FDA commissioner defends agency for taking its time to review coronavirus vaccine

‘This will meet our gold standard of safety and efficacy that the American people have come to trust,’ Dr Stephen Hahn says

Food and Drug Administration (FDA) Commissioner Dr Stephen Hahn has defended his agency taking its time to review coronavirus vaccine data before giving emergency authorisation, as he faces pressure from the White House and public.

In an effort to speed up the review process, Dr Hahn told The Wall Street Journal that 150 people in his agency were working days, nights, and weekends to review test data submitted by Pfizer and Germany company BioNtech.

“We realize there is an issue in the US around vaccine hesitancy. There have been concerns raised about the speed with which Covid-19 vaccines have been developed,” Dr Hahn said. “This will meet our gold standard of safety and efficacy that the American people have come to trust.”

His statement came on the same day that the United Kingdom gave emergency approval for Pfizer to roll out its vaccine to the public, which sparked scrutiny in the US for why it was taking so long for a similar authorisation to happen.

Dr Hahn was called to the White House this week to speak to Chief of Staff Mark Meadows and HHS Secretary Alex Azar about the review process for the coronavirus vaccine.

In particular, he was reportedly questioned why the FDA would not approve the vaccine prior to 10 December. An outside advisory committee would be reviewing testing data on that date for the FDA in an effort to further boost public opinion about the coronavirus vaccine, Dr Hahn told The Wall Street Journal.

President Donald Trump and other members within the Trump administration have reportedly grown frustrated about how long the FDA was taking to give emergency authorisation to the vaccine.

In comparison, Dr Anthony Fauci, the leading expert in America’s response to the coronavirus pandemic, supported the FDA on its thorough review of vaccine data.

“The way the FDA is ... doing it, is the correct way,” Dr Fauci told Fox News in an interview on Wednesday night.

“We really scrutinise the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine,” he said.

The infectious disease expert went on to criticise the UK’s rapid approval of Pfizer’s vaccine without further reviewing the data.

“We have the gold standard of a regulatory approach with the FDA. The UK did not do it as carefully and they got a couple of days ahead,” he said.

Pfizer submitted its application on 20 November to receive emergency authorisation. Once approved, it could start to distribute vaccine doses to states with the help of the federal government. It would then be on the states to decide who receives the vaccine first – likely being healthcare workers on the frontlines and those in long-term care facilities.

The careful scrutiny of the coronavirus vaccine data comes at a time when health officials are working to increase the public’s willingness to receive the jab if it were to become available.

Public confidence in the vaccine diminished over fears the trials were too accelerated, causing safety concerns. But that confidence has grown with more companies releasing data showing how effective their vaccines are against the novel virus. Pfizer, for example, said its trials showed the vaccine was 95 per cent effective against the novel virus.

The FDA using an independent review panel to analyse vaccine data was another attempt to raise public confidence that the vaccine would be safe if it received emergency authorisation.

Moderna, another pharmaceutical company, has also applied for emergency authorisation for its coronavirus vaccine. The FDA will review the application with an independent panel on 17 December.