The FDA recommends that Covid-19 vaccines be reformulated in the fall. Will there be a new booster?

"We advised manufacturers who want to update their COVID-19 vaccines to develop a modification that will include the Omicron BA.4/5 spike protein and that this variant of the booster vaccine will be available by mid-fall 2022," he said Dr. Peter Marks, director of the FDA's Biological Assessment and Research Center. The Advisory Committee on Vaccines and Associated Biological Products voted in favor of this recommendation, considering that such a vaccine would provide wider protection against the strains of the coronavirus that we are currently dealing with.

What's in the air?

According to the US Centers for Disease Control and Prevention (CDC), the United States currently has two Omicron sub-options: BA.4 and BA.5. Research suggests that the levels of neutralizing antibodies from previous infection or vaccinations are several times lower than these sub-variants compared to the first version of the coronavirus. This means that while current vaccines still offer significant protection against severe disease, these sub-options are likely to lead to a spike in new infections. Dr. Mark assured that FDA experts will analyze who will need the next injection-booster and what it should contain.

Recall that not so long ago, the agency emphasized in its announcements that "new normality" will mean renewing vaccination against COVID-19 every year.

According to Dr. Arnold Monto, who is the chairman of the independent committee of vaccine advisers, figuring out what should be in modified vaccines is a difficult decision because it is a virus that mutates very quickly and does not really help scientists to see to the future. Any predictions begin to lose their value.

The FDA has assessed that the coming year can be considered a "transition period." Manufacturers are not advised to alter their primary immunization for individuals who are still not vaccinated against COVID-19. The FDA has concluded that the first series of vaccinations continues to provide a basis for protection against severe COVID-19 symptoms, even with new coronavirus mutations circulating today.

There will be a new booster?

Vaccine manufacturers have already tested new versions of booster doses. Moderna has made available to the FDA the details of its bivalent booster candidate, which includes the ingredients of both the first version of the vaccine and the vaccine targeting the "base" omicron variant. While it is not specifically designed to combat the BA.4/5 variant, the company said this modification exhibited a "strong neutralizing antibody response" against these sub-variants.

Pfizer/BioNTech presented data showing that their two COVID-19 booster vaccines directed against Omicron BA.1 showed a significantly higher immune response than the current vaccine. Preliminary laboratory studies suggest that vaccines may also neutralize Omicron BA.4 and BA.5.

Another vaccine manufacturer, Novavax, has committee support for emergency vaccine use in the United States, but the FDA has not yet approved it. Novavax said that in addition to the modified vaccine, it is also developing a combination vaccine against COVID-19 and influenza.

What suits us?

The FDA also said it will request vaccine manufacturers to begin clinical trials of modified vaccines targeting Omicron BA.4/5. In turn, the World Health Organization asked an independent FDA commission with the information that the vaccination strategy in the future should be based on a vaccine that would offer the broadest possible type of protection. Dr. Kanta Subbarao added that the uncertainty as to the evolution of the virus is so great that we should not be guided by "fitting" to what variant is currently circulating.

Source: CNN