US FDA Allows Reduced Clinical Trials for Rapid Approval of Variant Vaccines

[Image source=AP Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The U.S. Food and Drug Administration (FDA) has decided not to require large-scale clinical trials for the rapid approval of COVID-19 variant virus vaccines. This decision reflects the pharmaceutical companies' opinion that existing vaccines can simply be "upgraded."

On the 22nd (local time), the FDA announced that COVID-19 variant virus vaccines can undergo clinical trials on a reduced scale. According to Bloomberg News, pharmaceutical companies only need to conduct small-scale studies comparable to flu vaccine approvals instead of large-scale Phase 1 to 3 clinical trials involving many participants.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research (CBER), said, "The size of clinical trials for variant virus vaccines can be a few hundred people rather than thousands," adding, "The clinical trials will take about 2 to 3 months."

This FDA decision is interpreted as accepting pharmaceutical companies' views that variant virus vaccines can be developed quickly by modifying existing vaccines to respond promptly to variant viruses.

Marks stated, "We hope that even a slight modification of existing vaccines will provide broad immune protection against both the original virus causing COVID-19 and the variant viruses," adding, "If multiple vaccines need to be combined like flu vaccines, it would place an even greater burden on the already insufficient production capacity."

The FDA also added that the currently administered Pfizer and Moderna vaccines are effective against variant viruses.

Pharmaceutical companies that have released COVID-19 vaccines are currently accelerating the development of variant virus vaccines. Pfizer and Moderna announced that they will soon conduct clinical trials on vaccines redesigned from existing ones.

Sanofi, which has re-entered COVID-19 vaccine development, has started research to ensure that the candidate vaccine jointly developed with GlaxoSmithKline (GSK) can also respond to variant viruses. AstraZeneca predicted that it can develop vaccines that can be quickly adapted to variant viruses.

This content was produced with the assistance of AI translation services.