Pharmaceutical companies continue to develop COVID-19 vaccine boosters amid condemnation of people in wealthy countries getting additional shots when much of the world is unvaccinated.

The US Health and Human Services Department reiterated on Monday that booster shots were not necessary for fully vaccinated Americans after meeting with Pfizer, which is conducting a booster trial.

Also on Monday, World Health Organization (WHO) Director-General Dr Tedros Adhanom Gheybreyesus urged Pfizer and Moderna to redirect its vaccines to the global access facility, COVAX, as reported by Health Policy Watch. 

Slamming plans by Pfizer, Moderna and a handful of rich countries, that are starting to offer  ‘booster’ vaccines to some groups of people, Tedros said that the world has evolved a “dangerous” two-tiered system of vaccinations, 

Pfizer-BioNTech have been running a clinical trial since February to test the efficacy of a third “booster” vaccine to act against virus variants to be given three months after a person has received their initial two-dose vaccination. 

The trial has two arms – one that tests an ordinary booster of the standard vaccine and the other that tests a booster tweaked to act against the Beta variant. It is being run at 17 sites in the US on people aged between 18 and 50 and its primary completion date is 22 July, according to the US National Institutes of Health clinical trials database.

Boosters Mooted Back in February

Albert Bourla, CEO of Pfizer.

Back in February, Johnson & Johnson CEO Alex Gorsky mooted annual vaccine booster shots to address variants and in April, Pfizer CEO Albert Bourla said that it was “likely” that people would need a third booster shot within a year of vaccination.

However, the US Centres for Disease Control and Prevention (CDC) and Federal Drug Administration issued a joint statement last Thursday stating “Americans who have been fully vaccinated do not need a booster shot at this time”. 

The HHS reaffirmed this statement after its meeting with Pfizer, although the pharmaceutical company said it would publish new data soon.

“FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively,” according to the statement.

“We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.”

White House Press Secretary Jen Psaki told the media at Monday’s briefing that any decision on booster shots was based on “a large swath of data” – not just that emanating from pharmaceutical companies.  

“Now, data — we continue to analyze,” said Psaki.  “Science evolves.  And we’ve long said that we will reserve options — optionality, including how we’re purchasing doses of vaccines to ensure we have maximum optionality for the American public.  But any assessment would be made by the CDC and the FDA.  And we made clear, last week, that wasn’t a recommendation being made at this time.” 

Tsaki added that if scientists “make a conclusion that booster shots are recommended, they will provide that information publicly and it would be based on a large range of data and information”.

According to recent reports, Thailand, the United Arab Emirates and Bahrain have already begun administering boosters to people who were immunized with either Chinese vaccines or the AstraZeneca vaccine.

In those three countries, the policy decision was partly fuelled by concerns that those vaccines were not sufficiently potent to ward off new variants, and particularly the powerful Delta variant, first detected in India. 

Israel, which is facing a new wave of COVID infections despite its 60% vaccine coverage, has already decided to giving boosters to immuno-compromised people fully vaccinated with Pfizer or Moderna vaccines.

The United Kingdom, which mainly administered Pfizer and AstraZeneca vaccines, is also preparing to begin offering boosters in September to more than 30 million people deemed to be at higher risk, including all adults over the age 69, immuno-suppressed groups and health workers.

 

Image Credits: Flickr – World Economic Forum.

Johnson & Johnson’s single-dose COVID-19 adenovirus vaccine.

The single-dose Johnson & Johnson COVID-19 vaccine could lead to an increased risk of a rare neurological condition, warned the US Food and Drug Administration (FDA) on Monday, adding it to the list of possible side effects. 

This comes along with a series of new reports on the side effects associated with the leading COVID-19 vaccines, which are becoming more evident through mass immunisation campaigns. 

The neurological disorder, Guillain Barré syndrome (GBS), is one in which the immune system damages nerve cells, causing muscle weakness and occasionally paralysis. Symptoms of the disorder include weakness or tingling sensations in the arms or legs; difficulty walking; difficulty with facial movements; double vision; and difficulty with bladder control. 

An estimated 3,000 to 6,000 people develop GBS each year in the US, most commonly those over the age of 50. 

Symptoms were reported in some of the recipients of the jab within 42 days of immunisation. 

“The chance of having this occur is very low,” said the updated FDA guidelines. 

There have been 100 preliminary reports of the syndrome in vaccine recipients, 95 of which were deemed serious and required hospitalisation. One case was fatal. With 12.8 million people immunized with the J&J vaccine, there is a rate of approximately one case of GBS per 128,000 people vaccinated.

The reports were made to the Vaccine Adverse Events Reporting System, a federal early warning system that monitors the safety of vaccines and possible health problems after vaccination. 

“Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship,” said the FDA. 

The agency emphasised that it “continues to find [that] the known and potential benefits [of the vaccine] clearly outweigh the known and potential risks.”

The CDC Advisory Committee on Immunization Practices will reportedly discuss the warning at its next meeting, which is scheduled for late October. 

J&J announced that the adverse event report would be shared with national and regional regulatory agencies that have authorised the vaccine, along with the World Health Organization (WHO). 

Rare Blood Clotting Associated with J&J Vaccine

This is the latest blow to the J&J vaccine, which has been sidelined in the United States. The vaccine was investigated in April by the CDC, FDA, and European Medicines Agency (EMA) for links to cases of blood clotting. 

Use of the vaccine was temporarily paused in the US, which contributed to public hesitancy about the jab. 

According to the US Centers for Disease Control and Protection, there is a “plausible causal relationship” between the J&J vaccine and thrombosis with thrombocytopenia syndrome, blood clots combined with low platelet levels. 

The European Medicines Agency (EMA) also noted the potential connection, but emphasised that it was a “very rare event.” 

Some 12.8 million doses of J&J’s vaccine have been administered in the US, only 4% of the total number of vaccines administered nationally and far lower than the 185.5 million doses of Pfizer/BioNTech’s vaccine administered or the 135.9 million doses of Moderna’s vaccine. 

Heart Inflammation Warning for Pfizer and Moderna Vaccines

A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US.

A warning to patients and healthcare providers was issued by the FDA in late June for the increased risk of heart inflammation associated with the Moderna and Pfizer/BioNTech vaccines. The EMA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have followed suit by launching investigations. 

Over 1,200 cases of myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the outer lining of the heart, have been reported in the US, the majority in patients under the age of 30. 

The symptoms often included shortness of breath, a fast-beating, irregular, or pounding heartbeat, and chest pain. 

Confirmed cases have occurred mostly in men aged 16 or older. Symptoms emerged within several days of the vaccination and more often after the second dose. 

A total of 321.4 million mRNA vaccines have been administered so far, meaning there have been approximately 12.6 cases per million doses administered. 

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” said Janet Woodcock, acting FDA commissioner, in a statement. 

In Europe, 145 cases of myocarditis have been reported among those who received the Pfizer/BioNTech vaccine and 19 cases among people who received the Moderna vaccine. Some 138 cases of pericarditis were reported in individuals following the administration of Pfizer’s vaccine, compared to 19 cases with Moderna. The cases were fatal for five people, who were either of advanced age or had concomitant diseases. 

As of mid July, some 284.6 million doses of Pfizer and 36.1 million doses of Moderna have been administered in Europe. 

The EMA’s safety committee found that the two types of heart inflammation conditions “can occur in very rare cases.”

Both the EMA and FDA reaffirmed that the benefits of the vaccines continue to outweigh their risks, particularly given the risk of COVID-19 illness.

Shingles as Possible Side Effect of Pfizer Vaccine

A study, conducted in Israel and published in Rheumatology journal in April, examined cases of shingles in patients with autoimmune inflammatory rheumatic diseases (AIIRD) after they received the Pfizer/BioNTech vaccine. 

Singles (herpes zoster) is a painful rash that can be accompanied by a fever, headache, chills, and an upset stomach. It is caused by the varicella zoster virus, the same virus that causes chickenpox. The virus can be reactivated in people who have recovered from chickenpox. 

The study, which had 491 participants, found that six female patients between the ages of 35 and 65 developed shingles for the first time in their lives after either the first or second dose.

The Pfizer/BioNTech vaccine “might provoke reactivation of herpes zoster in patients with AIIRD,” said the authors. 

The study suggested a “potential causal link between the vaccination and reactivation of zoster infection,” while some researchers argue that there is insufficient evidence to make that claim. 

“We cannot say the vaccine is the cause at this point,” Dr Victoria Furer, lead researcher on the study, told the Jerusalem Post. “We can say it might be a trigger in some patients.”

“So far, the data indicates that shingles and herpes are not occurring at an increased rate in the vaccinated population,” said Dr William Schaffner, Professor in the Division of Infectious Diseases at the Vanderbilt University School of Medicine. 

Image Credits: Johnson & Johnson, Johnson & Johnson, Flickr – Official US Navy.

“Sea of Solitude” Launch Trailer – the video game has been used to support more open mental health discussions during the COVID-19 pandemic

Connection, community, stability – these are not the usual terms associated with video games. Yet a groundbreaking new study from Oxford Internet Institute (OII) found that playing video games may also be beneficial to mental health – particularly in the context of pandemic lockdowns and social gathering restrictions that have been a common feature in many countries over the past 18 months.  

The study looked at the relationship between real game time data (as opposed to self-reported data) and well-being, and the relationship between directly measured behaviour and subjective mental health. It also investigated the roles of player experiences, specifically how feelings of autonomy, relatedness, competence, enjoyment, and pressure to play were related to well-being. 

“Our findings show video games aren’t necessarily bad for your health; there are other psychological factors which have a significant effect on a persons’ well-being. In fact, play can be an activity that relates positively to people’s mental health,” said Professor Andrew Przybylski, Director of Research at the Oxford Internet Institute, University of Oxford, and lead author of the study.

Przybylski will be one of the experts appearing a public webinar panel this Thursday, 15 July, to discuss the issue of video games and well being during the COVID-19 pandemic. Video games associations across the globe have come together to host the virtual panel session.

“The pandemic highlighted not only the joy and comfort that games provide, but also their ability to deliver health and safety messages all over the world,” according to the Interactive Software Federation of Europe, which is hosting the event.

During the pandemic, the #PlayApartTogether initiative was one of many successful industry initiatives that used video games to help disseminate public health messaging – encouraging gameplayers to follow WHO’s health advice on Covid-19 prevention. Meanwhile, games like Sea of Solitude helped players confront loneliness and depression, encouraging open discussion about mental health issues with other household members.

Washington Post games reporter Gene Park will moderate the panel that will explore video gameplay behaviour during the pandemic, as well as probing the question of what “games for health” can look like.  The panel members include: 

  • Professor Andrew Przybylski, Director of Research, Oxford Internet Institute will speak on the recent Oxford study
  • Cornelia Geppert, CEO/Writer/Art & Creative Director/Game Design, Jo-Mei Games will speak on the Sea of Solitude. You can find Guardian’s review of the game here.
  • Eduardo Mena, Research Director, Ipsos Mori will speak on the Q1/Q2 2020 video gameplay behaviour during lockdown report.

Anyone can register and join the conversation.

 

COVAX
COVAX COVID-19 vaccine deliveries in Africa in May 2021.

Gavi, the Vaccine Alliance has signed advanced purchase agreements (APAs) with Sinopharm and Sinovac, Chinese biotech firms, to immediately begin supplying the global COVAX Facility with 110 million doses of COVID-19 vaccines, the agency announced on Monday.

The agreements come as the Delta variant, first identified in India and classified as a WHO variant of concern in mid-May, increasingly poses a threat to health systems globally. It has been reported in 104 countries and is expected to become the dominant variant worldwide in the coming months.

GAVI committed to purchase 60 million doses from Sinopharm, which will be made available from July through October. An additional 60 million doses can be purchased between October and December and 50 million more doses will be available in the first half of 2022.

Some 50 million doses of the Sinovac vaccine were purchased in advance by GAVI, which will be available between July and September. GAVI will have the option to purchase a further 150 million doses from October to December and 180 million in the first half of 2022.

The addition of the Sinopharm and Sinovac vaccines diversifies COVAX’s portfolio, which now includes 11 vaccines and vaccine candidates.

The agreement also helps fill the huge gap that was created in the GAVI when the Serum Institute of India redirected hundreds of millions of AstraZeneca vaccine doses, originally promised to GAVI, to domestic Indian requirements earlier this spring.  Although a recent commitment by the United States and Pfizer, to provide 500 million doses of the mRNA vaccine at cost to COVAX, will help, it’s not enough to fill the vacuum created.  In addition, the Chinese-made vaccines are easier to administer since, unlike Pfizer, they don’t require ultra cold storage.

“I welcome today’s agreements with Sinopharm and Sinovac, which will make doses immediately available to COVAX participants,” said Dr Seth Berkley, CEO of GAVI. “This is yet another example of GAVI’s active portfolio management strategy, ensuring the Facility has options in the face of constraints such as supply delays.”

“Thanks to this deal, and because these vaccines have already received WHO Emergency Use Listing, we can move to start supplying doses to countries immediately,” Berkley added.

Gavi has recently published an updated Facility global supply forecast, which shows that, thanks to several deals with manufacturers as well as donations from countries with excess supply, COVAX is on track to deliver more than 2 billion doses by early 2022. Of these, 1.8 billion fully donor-funded doses will be available for the 92 lower-income participants eligible for support by the Gavi COVAX AMC.

Read the GAVI press release here.

Image Credits: Twitter – Chinese Embassy Manila, UNICEF.

Dr Soumya Swaminathan, WHO Chief Scientist, at a WHO press conference on Monday.

Human genome editing has great potential to improve health and serve as a tool for public health, according to two landmark WHO reports, the world’s first to issue global recommendations on the safe, effective, and ethical use of human genome editing. 

“These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science,” said Dr Soumya Swaminathan, WHO Chief Scientist, at a press conference on Monday. “As global research delves deeper into the human genome, we must minimize risks and leverage ways that science can drive better health for everyone, everywhere.”

Human genome editing refers to the use of tools, such as clustered regularly interspaced short palindromic repeats Cas9 nuclease (CRISPR-Cas9), to modify the human genome with the intention of treating or preventing disease. 

The two new WHO reports make technical recommendations on the use of human genome editing technologies – as well as proposing a governance framework for WHO member states to make more coherent global policy decisions on the emerging technology. 

“Human genome editing has the potential to advance our ability to treat and cure disease, but the full impact will only be realized if we deploy it for the benefit of all people, instead of fueling more health inequity between and within countries,” said Dr Tedros Adhanom Ghebreyesus, WHO director general, in a press release. 

Human genome editing has already demonstrated potential benefits for the diagnosis, treatment, and prevention of genetic disorders; treatment of infertility; promotion of disease resistance; development of vaccines; and enhancement of knowledge of human biology. 

Genome editing technologies can be used on somatic cells (non-heritable cells), germline cells (not for human reproduction) and heritable germline cells (used for human reproduction).

“Somatic gene editing is the one that has the immediate potential for the prevention and treatment of diseases,” said Dr Soumya Swaminathan, WHO chief scientist, at a WHO press conference on Monday. 

Somatic gene therapies have already been used in clinical trials to address HIV, sickle-cell disease, an inherited red blood cell disorder, and transthyretin amyloidosis, a life-threatening disease characterized by the progressive accumulation of proteins in tissues.

Of the 156 ongoing clinical trials using somatic genome editing, several have had promising results, according to experts at the press conference.

The technology could also improve the treatment of cancers. 

Human genome editing, however, raises numerous ethical, social, and equity issues. There are still significant gaps in scientific understanding and risks, particularly with germline and heritable genome editing. 

Heritable genome editing alters the genome of embryos, meaning that the resulting child would likely have the edits in all their cells, including their own germline, so they could pass the edits on to subsequent generations, modifying their traits. 

Controversial Genome Editing Experiments Prompted Creation of Advisory Committee

The forward-looking reports are the result of the first global consultations on human genome editing by the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing.

The global multidisciplinary expert advisory committee, composed of 18 experts, was convened by WHO in 2018 to develop global standards for governance and oversight of human genome editing by examining the scientific, ethical, social, and legal challenges associated with genome editing. 

The creation of the committee and the reports was prompted by controversial human genome editing experiments in China, Russia, and Ukraine. Researchers in China and Russia implanted gene-edited embryos into women in an attempt to prevent HIV infection.

In Ukraine, a country with no regulations on germline gene editing, embryonic germline genome editing is already being used in clinics to help infertile women with mitochondrial genetic diseases to have biological children. 

Such real-life germline genome editing experiments have, however, remained controversial. In a 2019 statement, the WHO DG said: “it would be irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing.”

“Human germline genome editing poses unique and unprecedented ethical and technical challenges,” said Tedros in his statement, advising then that: “regulatory authorities in all countries should not allow any further work in this area until its implications have been properly considered.”

“No one in their right mind, at the moment, should contemplate doing [heritable genome editing] because the techniques are simply not safe enough or efficient enough,” Professor Robin Lovell Badge, member of the Advisory Committee and head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute in the UK, said at the press conference on Monday. 

Professor Robin Lovell Badge, member of the WHO Expert Advisory Committee and head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute in the UK.

“There’s a long way to go to get those techniques to a state where they could be used, if ever,” said Badge.

Framework of Governance for Genome Editing

The new reports focus on providing mechanisms for the governance of applications of genome editing technologies, offering concrete recommendations for dealing with specific scientific scenarios. 

The governance framework was developed by drawing from good practices in the governance of emerging technologies and applying them to human genome editing. It is intended to assist in the strengthening of oversight mechanisms.

According to the committee, some existing governance structures and processes could be used for human genome editing, although they may need to be reinforced or amended. In countries where governance gaps exist, the framework advises national authorities to fill them.

The committee identified values and principles to guide policy making, noted the variety of ways governance mechanisms can be used to provide oversight, and used scenarios to demonstrate how to use the framework.  

“The framework calls on all countries to incorporate key values and principles into their chosen policies, such as inclusiveness, social justice, responsible stewardship of science, solidarity, and global health justice, and to use those to inform how and what policy decisions are made,” said Dr Margaret Hamburg, Co-chair of the Committee and former Commissioner of the US Food and Drug Administration. 

Dr Margaret Hamburg, Co-chair of the Committee and former Commissioner of the US Food and Drug Administration.

The framework outlines policy tools that could be used for governance, including domestic regulatory, judicial rulings, institutional standards, funding conditions, professional guidelines, and patent licensing provisions. 

The report applied the values, principle, and policy tools to a variety of research and clinical scenarios to demonstrate how the framework could operate in practice. 

The governance framework offers concrete recommendations for dealing with specific scenarios such as:

  • A hypothetical clinical trial of somatic human genome editing for sickle cell disease proposed to take place in West Africa;
  • Proposed use of somatic or epigenetic genome editing to enhance athletic performance; and
  • An imaginary clinic based in a country with minimal oversight of heritable human genome editing that offers these services to international clients following in vitro fertilization and preimplantation genetic diagnosis.

The governance framework was created to be “scalable, sustainable, fit for purpose at the international, regional, national, and local levels, and work in settings where regulation may be weaker or where genome editing research is not being pursued at present,” said Hamburg. “Above all it has to be practical and usable.”

“There is no one single mechanism to offer absolute oversight of these evolving technologies,” said Hamburg. 

“It really requires a multifaceted, multilayered approach and involves educating scientists about their own responsibilities, having standards and oversight at research institutions, having professional organizations develop codes of conduct, having national regulatory and legal frameworks, and having global guidelines and standards,” said Hamburg.

Recommendations on the Governance and Oversight of Genome Editing

The recommendations, covering a range of real opportunities and challenges, were designed to supplement the governance framework. 

The committee members called upon WHO and the Director General to build on the moral leadership it showed during the COVID-19 pandemic by continuing to make clear statements about the ethical and acceptable uses of the technology. 

In addition, WHO should integrate human genome editing into the regulatory strengthening and capacity building teams in WHO’s Department of Essential Medicines and Health Products. 

Partnerships between WHO, other UN agencies, research institutions, and civil society should be established to develop a coordinated and collaborative approach to standard setting and oversight. 

The global registry on human genome editing, which was launched in 2019 to track research on genome editing, should be improved by establishing a vetting mechanism to flag clinical trials that may be of concern; develop an additional registry for pre-clinical research, in order to help policymakers govern proactively to developments in the field; and establish a small committee to monitor the clinical trials registry and develop a set of international standards for clinical trials involving human genome editing. 

“Good policies begin with good facts and registries can help provide essential information about the state of the science and direction of future applications [of the technology],” said Hamburg. 

In order to counter the illegal, unregistered, unethical, or unsafe research activities in human genome editing, the committee recommended developing a mechanism for confidential reporting of concerns about such activities. 

“The formal mechanisms of whistleblowing…[that] we’re proposing in our report should really bring together all the different mechanisms that can be used to prevent inappropriate uses of technology,” said Badge.

The committee’s recommendations covered five additional areas, including:

  • International research and medical travel;
  • Intellectual property;
  • Education, engagement, and empowerment;
  • Ethical values and principles for use by WHO; and
  • Review of the recommendations.

Members of the expert committee advised that a review of the recommendations and progress made on them take place in no more than three years.

Image Credits: WHO.

lambda
The Lambda variant, originated in Peru in August 2020, has since become the dominant strain of the country.

The Lambda variant has now been found in 29 different countries, seven of them in Latin America and it is the dominant strain in Peru. 

The Lambda variant, or the C.37 strain, designated a variant of interest by the WHO on 15 June 2021, was first identified in Peru in August 2020. It is widespread across Argentina, Brazil, Colombia, Ecuador, and Mexico, and has since spread to the UK. 

Dr Maria Van Kerkove, WHO Technical Lead on COVID-19, has said that the WHO is currently tracking this strain to see if it should be upgraded to a variant of concern. 

“It would become a variant of concern if it has demonstrated properties of increased transmissibility, increased severity, or has some kind of impact on our counter-measures,” said Van Kerkhove during a 2 July briefing. 

Countries around the world, including Russia, Portugal, and South Africa, are currently scrambling to control the Delta variant, reported to be more deadly and infectious than any other variant. 

Lambda Majority of New Cases in Peru 

The Lambda variant now accounts for 82% of new cases in Peru.

In Peru, where the strain was first reported, the Lambda variant accounts for almost 71% of COVID-19 cases since January 2021 and almost 82% of case samples during May and June, according to the Pan American Health Organization (PAHO). 

“Lambda has become the dominant variant in Peru in a very short period of time,” said Pablo Tsukayama, who worked with his team at Lima’s Cayetano Heredia University, to trace the evolution of the Lambda variant in Peru. Tsukayama has also said that Lambda is more transmissible. 

“With 187,000 dead and the highest mortality rates in the world, we are the country that has struggled most when it comes to the coronavirus. Therefore, it is probably no wonder that the new variant has gotten its start here.”

However, PAHO’s Regional Advisor on emerging viral disease, Jairo Mendez-Rico, has said that there was not yet clear evidence it was a more transmissible virus. 

“So far we have seen no indication that the Lambda variant is more aggressive,” Mendez-Rico told DW. 

“It is possible that it may exhibit higher infection rates, but we don’t yet have enough reliable data to compare it to Gamma or Delta.” 

Mendez-Rico said inoculation presented the most effective defense: “All of the vaccines we have approved worldwide have been generally effective against circulating coronavirus variants, and there is no reason to suspect them to be less so against lambda.”

Variant is Potentially More Infectious 

A pre-print analysis published on 3 July, though yet to be peer-reviewed, of the spike proteins on the SARS-CoV-2 Lambda variant showed a two-fold increase in infectivity, due to a mutation of the virus called the L452Q mutation. 

In addition to testing the infectivity of the variant, researchers from the NYU Grossman School of Medicine also tested the effectiveness of mRNA vaccines Pfizer and Moderna against the C. 37 strain.

Though the virus with the Lambda spike protein demonstrated “a partial resistance to neutralization by vaccine-elicited antibodies” results “suggest that vaccines in current use will remain effective against the lambda variant”. 

Further Research Needed to Ascertain Effectiveness of Vaccines 

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

However, another pre-print paper found the Lambda variant to have mutations with increased resistance to the vaccine, CoronaVac. 

Researchers examined the impact of the lambda variant on infectivity and antibodies produced by the COVID-19 vaccine CoronaVac, using plasma samples from healthcare workers in Santiago, Chile, who received the two-doses of CoronaVac. 

They found that the Lambda spike protein had increased infectivity when compared to the Alpha or Gamma variants. 

The antibodies produced by CoronaVac decreased by a factor of 3.05 from the Lambda spike protein, while antibodies decreased by a factor of 2.33 for the Gamma spike, and 2.03 for the Alpha spike. 

“These data reinforce the idea that massive vaccination campaigns in countries with high SARS-CoV-2 circulation must be accompanied by strict genomic surveillance,” the paper said. 

Chile leads in its vaccination program with over 50% of its population vaccinated, the vast majority (78.2%) receiving CoronaVac. 

In another large study of the efficacy of the vaccine on 10.2 million Chileans, it was found that CoronaVac was 65.9% effective in preventing infection, 87.% effective in preventing hospitalization and 86% effective in preventing death after two doses, according to a report published in the New England Journal of Medicine (NEJM) on Thursday. 

However, further research will be needed to determine the effectiveness of vaccines against the new variant, according to the NEJM.

Eight Cases of New Strain in UK

The Delta variant remains the most dominant strain in the UK.

Eight people have tested positive with the Lambda variant in the UK, as of 2 July 2021. However, the Delta variant remains the prominent strain in the UK, with 161,981 total cases confirmed in the region. 

In spite of reports calling the Delta variant the “fastest and fittest variant”, the UK government is still moving forward with easing restrictions, planning to move to Step 4 in England on 19 July.  

“Of course the pandemic is not over. The virus is still with us, it hasn’t gone away – and the risk of a dangerous new variant that evades vaccines remains real,” said Sajid Javid, Secretary of State for Health and Social Care, in statement to Parliament. 

“We know that with COVID-19, the situation can change – and it can change quickly. But we cannot put our lives on hold forever.”

Step 4 will revoke all social distancing guidance in England, including the 2-metre (6-foot) rule, except for specific settings, such as ports of entry and medical settings. 

It will also no longer be required to wear a face mask in any setting, including on public transportation. It will also no longer be necessary to work from home. 

Image Credits: NewsBytesApp/Twitter, Flickr: Victor Idrogo / Iconica / Centella Comunicaciones para Banco Mundial, Twitter – Chinese Embassy Manila.

Fresh fruits are on sale across Africa but the fight against obesity is yet to attract enough attention.

The Kenyan government has taken the fight against childhood obesity to the classroom through a revised school curriculum that focuses on health and healthy lifestyle behaviours.

The initiative involves including science-based food and nutrition material in the academic content and introducing physical literacy from Grade One.

Addressing a recent Word Obesity Federation (WOF) virtual event on Obesity in Africa: An emerging challenge and a regional perspective, Amonje Moses, Executive Director and Founder of Wellness for Greatness Kenya, said this model was being used by the WOF to encourage governments worldwide to address childhood obesity.

“If you look at our approach of having curriculum support materials in schools, we deliberately made sure that teachers will be able to learn more ideas and have different strategies on how to engage students in physical activities. Physical literacy will make them understand the importance of participating in physical activity,” said Moses.

“We want children all the way from grade one to be taught on healthy eating. With that, we are going to inculcate good dietary behavior in children, so that as they develop to adulthood, they have good nutrition practices,” Veronica Kirogo, Director of the Division of Human Nutrition and Dietetics at Kenya’s Ministry of Health, told the event.

In addition to the adapted curriculum, Kenyans schools also have wellness councils and committees to support teachers, learners and parents to implement the programmes.

According to the World Health Organization (WHO), obesity has nearly tripled since 1975, and health issues associated with being overweight and obesity now kill more people globally than those linked to being underweight.  WHO data also reveal that a staggering 38 million children under the age of 5 were overweight or obese in 2019.

More Lasting Solutions Needed to Deal with Obesity

While education is one tool that can raise awareness about obesity, WOF chief executive Johanna Ralston and other health and nutrition experts say that more lasting solutions are needed to achieve long-term gains against obesity. 

These include properly defining what type of disease obesity is, clarifying societal confusions and scientific contradictions and taking action that will help raise children that are fully aware of good nutrition and continue to eat well as adults.

Cultural perceptions of obesity in sub-Saharan Africa are also hampering efforts to address it, as many communities see being overweight as a sign of wealth and influence in Africa.

“One of my colleagues from Kenya who works in the heart foundation said if you go to a wedding ceremony and the bride isn’t plump, everybody will say to the man, ‘you need to fatten her up to show that you’re successful’,” Ralston said.

The lack of data on obesity in lower-income countries also poses a major problem in getting a clearer picture of the state of the disease, resulting in many countries using data extrapolated from high-income and developed countries to try and address their unique issues.

“We have tons of data for some countries, and they tend to be more in Europe, in the US and high income countries, and much less for other countries,” Ralston said.

Obesity is a Malignant Disease with 200 Complications

One example of how data and science could assist in dealing with obesity is the proper education of Africa’s healthcare workers on how to properly frame obesity – as a disease or not and what type of disease it is.

Dr Carel Le Roux, Co-Director of the Metabolic Medicine Group Diabetes Complications Research Centre at Dublin-based Conway Institute University College, says that obesity can be regarded as a malignant disease, considering that the ill-health and deaths linked to it are not directly caused by the disease but via its contributions to hyperglycemia, nephropathy, neuropathy or macrovascular complications — heart attacks and strokes.

“I think we can frame obesity as a disease, but also it is a malignant disease —  it’s a disease that has more than 200 complications. So you can view it from different sides. If you are, for example, a respiratory physician and you treat sleep apnea, you will view obesity as a risk factor for sleep apnea and I understand that, I think that’s perfectly valid,” Roux said.

One of the challenges with this definition, said Roux, is that not everybody that has obesity develops type two diabetes and not everybody develops osteoarthritis.

“So we are just not clever enough yet to predict which patients with obesity will go on to develop the complications and that’s an important step that is needed,” Roux said.

There are also disagreements about how to refer to people living with obesity without contributing to their stigmatisation. Ralston had earlier told Health Policy Watch that graphic images used on news platforms to accompany stories on obesity often portray individuals living with the condition in a bad light and this belittles the person and shifts focus from regarding obesity as a disease to the result of an individual’s poor lifestyle choices.

Moses echoed Roux’s sentiments and added that such degrading references are not accorded to persons living with other non-communicable diseases including diabetes and cancer.

“I have never heard of a situation whereby a person living with cancer is referred to as ‘this person is cancerous’. So it is not tolerable to talk to and refer to people living with obesity like ‘this person is obese’,” he said.

According to him, the emotional wellbeing and concerns of persons living with obesity within and beyond Africa should always be put into consideration by everyone — including health workers providing services to them.

Preventing Adult Obesity by Focusing on Children and Education

In 2012, the World Health Assembly endorsed a plan on maternal, infant and young child nutrition, which specified a set of six global nutrition targets by 2025.

The plan aims to achieve a 40% reduction in the number of children under-5 who are stunted; a 50% reduction of anaemia in women of reproductive age; a 30% reduction in low birth weight; increase the rate of exclusive breastfeeding in the first 6 months up to at least 50%; reduce and maintain childhood wasting to less than 5%; and ensure that there is no increase in childhood obesity. Progress is being made on all fronts except obesity.

The COVID-19 and Obesity: The 2021 Atlas that was published in March 2021 also revealed that obesity exacerbates the burden of the COVID-19 pandemic —out of the 2.5 million COVID-19 deaths reported by the end of February 2021, 2.2 million were in countries where more than half the population is classified as overweight.

According to Dr Francesco Branca, Director of WHO’s Department of Nutrition for Health and Development, problems stem from food and food systems.

“Food systems, unfortunately, are not functional. They’re making us ill with non-communicable diseases, including obesity, but also they’re affecting our planet through climate change, and reducing biodiversity, and COVID-19 has demonstrated how vulnerable food systems can be,” Branca said.

Image Credits: WHO/Quinn Mattingly, Paul Adepoju/HPW .

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.