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CDC Gives Final Approval to Omicron COVID-19 Vaccine Boosters

September 1, 2022 – The CDC today approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a move that could help support the goal of a widespread immunization campaign before winter arrives in the U.S.

The CDC’s advisory committee on immunization practices voted 13-1 on two separate questions on Thursday. One sought the panel’s support for using a single dose of a new version of Pfizer’s COVID-19 vaccines for people 12 years and older. The second question was about a single dose of the reworked Moderna vaccine for people 18 years and older.

The federal government wants to accelerate the use of revamped COVID-19 shots, which the FDA approved Thursday for use in the U.S. Hours Later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation.

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has declined since previous vaccination and are designed to provide broader protection against newer variants. This recommendation followed an extensive scientific review and vigorous scientific discussion. there isn’t a bad time to get your COVID-19 booster and I highly recommend getting it.

The FDA vote on Wednesday expanded the EUA emergency use authorization for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also known as ‘updated boosters’. Both contain two mRNA components of the SARS-CoV-2 virus, one from the parent strain and another found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

In short, the FDA paved the way for these new boosters after relying heavily on the results of certain blood tests that suggested a boost in the immune response of the new formulas, plus 18 months of largely safe use of the original versions of the shots.

What neither the FDA nor the CDC have, however, is evidence from human studies about how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies of the new boosters done in mice.

ACIP committee member Pablo Sanchez, MD, of Ohio State University was the only “no” vote on every question.

“It’s a new vaccine, it’s a new platform. There is already a lot of hesitation. We need the human data,” Sanchez said.

Sanchez had no doubts that the newer versions of the vaccine would prove safe.

“Personally, I’m in the high-risk age group and I’m pretty sure I’ll get it,” Sanchez said. “I just feel like this was a little premature and I wish we’d seen that data. That said, I’m confident that the vaccine will probably be as safe as the others.”

Sanchez was not alone in raising concerns about supporting new COVID-19 injections for which there is no direct clinical evidence from human studies.

Commissioner Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion that she would vote “reluctantly” for the updated vaccines. She said she believes they have the potential to reduce hospitalizations and even deaths, even if questions about the data remain.

Lang joined other committee members by pointing out tthe approach to updating flu vaccines as a model. In an effort to stay ahead of the flu, companies are trying to beat new strains through tweaks to their FDA-approved vaccines. Not much clinical information is available about these revised products, Long said. She compared it to renovating an existing home.

“It’s the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the flu vaccine revisions, she said.

Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, NY, also used changes to annual flu shots as a model for advancing COVID-19 injections.

“So after thinking about it, I feel comfortable even though we don’t have human data,” he said.

There were several questions during the meeting as to why the FDA had not convened a meeting of its advisory committee on vaccines and related biologics regarding these specific bivalent vaccines. Typically, the FDA committee of advisors considers new vaccines before the agency approves their use. In this case, however, the agency acted alone.

FDA said the committee had considered the new, bivalent COVID-19 boosters in previous meetings, and that was enough outside feedback.

But holding a meeting of advisors on these specific products could have helped build public confidence in these drugs, said Dorit Reiss, PhD, of the University of California Hastings College of Law, during the public comment session of the CDC advisor meeting.

“We wish the vaccines were more effective against infections, but they are safe and prevent hospitalization and death,” she said.

ACIP support expected

The Department of Health and Human Services anticipated ACIP’s support and expected Walensky’s approval to follow. The Strategic Preparedness and Response Administration began distributing “millions of doses of the updated booster to tens of thousands of sites across the country,” Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog post.

“Pending the recommendation from the CDC, people will soon be able to receive their updated COVID-19 booster shot containing an Omicron component for free,” Roos wrote before the vote and Walensky’s approval. “These boosters will be available at tens of thousands of vaccination sites that have used them before, including local pharmacies, their physician offices and vaccine centers operated by state and local health officials.”