Americans are wondering why they must wait at least a week for FDA approval for US firm Pfizer’s coronavirus jab despite Britain giving it go ahead for a mass rollout.
Regulators are coming under fire for nor moving faster in approving the jabs
But in the US, regulators are not due to meet until December 10 and are coming under fire for not moving faster in approving the jabs.
President Donald Trump and his deputies are privately admonishing FDA officials for not moving faster to authorize promising coronavirus vaccines — a push partially motivated by Trump’s desire to claim credit for record-fast vaccine development.
HHS Secretary Alex Azar and White House Chief of Staff Mark Meadows grilled Commissioner Stephen Hahn and other top FDA officials in meetings this week on their decisions to require more rigorous review of initial data from the first vaccine candidates questioning why the agency won’t authorize a vaccine until after December 10 at the earliest.
Last month Pfizer reported that its shot was more than 90 percent effective, and Moderna announced similarly impressive findings for its jab.
Multiple Trump appointees and even some career civil servants have argued that every day of delay could make a difference for the most vulnerable populations in a life-threatening pandemic.
The US is still at least a week away from a vaccine being rolled out despite Britain approving the Pfizer jab on Wednesday
Dr Stephen Hahn, the commissioner of the FDA, was summoned to the White House on Tuesday to explain why it was taking so long for vaccines to be approved
White House officials are known to be angry as having the West’s first authorized vaccine was as a key element of Trump’s legacy.
“It’s crazy to imagine the European Union or U.K. may approve a vaccine developed in the United States before us though, right?” said a senior official involved in the process.
Many Americans have complained that another country has approved a US-produced drug before them.
Many Americans have complained that another country has approved a US-produced drug before them
Moderna, another US company, has also developed an effective vaccine which is awaiting approval.
It recently said it would apply to the FDA for emergency approval and injections could be given out by December 21.
Dr Stephen Hahn, the commissioner of the FDA, was summoned to the White House on Tuesday to explain why it was taking so long for vaccines to be approved.
The FDA’s approval process is considered more stringent than Britain’s because it analyzes the company’s raw data for the testing.
Speculation has grown that Trump would intervene and fire Dr Hahn if the process didn’t move quicker
British regulators gave the green light to start mass vaccination with the Pfizer-BioNTech doses which had been produced by a US firm.
The government used emergency powers to rush through the vaccine after ordering 40million doses, and will be the first country to start the long-awaited vaccination process.
British regulators, like EU regulators, rely more on the drug companies’ own analysis of their data but can verify the accuracy of these reports.
Dr Hahn told ABC News: ‘FDA is one of the few regulatory agencies in the world that actually looks at the raw data. We are going to do our own analysis.’
Speculation has grown that Trump would intervene and fire Dr Hahn if the process didn’t move quicker.
On Tuesday, experts voted 13 to 1 to include healthcare workers and care home residents in the first group to receive vaccinations.
Their decision will only take the form of guidance, with state governors deciding how the vaccines will be distributed and allocated.
Source: Daily Mail