Sept. 1, 2022 — The CDC today approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the U.S.
The CDC’s Advisory Committee on Immunization Practices voted 13-1 Thursday on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people age 12 and older. The second concern was a single dose (one) of the Moderna vaccine, which has been reworked for people 18 years and older.
Federal officials want to accelerate the use of the redesigned COVID-19 shots. The FDA approved their use in the U.S. 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 most recently circulating COVID-19 variant,” Walensky said in a statement. They can help restore protection that has decreased since previous vaccinations, and they are designed to provide greater protection against newer variants. After a thorough scientific review and solid scientific discussion, this recommendation was made. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
The FDA vote on Wednesday expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
These new boosters were approved by the FDA based on certain blood tests and 18 months of safe use of the old shots.
However, neither the FDA nor CDC have evidence from studies in humans that shows how these new vaccines work, or if they are as safe as the old ones. The FDA did however consider the clinical evidence and the results of studies in mice on the new boosters.
ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Sanchez said.
Sanchez was confident that the safer versions of the vaccines would be available.
“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”
Sanchez is not the only one to raise concerns about supporting new COVID-19 shots, for which there is no direct clinical evidence from human trials.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She stated that she believes the vaccines will reduce hospitalizations, and even death rates, although there are still questions about the data.
Long joined other members of the committee in pointing out tThe model for updating flu vaccines is the approach. To keep up with influenza, companies are working to improve their FDA-approved vaccines. Long stated that there isn’t much clinical information about the new products. It is like remodeling an existing house.
“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.
Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, NY, also used changes to the annual flu shots as the model for advancing COVID-19 shots.
“So after thinking about it, I am comfortable even though we don’t have human data,” he said.
Several people asked why the FDA didn’t convene a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss these bivalent vaccines. The FDA committee of advisors usually reviews new vaccines before authorizing their use. The agency took the initiative in this instance.
FDA stated that the FDA had considered the bivalent COVID-19 boosters at earlier meetings, and that there was sufficient outside feedback.
But holding a meeting of advisors on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisors’ meeting.
“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.
ACIP support is anticipated
The Department of Health and Human Services anticipated the backing of ACIP and expected Walensky’s endorsement wouldfollow. The Administration for Strategic Preparedness and Response on Wednesday began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” wrote Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, in a blog.
“Pending the CDC’s recommendation, people will soon be able to receive – at no charge – their updated COVID-19 booster shot containing an Omicron component,” Roos was a writer before the vote, and Walensky was an endorser. “These boosters will be available at tens of thousands of vaccination sites they’ve used previously, including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials.”
