A nurse fills syringes with coronavirus disease vaccines (COVID-19) for residents who are over 50 and immunocompromised and may receive their second booster injections in Waterford, Michigan, USA, April 8, 2022. REUTERS / Emily Elconin / Stock Photo
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NEW YORK, June 30 (Reuters) – U.S. health regulators will not require companies to submit new clinical trial data on COVID-19 vaccines targeting Omicron BA.4 and BA.5 subvariants , now dominant, to authorize these injections, but they will trust instead. on studies showing the effectiveness of targeting the previous BA.1 subvariant, a senior official said Thursday.
Dr Peter Marks, a senior official overseeing vaccines from the U.S. Food and Drug Administration, told Reuters the agency would also consider specific manufacturing data for a BA.4 and BA.5 vaccine. , and that preclinical animal study data and safety data for these traits may also be available.
The FDA on Thursday recommended vaccine manufacturers against COVID-19 Pfizer Inc (PFE.N) / BioNTech SE and Modern Inc (MRNA.O) change the design of their booster injections starting this fall to include components adapted to combat BA.4 and BA. 5. It plans to review them for emergency use authorization. Read more
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“It’s very similar to what we do with flu strain changes where there will be a couple of amino acid differences, but we don’t expect any difference in safety that we’ll see,” Marks said.
He said he expects the immune response to the BA.4 / 5 booster vaccine to be similar to that seen with BA.1.
“We’re very comfortable doing this, because it will help us move forward,” Marks said.
The FDA has ordered manufacturers to launch clinical trials in humans to study BA.4 / 5 vaccines, but said the data will be used to assess the continued effectiveness of enhancers against new variants that may arise.
Marks said he believes regulators in other countries are seriously considering the use of BA.1-based vaccines, which some drug manufacturers have already been producing and which may be available sooner.
“I’ll tell you that globally, for you to understand, different regulators feel different levels of comfort with that,” Marks said.
He said the United States should conduct a broader vaccination campaign this fall than in the spring, when attention was focused on the elderly and others at high risk.
“In fact, I think this fall we’re going to have to do everything we can for our reinforcement campaign,” Marks said.
“It will be very critical as we move towards this autumn where we have seen this evolution towards BA4 / 5, where we could see one more evolution, to try to drive as many people as we can.”
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Report by Michael Erman Editing by Bill Berkrot and Rosalba O’Brien
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