Saturday, January 23, 2021

Drugmakers hit back at UK plan to delay second dose of COVID vaccines

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Global drugmakers have added to doubts over Britain’s strategy to deliver Covid-19 vaccines to as many people as possible as soon as possible.

Industrial groups representing pharmaceutical companies in the United States and Europe joined the main drug regulators in both markets on Wednesday to question any initiative to change the timing or dosage of Covid-19 injections in order to ‘stretch supplies.

“The biopharmaceutical industry supports adherence to the dosage that has been evaluated in clinical trials,” according to their statement. Any changes from the approved vaccine dosage and schedules “should follow science and be based on transparent deliberation of available data.”

Lily: UK is postponing second dose of COVID vaccine to 12 weeks. Is it even safe?

A new outbreak of infections has increased pressure around the world to experiment with dosing regimens to get more people on their first of two injections and provide initial protection as quickly as possible.Britain saidthis would allow second doses of some vaccines to be administered up to 12 weeks after the first, longer than the time determined to be optimal for the vaccine created by Pfizer Inc. and BioNTech SE. A key official in Operation Warp Speed ​​in the United States has suggested that the dosage levels of Moderna Inc.’s vaccine may be reduced for some people, but drug regulators thererejectedthe idea.

The industry statement – from groups such as the International Federation of Pharmaceutical Manufacturers and Associations, the European Federation of Pharmaceutical Industries and Associations and PhRMA – is the latest to question the dose stretch proposals. Deployment strategies are expected to depend on the results of ongoing clinical studies, and industry will help collect additional data to provide answers, the organizations said.

The European Medicines AgencysaidLast week, developers failed to provide sufficient evidence to justify reducing the number of doses each person receives, extending the time between injections, or mixing vaccines from different companies, while the Food and Drug US administrationofficials saidpreviously, extending the time between injections or halving the doses could pose risks to public health.

UK officials said data shows licensed vaccines offer considerable defense after a single dose, with the second injection being important in the long run; the two companies and the FDA said it’s not clear how long the protection will last on the first try. Pfizersaidthat the second dose of its Covid-19 vaccine should be given to individuals within the recommended time frame of 21 days.

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