WASHINGTON – Novavax Inc said on Friday (July 1) it expects to provide a Covid-19 vaccine targeting Omicron in the fourth quarter as it accelerates development of shots to protect against the BA.4 and BA.5 subvariants.
The US FDA on Thursday recommended Covid-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants.
Novavax expects additional preclinical data on shots tailored against the fast-spreading Omicron subvariants in late summer or fall.
The company’s vaccine, based on an earlier strain of the virus, has not yet been authorised in the United States and is currently under US Food and Drug Administration review.
Meanwhile, US health regulators will not require companies to submit new clinical trial data on Covid-19 vaccines that target the now dominant BA.4 and BA.5
Omicron subvariants to authorise those shots, but will instead rely on studies showing the efficacy of targeting the earlier BA.1 subvariant, a top official said on Thursday.
Dr Peter Marks, a senior official overseeing vaccines at the US FDA, told Reuters the agency would also consider manufacturing data specific to a BA.4 and BA.5 vaccine, and that preclinical data from animal studies and safety data for those shots could also be available.