FDA panel recommends emergency use authorisation for Pfizer vaccine in US; approval soon

An advisory panel for the US Food and Drug Administration (FDA) on Thursday recommended the approval for emergency use of Pfizer-BioNTech Covid-19 vaccine.

The FDA's vaccine advisory panel, comprising of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member favouring its emergency for people aged 16 years or older.

The agency is expected to authorise the vaccine in the following days, prioritising health care workers and nursing home residents for receiving the first shots of the vaccine early next year.

READ | Canada Health Regulators Approve Pfizer-BioNtech's COVID-19 Vaccine

With this recommendation, the nation may finally begin to slow the spread of Coronavirus as both infections and fatalities have surged in the country, reaching a record high of 3,000 daily deaths on Wednesday.

The FDA is expected to grant an emergency use authorisation for Pfizer vaccine on Saturday, though last-minute legal or bureaucratic requirements could push the announcement to a later date.

The Pfizer vaccine has been approved for public use in the UK, Canada, Bahrain and Saudi Arabia. The US authorization of the vaccine is likely to follow soon after one for Moderna's version, which uses similar technology and has also shown promising results in clinical trials.

READ | Pfizer-BioNtech COVID-19 Vaccine Data Hacked In Cyberattack On European Medicines Agency

Difficult for the US to achieve herd immunity

Operation Warp Speed, the Trump administration's multi-billion-dollar program for vaccine development, had pre-ordered 100 million doses of Pfizer's vaccine in July and heavily backed the development and manufacturing of Moderna's vaccine in the US.

However, the country needs to vaccinate at least 70% of the population to achieve herd immunity, which will take time, even if the vaccine is widely accepted.

"I think the data was pretty compelling that the benefits greatly outweigh the risks. I wish there could have been slightly more enrollment of minorities in the trial. But I think the numbers were sufficient to make a decision," Dr. James Hildreth, a member of the FDA advisory committee said told CNN.

"We know at least in tens of thousands of people followed for two months, it doesn't have any serious, adverse events. ... I think we know enough now to say that this appears to be our way out of this awful, awful mess," said Dr Paul Offit, another member of the committee.

READ | Key Meet At DCGI On Pfizer, Serum & Covaxin's Vaccines; 64 Diplomats Visit Bharat Biotech

Pfizer's chairman pleased with the expert panel's recommendation to FDA

Meanwhile, Pfizer's chairman & CEO was pleased on FDA's vaccine advisers recommending the agency grant emergency use authorization for its coronavirus vaccine in the US.

"We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year," Pfizer Chairman and CEO Albert Bourla said in a statement to CNN.

Earlier this week, the UK became the first country in the world to administer a vaccine against coronavirus, that was developed jointly by the American drugmaker Pfizer and Germany's BioNTech in a vaccination programme watched closely around the world. After the UK, Canada became the second country to approve Pfizer-BioNTech’s vaccine for its citizens.

READ | US Experts Convene To Decide Whether To Authorize Pfizer Vaccine

(With inputs from agency)