Fri 19 November 2021:
The Food and Drug Administration authorized Moderna and Pfizer’s Covid booster shots for all U.S. adults on Friday, as growing data demonstrates the efficacy of vaccines wanes over time.
Boosters were previously only offered to persons with compromised immune systems, those over the age of 65, those at high risk of serious disease, and those working in high-risk occupations.
According to acting FDA commissioner Janet Woodcock, the decision “helps to provide continued protection against Covid-19, including the serious consequences that can occur, such as hospitalization and death.”
“This emergency use authorization comes at a critical time as we enter the winter months and face increasing Covid-19 case counts and hospitalizations across the country,” added Moderna CEO Stephane Bancel.
The approval comes nearly two months after experts advising the FDA rejected the administration’s first proposal to begin delivering boosters to all adults the week of September 20, citing a lack of data supporting the third doses.
The FDA said it based its decision on strong immune response data from hundreds of people dosed with the two vaccines.
Pfizer’s vaccine is dosed at 30 micrograms, the same as the primary series, whereas Moderna’s is dosed at 50 micrograms, half the primary series – however this was not referenced as data by the FDA in making its judgment.
Pfizer also conducted a clinical experiment involving 10,000 persons over the age of 16 and discovered that the booster restored vaccine efficacy to 95%.
Later Friday, the Centers for Disease Control and Prevention will conduct a conference to examine clinical recommendations for who should now seek a vaccine.
Both companies are doing post-approval studies to investigate the risks of myocarditis, or heart inflammation, which is more common in young males.
Public health officials are divided on the issue of widely distributing booster shots. The World Health Organization has chastised wealthier countries for administering third vaccinations when people in poorer countries have very limited access to Covid vaccines.
(with agencies)
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