U.K. regulators to fast-track development of modified COVID vaccines

FILE - In this Tuesday, Dec. 8, 2020 file photo, British Prime Minister Boris Johnson watches as nurse Rebecca Cathersides administers the Pfizer-BioNTech COVID-19 vaccine to Lyn Wheeler at Guy's Hospital in London. Britain is racing to vaccinate more than 15 million people by mid-February, and in an effort to ensure vaccines get to the right places at the right times, along with the syringes, alcohol swabs and protective equipment needed to administer them, the government has called in the army.

Regulators in the U.K. and four other countries have announced new rules to fast-track the development of modified COVID-19 vaccines to ensure drugmakers can move swiftly to target emerging variants of the disease.

Previously authorized vaccines that are modified to combat new variants “will not need a brand new approval or ‘lengthy’ clinical studies,” Britain’s Medicines and Healthcare Products Regulatory Agency said Thursday.

“The clear goal is that future vaccine modifications that respond to the new variants of coronavirus can be made available in the shortest possible time to U.K. recipients without compromising at any stage on safety, quality or effectiveness,” Dr. June Raine, the head of the agency, said in a briefing.

The new guidance is based on the model already used to modify the seasonal flu vaccine to keep up with annual changes in the virus and was issued jointly by regulators in the U.K., Australia, Canada, Singapore and Switzerland. The U.S. Food and Drug Administration and European Medicines Agency have issued similar guidance.

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