Biden’s announcement on COVID booster shots was premature, experts say
In mid-August, just as half of all Americans became fully vaccinated against COVID-19, President Joe Biden announced that booster shots would be rolled out beginning Sept. 20.
Confusion ensued. Does everyone need a booster shot? If so, when? These questions remain open to debate.
“I think it’s generally agreed — maybe not by everyone, but many people — that the cart got before the horse here, and that this was, shall we say, an atypical way to proceed with vaccine-related public policy decisions,” Dr. William Schaffner, a member of the independent panel advising the Centers for Disease Control and Prevention on booster shots, said last week.
“I think there is a bit of a debate still in the public health community about whether the average person needs a booster right now,” said Schaffner, a professor of preventive medicine and health policy at Vanderbilt University.
Third doses are currently approved in the U.S. only for individuals with severely or moderately weakened immune systems, such as those with an organ transplant or undergoing cancer treatment. The Food and Drug Administration and CDC have yet to weigh the evidence, let alone make a formal determination, on a third dose for the general public.
Still, anecdotal evidence abounds of people already getting their third shots, to the dismay of Schaffner, who said an ill-timed booster won’t yield optimal benefits.
Boosters announced
The controversy began following Biden’s Aug. 18 announcement that a third dose of the messenger RNA vaccines — the Pfizer-BioNTech and Moderna brands — would be available beginning the week of Sept. 20. The president said the third dose was the best way to protect against the highly infectious delta variant and future variants.
That same day top federal health officials issued a joint statement on why booster shots would be needed, saying they were starting to see evidence of reduced protection against mild to moderate disease.
Protection against severe disease, hospitalization and death “could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout,” administration officials, including CDC Director Dr. Rochelle Walensky, Food and Drug Administration Acting Commissioner Dr. Janet Woodcock and U.S. Surgeon General Dr. Vivek Murthy, among others, said in their statement.
“For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability,” it said. “We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting eight months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster.”
Cart before horse
But first, the FDA must conduct an independent evaluation of the effectiveness and safety of a third shot. Then, the CDC panel on which Schaffner serves must review the evidence and make a recommendation.
Typically, these steps would take place before a course of action were to be announced. Not this time.
“This time, it worked the way it worked in the last administration, which is that you just had this ex cathedra (from the throne) proclamation from the administration saying, ‘This is what we’re going to do,’ without presenting the data,” Dr. Paul Offit, a member of the FDA’s vaccine advisory committee and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said last week.
Offit does not believe the evidence indicates that a third shot is yet warranted for the general public, if the primary goal of vaccination continues to be to prevent serious illness.
“All the data that have been generated so far — all the real word data, the observational data — is that this vaccine continues to do that,” Offit said. “It does it in recent studies. It does it against the delta variant. It does it independent of your age or comorbidity. Even those over 75 still have excellent protection against serious illness.”
It could be years before the protection afforded by vaccination against serious illness begins to wane, Offit said.
“So what’s the rush to give a third dose of vaccine?” he said. “The real problem is not boosting the vaccine. It’s vaccinating the unvaccinated.”
On Friday, the New York Times reported that regulators told the White House that they needed more time to collect and review data and that the booster shot rollout might need to initially be scaled back. Last week, the Times reported that two top vaccine regulators with the FDA were leaving the agency over the Biden’s administration announcement on booster shots, believing there isn’t enough data to justify the third shots.
Not if, but when
However, the question now isn’t whether booster shots will be offered, according to Schaffner.
“It’s how, what’s the timing, what’s the prioritization,” he said.
Discussion Monday by the CDC’s Advisory Committee on Immunization Practices, of which Schaffner is a non-voting member, suggested that third shots would likely first be given to those at highest risk, such as health-care workers and people in nursing homes, followed by older individuals.
Yet Schaffner has heard report after report of members of the general public getting third shots.
“I don’t think it’s harmful, in the sense that we’re all, I think, pretty comfortable that getting a third dose doesn’t have any more local or short-term side effects than getting a first or second dose,” he said.
More concerning to Schaffner is that some people are seeking a third shot immediately after the second.
“A longer duration is better, actually,” he said. “You’ve got to give the immune system a little time to be able to respond.”
Although U.S. health officials last month said they were prepared to offer third shots eights months after second shots, a shorter timeframe of six months or even five is under consideration.
Biden said in speaking with Israeli Prime Minister Naftali Bennett on Aug. 27 that U.S. health officials are considering offering a booster just five months after a second dose. Israel already is offering booster shots to its citizens.
Later in the day, White House spokeswoman Jen Psaki clarified the president’s comments.
“Let me be very clear. The president would rely on any guidance by the CDC and the FDA and his health and medical experts,” Psaki said, according to a White House transcript.
“If they were to change their guidance, based on data, for any particular group, he would, of course, abide by that.”
Contact Mary Hynes at mhynes@reviewjournal.com or 702-383-0336. Follow @MaryHynes1 on Twitter.
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