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professor emeritus of epidemiology at the Yale School of Public Health, expressed concerns that the boosters will be out-of-date before they are even released.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.
A health worker fills a syringe with a Pfizer-BioNTech COVID-19 vaccine in a file image. (Emmi Korhonen/Lehtikuva/AFP via Getty Images)
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.
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