A key advisory committee at the Centers for Disease Control and Prevention advisory committee may back a more limited approach to Covid-19 boosters than the one announced by Biden administration health officials.
In a joint statement last week, the heads of federal health agencies, including the CDC and the U.S. Food and Drug Administration, unveiled a plan to begin allowing all Americans to receive booster shots of the messenger RNA-based vaccines developed by
(ticker: PFE) and
(MRNA) the week of Sept. 20.
Before that can happen, however, FDA staff must authorize booster doses of the vaccine for widespread administration, and the CDC’s Advisory Committee on Immunization Practices must issue a recommendation. Comments by ACIP members in a meeting on Monday suggested that their go-ahead wasn’t a sure thing.
“Process really does matter,” said Dr. Beth Bell, a member of ACIP and a professor at the School of Public Health at the University of Washington. “I think it’s really quite important that we’re continuing to highlight what our process is, and how we get to a point of making recommendations.”
A presentation at the meeting made by a CDC staffer, Dr. Sara Oliver, noted that the vaccines continue to offer high protection against severe disease, hospitalization, and death, though protection against asymptomatic and mild infections appears to be lower.
The presentation, based on the discussions of a working group, suggested that the priority should continue to be vaccination of unvaccinated people, and that the priority for a booster-dose policy should be “prevention of severe disease in at-risk populations.”
The CDC work group is discussing a booster-dose recommendation approach that targets long-term-care residents, older adults, and healthcare personnel, according to Oliver’s presentation.
That appears to be setting the stage for a narrower set of recommendations than Biden administration officials have been promising. “We expect the rule will be simple,” White House Coronavirus Response Coordinator Jeffrey Zients said at a White House briefing last week. “Get your booster shot eight months after you’ve got your second shot.”
In a note out Tuesday morning, SVB Leerink analyst Daina Graybosch wrote that the ACIP comments should dampen near-term expectations for booster doses. “We read this meeting timing and the additional dose (‘booster’) discussion as an indication that uptick in third doses may not come as rapidly as investors have been expecting,” Graybosch wrote.
In a separate note, Jefferies analyst Michael Yee wrote that ACIP was taking a conservative approach. “ACIP still appears to be hesitant on whether [additional] doses are needed despite waning antibodies and increasing infections,” Yee wrote. “We think the ACIP could be leaning toward just a narrow 3rd dose recommendation for high-risk people (healthcare workers, elderly) vs. the more blanket recommendation the White House favors.”
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Some ACIP members were critical of the Biden administration’s approach to the booster rollout. One member, Dr. Helen Keipp Talbot, a professor of medicine at Vanderbilt University, said that “many many many” hospitals in the south had begun giving boosters to patients and healthcare workers, despite the FDA and CDC not yet signing off.
“Since it was given a date, many assumed it was given a blessing by the White House, and this was the next step,” Talbot said.
Talbot said that these healthcare providers won’t be covered by the PREP Act, which offers Covid-19 vaccinators immunity from liability. “Many people did not read the fine print,” Talbot said.
In her note, Graybosch said that comments at the meeting on the question of whether PREP Act protections apply to vaccinators giving third doses before approval by the FDA and CDC would cut down on near-term demand for boosters. “Physicians expressed their surprise” at this point, Graybosch said, and “we expect early boost demand will pullback until FDA / ACIP action.”
In addition to the discussion of boosters, ACIP also voted to recommend Pfizer and BioNTech’s vaccine for people aged 16 and above, following the FDA’s decision to fully approve the vaccine last week. “If you have been waiting for this approval before getting the vaccine, now is the time to get vaccinated and join the more than 173 million Americans who are already fully vaccinated,” the CDC’s director, Dr. Rochelle Walensky, said in a statement.
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