New York : Pfizer’s Covid-19 vaccine is edging closer to approval in the United States and will star in a historic ‘science court’ that will be live streamed to the world on December 10.Starting 9 a.m. EST on December 10, US regulators and independent experts who make up the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will debate if clinical evidence is strong enough to recommend vaccinating Americans 16 years of age and older.Earlier this week, in a 92 page document, the US Food and Drug Administration released a sunny evaluation of the vaccine, setting an upbeat tone ahead of what will be the biggest vaccination effort in the nation’s history. Most physicians are expecting to start getting shots in arms by December 15.The Trump administration’s vaccine czar Moncef Slaoui said on Wednesday that all systems are locked and ready for an imminent emergency use approval.
Here are highlights that will inform the 12-hour long December 10 FDA meeting and what follows soon after:
Pfizer and its German partner BioNTech have reported their shots are 95 per cent effective at preventing mild to severe Covid-19 disease in a large, ongoing study. The efficacy results are based on 170 infections. Only eight of the infections were among volunteers who got the vaccine; the rest were among those who got dummy shots.New revelations this week show that the Trump administration this summer passed up a chance to buy millions of additional doses of the Pfizer vaccine and this could significantly delay the second batch of doses early next year. Under its contract with Pfizer, the Trump administration committed to buy an initial 100 million doses and opted not to lock in an additional 100 million doses for delivery in the second quarter of 2021.The FDA is expected to go along with the advice of the VRBPAC and there is no deadline for a decision. “We want people to see this discussion, to see the issues that are brought up, and have a vigorous discussion of the data elements by the outside experts,” FDA Commissioner Stephen Hahn said in an interview. When vaccinations do begin, health care workers and nursing home residents will be first in line.Some of the big question marks swirling ahead of Thursday’s meeting relate to the kind of protection it offers and testing scale in subsets of vulnerable populations. Could vaccinated people still spread the virus while staying asymptomatic? Were the shots adequately tested in communities of colour? What should pregnant women and children be told about vaccination, since they were either not tested in the Pfizer study or studies are just beginning.
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