FDA Says Conduct Smaller Trials To Test Vaccine Efficacy Against COVID Variants

Amid concerning virus variants, the FDA said it would quickly analyze any vaccine booster shots against COVID-19 variants. The companies would not need to conduct lengthy randomized controlled trials to test the new shot effectiveness, the Wall Street Journal reports.
The recommendation calls for small trials involving a few hundred subjects over a couple of months, potentially accelerating the review process.
The agency issued new guidelines for makers of diagnostic tests and monoclonal-antibody drugs about how these companies can best adapt their products to address mutations.
The federal agency has been criticized for taking up to three weeks to analyze the vaccine data from Johnson & Johnson (NYSE: JNJ) that demonstrated 72% effectiveness in the U.S. compared with 57% in South Africa, where the mutant strain has been prominently present.
JNJ filed for FDA emergency use authorization earlier this month.
The JNJ vaccine will be evaluated on 26 February. The company also partnered with Sanofi to support the manufacturing of its COVID-19 shot, as it reportedly has an inventory of just a few million doses.
Two COVID-19 vaccines have already received an FDA green signal, one from Moderna Inc (NASDAQ: MRNA) and the other from a partnership of Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX)
Price Action: JNJ closed 0.06% lower at 161.87 on Monday.