The US Food and Drug Administration (FDA) review comes before a Thursday meeting where independent experts will scrutinise the data and vote on whether to recommend use of the vaccine. The vote isn’t binding but the FDA usually follows the group’s guidance. A US decision to allow use of the vaccine is expected within days.
US Food and Drug Administration (FDA) said on Tuesday that the Pfizer-BioNTech vaccine is 95% protective against Covid-19.
Data from 38,000 US trial participants “suggest a favourable safety profile, with no specific safety concerns identified that would preclude issuance” of emergency use nod, the review said. (via AP)
The FDA review comes before a Thursday meeting where independent experts will scrutinise the data and vote on whether to recommend use of the vaccine. The vote isn’t binding but the FDA usually follows the group’s guidance. A US decision to allow use of the vaccine is expected within days.
The review also said that, while the vaccine prevents symptomatic cases, it’s not clear if it keeps the disease from being transmitted. That highlights a major unknown: How effective they’ll be in stemming the spread of coronavirus at a population level. Data from 38,000 US trial participants “suggest a favourable safety profile, with no specific safety concerns identified that would preclude issuance” of emergency use nod, the review said.
Meanwhile the UK, which on Tuesday started its vaccination drive, is planning to test the Pfizer shot in combination with another jab from AstraZeneca and Oxford University. Studies aimed at determining if using the two vaccines together can enhance immunity are planned for next year, said the UK Vaccine Taskforce. The group disclosed the plans as it published a report on its work so far, including deals for 357 million doses from seven makers and investments in three sites to expand the nation’s manufacturing capacity.
Approval for the Oxford shot is likely by year-end, setting the stage for the combination trials, which will involve initial shots from one vaccine, followed by a booster jab from the other.
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