Pfizer, BioNTech Vaccine Recommended by CDC Advisory Panel
(Bloomberg) -- Pfizer Inc. and BioNTech SE’s Covid shot got the backing of key U.S. health advisers, putting the vaccine on the cusp of a final signoff that would help the government and business push wider adoption.
The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously in favor of the two-dose regimen in people 16 and older on Monday. The recommendation still needs a final nod from CDC Director Rochelle Walensky.
The Pfizer-BioNTech shot’s approval last week by the Food and Drug Administration is the first for a Covid vaccine in the U.S., coming as the Biden administration tries to control the spread of the highly transmissible delta variant. The administration expects the approval to help address vaccine hesitancy by raising confidence among people who say they are wary of the shot’s rapid development.
Regulators cleared the shot for people 16 and older on Aug. 23, and as of Aug. 29, more than 207 million doses have been administered. The shot is also authorized for emergency use in people from the ages of 12 to 15 years, and a third dose is permitted for people whose immune systems are weakened by disease or treatments.
Many large employers, schools and state and local governments have already put in place vaccine requirements in the wake of the approval. Still, 38% of Americans 16 and older remain unvaccinated, according to data presented at the meeting, and of those not vaccinated, 20% said they’d only get shots if required.
Since it gained U.S. emergency use authorization in December, the Pfizer vaccine has become the most widely used of three available vaccines, according to data from the CDC.
Both Pfizer’s and Moderna’s shot have been associated with an elevated rate of heart inflammation in people 12 to 39 years old. However, the benefits of the vaccine in preventing death and hospitalization from Covid in the target population far outweighs such risks, the panel observed. A warning about the risks of those side effects was first added to both the Pfizer and Moderna fact sheets in June.
Monday’s meeting to consider Pfizer and BioNTech’s vaccine was originally intended to be occupied with the discussion of boosters. Now it appears that the the bulk of the booster discussion will take place in mid-September as the administration rushes ahead toward a Sept. 20 kickoff for rolling out the extra shots.
The panel will continue to follow the usual processes in its consideration of boosters, with a vote on recommendation in the “very near future,” Grace Lee, a Stanford University pediatric infectious disease specialist and the panel’s chairperson, said.
The meeting agenda includes a discussion of how to address recommendations for booster doses as well as data supporting the argument for using them.
While vaccines continue to maintain high protection against severe disease, hospitalization, and death, they may be less effective in preventing infection or milder symptomatic illness due to both waning over time and the delta variant, according to ACIP slides published ahead of Monday’s meeting.
There are limited data available to evaluate potential impact of boosters in a variety of populations and settings, according to the slides. Moreover, there’s a need to ensure global vaccine availability because uncontrolled spread of Covid could lead to new variants that “threaten control of the pandemic everywhere.”
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