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US FDA panel to discuss emergency use of Pfizer Covid-19 vaccine tomorrow
On Tuesday, it cleared a major hurdle after the FDA released documents in which it raised no new red flags over the safety and efficacy of the vaccine.
A panel of outside advisers will meet on Thursday to discuss whether to recommend Food and Drug Administration (FDA) emergency use authorisation of the Pfizer vaccine for the coronavirus disease (Covid-19) in the United States. Pfizer, along with its German partner BioNTech, has developed the vaccine which has an efficacy rate of nearly 95%.
On Tuesday, it cleared a major hurdle after the FDA released documents in which it raised no new red flags over the safety and efficacy of the vaccine.
“The vaccine’s efficacy and safety data met its expectations for emergency use authorisation,” Reuters reported citing FDA official.
The agency typically follows the recommendations of its advisory panels but is not required to do so. It is not clear how many days or weeks the FDA will take to make a decision, but states are prepping for vaccine deliveries in mid-December.
Meanwhile, Pfizer Chief Executive Albert Bourla said earlier that he is expecting a “very intense” meeting with a US vaccine advisory panel. However, remaining optimistic about the approval, Bourla said that is counting on the panel of outside experts to sign off on his company’s Covid-19 vaccine candidate.
“I think they will vote ‘yes’ given the strength of the data,” Bourla said.
On Wednesday, Canada became the second country to approve Pfizer vaccine. It has already been approved by the United Kingdom.
Besides the US, European Medicines Agency (EMA) is also assessing data to approve the vaccine.
The United States is the worst affected country due to coronavirus disease. As per the figures by the John Hopkins University, as many as 15,189,410 people have been infected by the viral disease pushing the healthcare system under the crumbling pressure. While the 286,461 others have succumbed to the disease.
(With agency inputs)
