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author_name|Kris Holt health language|en-US Pharmaceuticals & Drug Trials provider_name|Engadget region|US site|engadget

FDA says updated COVID-19 Omicron boosters will not require new clinical trials


One official said that vaccine manufacturers don’t need to run new clinical trials to get approval for booster vaccines they’ve updated for newer Omicron variants. Director of the FDA’s Center for Biological Evaluation and Research, Dr. Peter Marks said: The agency will use data from trials for vaccines targeting BA.1, the Omicron variant that caused a large increase in infections last winter, and production data to evaluate vaccines. Safety data and preclinical data from animal studies may also be used.

This week, the FDA has asked vaccine manufacturers to modify booster vaccines to target Omicron BA.4 and BA.5 variants in addition to the original strain of the virus. The agency hopes the updated boosters will be ready by the fall. “When we see this evolution in BA.4/5, where we may see more evolution this fall, it will be really critical to try to empower as many people as possible,” Marks said.

Centers for Disease Control and Prevention says BA.1 no longer circulates in the US, but BA.4 and BA.5 currently account for more than 52 percent of COVID-19 infections in the country. Combined, they accounted for just 0.5 percent of cases in the US at the end of April.

Pfizer and Moderna this week Clinical trial data suggesting versions of its shots targeting BA.1 offered a stronger immune response than the first COVID-19 vaccines. These boosters did not perform very well against BA.4 and BA.5. However, the data showed that the immune response was still strong.

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