CDC recommends Pfizer/BioNTech boosters for certain segments of population

·Senior Reporter
·5 min read

The U.S. Centers for Disease Control and Prevention (CDC) released new guidance for booster doses of the Pfizer(PFE)/BioNTech's (BNTX) COVID-19 vaccine early Friday, overruling an advisory committee vote just hours before.

The Advisory Committee on Immunization Practices (ACIP) approved the additional shot for anyone 65 years and older; residents of long-term care facilities; 50-64 year-olds with underlying medical conditions; and 18-49 year-olds with underlying medical conditions based on individual risk benefits.

The panel voted Thursday against an additional dose for those who have a high risk of exposure to the virus due to occupation or the institution they reside. That would include health care workers and teachers, who were included in the U.S. Food and Drug Administration's (FDA) emergency use authorization (EUA) of the additional doses late Wednesday.

The decision to overrule the vote and align with the FDA, by CDC Director Dr. Rochelle Walensky, has been hailed by experts, noting it has the largest impact on severely understaffed hospitals and health care systems.

The last two policies resulted in the most debate Thursday, with dissenting members concerned they were too wide and could open the door to boosters for those who won't need it.

However, the vote was fraught with controversy. Some ACIP members expressed concerns about the FDA's authorization based on skimpy data, and that they were being tasked with a similar decision based on equally lacking data.

FDA officials were present, including Dr. Peter Marks and Dr. Doran Fink, who said they understood the frustration of not having access to more real-world data, to support better evidence-based recommendations. 

While the FDA was working on gathering more information, there was no exact timeline available. To-date, much of the data has been provided by overseas studies including Israel and the U.K.

Walensky also briefly joined the meeting prior to the vote Thursday, noting the panel has been operating under unprecedented pressure.

"These data are not perfect, yet collectively they form a picture for us, and they are what we have in this moment, to make a decision about the next stage in this pandemic," she said.

CDC panel members also expressed concern Thursday about the issue of limited vaccine supply, but officials said there is ample supply, especially of Pfizer's vaccine. 

The vote followed an emergency use authorization (EUA) for a third COVID-19 vaccine dose in some high risk individuals, six months after the initial course, by FDA late Wednesday.

In a statement to Yahoo Finance Wednesday, Pfizer chairman and CEO Albert Bourla hailed the booster vote.

"We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated," he said.

"Today’s FDA action is an important step in helping the most vulnerable among us remain protected from COVID-19," Bourla added.

Panel chair Dr. Grace Lee said it was also important to note that the EUA did not require boosters after six months, but rather allowed a booster any time after six months, allowing for more time to find an additional dose.

'Putting lipstick on frogs'

The additional dose authorization broke from some recommendations from an FDA advisory panel made last week. It only applies to original recipients of the Pfizer shot.

It includes a third dose for anyone over the age of 65 and the immunocompromised over the age of 18 that are at risk of contracting severe COVID-19, as well as anyone over the age of 18 that is exposed to COVID-19 at work. That includes health care workers, teachers, day care staff, grocery workers, and those in homeless shelters or prisons, according to acting FDA Commissioner Dr. Janet Woodcock.

The EUA was decided after a contentious discussion among panel experts Friday, and is a significantly narrower population than the one sought by Pfizer, which applied for a supplemental approval. 

It also is a significantly smaller population than the Biden administration wanted, after announcing boosters would be available for all adults starting September 20. 

That move spurred frustration among health experts, who drew comparisons to the Trump administration and its political heads pressuring regulatory and public health bodies. It also fanned criticism that the U.S. has been hoarding vaccine supplies amid the struggle to inoculate low- and middle-income countries, as well as ongoing constraints on global supply.

U.S. Surgeon General Vivek Murthy, previously said the deadline was set in order to help states prepare for dose distribution and administration. At the CDC advisory meeting Thursday, officials said 70% of vaccinations have been occurring at pharmacies.

Still, global concerns of vaccine supply have been mounting in recent weeks, as experts warn that an unchecked pandemic could rage on without better immunity globally — and could eventually render vaccines, including boosters, useless.

CDC advisory member Dr. Keipp Talbot said Thursday that "I feel like we’re putting lipstick on frogs" in discussing booster doses.

Another member noted there were few negatives to booster doses aside from limited vaccine supply.

Earlier in the day, Biden announced the U.S. was doubling its donation to the world, with a purchase of 500 million Pfizer doses in a $3.5 billion deal. The addition puts the total of donations at more than 1 billion doses, of which 157 million have been shipped out, according to the U.S. State Department

In addition, Biden announced a partnership with the European Union to produce and donate more vaccine doses globally. The move comes after weeks of pressure on the administration to do more for the global vaccination push which United Nations Secretary General Antonio Guterres graded with an "F in ethics" on Tuesday.

Follow Anjalee on Twitter @AnjKhem

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