Vaccine Booster Shot Row Continues as Pfizer Trial Nears Conclusion

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.

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