FDA advisers vote to include an Omicron-specific component for a coronavirus booster in the US

By Jen Christensen, CNN

The US Food and Drug Administration’s independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted Tuesday to support recommending inclusion of an Omicron specific component for a COVID-19 booster vaccine.

Twenty-one voting members of the FDA’s independent committee voted on the question:

“Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States?”

Nineteen of the members voted yes, two voted no.

“I voted in favor of Omicron because I think it’s important to broaden immunity,” said Dr. Wayne Marasco, a professor of medicine with the department of cancer immunology & virology Dana-Farber Cancer Institute Harvard Medical School. “I will say that I was pretty impressed today that we can do better.”

“I think this is a step in the right direction, but we have to reevaluate this as we move forward,” he added.

The committee felt that a modified vaccine would offer broader protection to match the coronavirus strain that is in circulation now.

Two Omicron subvariants, BA.4 and BA.5, are now dominating transmission of COVID-19 in the United States, according to the US Centers for Disease Control and Prevention.

This means that the COVID-19 vaccine people in the US will get in the future will be different. The committee does not determine how. The committee was not asked to vote on what sub lineage to include or whether the booster should be a bivalent or monovalent vaccine.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said that there will be a conversation going forward to determine who needs another booster and what that booster will look like. Marks did note that a bivalent vaccine targeting the BA.4 and BA.5 Omicron subvariants did seem to be the preference of the committee.

When the FDA’s independent vaccine advisers had met in April they agreed that they had to develop a framework for how the country can keep up with the evolving virus with an appropriate vaccine strategy. The FDA said in May that the “new normal” may include an annual COVID-19 and flu shot for people in the fall. Cases are expected to rise again in the fall and winter.

Current COVID-19 vaccines are based on the coronavirus that emerged in late 2019, but Pfizer and Moderna have been working on updated versions of the vaccines. The current vaccines are not as effective against the variants in circulation.

Moderna presented details about its bivalent COVID-19 vaccine booster, mRNA-1273.214, which the company said elicits “potent” immune responses against the Omicron subvariants BA.4 and BA.5.

Moderna’s bivalent booster vaccine candidate contains components of both Moderna’s original COVID-19 vaccine and a vaccine that targets the Omicron variant.

Pfizer/BioNTech also presented data to the committee that showed that their two COVID-19 vaccine boosters targeting Omicron showed a substantially higher immune response than its current COVID-19 vaccine. Preliminary lab studies suggest the vaccines could neutralize the Omicron BA.4 and BA.5.

Another vaccine maker, Novavax, has committee support for emergency use authorization in the United States, but the FDA has not yet authorized its vaccine. Novavax told the committee that it has been developing variant-specific updated versions of their COVID-19 vaccine as well as a COVID-19 and flu combination vaccine.

Following the VRBPAC vote, the FDA will rule on the updated vaccine. Next a panel of independent experts that advise the CDC will take a closer look at the available data and make a recommendation that the head of the CDC would decide if they should sign off on these recommendations.

The-CNN-Wire
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