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Investing.com -- The U.S. Food and Drug Administration (FDA) has announced plans to mandate fresh clinical trials for the approval of annual COVID-19 booster shots for healthy Americans under 65. Consequently, the availability of these boosters will be primarily restricted to older adults and individuals at a higher risk of severe illness this fall, according to FDA leaders on Tuesday.
FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad predict that the FDA will approve the boosters for adults over the age of 65 based on immune response data from patient tests. The boosters will also be available for all individuals over six months old who possess one or more risk factors that increase their chances of severe COVID-19 outcomes. This information was published in the New England Journal of Medicine on Tuesday.
However, for healthy individuals aged between six months and 64 years, the FDA expects drugmakers to conduct randomized, controlled trials to obtain approval for annual shots. In these trials, saline could serve as a placebo, as stated by Prasad and Makary.
Vaccine manufacturers have argued that annual modifications to COVID vaccines to match the current virus strain could result in new placebo-controlled trials delaying the availability of the shots until after their effectiveness has expired.
Prasad and Makary, however, believe these studies are essential to verify that annual shots for healthy younger Americans are evidence-based. They argue that without these studies, it’s unclear whether a healthy 52-year-old woman who has had COVID-19 three times and has received six previous COVID-19 vaccine doses will benefit from a seventh.
Currently, there are three approved COVID-19 vaccines in the U.S.: Moderna Inc (BMV:MRNA)’s and Pfizer-BioNTech’s messenger RNA-based shots, and a protein-based vaccine by Novavax (NASDAQ:NVAX) Inc.
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