The US Food and Drug Administration (FDA) is set to restrict Covid-19 booster doses to older adults and those at risk of severe illness.
Manufacturers are required to conduct new clinical trials for the approval of annual boosters for healthy individuals in the US under the age of 65 years, as reported by Reuters.
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FDA commissioner Marty Makary and director of the Center for Biologics Evaluation and Research (CBER) Vinay Prasad stated in the New England Journal of Medicine that the benefits of annual shots for healthy adults are uncertain after many years of vaccine availability and virus circulation.
The US regulator is expected to approve boosters for adults over 65 based on immune response data, and for individuals over six months old with conditions that increase their risk for severe Covid-19.
However, for healthy individuals between six months and 64 years of age, the agency anticipates a formal study requirement for pharma companies to gain approval for annual shots.
Prasad noted that the manufacturers of Covid-19 vaccines will be asked to carry out placebo-controlled studies in healthy people aged 50 to 64 years and are encouraged to do so for the very young paediatric population.
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By GlobalDataNew trials might not be needed annually, but only when significant changes in the virus occur.
Manufacturers have argued that new trials could delay the shots’ availability, as the vaccines are updated annually to match the circulating strain.
Makary and Prasad, both of whom are new to the agency in 2025, have been crucial in the previous approval process and the evidence backing the necessity of annual shots for many US citizens.
They acknowledged the rapid development of the vaccines in 2020 as a medical achievement.
In early May 2025, the US Department of Health and Human Services launched a $500m initiative to expedite the development of universal vaccines against viruses with pandemic potential, such as coronaviruses, respiratory syncytial virus and influenza.
