The US Food and Drug Administration (FDA) said on Tuesday that data from 38,000 trial participants involved in testing the Pfizer vaccine suggest a "favourable safety profile". The regulators have confirmed it offers strong protection and will set a stage for the government to give a green light to the nation’s biggest effort in saving lives.
The data on the vaccine showed no "specific safety concerns," the FDA said in a document.
The report comes two days before a group of experts from FDA meet to discuss an emergency use authorisation request for a Covid-19 vaccine. The agency in the meeting will be discussing if data evidence is strong enough to recommend vaccinating millions of Americans and the final decision will come in a few days.
Pfizer and BioNTech had submitted a request for emergency use authorisation of its investigational Covid-19 vaccine to the US FDA on November 20.
"As such, FDA has determined that the sponsor has provided adequate information to ensure the vaccine's quality and consistency for authorization of the product under a EUA (Emergency Use Authorisation)," the agency wrote in documents posted.
FDA scientists reanalyzed data from Pfizer’s and found it to be safe and more than 90% effective in treating patients of different ages, races and underlying health conditions. The FDA has confirmed it works fine in older people who are especially vulnerable to the virus.
Britain has already approved the vaccine for emergency use and on Tuesday, a 90-year-old woman named Margaret Keenan became the first person in the world to receive the Pfizer-BioNTech Covid-19 vaccine as part of the mass vaccination programme being rolled out across the UK.
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As experts are worried about Americans being sceptical of the vaccine it is important to restore confidence in them. “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. “That will be an important part of showing what goes into our decision making.”
The FDA will be following its committee’s advice, and then once the vaccination drive begins, health care workers and nursing home residents would be first to receive the shot.