CDC Grants Final Approval for Omicron COVID-19 Vaccine Booster

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Sept. 1, 2022 — The CDC today approved the use of vaccines targeting both Omicron and the older variants of the coronavirus, a move that could support the goal of a widespread vaccination campaign before winter sets in USA arrives

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions Thursday. One sought panel support for the use of a single dose of a new version of Pfizer’s COVID-19 vaccines for people 12 and older. The second question was about a single dose of the revised Moderna vaccine for people 18 and older.

The federal government wants to expedite the use of revised COVID-19 recordings that the FDA cleared for use in the United States on Thursday. 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 last circulating COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has waned since the previous vaccination and are designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and a well-founded scientific discussion. If you are eligible, there is no bad time to get your COVID-19 refresher and I strongly encourage you to get it.”

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

Basically, the FDA cleared the way for these new boosters after heavily relying on the results of certain blood tests that indicated an increase in immune response from the new formulas, plus 18 months of largely safe use of the original versions of the shots.

However, what neither the FDA nor the CDC have is evidence from human studies on how well these new vaccines work, or whether they are as safe as the originals. But the FDA considered clinical evidence for the older vaccines 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 for each question.

“It’s a new vaccine, it’s a new platform. There’s 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 age group where I’m at high risk, and I’m almost certain I’ll get it,” Sanchez said. “I just feel like this was a bit premature and I wish we had seen that data. Still, I’m confident that the vaccine will likely be as safe as the others.”

Sanchez wasn’t the only one to raise concerns about supporting new COVID-19 vaccines that lack direct clinical evidence from human trials.

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

Long joined other committee members in pointing to the flu vaccine update approach as a model. To stay one step ahead of influenza, companies are trying to defeat new strains by optimizing their FDA-approved vaccines. There isn’t much clinical information about these revised products, Long said. She compared it to remodeling an existing home.

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

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 COVID-19 vaccine advancement.

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

During the meeting, there were several questions as to why the FDA had not called a meeting of its Vaccines and Related Biological Products Advisory Committee on these specific bivalent vaccines. Typically, the FDA Advisory Committee reviews new vaccines before the agency approves their use. However, in this case, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters at previous meetings, and that’s enough outside feedback.

But holding an advisors’ meeting on those 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 CDC Advisory Meeting’s public comment session.

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

ACIP support expected

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

“Pending the CDC’s recommendation, people will soon be able to get their updated COVID-19 booster shot with an Omicron component — at no cost,” Roos wrote ahead of the vote and Walensky’s endorsement. “These boosters will be available at tens of thousands of immunization sites that previously used them, including local pharmacies, their doctor’s offices, and immunization centers operated by state and local health departments.”



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