A group of senior U.S. Food and Drug Administration (FDA) officials – including two who announced they will soon resign – have authored a report disagreeing with the White House’s plan to roll out COVID-19 vaccine boosters next week.
In a report published in in The Lancet on Monday, the 18 officials write that there is no evidence supporting the need for boosters because fully vaccinated people still have high levels of protection against hospitalization or death.
Instead, they say, vaccine doses should be donated to areas with lower vaccination rates to prevent the emergence of more COVID-19 variants.
Although the administration is ready to roll out boosters starting September 20, President Joe Biden said last week that any decisions – including when to authorize boosters and who should receive them – will be left up to the FDA and the Centers for Disease Control and Prevention (CDC).
The group of FDA authors of the new report include Dr Marion Gruber and Dr Philip Krause, who plan to step down in the coming months due to disagreements over the rollout of vaccines.
Dr Philip Krause (left) and Dr Marion Gruber (right) were both among 18 FDA officials who published a report opposing the White House’s proposed plans to roll out COVID-19 vaccine boosters. Both also plan to resign in protest in the coming months.
‘Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society,’ the officials wrote in the report.
‘COVID-19 vaccines continue to be effective against severe disease, including that caused by the Delta variant.
‘Most of the observational studies on which this conclusion is based are, however, preliminary and difficult to interpret precisely due to potential confounding and selective reporting.’
Like many other vaccines, the Covid jabs have declining efficacy over time.
The Delta variant, which is now the dominant variant in the U.S. and across the world, is also believed to have an increased ability to cause breakthrough cases.
According to a study by the Mayo Clinic – which was cited by White House officials as data supporting the need for boosters – the Pfizer-BioNTech vaccine is only 42 percent effect against the variant and the Moderna vaccine is 76 percent effective.
The White House plans to roll out vaccine boosters next week, though the shots are unlikely to receive regulatory approval before then, halting the plan. Pictured: A woman in Tel Aviv, Israel receives a vaccine booster shot on August 30
The same study finds that the vaccines are 75 percent effective at preventing hospitalizations or deaths from the virus, though.
Whether the waning effectiveness of the vaccines is because of features of the Delta variant in particular, or just a decreasing effectiveness over time in general, could not be determined.
But as long as the vaccines are effective at preventing severe disease and death, that’s the most important factor, the officials wrote.
‘Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,’ they wrote.
Vaccinating others abroad could also prevent the creation of variants which eventually find their way to the U.S., like the Delta variant that originated in India.
The vaccines also have rare, but potentially dangerous side effects, though, and every time a person receives a shot there is a chance they suffer one of the symptoms.
Receiving boosters a person does not need could be opening them to unneeded risk.
‘There could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines,’ the report reads.
The officials are not entirely writing off boosters, though, saying that there could be need for them in the future, just not now.
‘Boosting might ultimately be needed in the general population because of waning immunity to the primary vaccination or because variants expressing new antigens have evolved to the point at which immune responses to the original vaccine antigens no longer protect adequately against currently circulating viruses,’ they wrote.
The letter could prove to be yet another setback for the White House’s attempt to get vaccine booster shots out.
Last month, health officials announced the those who received the Pfizer-BioNTech or Moderna vaccine would be eligible for a third shot eight months after receiving their second, starting September 20.
The move was pending approval from the regulators like the FDA, though, and it appears they will not be approved by the planned roll out date next Monday.
Gruber and Krause were frustrated by the decision from the White House to make the public announcement for the shots before approval, leading to the pair – who are crucial to the FDA’s process of approval of vaccines – announcing they will soon resign.
Gruber is the director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research (CBER).
Krause is the deputy director of CBER.
The office is responsible for regulating ‘biological products for human use under applicable federal laws,’ according to the FDA.
In essence, the office is largely responsible for making final decisions regarding things like vaccines, and making sure they are safe for human consumption.
Gruber is one of the most important figures in the approval of vaccines.
Now with senior officials choosing to publicly oppose the measure, the White House’s plans could be in turmoil.