WASHINGTON — President Joe Biden told Americans last month that, “as a simple rule,” they should plan to get a COVID-19 vaccine booster shot eight months after their last dose, starting Sept. 20.
But weeks before that federal booster shot program is set to begin, his plan faces growing skepticism from key decision-makers.
Two of the three vaccine manufacturers have only just submitted booster shot data to the Food and Drug Administration. None has provided data demonstrating the average adult needs a booster eight months after their last shot in order to stave off severe disease or death. And key advisers have indicated they are not prepared to recommend their use for anyone but the most at-risk individuals by that deadline.
The expectation set by Biden and his team that boosters will soon be available to all has frustrated public health officials at the FDA and advisers and experts at the Centers for Disease Control and Prevention, who say the standards set in August by politicians and their appointees have unnecessarily pressured them and set the stage for public confusion in the coming weeks.
“We can’t move any faster than the companies themselves,” a public health official told McClatchy, who spoke on the condition of anonymity because they did not have permission to publicly discuss the matter. “I think we’re trying to work back from that Sept. 20 date.”
Pfizer and BioNTech initiated the submission of data on booster shots to the FDA at the end of August, while Moderna began to submit theirs on Wednesday. Johnson & Johnson has not submitted data to the FDA for review on a booster shot yet.
The data shows differences by age group and does not necessarily indicate that the vaccine is failing in its intended purpose of preventing hospitalizations and death from COVID-19.
To the contrary, regulators and medical advisers say the data reinforces the effectiveness of the current regimen of two doses for both the Pfizer and Moderna vaccines, spread three to four weeks apart.
The White House coronavirus response team recommended individuals prepare to receive booster shots eight months after their last dose based on the clinical judgment of the government’s top health and medical experts, administration officials said.
At the time, the group – including Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Rochelle Walensky, director of the CDC – put out a statement that “based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead.”
In a presentation at a press briefing on Thursday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that data from Israel showed that the delta variant of the coronavirus had increased the rate of severe disease among vaccinated individuals, and that booster shots diminished the risk.
“There’s no doubt, from the dramatic data from the Israeli study, that the boosts that are now being done there and contemplated here support very strongly the rationale for such an approach, based on the very favorable data associated with boosts,” Fauci said.
But the data submitted to the FDA does not yet bear out this projection.
Evidence that the vaccine’s effectiveness is waning is concentrated among the elderly, who were among the first people eligible to receive the vaccine first last winter and are among those with the weakest immune systems.
Endpoints, a biotech industry publication, recently reported that two senior FDA officials working on vaccine review resigned in frustration over Biden’s booster announcement, concerned that it had undermined the agency’s oversight authority.
The FDA has scheduled a meeting on Sept. 17 to review Pfizer’s booster submission and could authorize their use within days after that.
If and when the FDA approves the use of Pfizer booster shots, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet to recommend their use.
Discussions at recent meetings of the ACIP suggest the group may recommend a risk-based strategy for the distribution of boosters based on age and profession, rather than simply opening boosters up to the general public.
But they may not recommend boosters for all. The “priority for booster dose policy,” the ACIP group’s lead, Dr. Sara Oliver, wrote in a slide presentation for the meeting, should be “prevention of severe disease in at-risk populations.”
“There is frustration with the process,” said Dr. Julie Swann, head of the Department of Industrial and Systems Engineering at North Carolina State University and an adviser to the CDC during its response to the H1N1 pandemic in 2009.
Swann said the ACIP should not rush to approve booster shots based on projected data or the submissions of companies who would stand to gain from increased production.
“The ACIP is made up of a bunch of physicians, and what I partly heard from them is – if this data hasn’t even fully been submitted and a booster requested, how can we make a recommendation?”
The ACIP discussed convening again the week of Sept. 13 if there is something new from the FDA to discuss.
Addressing the booster program on Aug. 18, Biden said that “the plan is for every adult to get a booster shot eight months after you got your second shot.”
“Pending approval from the Food and Drug Administration and the CDC’s Committee of outside experts, we’ll be ready to start this booster program during the week of Sept. 20, in which time anyone fully vaccinated on or before Jan. 20 will be eligible to get a booster shot,” he said. “Just remember, as a simple rule: Eight months after your second shot, get a booster shot.”
Members of Biden’s COVID-19 response team said at the time they were simply preparing for the distribution of boosters, because they had seen “signals” in new data indicating waning vaccine effectiveness.
But those involved in the approval process say the administration’s announcement got ahead of the scientific review.
A source intimately familiar with the CDC review expressed skepticism that the Biden administration had proven its case for booster shots before announcing its plans last month, to the surprise of CDC, ACIP and FDA officials.
“The goal of this vaccine is to protect against severe disease,” said the source, who was not authorized to speak publicly on the matter. “What’s the evidence that there’s been an erosion in protection against serious illness? I don’t see how the administration has made a compelling case for a need for a third dose.”
Even if emerging data suggests that asymptomatic, “breakthrough” infections are increasing among the vaccinated, that does not signal the current vaccines are ineffective at preventing severe illness and death, the source said.
“There is real reluctance at the ACIP to agree to this,” the source added. “The administration has to clearly state the need for a booster dose. I don’t know why that announcement was made.”
White House officials referred requests for comment to the Department of Health and Human Services. An HHS spokesperson referred to the public comments made on Thursday by Fauci and other members of the White House coronavirus response team.
“Could it move in three weeks? I think it is highly unlikely that it would happen in that amount of time,” Swann said.
“If people move heaven and earth, they could probably make it happen,” she added. “But I don’t think the ACIP will be moving heaven and earth for this. The numbers of hospitalizations and deaths we’re seeing among the vaccinated are simply not there.”
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