by COVAX. It will mean that many people in lower-income countries will be discriminated against,” added Gostin, who is also the Director of the WHO Collaborating Center on National and Global Health Law. 

Covishield represents 90% of the 89 million vaccines distributed to Africa by the global COVAX facility and 80% of the 350 million jabs administered so far in India.  The vaccine also has been sold or distributed in a range of other SouthEast Asian and Latin American countries. Some Covishield vaccines also have been donated to UN peacekeepers in Africa and elsewhere.  

The WHO-approved  Sinovac and Sinopharm vaccines – which also lack wide EU recognition – have meanwhile been widely deployed Latin America and South East Asia. 

 

The European digital green passport

France, Italy, Poland – Denying Covishield Recognition

The  protests, including by WHO and other lead agencies of the COVAX initiative, as well as the Indian government, have so far left a number of EU countries unmoved. 

France, Poland, and Italy, continue to be among those EU/ EFTA countries that consider travelers as “unvaccinated” unless they have received one of the four EMA-approved jabs, the Health Policy Watch review of their official travel guidance found. 

As a result, tens of millions of vaccinated people in Africa, Asia and Latin America, along with the five million Brits who received Covishield as as part of the UK’s national vaccination drive, still may face quarantine or test requirements upon their arrival to the more than dozen EU countries that don’t recognize the Covishield vaccine – if they are allowed to travel to those countries at all. 

That’s in comparison to vaccinated peers in countries like the United States or Canada, who received EMA-approved jabs. 

To date, the EMA has approved AstraZeneca manufacturing sites in the EU, the UK, the US, and China. In contrast, AstraZeneca’s production sites in India (Serum Institute), Korea (SK Bioscience), and Thailand (Siam Bioscience), were never submitted to the EMA for approval.

India Warns of Potential Retaliation If Covishield Not Approved By EMA 

Should the EU fail to greenlight Covishield, India has warned that it will retaliate by mandating quarantines to EU citizens upon their arrival to India, irrespective of their vaccination status.

But Serum Institute’s CEO Adar Poonawalla has said that is unlikely to happen; in a recent tweet he predicted that the EMA would approve Covishield region-wide by the end of July.

“I realise that a lot of Indians who have taken Covishield are facing issues with travel to the EU. I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries,” said Poonawalla. 

“In a month we are confident the EMA will approve Covishield,” Poonawall also told the Times of India last week. “There is no reason not to, as it is based on AstraZeneca data and our product is identical to AstraZeneca more or less.”

Adding more to the confusion, four EU countries, including Greece, Cyprus, Hungary, and Slovenia, have also recognized the Russian-made Sputnik V vaccine as valid for entry by tourists and other non-essential travelers – even though that vaccine has yet to get any WHO approval at all. The WHO review process stalled recently after reports of contamination issues identified at a Russian vaccine “fill and finish” manufacturing plant.   

Says Gostin, “it is clear” that more harmonization between the WHO, EU and EMA is urgently needed to streamline global travel and ensure travel policies are fair.

“I do think the EU will ultimately accept Covishield,” predicted Gostin. But he warns that delaying such a decision “will lower confidence in that vaccine to the detriment of the global vaccination campaign.”

– Surabhi Agarwal contributed to the creation of Tableau charts.

Image Credits: Azhar Khan, Algorithm Watch.

COVAX
COVAX is relying on donated doses, but expected accelerated vaccine deliveries from September.

As Africa recorded its worst pandemic week, the COVAX Facility announced on Thursday that it has taken steps to quickly resume the delivery of vaccines to African countries including diversifying its portfolio of COVID-19 vaccines. 

Aurélia Nguyen, Managing Director of the COVAX Facility based at Gavi, the Vaccine Alliance, said the COVAX portfolio now consists of nine vaccines and vaccine candidates.

“We have legally binding contracts in place for 2.8 billion doses. We also have commitments for further 1.3 billion doses,” Nguyen told the World Health Organization (WHO) Africa’s weekly COVID-19 briefing on Thursday.

COVAX will have supplied 520 million doses by the end of 2021 and nearly 850 million by the end of the first quarter of 2022, said Nguyen.

“These are all funded following our successful fundraising summit that we had in early June. Now we have the resources in place to be able to protect up to 30% of the population in every eligible African country,” she added.

Aurélia Nguyen, Managing Director of the COVAX Facility

The majority of the doses will be delivered from September onwards and in the interim, COVAX will be getting countries with excess doses to share with countries that do not have.

“This week, those donations from France reached Mozambique and Zambia. Kenya and Somalia are set to receive vaccines. We’re also working very closely with our partners in the US government and in coordination with the African Union, to facilitate doses from the US, as well as other donations from other countries,” she added.

Regarding the resumption of shipments from India, she said COVAX has been in close discussions with the Government of India and with the Serum Institute of India (SII), COVAX’s main supplier until vaccine exports were banned in India to address its domestic COVID-19 crisis. 

“I think it’s still a fluid situation given the situation in India, and we’ve been factoring in the resumption of supplies towards the later part of the year,” she said.

Slow vaccination and increasingly worrisome Delta variant

The slow vaccination rate in Africa could result in the emergence of new variants that could threaten global health, Professor Tulio de Oliveira, Director of the KwaZulu-Natal Research and Innovation Sequencing Platform in South Africa told the briefing.

“We just give more chances for the virus to evolve and for new variants to emerge. So it’s very important, more than ever, that we treat this as a global pandemic, and if we leave countries in Africa behind, we just give chance for new variants to emerge,” de Oliveira said.

Professor Tulio de Oliveira, Director of KwaZulu-Natal Research and Innovation Sequencing Platform in South Africa

Regarding the Delta variant, de Oliveira said it is becoming increasingly worrisome as it is now accounting for up to half of COVID-19 cases in Africa.

According to Dr John Nkengasong, director of the Africa Centre for Disease Control (CDC), the Delta variant has now been reported in 15 African countries — Algeria, Botswana, DR Congo, Gambia, Ghana, Kenya, Malawi, Mauritius, Morocco, Nigeria, Rwanda, South Africa, Uganda, Zambia and Zimbabwe. 

“The public health measures are still effective against the Delta variant so we just have to keep implementing those measures rigorously to block the spread of this variant. We shall overcome, and we have to overcome as a continent. We have fought a good fight, to keep maintaining the virus where it is. It was known, and it was predicted that we cannot win the battle against this terrible virus with only public health measures,” Nkengasong said. 

Africa’s worst pandemic week ever

WHO Africa Director Dr Matshidiso Moeti, said that the continent had marked its worst pandemic week ever — surpassing the second wave peak during the seven days ending on 4 July 2021.

Dr Matshidiso Moeti, WHO Regional Director for Africa.

“Africa has just marked the continent’s most dire pandemic week ever. But the worst is yet to come as the fast-moving third wave continues to gain speed and new ground,” Moeti said. “The end to this precipitous rise is still weeks away. Cases are doubling now every 18 days, compared with every 21 days only a week ago. We can still break the chain of transmission by testing, isolating contacts and cases and following key public health measures.”

In the past two weeks, she revealed that over 1.6 million vaccine doses had been delivered to Africa through COVAX, and more than 20 million doses – primarily Johnson & Johnson/Janssen vaccines, with some Pfizer-BioNTech – are expectedimminently from the United States through COVAX, in coordination with the African Union. 

Some 49 countries have also been notified of the allocations they will receive, while other significant dose donations from Norway and Sweden are expected to arrive in the coming weeks. 

With much larger COVID-19 vaccine deliveries expected to arrive in July and August, Moeti urged African countries to prepare to rapidly expand the roll-out.

“Governments and partners can do this by planning to expand vaccination sites, improving cold chain capacities beyond capital cities, sensitizing communities to boost vaccine confidence and demand, and ensuring that operational funding is ready to go when it is needed,” Moeti said.

Regarding vaccine hesitancy, Nkengasong said availability of the doses has shown that people in Africa will receive it when they see their relatives accepting the doses. 

“About 75% of vaccines that are available on the continent have been used. If the vaccines are available in a predictable way, I’m very convinced that the population will cooperate because they know that vaccines save lives, and they save their loved ones,” Nkengasong said.

Image Credits: UNICEF.

Mortality data from Brazil reveals shocking detail of a hidden epidemic of femicides and domestic violence in the country.

A “hidden epidemic” of femicides and domestic violence in Brazil has been unearthed by a careful examination of mortality data, a Vital Strategies webinar on women and health was told on Thursday.

Fatima Marinho, Principal Technical Advisor in Vital Strategies’ Brazil office, described the mortality findings as “shocking” – but added that they showed how important data collection and analysis was for women’s health.

“Every day, women have their deaths recorded as traffic injuries or heart attacks or suicides, when they are dying from causes related to violence,” revealed Marinho, adding that their data report has resulted in more attention being paid to autopsies and more rigorous collection of  data to identify deaths rooted in violence.

Brazilian women exposed to violence, according to Marinho, have an estimated mortality risk that is nearly eight times higher than that of the general population. An estimated 400 deaths per week is a direct and indirect consequence of exposure to violence.

Most shockingly, Marinho said the data showed that pregnant women living in abusive relationships were at a higher risk of femicide after giving birth.

“We realize that women who are victims of violence are coming to health services, searching for care, safety and healing, but they are not being listening too,” said Marinho.

“When we constructed the journey of those women’s health service, we saw that we are missing so many opportunities to address violence. They are hospitalized for injury or even during pregnancy during routine care or suicide attempts…”

Princess Dina Mired of Jordan, a health advocate and Special Envoy for Noncommunicable Diseases (NCDs) at Vital Strategies, described the COVID-19 pandemic as a “disaster” for women that has reversed progress made with regards to women’s health.

“If we are thinking to build back better post-corona without gender perspective at the core of every single policy, we will simply fail,” said Princess Dina.

Princess Dina Mired of Jordan

She applauded the women leadership of New Zealand, Singapore and Germany during the pandemic , saying their responses were based on science and empathy. 

“They have established a new brand of leadership.There is no negotiation on that, we’ve seen it, we’ve heard it and we’ve seen the results,” she said.

Advancing Women’s Health Using Data

Christina Chang, Vital Strategies deputy CEO, said the organisation is collaborating with ministers of health and local partners to reduce maternal morbidity and mortality resulting from unintended pregnancies, unsafe abortions and complications of pregnancy and childbirth.

The initiative is run in Bangladesh, Rwanda and Uganda – countries that have high mortality rates due to unsafe abortions and unintended pregnancies. 

Chang said all three countries have identified gaps in the availability and use of timely data and are working to strengthen data collection analysis that will be used to improve policy advocacy, communications and program implementation.

“It’s really an experiment of using the tools… using data driven and evidence based interventions …to be able to increase access to safe abortion. And in the process, hoping to be able to reduce maternal mortality and morbidity,” said Chang.

In Bangladesh, for example, an increasing number of health complications are being recorded due to the informal use of medical menstrual regulation which involves treatment that is administered within 14 days of a missed menstrual period to ensure that a woman either is not pregnant or does not remain pregnant. 

In Rwanda, the stigma of abortion and limited quality of healthcare providers, is also a major health risk.

Chang however said too often women’s health is limited to reproductive health, but that the scope is broader and should include issues of non-communicable diseases “which are the greatest threat to women’s health and well-being”.

“We are actually much more than our uteruses right, we’re much more than that,” said Chang. 

“Heart disease, cancer and diabetes are responsible for two in every three deaths among women each year, and the factors that drive non communicable diseases are in the environments that we live in, the food we eat and the air.”

Citing air pollution as another women’s health issue, Chang said millions of households rely on traditional stoves and polluting fuels and that these smokes pose huge risks to women who are most often responsible for cooking and caring for their families.

“We need to address this leading cause of exposure for women and promote clean household energy, including access to cleaner fuels and better technologies for cooking.”

Other issues affecting women’s health that are not getting as much attention include forced marriages,  lack of education and women’s rights to child custody.

Image Credits: Pxfuel.

Tocilizumab, manufactured by Roche.

Swiss pharmaceutical company Roche has suspended its patent rights on the medication tocilizumab in low- and middle-income countries (LMICs) for the duration of the pandemic, the company announced Tuesday.

This follows the World Health Organization (WHO) recommendation on Monday for   interleukin-6 (IL-6) receptor blockers to be given to patients hospitalised with severe or critical COVID-19. 

The interleukin-6 (IL-6) receptor blockers, tocilizumab and sarilumab, reduced the risk of death and ventilation when combined with corticosteroids, according to a study published the same day in the Journal of the American Medical Association (JAMA).

However, the medicines are currently very costly, as reported by Health Policy Watch. Describing the WHO’s new guidance as “an important development for patients hospitalised with severe or critical COVID-19”, Roche said it had been “working around the clock” to try to meet the need for tocilizumab.

“We have increased our own production capacity significantly and have been working with external manufacturers on transferring our technologies to further increase global supply. Despite all these efforts, it may still not be enough to meet the unprecedented demand for Actemra/RoActemra,” the company explained.

By announcing that it would not be asserting any patents against tocilizumab in LMICs “during this current pandemic”, Roche said that it wanted to “provide legal certainty for biologic manufacturers”.

“We are working closely with the WHO on the implications of this guideline and on mechanisms (WHO PreQualification) that may enhance access in LMICs,” Roche added in a statement.

“At the same time, we strongly believe that robust intellectual property (IP) systems are a prerequisite for innovation and improving treatments for the benefit of every human being and society as a whole,” the company asserted.

“IP protection is mandatory to address the huge healthcare challenges the world is facing – also beyond COVID19. It has been the basis for the industry’s quick and comprehensive response to the challenges of the pandemic – an unprecedented success of healthcare innovation.”

Earlier in the week, Médecins Sans Frontières (MSF) called on Roche, the world’s only producer of tocilizumab, to lower its price “to make it affordable and accessible for everyone who needs it”.

“Even though tocilizumab has been on the market since 2009 for treatment of rheumatologic diseases, access has remained a challenge,” according to MSF. 

“Roche kept the price of this drug very high in most countries, with price tags ranging from US$410 in Australia, $646 in India to $3,625 in the USA per dose of 600mg for COVID-19.”

Regeneron holds the patent for the second drug, sarilumab, in “at least 50 low- and middle-income countries, raising immediate challenges of ensuring uninterrupted production and supply by diverse producers in these countries”, according to MSF.

Interestingly, a trial on sarilumab conducted by Regeneron and Sanofi on whether it could reduce mechanical ventilation in severely ill COVID-19 patients was abandoned a year ago after failing to show statistically significant results.

 

Image Credits: Roche.

PAHO Director Dr Carissa Etienne

Though the Americas is the only World Health Organization (WHO) region that is reporting a slight decline in new COVID-19 cases this week, countries in Central and South America, Canada and Mexico are still experiencing rising rates of infection. 

Over 1.1 million new COVID-19 cases were reported in the Americas over the last week, officials from the Pan American Health Organization (PAHO) announced at a press briefing on Wednesday. 

The Central American countries of Belize, El Salvador, Honduras and Panama, and South America’s Brazil, Colombia, and Ecuador, are also reporting high numbers of new cases.  

In North America, while overall trends are declining, cases are rising in the Mexican state of Baja California Sur, and Canada’s Yukon province in Canada. 

Brazil in particular has reported almost 19 million cases and more than half a million deaths due to COVID-19 over the course of its 15-month state of emergency, with an average of more than 49,000 cases and 1500 deaths over the last seven days. 

Cuba is reporting the highest number of new cases per week since the beginning of the pandemic, and Trinidad and Tobago are facing increased mortality due to COVID-19. 

“This is a clear sign that the toll of the pandemic in the Americas continues to devastate families and communities, even as parts of our region are experiencing some relief,” said PAHO Director Carissa Etienne. 

Deaths in Latin America remain the highest per capita, even with global declines. 

Majority of Vaccinations Administered in the United States

While one in four people are fully immunized against COVID-19 in the Americas and over 600 million doses have been administered in the region, over half of these shots have been given to the United States. 

“We must celebrate a nation that has been so heavily impacted by the pandemic, was able to turn the tide,” said Etienne. 

Chile and Canada have also been leaders in their vaccination programs, fully vaccinating over 50% and 30% of their populations, respectively. 

Nursing technician Vanda Ortega, indigenous to the Witoto people, was the first person to receive a dose of the COVID-19 vaccine in Manaus, Amazonas, Brazil, on January 18, 2021.
There is still a sharp divide in access to COVID-19 vaccines across the Americas.

Though PAHO officials praised some countries for their “remarkable job” in administering doses, there remain other countries in the region where vaccination has yet to even begin.

Haiti has not administered a single vaccine dose, while Jamaica is also struggling to access enough vaccines to cover high priority groups. Some countries in South and Central America, where the pandemic has hit particularly hard, have not been able to access enough vaccines to fully vaccinate even 3% of their populations.   

“We can’t close our eyes to the stark inequalities of vaccine access in several countries,” noted Etienne. “It is not a time to roll out boosters when millions have yet to receive one dose.” 

Etienne urged countries and governments globally to continue their donations. 

“The vaccines that we have at hand do work remarkably well and will help us overcome the pandemic, but only if we take this opportunity to address the challenges that have held us back, especially the pervasive inequality in access to health care. Broad vaccine access must be the first step in the process.” 

This week, El Salvador welcomed 1.5 million new vaccine doses from the US government, as part of its pledge to share at least 20 million doses with the WHO-cosponsored COVAX global vaccine facility. 

Japan will also be donating over 11 million doses through COVAX. Gavi, also co-sponsoring COVAX, has received tremendous support from Japan, with the country pledging a total of US $1 billion to COVAX. 

PAHO Reaffirms COVID-19 Support of Haiti Following Assassination its President

Assassinated: Haitian President Jovenel Moïse.

Etienne offered her condolences and expressed solidarity with the Haitian people following the Wednesday morning assassination of Haiti’s President Jovenel Moise during an attack on his private residence.

She reaffirmed PAHO’s support of Haiti during these “uncertain times” and said the organisation would continue to help control the spread of COVID-19 and work towards vaccinating its people.  

Haiti has been prioritized to receive vaccines from COVAX because of the deadly wave that has been hitting the country, with sharply escalating cases, hospitalizations, and deaths in recent weeks. 

However, it is the only country in the Americas participating in COVAX that hasn’t received any vaccines.

A shipment of 132,000 AstraZeneca vaccine doses from COVAX is scheduled to arrive in Haiti later this month and the US plans to deliver doses in the near future.

‘False Sense of Security’ From COVID Travel Certificates

Dr. Ciro Ugarte, Director of Health Emergencies, PAHO

Though countries are easing their travel restrictions and reopening borders, and with complications arising from the European Union’s new COVID ‘Green Pass’,  PAHO officials still advised travellers to continue to take necessary precautions to prevent the spread of the virus.  

“Even people who are completely vaccinated still have a risk of becoming infected and transmitting the disease, so a passport that verifies the vaccination or some proof can create a false sense of security,” said PAHO Director of Health Emergencies Ciro Ugarte. 

Ugarte also added that requiring proof of vaccination may exacerbate inequality between countries, as many countries still do not have sufficient access to vaccines.

This is seen with the EU Digital Green Pass, launched 1 July. Those vaccinated with an AstraZeneca vaccine “Covishield” produced by the Serum Institute of India – which includes most citizens of low- and middle-income countries who were immunized with vaccines distributed by the COVAX initiative – would not be qualified to get the pass. 

Image Credits: Flickr: IMF/Raphael Alves, PAHO, Tariq Nasheed/Twitter.

Fans watching a Premier League football match in London Stadium in lat May. Spectators were socially distanced and hygiene safety warning signs were displayed.

WHO urged high income countries in Europe and elsewhere to reconsider the reopening of mass events, and keep strict social distancing rules in place – in the wake of a surge in COVID cases almost everywhere but Latin America. 

They spoke at a press briefing on the day that the world passed the tragic milestone of four million COVID-19 deaths since the beginning of the pandemic in January 2020. 

“The world is at a perilous point in this pandemic,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, at the WHO press conference on Wednesday.

Globally, only a slight increase in new weekly cases has been recorded over the past two weeks – but that is still worrisome after six weeks or more of declines in Europe, Asia and Africa. 

“More than two dozen countries have epidemic curves that are almost vertical right now,” said Dr Maria Van Kerkhove, WHO COVID-19 Technical Lead. 

Among those are the United Kingdom, where new cases have increased 18 fold since 20 May, and by 67% over just the past week, according to WHO. Deaths in the UK also are increasing, although much more gradually – testifying to the continued efficacy of vaccines.   

Cases on Rise in Most Parts of World 

Indeed, after sharp declines in most regions and key countries of the world over the past eight weeks, new cases are now on the increase almost everywhere – except for Latin America which had been riding an enormous fourth COVID wave, now in decline (see related HP-Watch story). 

Outside of the UK, infections were also rising fast in other European countries that have been slowly reopening this summer, with a 30% overall increase in incidence, as well as in the United States, with deaths also tilting upwards. 

This was followed by a 15% increase in cases in the African region, 11% increase in the Eastern Mediterranean region, 10% increase in the Western Pacific region, and 7% increase in the Southeast Asia region. 

In Africa, which has very low vaccine rates as well as hospital capacity, deaths per capita are approaching the all time peaks seen in January 2021, during Africa’s second wave. 

African Region Seeing Fastest Rise in Mortality  

Even more worrisome, the African region, which also lacks hospital and oxygen capacity,  has witnessed a sharp increase in mortality by 23% over just the past week, the highest out of all six WHO regions, WHO said. 

“Compounded by fast moving variants and shocking inequity in vaccinations, far too many countries in every region of the world are seeing sharp spikes in cases and hospitalizations,” said Tedros. “This is leading to an acute shortage of oxygen treatments and driving a wave of deaths in parts of Africa, Asia, and Latin America.”

Devastating Milestone – Four Million 

“Today, the world passed another devastating milestone: four million reported deaths,” said Jeremy Farrar, Director of Wellcome, in a statement. “Sadly, the true figure is undoubtedly much higher.”

“In countries with widespread vaccination coverage there thankfully appears to be a weakened link between infection rates, hospitalizations and deaths. But for large parts of the world facing a vaccine shortfall and the highly infectious Delta variant, it’s a tragically different picture,” Farrar said. 

The four major factors that are driving transmission are: the more transmissible virus variants, particularly the Delta variant; increased social mixing in reopening economies; reduced or inappropriate use of public health and social measures; and inequitable and uneven distribution of vaccines, said Van Kerkhove. 

Dr Maria Van Kerkhove, WHO COVID-19 Technical Lead, at the press conference on Wednesday.

The Delta variant, first identified in India and classified as a WHO variant of concern in mid-May, is considered 40-60% more transmissible than the Alpha variant, identified in the United Kingdom. It has been reported in 104 countries and is expected to become the dominant variant worldwide in the coming months.

WHO Urges Continued Restrictions – Despite Tourism & European Cup Pressures 

European countries have been in the process of gradually lifting public health measures for the summer months, in an attempt to revive economies, including sports summer tourism, after vaccinating a significant proportion of their populations.  

Despite the surge in new cases, the UK, which is also one of the most heavily vaccinated European countries nearly 50% of the total population fully covered, has taken the most dramatic steps towards the easing of COVID restrictions since the lockdowns were first applied last year. 

Meanwhile, European Cup matches have been played out over the past several weeks across the region in stadiums of live fans, for the first time in over a year, with the finals set for the UK’s Wembley Stadium on Sunday. However Dr Mike Ryan, WHO Head of the Health Emergencies Programme, declined to comment on whether it was wise for UK officials to permit live spectators at specific events.  

“I’m not going to comment on specific events for mass gatherings, but I would want to make sure that all of those individuals, countries, and institutions planning events in the coming months take due care and attention to managing risks,” Ryan said. 

Dr Mike Ryan, WHO Head of the Health Emergencies Programme.

On 19 July, limits on the number of people that can gather in the UK, as well as the legal obligation to wear face masks will be lifted, and all businesses still closed due to such restrictions will be allowed to reopen.

The government has made this controversial decision despite the doubling of new cases every nine days and predictions that the country could see two million individuals contract COVID over the summer.

A drop off in hospitalizations and deaths has been seen in countries with high vaccination coverage, however, the vaccination rate is not high enough to prevent transmission. In addition, the science is not yet clear on the ability of vaccinated people to transmit the virus or become reinfected, said WHO officials.

Some 49.9% of the UK’s population is fully vaccinated and 66.9% have received at least one dose. 

“The lifting of all public health and social measures [is] prudent at this time,” said Ryan.

“We would ask governments to be really careful at this moment not to lose the gains they’ve made,” said Ryan. “I would hope that in the European environment we won’t see a return to the overwhelmed hospitals and the exhausted health workers, but that’s not a given.”

He stressed the continued need for robust surveillance, active testing, and contact tracing to prevent cases from spiralling out of control again. 

“Risk management hasn’t been perfect in this pandemic, but it has saved lives, slowed down the pandemic, and kept the pressure off the health system,” said Ryan. 

“Our goal is to suppress transmission and save lives, so we need those policies in place in all countries” to meet the goal, said Van Kerkhove.

Calls for Action on Vaccine Inequity 

“Variants are currently winning the race against vaccines because of inequitable vaccine production and distribution, which also threatens the global economic recovery,” said Tedros, sounding yet another, in a series of calls to mobilise the global conscience – with mixed results.  

Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

“At this stage in the pandemic, the fact that millions of health and care workers have still not been vaccinated is abhorrent,” said Tedros. 

The WHO Director General has set out a goal of vaccinating 10% of people in all countries by September, 40% by the end of the year, and 70% by mid 2022 – although at present vaccination rates, it remains entirely unclear if those targets can really be reached. 

“In this pandemic right now…protect[ing] vulnerable healthcare workers and the elderly in low-income countries before expanding into populations in high-income countries that may not suffer the same consequences of the infection,” should be prioritised, said Ann Lindstrand, WHO Head of the Essential Programme on Immunisation. 

WHO officials called upon the Group of 20 (G20) finance ministers, who will meet later this week, to take the steps necessary to end the acute phase of the pandemic, provide the funding to scale up vaccine manufacturing, and get behind Tedros’ vaccination targets.

“We have the tools we need to end this pandemic – vaccines, treatments and tests – but this will only work when they’re available to everyone, everywhere,” said Farrar. “Recent pledges from the G7 and G20 do not go far or fast enough. They are the only ones that can make vaccines available now.”

Image Credits: Wikimedia, WHO.

Levels of neutralizing antibodies in vaccinated individuals is a strong indicator of COVID-19 vaccine success- and this knowledge could be used to jump-start vaccine approvals and mass administration – even before large Phase 3 clinical trials are completed, suggests a new study by the University of Oxford Vaccine Group, Public Health England, and AstraZeneca. 

Knowledge of immune biomarkers could allow new vaccines to be authorised only with immunogenicity and safety data, and even before costly and time-consuming large scale efficacy trials are completed, the study published on the preprint server, Medrxiv.org, suggests. 

So using antibody biomarkers to further accelerate vaccine approvals could still help meet the huge unmet global demand that still exists, the study authors concluded, suggesting a bold new approach to vaccine approvals.  

“Understanding the relationship between immune responses to vaccines and protection against clinical outcomes is urgently needed to speed up vaccine development,” the researchers observed.

“The power of a correlate in vaccines is profound,” said Dan Barouch, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, who authored an independent commentary in Nature on the new research.  

“If there’s a reliable correlate, then it can be used in clinical trials to make decisions as to what vaccines are likely to work, what form of vaccines are likely to work, or how durable the vaccines are going to be,” said Barouch. 

Even so, the science of antibody response is uneven, even with respect to the same vaccine.

“The probability of infection decreases on average with higher immune responses, but substantial variation exists between individuals,” acknowledged the authors.   

Eight vaccines have so far been recommended for use by the World Health Organization (WHO) – including the addition of two Chinese-made vaccines in June. Despite a vastly accelerated R&D timeline, approvals of other COVID vaccines in the pipeline still require many months as large-scale Phase 3 trials demonstrating efficacy must be completed. 

Study Vaccines Approved by WHO – More In Pipeline Now

Adjusted risk of primary symptomatic COVID-19 as a function of immune markers measured 28 days post second dose.
Top left: Anti-Spike IgG 28 days post boost Top right: Anti-RBD IgG 28 days post boost Bottom left: pseudovirus neutralisation antibody titres 28 days post boost
Bottom right: live neutralisation antibody titres 28 days post boost.
Grey lines show control (MenACWY) overall risk and vaccine (ChAdOx1 nCoV-19) overall risk. Blue dots show the absolute risk predicted from the model across the range of antibody values included in the analysis, adjusting for baseline exposure risk to SARS-CoV-2 infection (logit-transformed linear covariate including age, ethnicity, BMI, co-morbidities and healthcare worker status). Green shaded areas show the confidence interval around the predicted mean probability (green line) 

The Oxford and AstraZeneca study compared the immune responses of 171 vaccinated people who developed symptomatic infections to 1,404 vaccinated participants without a SARS-CoV2 infection, comparing four key biomarkers of antibody levels. 

Participants with higher levels of neutralizing antibodies tended to have stronger, although not complete protection from a symptomatic infection, the study found.

The risk of symptomatic COVID decreased with increasing levels of the following biomarkers of neutralizing antibodies: anti-spike immunoglobulin G (IgG), anti-receptor binding domain (RBD) IgG, pseudovirus neutralization titre, and live neutralization titre.  Immunoglobulin G antibodies are the basis of long-term protection.

“Finding the correlate of protection has really been a holy grail for this disease, as for others,” said Daniel Altmann, Professor of Immunology at Imperial College in a Nature commentary. “It’s surprisingly hard to do.” 

At the same time, while the antibody responses documented in the study proved to be a strong predictor for the development of symptomatic COVID infections, that was not at all the case for vaccine efficacy in terms of preventing asymptomatic infections. 

“Antibody responses did not correlate with overall protection against asymptomatic infection,” said the authors – meaning that the drivers of asymptomatic infections continue to elude researchers. 

Earlier Study Found Pfizer & Moderna Vaccines Produced More Neutralizing Antibodies that Other Vaccines 

Other studies have also demonstrated that vaccine-induced antibody levels are higher with some vaccines than others – explaining why some vaccines achieve higher levels of over all efficacy. Notably, a study in late May found induced levels of neutralizing antiboides to be highest with Moderna and Pfizer vaccines, as compared with Johnson & Johnson and AstraZeneca. 

The mRNA vaccines generated the strongest neutralizing antibody responses, and as a result were more protective. Vaccines that induced a weaker response provided lower levels of protection, said the authors. 

In the study published in Nature, researchers found a link between participants’ antibody levels recorded in early-stage trials and vaccine efficacy results from late-stage trials. 

The study estimated that a vaccine would have an efficacy of 50%, even if it induced antibody levels 80% lower than what would be found in a person who recovered from COVID-19. 

“Even low antibody levels, lower than we thought, will probably see you through,” said Altmann. 

Image Credits: WHO PAHO, Medrxiv.

Tocilizumab, manufactured by Roche.

After months with virtually no therapeutic options for people with severe COVID-19, the World Health Organization (WHO) recommended the use of a class of medicines called interleukin-6 antagonists on Tuesday.

The medicines, tocilizumab and sarilumab, reduced the risk of death and ventilation when combined with corticosteroids, according to a study published the same day in the Journal of the American Medical Association (JAMA).

Interleukin-6 is a protein or cytokine that can cause excessive inflammation, and it is a factor in rheumatoid arthritis and many cancers.

“In severely ill COVID-19 patients, the immune system overreacts, generating cytokines such as interleukin-6. Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction,” according to the WHO>

The use of these drugs reduced the odds of death by 13% in severely ill and critical patients, and the odds of them needing mechanical ventilation by 28%, compared with standard care.

These are the first drugs found to be effective against COVID-19 since corticosteroids were recommended by WHO in September 2020 – but they are costly

“These drugs offer hope for patients and families who are suffering from the devastating impact of severe and critical COVID-19. But IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

“The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19. So, the greatest need for these drugs is in countries that currently have the least access. We must urgently change this,” said Tedros.

MSF Calls on Roche to Reduce Prices

Meanwhile, Médecins Sans Frontières (MSF) called on the Swiss pharmaceutical company, Roche, the world’s only producer of tocilizumab, to lower its price “to make it affordable and accessible for everyone who needs it”.

“Even though tocilizumab has been on the market since 2009 for treatment of rheumatologic diseases, access has remained a challenge,” according to MSF. 

“Roche kept the price of this drug very high in most countries, with price tags ranging from US$410 in Australia, $646 in India to $3,625 in the USA per dose of 600mg for COVID-19.”

Julien Potet, Policy Advisor at MSF’s Access Campaign, called on Roche to “take urgent steps to make this drug accessible and affordable for everyone who needs it by reducing the price and transferring the technology, know-how and cell lines to other manufacturers”.

“Medical practitioners in many countries in Africa and Latin America, who are grappling with newer and more transmissible variants of coronavirus, are right now struggling to keep their patients alive,” said Potet.

“This drug could become essential for treating people with critical and severe cases of COVID-19 and reduce the need for ventilators and medical oxygen which are scarce resources in many places.”

Regeneron holds the patent for the second drug, sarilumab, in “at least 50 low- and middle-income countries, raising immediate challenges of ensuring uninterrupted production and supply by diverse producers in these countries”, according to MSF.

Study involved almost 11,000 patients

The study, a meta-analysis of 27 randomised trials involving nearly 11,000 patients, was coordinated by the WHO in partnership with King’s College London, the University of Bristol, University College London and Guy’s and St Thomas’ NHS Foundation Trust.

Researchers examined the clinical benefit of treating hospitalised COVID-19 patients with interleukin-6 antagonists, compared with either a placebo or usual care. 

They combined data from 27 randomised trials in 28 countries, involving 10,930 patients, 6,449 of whom were randomly assigned to receive interleukin-6 antagonists and 4,481 to receive usual care or placebo.

“While science has delivered, we must now turn our attention to access. Given the extent of global vaccine inequity, people in the lowest income countries will be the ones most at risk of severe and critical COVID-19. Those are the people these drugs need to reach,” said Dr Janet Diaz, Lead for Clinical management, WHO Health Emergencies.

The WHO has called on companies making the medicines to issue “transparent, non-exclusive voluntary licensing agreements using the C-TAP platform and the Medicines Patent Pool, or to waive exclusivity rights”.

It has also launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers.

“The main patent on tocilizumab expired in 2017, yet several secondary patents remain on the medicine in a number of low- and middle-income countries that may cause uncertainties,” according to MSF.

“Several ‘biosimilar’ versions are under development, but none have been approved by a regulatory authority, meaning that despite being off-patent, Roche continue to have de facto market exclusivity.”

India has already started using tocilizumab to treat those with severe COVID-19, but supplies ran out during May, according to MSF.

“Over the last few months, we have helplessly witnessed people in South Asia scrambling to get hold of tocilizumab for patients with severe forms of COVID-19,” said Leena Menghaney, Global IP advisor for MSF Access Campaign. 

“Manufacturers based in low- and middle-income countries urgently need to register and scale up production to increase the global supply. With more than 3.9 million lives already lost to COVID-19, the world cannot wait any longer for access to treatments that can help in increasing the chances of survival.” 

 

Image Credits: Roche, WHO.

Dr Nono Simelela, WHO Assistant Director-General for Strategic Programmatic Priorities: Cervical Cancer Elimination.

At least 70% of women should be screened for cervical cancer via high-performing DNA-based tests to identify the human papillomavirus (HPV), not a visual inspection with acetic acid or a Pap smear, which are more common. 

The HPV DNA test is not only more accurate, but it is also more cost-effective, according to the World Health Organization (WHO), which launched new guidelines on screening and treatment to prevent cervical cancer on Tuesday.

“Effective and accessible cervical screening and treatment programmes in every country are non-negotiable if we are going to end the unimaginable suffering caused by cervical cancer,” said Dr Nono Simelela, WHO Assistant Director-General for Strategic Programmatic Priorities: Cervical Cancer Elimination. 

“This new WHO guideline will guide public health investment in better diagnostic tools, stronger implementation processes and more acceptable options for screening to reach more women –  and save more lives,” she told a webinar to launch the guidelines.

Last year more than half a million women contracted cervical cancer, and about 342 000 women died as a result – most in the poorest countries.

The guidelines recommend important shifts in care, including more access to self-sampling to achieve the goal of having 70% of women aged between 35 and 40 tested by 2030 and at least 90% of people who need treatment to receive it.

“Studies show that women often feel more comfortable taking their own samples, for instance in the comfort of their own home, rather than going to see a provider for screening. However, women need to receive appropriate support to feel confident in managing the process,” WHO said in a statement.

This, said WHO, paired with screening women for HPV and vaccinating girls against HPV, may help prevent more than 62 million deaths from cervical cancer in the next century.

More Research Needed to Combat Cervical Cancer

Several experts also highlighted the need for more research, training of health professionals and destigmatising the disease to combat one of the biggest killers of women, particularly those in poor countries.

They said research into HPV should not only be focused on medical objectives, but should include social and political activism if deaths are to be prevented.

Professor Lynette Denny, a South African gynaecologist and champion of cervical cancer, described cervical cancer as “a disease of poverty, but also a disease of prejudice”.

“It’s a disease of saving some lives over others,” said Denny who called on research to be extended to patients’ history and the social impacts of women post HPV-diagnosis.

“When we talk about research, we have to talk about where are our patients coming from. What are they experiencing on a day-to-day basis and what are we as researchers, and healthcare professionals hearing,” said Denny.

“There have been some studies [that show] that if a woman dies and her child is under the age of 10, the chances that that child will live to 10-years-old are about 25%. And this is what’s happening in many, many countries as well where women are dying, and have young children in communities that often are unable to take care of these children without the support of the mother.”

Responding to the Link Between HPV and HIV

And while experts called for more research into HPV, WHO said more emphasis needs to be made on the link between HPV and HIV, as women with HIV are six times more likely to get HPV than those without HIV.

With HPV being the main driver behind most cervical cancer diagnoses, this cannot be overlooked.  The guidelines state that women with HIV should start cervical cancer screening at an earlier age (25) as opposed to the general population recommendation of 30 years.

“With these new guidelines, we must leverage the platforms already developed for HIV care and treatment to better integrate cervical cancer screening and treatment to meet the health needs and rights of the diverse group of women living with HIV to increase access, improve coverage, and save lives,” said Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes.

WHO recommends that all women who test positive for cervical cancer should receive treatment soon after diagnosis.

“Cost-effectiveness of screening tests is important for scaling up programmes, but other aspects of the public health approach to eliminating cervical cancer are also vital,” said Dr. Nathalie Broutet, WHO Department of Sexual and Reproductive Health and Research and HRP. “What matters most is the coherence of every country’s programme in ensuring the continuum of care: that all women have access to screening, health care providers are informed in a timely manner about the results of the screening test and can in turn share this information with their client, and that women can access appropriate treatment or referral if needed.”

Professor Groesbeck Parham, Director of the CIDRZ Cervical Cancer Prevention Program, professor of gynaecological oncology at UNC-Chapel Hill, agreed with Denny and said that despite technological advances in trying to understand cervical cancer, “we won’t get very far unless we put this disease in the women who have it in the proper social context”

“That’s the only thing that’s going to drive this off the planet as a social movement, because it is a social disease. Women diagnosed with HPV are often stigmatised and live in shame, and this needs to be addressed, said Parham.

Image Credits: WHO.