FDA advisers vote to include an Omicron-specific component for a coronavirus booster in the US | News – Tucson, Arizona

Tucson, Arizona 2022-06-29 08:20:00 –

First Edition: June 28, 17:27 ET

Updated: June 29, 06:56 ET

Jen Kristensen, CNN

(CNN)- Independent Vaccine and Related Biological Products Advisory Board of the U.S. Food and Drug Administration We voted on Tuesday to support the recommendation to include Omicron-specific ingredients in the Covid-19 booster vaccine.

Twenty-one voting members of the FDA’s Independent Committee voted question:

“Does the Commission recommend the inclusion of the SARS-CoV-2 Omicron component in the US COVID-19 booster vaccine?”

Nineteen of the members agreed and two disagreed.

“I agree with Omicron because I think it’s important to spread immunity,” said Dr. Wayne Marasco, a professor of medicine at the Dana-Farber Cancer Institute Harvard Medical School in the Department of Cancer Immunology and Virus. “I say today I’m pretty impressed with how we can do better.”

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

The Commission believed that the modified vaccine would provide broader protection for the coronavirus strains currently in circulation.

According to the US Centers for Disease Control and Prevention, two Omicron submutants BA.4 and BA.5 currently dominate Covid-19 infection in the United States.

Future US Covid-19 vaccines will be different

This means that people with the Covid-19 vaccine in the United States will get it in the future. The Commission did not decide how to do this, and the Commission was not asked to vote on which sublineage to include, or whether the booster would be a monovalent or bivalent vaccine (including two strains). did.

Dr. Peter Markes, director of the FDA’s Center for Biopharmaceutical Evaluation and Research, said future discussions will be held to determine who needs another booster and what that booster will look like. Marks said bivalent vaccines targeting BA.4 and BA.5 omicron submutants appear to be a priority of the Commission.

When the FDA’s independent vaccine advisors met in April, they agreed that a framework should be developed on how countries can catch up with evolving viruses with appropriate vaccine strategies.

The FDA said in May that “New Normal” could include annual Covid-19 and influenza vaccinations for people in the fall. Cases are expected to increase again in the fall and winter.

Future challenging work

Dr. Arnold Monto, Deputy Chairman of the Independent Vaccine Advisory Board, suggested that deciding what would go into the booster would not be easy.

“I think we did our best in the difficult situation where the data was incomplete and we couldn’t say what would follow what looked like an Omicron 4 or 5 wave,” Monto said. rice field. “We reviewed the available options and came up with a set of recommendations and some advice that the FDA can follow.”

Moving forward to create a vaccine to best fight the rapidly changing virus is an “undeveloped territory”

“Looking at the past doesn’t help much in the future to find this virus, which has confused many of us and made predictions almost irrelevant,” Monto added.

What the company is working on

The current Covid-19 vaccine is based on the coronavirus that emerged in late 2019, but Pfizer and Moderna are working on an updated version of the vaccine. Current vaccines are not very effective against the mutants in circulation.

Moderna has released details about its divalent Covid-19 vaccine booster, mRNA-1273.214. The company states that it elicits a “strong” immune response to the Omicron subvariants BA.4 and BA.5.

Moderna’s bivalent booster vaccine candidates include components from both Moderna’s original Covid-19 vaccine and a vaccine that targets the Omicron variant.

Pfizer / BioNTech also submitted data to the Commission showing that the two Covid-19 vaccine boosters targeting Omicron showed a significantly higher immune response than the current Covid-19 vaccine. Preliminary laboratory studies suggest that the vaccine may neutralize Omicron BA.4 and BA.5.

Another vaccine maker, Novavax, has the support of the Commission on Emergency Use Authorization in the United States, but the FDA has not yet approved the vaccine. Novavax told the Commission that it is developing a variant-specific updated version of the Covid-19 vaccine and a combination vaccine of Covid-19 and influenza.

The wider the better

The World Health Organization told an independent committee of vaccine advisors on Tuesday that future vaccination strategies will provide the widest possible range of protection, rather than simply continuing the vaccine made against the original vaccine. He said it should be based on. Stocks that are no longer circulating.

“I think it’s still worth it to boost immunity. We repeat that we’re not trying to match what might be circulating,” said World Health on Influenza and Universities. Dr. Kanta Subbarao of the Institutional Collaborative Research Center said. Of Melbourne. “There is so much uncertainty about this evolutionary trajectory that it is less likely to match what may circulate.”

Although it may be helpful to include Omicron in future vaccines, as Omicron is the clearest of the variants of concern, stand-alone vaccines that match only Omicron are sufficient to protect against other mutants in the future. It may not be large.

“We are trying to broaden the immune response without losing the benefits of a very well-functioning index vaccine,” she added.

“We don’t have enough information about other variants, but based on our experience with the flu, we make a strong claim that boosting with as much antigenic virus as possible is a better strategy. You can, on the way, “she added.

The longer Omicron is the major variant of the world’s epidemic, the more likely it is to come after it comes from Omicron.

“At least that’s a real possibility,” Jerry Weir, director of the FDA’s Vaccine Laboratory’s Virus Products Division, told the Commission.

Future Covid-19 vaccine strategy

In the future, as the Commission decides how to create future processes in the event that regular Covid-19 boosters are needed, members will need better central coordination for research and future plans. I agreed.

Dr. Bruce Gerin, a member of the Commission responsible for the Rockefeller Foundation’s Global Public Health Strategy, said:

“This will be better, but we still have to go ahead,” he said.

Weir, along with the FDA, sought to help maintain the Commission’s achievements in view.

“I think we’ve made great strides in this whole effort in the last few months, but that a kind of parallel track of influenza strain selection that works very well was a process that was honed by many. Remind me. It’s going to take years, so it’s probably going to take a lot of work. This is another virus. There’s a lot of work to be done in the strain selection process for the Covid vaccine. “

Members of some committees were also concerned about the lack of data on what to put in future pediatric vaccines.

Dr. Archana Chatterjee, Dean of the Chicago Medical College and a member of the Commission, said: “I need to do pediatric research, and I think I need to do it right now.”

Following the VRBPAC vote, the FDA will determine the renewed vaccine. An independent panel of experts advising the CDC then scrutinizes the available data to make recommendations and the CDC manager decides whether to approve them.


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