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Tuesday, Jan 5 2021

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Stick To Full Two-Dose Vaccine Regimen, FDA Tells Health Officials

Ideas like cutting dosages in half or skipping the second shot have been floated to accelerate U.S. distribution of the covid vaccine. But FDA officials says that deviating from the tested and approved protocols could undermine the vaccination efforts.

The U.S. Food and Drug Administration is warning health care workers that any changes to the authorized dosing schedules of COVID-19 vaccines currently being administered significantly place public health at risk and undermine "the historic vaccination effort to protect the population" from the coronavirus pandemic. The first and second doses of the Pfizer-BioNTech vaccine are approved to be delivered within a 21-day window, while the Moderna injections should be spread over 28 days. When given at those intervals, both vaccines are about 95% effective, according to the respective drugmakers. But the FDA has heard suggestions that the number of limited doses could be stretched by cutting them in half, extending the length of time between doses, or mixing and matching vaccines in order to immunize more people against COVID-19. (Romo, 1/4)

Anyone who receives the Moderna or Pfizer vaccine must get two full doses, two top US Food and Drug Administration officials said Monday. They also dismissed other ideas for stretching the vaccine supply and said people who are speculating about the possibility of making do with just one dose or cutting doses in half are misinterpreting the data. (Fox, 1/4)

The U.S. government鈥檚 top infectious-disease doctor, a leading drug regulator and the Health and Human Services secretary are dismissing suggestions that the second shot of authorized coronavirus vaccines could be delayed to make more doses available faster to more people. In recent days, some public health experts have debated whether it is worth taking a scientific gamble by altering the two-dose regimen that proved highly effective in trials to maximize the number of people partially protected with at least one shot as the pandemic surges. (Johnson, 1/4)

Moncef Slaoui, chief scientific officer of Operation Warp Speed, the U.S. government鈥檚 vaccine drive, asked Moderna and the FDA to cut in half the dose of the company鈥檚 vaccination for people 18 to 55 after finding evidence that it induces the same immune response. That would double the amount of vaccine available for the age group, while providing the same level of protection, he said on CBS鈥檚 鈥淔ace the Nation鈥 on Sunday. Meanwhile, a U.K. plan would allow for second doses of vaccines to be administered as many as 12 weeks after the first, longer than the timing determined as optimal for shots developed by Pfizer Inc. and Moderna. (1/5)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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