Updated COVID shots are set for U.S. rollout without human data
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COVID-19 vaccine boosters adjusted for the latest Omicron subvariants are likely to receive U.S. authorizations this week before their human testing is complete, according to regulatory submissions filed by vaccine makers, Pfizer (NYSE:PFE)/BioNTech (BNTX) and Moderna (MRNA).
The head of Food and Drug Administration (FDA) Robert Califf, said last Thursday that the agency would not conduct an advisory committee meeting to evaluate the companiesâ emergency use requests for the shots adapted for Omicron BA.4 and BA.5 subvariants.
Meanwhile, a group of independent advisers of the Centers for Disease Control and Prevention (CDC), whose recommendations the agency usually follows before a final decision, will likely discuss the updated COVID-19 vaccines on Sept. 1 and 2.
However, requests submitted by Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) seeking U.S. emergency use authorizations (EUA) for their latest BA.4 and BA5.-adapted boosters contain only data from studies based on animals such as mice.
While Pfizer (PFE)/BioNTech (BNTX) said a clinical study on its BA.4/BA.5-adapted vaccine was expected to start this month, targeting those aged 12 years and above, Modernaâs (MRNA) human trial on the vaccine named mRNA-1273.222 is currently underway.
For decisions on vaccines, the FDA plans to conduct a review combining that preclinical data, clinical data for vaccines adapted for earlier subvariants of Omicron, such as BA.1, and the clinical profile of original COVID-19 shots.
âReal world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,â Dr. Califf said in a recent tweet.
Last week, The New York Times reported that the Biden administration plans to launch the U.S. rollout of updated COVID-19 vaccines soon after Labor Day.