Drugmakers Push Back on U.K. Plan to Stretch Out Vaccine Doses
(Bloomberg) -- Global drugmakers added to doubts raised about Britain’s strategy for giving Covid-19 vaccines to as many people as possible in the shortest amount of time.
Industry groups representing pharmaceutical companies in the U.S. and Europe on Wednesday joined the top medicines regulators in both markets in questioning any moves to alter the timing or dosage of Covid-19 shots in a bid to stretch supplies.
“The biopharmaceutical industry supports adhering to the dosing that has been assessed in clinical trials,” according to their statement. Any changes from approved vaccine dosing and schedules “should follow the science and be based on a transparent deliberation of the available data.”
A new surge in infections has increased pressure worldwide to experiment with dosing regimens to get more people their first of two shots, and provide initial protection as quickly as possible. Britain has said it would allow for second doses of some vaccines to be given as many as 12 weeks after the first, longer than the timing determined as optimal for the shot created by Pfizer Inc. and BioNTech SE. A key U.S. Operation Warp Speed official suggested that dosage levels for Moderna Inc.’s vaccine could be cut for some people, but drug regulators there rejected the idea.
The industry statement -- from groups including the International Federation of Pharmaceutical Manufacturers and Associations, the European Federation of Pharmaceutical Industries and Associations and PhRMA -- is the latest to question dose-stretching proposals. Deployment strategies should depend on the outcome of continuing clinical studies, and the industry will help gather further data to provide answers, the organizations said.
The European Medicines Agency said last week that developers haven’t provided sufficient evidence to justify cutting the number of doses each person gets, lengthening the time between shots or mixing vaccines from different companies, while U.S. Food and Drug Administration officials said previously that extending the length of time between shots or cutting doses by half could pose public health risks.
U.K. officials have said the data show the authorized vaccines provide considerable defense after a single dose, with the second shot important over the longer term; both companies and the FDA have said it’s unclear how long protection from the first shot will last. Pfizer has said that the second dose of its Covid-19 vaccine should be delivered to individuals within the recommended 21-day period.
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