FDA expects new COVID-19 vaccines to safeguard against emerging variants.

The U.S. Food and Drug Administration (FDA) has exciting news about the forthcoming COVID-19 vaccines. According to an FDA spokesperson, these vaccines with a monovalent XBB.1.5 composition ⁤will provide‌ the best available ​protection against the⁢ most serious consequences of the⁣ disease⁢ resulting from currently circulating variants.

The FDA’s statement comes in response to concerns raised by the U.S. Centers for Disease Control and Prevention (CDC) about a new subvariant that may have ‍an increased ability to escape‌ immunity.

The FDA, however, ‍has not provided ⁢any evidence to support their‌ belief that the newly‌ formulated vaccines will protect against COVID-19 illness.

Earlier this year, the FDA directed Pfizer,⁤ Moderna, and Novavax to update‌ their shots to focus on XBB.1.5, one⁢ of the Omicron subvariants, due to the waning effectiveness of the⁣ shots.

Despite this, XBB.1.5 has since ‍been largely displaced by other subvariants, including FL.1.5.1 and EG.5, according to‍ CDC genomic surveillance.

Dr. Harvey Risch, professor emeritus ​of epidemiology at the Yale School of Public Health, expressed concerns that​ the boosters will be⁢ out-of-date​ before they ‍are even released.

The vaccine manufacturers claim that the updated shots trigger higher levels of neutralizing antibodies, which are believed to be ⁣a marker of protection⁢ against COVID-19. However, the full datasets and efficacy⁣ estimates have not been released‍ to the public​ or published in medical journals.

Influenza Model

Authorities are adopting a similar system for COVID-19 vaccines as used for influenza vaccines. This system allows manufacturers to update ​shots‌ on an annual basis based on estimates of prevalent strains, without the need for clinical trials.

Pfizer, Moderna, and Novavax have all requested FDA‍ clearance​ for their updated⁢ shots, and⁢ the FDA ​has rarely‍ turned ⁣down such requests during the COVID-19 pandemic.

The⁢ shots are expected‍ to ​be available in mid-September, ⁤pending FDA ​and CDC action.

Dr. ⁤Vinay Prasad, a professor at the University of California, San Francisco’s Department of Epidemiology and Biostatistics, ​criticized ⁣the U.S. government’s approach to COVID-19 vaccines. He emphasized the importance of conducting ‍clinical trials‌ for new shots and called the FDA ‍a‌ “failed agency.”

The ​FDA authorizes or approves vaccines, while ‌the‌ CDC ‌decides whether ‌to recommend them or not.

The ⁣CDC has scheduled‌ a meeting ⁤with its vaccine advisers⁤ for Sept. 12 to discuss COVID-19 vaccines, indicating that FDA ‍action will come before ‌then.

Dr. Mandy Cohen, the CDC’s‍ new director, recently stated that people will ‍likely be advised to get a COVID-19 vaccine once a‍ year to ensure ongoing protection.

The‍ latest updates are expected to address the limited effectiveness of the original shots, as shown by ⁤CDC ⁢data. The government has also announced a $1 ‍billion investment in next-generation shots that officials hope will ​perform better.

“The problem ⁢is…