The US Food and Drug Administration’s independent Vaccines and Related Biological Products Advisory Committee 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 and 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.
Future US Covid-19 vaccines will be different
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, and the committee was not asked to vote on what sublineage to include or whether the booster should be monovalent vaccine or a bivalent vaccine, which would include two strains.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said there will be a conversation going forward to determine who needs another booster and what that booster will look like. Marks noted that a bivalent vaccine targeting the BA.4 and BA.5 Omicron subvariants seemed 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.
Challenging work ahead
Dr. Arnold Monto, the acting chair of the independent vaccine advisers committee, suggested determining what goes into the booster will not be easy.
“I think we have done the best we can in a difficult situation with imperfect data and inability to say what is going to follow what looks like Omicron 4 or 5 wave,” said Monto. “We’ve looked at the options that are available and come up with a set of recommendations and some advice that FDA can follow.”
Moving forward to create a vaccine to best fight a virus that changes quickly is “uncharted territory”
“Looking in the past doesn’t help us a great deal to look in the future for this virus which has baffled a lot of us and made predictions almost irrelevant,” Monto added.
What the companies are working on
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.