Omicron Subvariant-Targeted Booster Vaccines May Receive U.S. Authorization Before Completion of Human Trials

According to regulatory filings submitted by vaccine manufacturers Pfizer (PFE.US)/BioNTech (BNTX.US) and Moderna (MRNA.US), COVID-19 vaccine boosters adjusted for the latest Omicron subvariants may receive U.S. authorization this week before human trials are completed, as reported by Zhitong Finance APP.

According to reports, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf said last Thursday that the FDA will not hold an advisory committee meeting to evaluate the aforementioned company’s emergency use application for vaccines targeting the Omicron subvariants BA.4/BA.5. Meanwhile, a group of independent advisors from the U.S. Centers for Disease Control and Prevention (CDC) may discuss updated COVID-19 vaccines on September 1 and 2. The agency typically follows their recommendations before making a final decision.

However, the US Emergency Use Authorization (EUA) applications submitted by Pfizer/BioNTech and Moderna for their latest Omicron subvariant BA.4 and BA.5 boosters contain only research data based on animals (such as mice). Pfizer/BioNTech stated that clinical studies of their BA.4/BA.5 COVID-19 vaccine are expected to begin this month, targeting populations aged 12 years and above, while Moderna noted that human trials of the vaccine, named mRNA-1273.222, are currently underway.

For the decision on the vaccine, the FDA plans to review the combination of preclinical data, clinical data of vaccines targeting the early Omicron subvariant BA.1, and the clinical characteristics of the original COVID-19 vaccine. Dr. Califf recently tweeted, "Real-world evidence from the mRNA COVID-19 vaccines administered to millions of people shows that these vaccines are safe."

Last week, it was reported that the Biden administration plans to launch an updated COVID-19 vaccine in the United States shortly after the U.S. Labor Day.