The Food and Drug Administration (FDA) is receiving mounting opposition to its approval of fourth COVID-19 vaccine doses for all Americans aged 50 and older. The agency broke standard practice when it made the decision last month, electing not to take advise from a panel of independent experts. Now, experts, including some that would have been on that panel, are criticizing the decision.
Dr Marty Makary, a medical commentator and public policy expert from Johns Hopkins University, wrote an op-ed for the Wall Street Journal (WSJ) this week criticizing the FDA and its lack of transparency in the process of approving the additional shot.
The FDA made the decision quickly, only days after applications were submitted for review, and it also granted Pfizer a wider eligibility for its approval than the firm asked for.
While federal regulators push for more Covid vaccines, case in the U.S. have fallen below 30,000 per day once again and deaths from the virus remain low as well.
‘Some of the FDA’s own experts disagree with the decision, but the agency simply ignored them,’ Makary wrote.
Last week, the FDA approved second booster shots, or fourth doses overall, of the Pfizer-BioNTech and Moderna COVID-19 vaccines for all Americans aged 50 and older. Immunocompromised people 12 and older can receive the Pfizer jab as well. Severely vulnerable people are also now eligible to receive a fifth dose of the vaccine.
Authorization came quickly after the companies submitted information regarding the shots to regulators. The Pfizer shot’s authorization was especially bizarre, as the company had only requested in for Americans 65 and older, but received it for people as young as 50.
The agency made the decision citing the waning immunity against infection provided by the shots. It is believed that the vaccine is only acceptably effective against infection for a few months after receival, and with the first booster approved as far back as September, much of the protection early recipients received has waned.
Makary points out that, while the immunity against infection has waned, boosted Americans are still very unlikely to suffer hospitalization or death from the virus.
‘At the crux of the broad opposition to second boosters is the recognition of B- and T-cells, which public-health officials have long ignored,’ Makary writes.
‘They talk only about antibody levels, which tend to decline in the months after vaccination. B- and T-cells, activated by the primary vaccine series or an infection (and augmented by a single booster in older patients), are highly and durably effective at preventing serious illness from Covid.’
There is growing support for Makary’s position as well.
Upon the approval of the shots, multiple health experts arose criticizing the decision from the FDA and its refusal to hold an advisory committee meeting.
Dr Anna Durbin is an international public health expert at Johns Hopkins University in Baltimore, Maryland, has been a critic of Pfizer, Moderna and the White House’s insistence to rollout COVID-19 booster shots before they are needed. She told ABC last week that she does not believe many Americans will benefit from additional shots.
‘There are very few, if any, people who, in my opinion require a fourth dose,’ she said.
‘In general, it’s too early to recommend a fourth dose, except for those who are immune compromised,’ Dr Paul Goepfert, professor of medicine at the University of Alabama at Birmingham, also told ABC.
Dr Eric Rubin, editor in chief of the New England Journal of Medicine, and member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) – which usually advises on these decisions, said last month he did not see enough data to support the need for the shots.
‘The only data that I’ve seen has been for participants followed for just a few weeks,’ Rubin told CNN.
‘The most important information is going to be how well a fourth dose protects highly vulnerable people against serious disease and death, and I don’t know when that will be available.’
Dr Paul Offit, also a VRBPAC member and the director of the vaccine education center at the Children’s Hospital of Philadelphia, was a critic of the rollout of the first booster dose and takes issue with this approval as well.
‘Where’s the evidence that somebody over 50 benefits from a fourth dose? Because the evidence to date appears to support the possibility for those over 65, although I haven’t, we haven’t, seen all the data… but where’s the evidence for a 50 to 64 year old? Where’s that evidence? Because absent that evidence, then there shouldn’t be this recommendation’ he told CNN.
Many of these experts will have a chance to speak their opinion on April 6, when the FDA will hold a VRBPAC meeting to discuss the general future rollout of COVID-19 vaccines and boosters going forward.
Makary does not see much use for that meeting at this point, though.
‘That’s like having lawyers present arguments to a judge who’s already issued a verdict,’ he said of the meeting in his WSJ column.
There is also the question of whether Americans will even be willing to receive the additional shot. The country’s Covid booster shot rollout has slowed to a halt after a surge of demand for the additional shots in early 2022.
America’s vaccine coverage is among the best in the world, though, with nearly 90 percent of adults having received at least one shot.
The successful vaccine rollout has translated into a greater control over the virus as well. Cases and deaths from the virus in the U.S. have plummeted in recent months. The nation is currently averaging 29,226 daily infections, down eight percent over the past week. Deaths have stayed flat over that period, with the virus costing 835 deaths daily.
Officials from the FDA expect to roll out the shots to even more Americans in the near future.
Last week, Dr Peter Marks, who leads the FDA’s Center for Biologics Evaluation and Research, making him the top vaccine regulator in the agency, said he believes all Americans will need the fourth jab as early as this fall.
‘It would not be surprising if there is a potential need for people to get an additional booster in the fall along with a more general booster campaign if that takes place,’ Marks told reporters during a news briefing after the FDA’s authorization of the fourth jab.
‘It may be that a decision is made that rather than the vaccines we currently have, which are called vaccines against the prototype virus, that we will move to a vaccine that is either against one of the variants or something else.’
