More than 740,000 newly diagnosed cancer cases in 2020 may be linked to alcohol consumption, with men accounting for more than three-quarters of those cases, a new global study estimates.

The study published in The Lancet Oncology estimates that men accounted for 77% (568,700) of alcohol-associated cancer cases last year, compared with women, who accounted for 23% (172, 600) cases. 

The highest number of alcohol-associated cancers were found in Eastern Asia and Central and Eastern Europe, while the lowest was found in Northern Africa and Western Asia.

Globally, an estimated 4% (741,300) of all new cases of cancer in 2020 were associated with alcohol consumption, with cancers of the oesophagus (189,700 cases), liver (154,700 cases), and breast (98,300 cases) accounting for the largest number of new cases, followed by colorectal cancers and cancers of the mouth and throat. 

The authors of the first-of-its-kind study have called for greater public awareness of the link between alcohol and cancers and increased government interventions to reduce alcohol consumption in worst-affected regions.

“We urgently need to raise awareness about the link between alcohol consumption and cancer risk among policymakers and the general public,” said Harriet Rumgay of the International Agency for Research on Cancer (IARC) in France.

Rumgay said public health strategies, such as reduced alcohol availability, labelling alcohol products with a health warning, and marketing bans could reduce rates of alcohol-driven cancer. 

“Tax and pricing policies that have led to decreased alcohol intake in Europe, including increased excise taxes and minimum unit pricing, could also be implemented in other world regions. Local context is essential for successful policy around alcohol consumption and will be key to reducing cancer cases linked to drinking,” said Rumgay.

The authors estimate that there were more than 6.3 million cases of mouth, pharynx, voice box (larynx), oesophageal, colon, rectum, liver, and breast cancer in 2020.

However, they say the number of cancer cases are likely to be higher as disruptions to health care and cancer services due to the COVID-19 pandemic are likely to have affected diagnosis rates.

Other limitations to the study include not taking into account former drinking or any relationships between tobacco or obesity with alcohol. This, researchers said, could have “attributed some cases to alcohol that were actually driven by, for example, smoking”.

The study was conducted by researchers from IARC, Centre for Addiction and Mental Health in Canada, the University of Toronto, Canada, Centre for Research and Information on Substance Abuse in Nigeria, American Cancer Society,  Netherlands Comprehensive Cancer Organisation, Erasmus MC University Medical Centre, the Netherlands,Sechenov First Moscow State Medical University, Russia and Technische Universität Dresden in Germany.

More Accurate Measure of Alcohol Exposure Could Improve Health Intervention

Professor Amy C. Justice, Yale University, USA, (who was not involved in the study), notes that estimating the effects of alcohol intake on cancer rates across countries is “notoriously difficult”. She  said a quarter of alcohol purchases are not captured by government data, making it difficult to estimate accurate sales figures. 

“Achieving a solid understanding of the burden of cancer associated with alcohol use, underlying mechanisms, and how best to intervene rely on accurate measures of alcohol exposure… Until we address limitations in measurement, we might be underestimating health risks, especially cancer risks, associated with alcohol,” said Justice.

In population-based study, researchers established levels of alcohol intake per person per country for 2010 then combined it with estimated new cancer cases in 2020 to estimate the number of alcohol-associated cancers in each country.  

They could estimate how much alcohol people drank per year using estimates for alcohol intake in litres per year per adult based on alcohol production data, tax and sales data, surveys and opinion on unrecorded alcohol intake, and tourist alcohol consumption data.

Moderate drinking was classed as intake of 0·1 to 20 grams per day, the equivalent of up to two alcoholic drinks; risky drinking as 20 to 60 g per day, between two and six alcoholic drinks per day; and heavy drinking as more than 60 g per day, more than six alcoholic drinks per day. 

Small Changes to Drinking Behaviour Could Positively Impact Future Cancer Rates

The researchers used figures outlining the risk of each cancer type included from alcohol consumption (per 10 grams of alcohol consumed per day) from existing scientific reports. 

Risky drinking and heavy drinking led to the largest proportion of cancer cases at 39% (291,800 cases) and 47% (346,400 cases) respectively. However, moderate drinking was also found to be problematic, with estimates that this level of drinking accounted for 14% (103,100 cases) of the total of alcohol-caused cases.

The highest proportions (6%) of cancer cases that could be associated with alcohol were registered in Eastern Asia and Central and Eastern Europe regions. Northern Africa and Western Asia had the lowest proportions(1%).

At a country level, the proportions of cancer cases associated with alcohol were estimated to be highest in Mongolia (10%, 560 cases) and lowest in Kuwait (estimated at 0%, less than 5 cases). The UK had an estimated 4% of cancer cases linked to alcohol (16,800), with the United States at 3% (52,700), Brazil at 4% (20,500), India at 5% (62,100), China 6% (282,300), Germany 4% (21,500) and France at 5% (20,000 cases).

However, the researchers note that in some cases, including Mongolia, they may have overestimated liver cancers that could have been caused by alcohol because of a possible interaction with Hepatitis B and C virus infection. 

Amongst women, the largest proportions of cancer cases that were attributed to alcohol were in Central and Eastern Europe (3%, 21,500 cases), and Australia and New Zealand (3%, 2,600 cases). Amongst men, the largest proportions of cancer cases linked to alcohol were found in Eastern Asia (9%, 275,900 cases) and Central and Eastern Europe (8%, 49,900 cases). 

“Trends suggest that although there is a decrease in alcohol consumption per person in many European countries, alcohol use is on the rise in Asian countries such as China and India, and in sub-Saharan Africa,” said Rumgay, adding that the COVID-19 pandemic had increased rates of drinking in some countries.

“Our study highlights the contribution of even relatively low levels of drinking to rates of cancer, which is concerning, but also suggests that small changes to public drinking behaviour could positively impact future cancer rates.” said Rumgay.

The Sputnik V vaccine will increase its production globally through the new partnership with the Serum Institute of India.

The Serum Institute of India (SII), the world’s largest vaccine manufacturer, is set to begin producing Russia’s Sputnik V COVID-19 vaccine in September, paving the way to scale up globally available COVID vaccines. 

The Sputnik V vaccine, produced by Moscow’s Gamaleya Institute and marketed abroad by the Russian Direct Investment Fund (RDIF), is a two-dose adenovirus vaccine that has boasted an efficacy of 91.6% in clinical trials. 

The new agreement with SII will produce over 300 million doses of the vaccine in India every year. 

“RDIF is delighted to cooperate with Serum Institute of India, the world’s largest vaccine manufacturer,” said Kirill Dmitriev, CEO of the Russian Direct Investment Fund, in a press release.

“This strategic partnership is a major step to substantially increase our production capabilities demonstrating a perfect example of joining forces and expertise to save lives both in India and around the world,” Dmitriev added.

The cell and vector samples for the vaccine have been sent from the Gamaleya Center as part of the technology transfer process. 

“With technology transfer underway, we expect the first batches of the vaccine to be produced jointly with SII in coming months,” said Dmitriev.

RDIF currently has agreements with six pharmaceutical companies in India to produce Sputnik V, making India the hub of production for the vaccine.

Sputnik V is priced at only $10 per dose, which is only a third of the cost of its mRNA counterparts – Moderna and Pfizer/BioNTech – and it can be stored in conventional refrigerators for months.

“With high efficacy and a good safety profile, it is critical that the Sputnik vaccine is accessible in full measure for people across India and the world,” said Adar Poonawalla, CEO of the Serum Institute of India.

Study Shows Sputnik Produces Weaker Antibody Response Against Some Variants

A new study, conducted by Russian researchers and published in Vaccines journal on Monday, found that the Sputnik V vaccine was less effective against agressive new SARS-CoV2 variants.

Researchers of the study, who were involved in the development of the vaccine, used blood samples from people who had been fully vaccinated to test the vaccine-induced neutralizing antibody response against seven prominent variants.

Significant reductions in the neutralizing effect was observed against three variants of concern identified by WHO: Delta, first identified in India, Beta, identified in South Africa, and Gamma, identified in Brazil.

A 3.1 fold reduction in virus-neutralizing activity was found against Delta, 2.8 fold decrease against Beta, and 2.5 fold reduction agsinst Gamma.

Although there was a “statistically significant…reduction…Notably, this decrease is lower than reported in publications for other vaccines,” said the study.

The Gamaleya Center and RDIF are reportedly studying opportunities to develop vaccine cocktails jointly with other leading COVID vaccine producers using the first component of Sputnik V.

Sputnik Awaits Authorization from WHO and EMA

Sputnik V has been authorised for use in 67 countries, but it is still awaiting emergency use listing from WHO and authorization from the European Medicines Agency (EMA).

WHO has required additional data from the Gamaleya Center and plans to follow up on inspections of Sputnik V’s domestic production facilities, with no date set to make the final decision on authorization. 

The EMA has delayed Sputnik V’s approval following the RDIF’s failure to submit additional clinical trial data by a deadline that was initially set for early June.

Image Credits: Ministry of Defence of the Russian Federation, RDIF.

A South African police officer walks through a looted store in Vosloorus, Johannesburg on 12 July 2021.

JOHANNESBURG – Violent unrest in South Africa has had a disastrous impact on the country’s healthcare and emergency services and has brought the COVID-19 vaccine roll-out to a near standstill in at least two provinces, as the country continues to battle with a third wave of the pandemic.

On Tuesday, the national health department temporarily halted vaccinations in the Gauteng and KwaZulu-Natal provinces where sites have been affected by the ongoing looting and unrest in the country.  The setback comes as the country is trying to contain COVID-19 infections with a strict curfew, a ban on alcohol sales and restrictions on movement. The majority of daily infections (80 640 on 12 July ) are recorded in Gauteng.

Parts of the two provinces experienced mayhem with several businesses looted, destroyed and set ablaze. Chaos descended following the imprisonment of former president Jacob Zuma on 7 July for contempt of court for refusing to appear before a commission of inquiry into corruption.

The country’s biggest pharmaceutical chains, Dis-Chem and Clicks,  on Monday also announced that they will not be open for regular business or COVID-19 vaccines in KwaZulu-Natal following violence including shops being looted and set ablaze.

Discovery Medical Scheme, the biggest medical-scheme administrator in SA, closed all its vaccination sites except one in Cape Town on Tuesday. The company said it was prioritising the safety of its staff and would reopen when possible.

The Department of Health said that the violent unrest had impacted on the vaccine rollout and access to chronic medication for TB, HIV and diabetes patients in parts of KwaZulu-Natal and Gauteng.  

“Government and the private sector’s priority is to protect lives and prevent harm to staff, patients and the medical supplies and property that form part of the vaccination programme. Consequently, Government and the private sector are adopting a precautionary principle and will be temporarily closing some vaccination sites which have been damaged or which may be at risk,” said Popo Maja, health department spokesman.

The department advised those in areas affected by the unrest to postpone their vaccination, saying they would soon be releasing a list of those areas. 

“The Electronic Vaccine Data System (EVDS) will automatically reschedule appointments for those unable to attend; it is programmed to reschedule up to two missed appointments. If it is not clear whether an area has been affected, the public is advised to contact the vaccination site to which they have been scheduled before proceeding to the site for the administration of vaccines,” said Papa.

Unrest is a Blow to SA’s Vaccine Rollout

The disruption is the latest blow to the country’s rollout that has been criticised for its late start. Earlier disruptions include a decision not to use the AstraZeneca vaccine amid fears of its efficacy against the Beta variant of the virus, while the delivery of Johnson & Johnson vaccines were delayed after a contamination incident at a US factory.

Prior to the violence that erupted last week, the vaccination numbers had been climbing steadily towards a target of 300,000 a day set by President Cyril Ramaphosa.

“Our vaccination program has been severely disrupted just as it is gaining momentum,” Ramaphosa said in a televised address on Monday. “This will have lasting effects on our ability to consolidate some of the progress we were already witnessing in our economic recovery.”

South Africa has the highest number of confirmed COVID-19 infections (2.2million) in Africa. More than 64,000 people have died of the disease. Of the almost 4.4 million doses of vaccines administered in the country so far, 23% have been in Gauteng and 22% in KwaZulu-Natal.

Looting Becoming COVID-19 Superspreader Event

The Independent Community Pharmacy Association (ICPA) said its pharmacies, some of which were offering Covid-19 vaccinations, were badly affected by unrest over the weekend and on Monday. 

“As a direct result of the violence that has spread across the country, our independent pharmacies have been looted and destroyed, with millions of rand of much-needed medication lost and destroyed,” the ICPA said.

The association said it was concerned that the latest developments would severely hamper the plan to reach the country’s daily vaccination targets.

It further warned that the destruction of pharmacies not only affected vaccination plans but patients in dire need of chronic medication and called on the government for better protection of its facilities.

“This becomes impossible since pharmacy vaccination sites have been destroyed and looted,” it said.

While SA’s vaccination programme has been severely impacted by the unrest, Caribbean country Haiti is yet to administer a single vaccine dose.

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.

Image Credits: TimesLive.

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.

 

WHO’s Director General Dr Tedros Adhanom Ghebreyesus slammed plans by Pfizer and Moderna, as well as a handful of rich countries, to begin offering ‘booster’ COVID vaccines to some groups of people – saying that the world has evolved a “dangerous” two-tiered system of vaccinations, driven by greed instead of enlightened self-interest.

“It’s becoming a two tier system, and higher income countries who are vaccinating their population significantly are starting to see the COVID-19 pandemic as if it’s not their problem. That is dangerous,” said the WHO Director General.  He noted that plans in some high-income countries to administer booster shots come at a time when the Delta variant is advancing across the world “at a scorching pace” causing increased rates of hospitalizations and deaths in many countries and regions that had beaten back previous waves – even without vaccinations.

Speaking at a WHO press conference on Monday, Tedros also called upon the G-20, the world’s most industrialized countries, which are meeting this week, to more aggressively expand vaccine manufacturing and quicken the pace of vaccine donations – while holding off on additional ‘boosters’ to their own populations.

“Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers, and the most vulnerable. I ask you, who would put firefighters on the front line without protection – and who are most vulnerable to the flames of this pandemic? Health workers are on the front lines,” he said.

“Currently, data shows us that vaccination offers long lasting immunity against severe and deadly COVID-19. The priority now must be to vaccinate those who have received no doses and protection,” the WHO DG added. “Instead of Moderna and Pfizer prioritizing the supply of vaccines as boosters to countries whose populations have relatively high coverage, we need them to go all out to channel supply to COVAX, the Africa Vaccine Acquisition Task Team, and low- and middle-income countries, which have very low vaccine coverage.”

Saying that “the whole world has been taken hostage by the virus,” he asserted that such short-sighted policies are “prolonging hostage drama.”

“Enlightened self-interest” should lead countries to conclude that it would be more prudent to see that high risk groups around the world are vaccinated as soon as possible, he added. “But I’m sorry to say that if solidarity is not working [as a motivator], then there is only one word that can explain it, and that is greed.”

Boosters Not Needed – WHO Experts Contend

Ann Lindstrand, head of WHO’s Essential Programme on Immunizations (EPI)

WHO’s Ann Lindstrand, who heads the Agency’s Essential Programme on Immunization (EPI) told reporters that as of yet, “we have not any systematic evidence that could point us to the need for booster doses.”

While acknowledging that there is a decline in vaccine-stimulated immunity over time “as it is with many different vaccines,” she said that a full course of any WHO-approved vaccine provides good protection:

“And if you look at it on the global public health impact at this moment in time, we’re confident that giving a full course… of the vaccines in place, it is at this point in time more important to be able to vaccinate larger global population with the vaccines we have rather than…to use the limited supply of doses that we have, to give them to already vaccinated populations.”

Lindstrand and other WHO officials at the briefing urged countries that “have either started or are thinking about starting to use those booster doses, that they do reconsider and think about it in a global perspective – and maybe hold off thinking about this policy change.”

She added that such doses would better be used as donations to other countries with less vaccine access:

“Particularly with the limited global supply, it is important to rethink if any country is wondering about using booster doses, and instead think of giving that supply or sharing that supply to countries that had not even reached their healthcare workers.”

Some Countries Already Offering Boosters – United Kingdom Laying Plans

According to the most 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. The Chinese vaccines, in particular, based on older technologies that use inactivated coronaviruses to bequeath immunity, have come under greater scrutiny recently after a wave of serious cases and even deaths in some countries like the Seychelles, Indonesia and Mongolia that relied heavily on those vaccines.

But 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 age 70 and over, immuno-suppressed groups and health workers.

In the United States, Pfizer was meeting with US Administration officials over the company’s plans to submit for US Food and Drug Administration approval of a third booster vaccine to battle the Delta variant.  The company statement said that its assessment that a booster will be needed is based both on laboratory analyses as well as on real-life data from Israel, one of the first countries to immunize most of its population, has shown vaccine potency waning after six months.

“As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high,” the Pfizer statement said.  “That is why we have said, and we continue to believe that it is likely, based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination.”

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 who may not have been sufficiently protected by the first two Pfizer or Moderna vaccine courses – even ahead of a US FDA decision on the proposed Pfizer booster shot.

While only four countries are actively offering boosters right now, nearly a dozen may begin to do so very soon, said WHO Chief Scientist Soumya Swaminathan at the WHO briefing.  Their combined demand would divert hundreds of millions of vital vaccines from the WHO co-sponsored COVAX facility, which is focused on supplying countries that haven’t been able to even administer a first shot to their highest-risk populations.

“If 11 high- and upper-middle-income countries decide – some of them are large countries – that they will go for a booster for their populations or even subgroups, this will require an additional 800 million doses of vaccine,” Swaminathan said.

Instead, the priority right now should still be for “doses, through COVAX, to go to countries where the front line and health care workers have not been vaccinated…[and] when there is no scientific evidence to suggest that boosters are definitely needed,” she stressed.

In a rebuttal to the Pfizer claims, Swaminathan conceded that while “”we have seen in some countries an increase in infections,” there has so far been “no significant increase in hospitalizations or deaths.”

WHO, she added, “will make recommendations on boosters when we think that they are needed. And that has to be based on the science and the data, and not on individual companies declaring that their vaccines should be administered as a booster dose.”

WHO Chief Scientist Reaffirms Efficacy of Chinese Sinovac Jab; Warns Against Ad Hoc Vaccine Mix & Matching

Swaminathan also warned against the adhoc “mixing and matching” that some countries are contemplating as part of their vaccine booster plans – saying that there is as of yet, little evidence of efficacy – except for one tested combination of a first AstraZeneca vaccine, followed by a second Pfizer jab.

“It’s a bit of a dangerous trend here, where people are in a data-free, evidence-free ozone as far as mix and match,” she said.

She meanwhile lauded a recent deal between Gavi, The Vaccine Alliance and the two Chinese vaccine manufacturers, Sinopharm and Sinovac, to supply the global COVAX facility with some 110 milion vaccine doses, beginning in July.

And she cautioned against reliance on “anecdotal reports” that the two globally-available Chinese vaccines, by Sinopharm and Sinovac, had been less effective in preventing COVID-19.

As evidence of efficacy, she cited a recent study in the New England Journal of Medicine on the mass administration of the Sinovac jab. The study, which followed some ten million people in Chile that had received the vaccine, showed the vaccine was highly effective against severe disease and death – although less so (66%) effective against symptomatic infection.

“It was done with very good statistical design and data that showed that the Sinovac was about 87% effective against hospitalization; 90% against severe disease; and 86.3% against deaths. So it shows very high efficacy, especially against the severe forms of the disease…so it was in the range of, what we’ve been expecting,” said the WHO chief scientist.  As for Sinopharm, she added:

“We are tracking also the data from Sinopharm.  We are in touch with the Chinese authorities, as well; any company that receives an emergency use listing is expected to provide additional data as, as time goes on. And at any point, if we have concerns with the efficacy of these vaccines, we would definitely make that known.”

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.