The Fall Covid-19 booster will look a little different in the future.
The US Food and Drug Administration has decided on Thursday to advise manufacturers that Omicron BA.4 / 5 should be added when updating the Covid-19 vaccine booster. Ingredients for the current vaccine mix. This creates what is known as divalent, or two components. amplifier.
“Advising manufacturers seeking to renew the COVID-19 vaccine to develop an improved vaccine that adds the Omicron BA.4 / 5 peplomer component to the current vaccine composition to create a two-component (divalent) booster vaccine. The modified vaccine may be available from early fall to mid-2022, “said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, Thursday. In the statement.
FDA’s independent advisors met on Tuesday to meet Vaccine and related biological product advisory board We voted to support recommending the inclusion of Omicron-specific components in the Covid-19 booster.
The Commission felt that the modified vaccine would provide broader protection to match the coronavirus strains currently in circulation. The Commission was not asked to vote on which sublineage to include, or whether booster vaccines should be monovalent or bivalent (including two strains).
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.The levels of neutralizing antibodies induced by previous infections or vaccinations are several times lower than these. Subvariant Compared to the original coronavirus, the study suggestion. This means that while current vaccines still provide substantial protection against serious diseases, these submutants can lead to a surge in new infections.
Marks said Tuesday that there will be a conversation going on to determine who needs another booster and what that booster will look like.
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.
This is changing rapidly, as Dr. Arnold Monto, Deputy Chairman of the Independent Vaccine Advisory Board, has suggested. “Unknown area”
“Looking at the past doesn’t help much to look for this virus in the future, which has confused many of us and made predictions almost irrelevant,” Monto added.
FDA Said on thursday Next year will be considered a “transitional period”. We have not advised manufacturers to change their primary vaccine for those who have not yet been vaccinated with Covid-19. The FDA uses a formula created to combat the virus version that first appeared in 2019. A series of major shots are protection against severe Covid-19 symptoms, even with the virus version currently in existence. Said to provide the foundation for. circulation.
The new formula will instead go into booster shots that may be introduced in the fall.
Vaccine makers are already testing new versions of the vaccine and released data at an independent advisory meeting on Tuesday.
Moderna provided details on a candidate for a bivalent booster vaccine that contains both components of Moderna’s original Covid-19 vaccine and a vaccine that targets the original Omicron variant.
Although not specifically designed to target BA.4 / 5, the booster known as mRNA-1273.214, according to the company, is “Strong neutralizing antibody reaction” For these subvariants.
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 also neutralize Omicron BA.4 and BA.5.
“Based on the strength of the initial data from the Omicron BA.1 divalent candidate, a powerful solution using the divalent BA.4 / BA.5 subvariant booster as we move on to the next chapter of the pandemic We believe there is. We will continue to share the available data with health professionals and regulators. We are ready to distribute the vaccine worldwide by early October 2022, awaiting regulatory approval. “A Pfizer spokeswoman said in a statement to CNN.
Another vaccine maker, Novavax Committee support Due to an emergency use authorization in the United States, 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.
On Thursday, the FDA urged vaccine manufacturers to submit up-to-date data on these modified vaccines to the FDA for evaluation prior to approval of the Omicron BA.4 / 5 component vaccine.
The FDA also said the data would be useful as the pandemic “further progresses” and urges vaccine manufacturers to begin clinical trials with a modified vaccine containing the Omicron BA.4 / 5 component.
At a meeting on Tuesday, the World Health Organization told the FDA’s Independent Committee that future vaccination strategies are the original strains 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.”
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