The US Food and Drug Administration recommends changing the composition of “Corona” vaccines for the fall season

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DUBAI, United Arab Emirates (CNN) – The anti-coronavirus booster dose in the fall will likely be a little different, as the US Food and Drug Administration (FDA) decided on Thursday to notify manufacturers that Omicron BA4 /5 should be added to the booster dose. This would create what is known as a bivalent or two-component booster.

“We have advised manufacturers looking to update their COVID-19 vaccines to develop modified vaccines by adding the omicron BA4/5 protein component to the existing vaccine formulation to create a booster vaccine consisting of two components (bivalent ), and therefore the modified vaccines can be used from early to mid-autumn 2022.

Independent advisers from the U.S. Food and Drug Administration met on Tuesday, and the Vaccines and Related Biologics Advisory Committee voted in favor of the recommendation to include an ingredient for Omicron for the booster dose.” covid-19″.

The committee felt that the modified vaccine would provide broader protection that matches the strains of the Corona virus that are currently prevalent. The committee was not asked to vote on which substrain to include or whether the booster vaccine should be monovalent or bivalent to include both strains.

According to the US Centers for Disease Control and Control (CDC), two submutants of Omicron are currently dominant in the US, BA.4 and BA.5. Studies indicate that the levels of neutralizing antibodies caused by previous infection or vaccines are several times lower in these two variants compared to the original Corona virus. This means that while current vaccines still provide significant protection against serious disease, these two variants could cause a new spike in infections.

Deciding what goes into the next vaccine formulation is a tough call, said Dr. Arnold Monto, acting chair of the Independent Vaccine Advisory Committee, because this virus is evolving rapidly and puts scientists in “uncharted territory”.

“Studying the above doesn’t help us much in predicting what this virus will look like in the future, because it has confused many of us and makes speculation somewhat irrelevant,” Monto added.

And on Thursday, the Food and Drug Administration described the coming year as a “period of transition.” Manufacturers have not advised changing the core vaccine for those who have not yet received a COVID-19 vaccine. And the agency said the initial series of doses that use the first combination designed to fight the version of the virus that first emerged in 2019 still provides a baseline of protection against severe Covid symptoms, even the current sub-strain. dominant.

She noted that the new formula is a booster dose that can be given in the fall.

Vaccine makers were testing new versions of their vaccines and presented the data they gathered at a meeting of independent advisers on Tuesday.

Moderna provided details of its bivalent booster vaccine that contains components of its primary COVID-19 vaccine and a vaccine targeting the primary Omicron mutant.

Although its vaccine was not designed to target both sub-mutants of Omicron’s BA.4/5 sub-mutants, the company reported that its booster known as mRNA-1273.214 showed ” strong neutralizing antibody response” against these two submutants.

Pfizer/BioNTech also submitted data to the committee showing that their two booster doses targeting Omicron elicited a significantly higher immune response than the current COVID-19 vaccine. Results of preliminary laboratory studies have shown that both vaccines can also neutralize Omicron BA.4/5.

“Based on the strength of our preliminary data from our two bivalent Omicron BA.1 vaccine candidates, we believe we have a strong solution with a bivalent BA.4/BA.5 booster in place as we enter this phase,” said Pfizer. “The next outbreak of the pandemic, we will continue to share our available data with health experts and regulators. We are ready to distribute the vaccine globally by early October 2022, once we receive clearances regulations,” the spokesperson said in a statement to CNN.

Novavax had won the committee’s support to obtain emergency use authorization for its Covid-19 vaccine in the United States of America, but the US Food and Drug Administration has yet to grant it. Novavax informed the committee that it was developing specific updated versions of the “Covid-19” vaccine, as well as a combined “Covid-19” and influenza vaccine.

On Thursday, the agency encouraged vaccine makers to provide the most recent data on these modified vaccines for them to evaluate before approving a vaccine made with Omicron BA.4/5.

The agency also said it would require vaccine makers to start clinical trials of modified vaccines using the Omicron BA.4/5 component, as the data will be useful alongside the “increased development” of the pandemic.

At Tuesday’s meeting, the WHO asked the FDA’s independent panel that a future vaccination strategy would likely be based on a vaccine that would provide the greatest protection possible, rather than simply continuing with vaccines made to counter the original strain that had disappeared.


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