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FDA authorizes Pfizer Coronavirus Vaccine for emergency use

The United States Food and Drug Administration (FDA) approved the Pfizer BioNTech COVID-19 vaccine for emergency use in the country. The drug agency come under intense pressure from the Trump government to authorize the use of the vaccine. The administration told Stephen Hahn, the commissioner of FDA, to approve it on Friday or leave, according to United States media. However, he called this story untrue.

Donald Trump, the U.S. president, says the first COVID-19 vaccinations will take place in less than 24 hours. Until now, the fatal virus killed over 292,000 in the United States. Alex Azar, the Health & Human Services Secretary, told news reporters on Friday that his department would work with Pfizer to provide the mass vaccination programmed to start from Monday or Tuesday.

Moreover, the Pfizer vaccine received regulatory approval in the United Kingdom, Bahrain, Canada and Saudi Arabia. The United States reported over three thousand deaths on Wednesday – the highest total in a single day globally.

On Thursday, health experts directing the FDA approved the emergency-use recommendation. A twenty-three-member panel settled on the benefits of the vaccine and outweighed its risks. In addition, the FDA statement stated that following the positive advisory committee meeting conclusion regarding the Pfizer-BioNTech coronavirus vaccine, the FDA informed the sponsor that it would instantly work toward completion and issuance of an emergency use authorization.

The FDA also notified the United States Centers for Disease Control (CDC) and Prevention and Operation Warp Speed so that they can implement their plans for timely distribution of the vaccine.

Donald Trump criticized the FDA agency

On Friday, the president criticized the agency in a tweet and called it a big, old and slow turtle. Further, he demanded Dr Hahn to out the vaccine and asked him to stop playing games and start saving lives. Citing three sources, the Washington Post said that Mark Meadows, the White House chief of staff ordered FDA head Hahn to authorize the vaccine on Friday or resign from his designation.

However, Hahn told the national media that the Trump administration only encouraged him to continue working expeditiously on the approval of COVID-19 vaccine. Likewise, the media representation of the phone call of the chief of staff was wrong. After the reports of the pressure from the White House, coming President Joe-Biden said he wanted to make it clear to his nation that they should feel confident in the vaccine without any political influence.

FDA authorizes Pfizer Coronavirus Vaccine for emergency use
FDA authorizes Pfizer Coronavirus Vaccine for emergency use
Source: Web

Operation Warp Speed (OWS) states that vaccine deliveries will start within twenty-four hours of approval. Azar said that the United States would work with Pfizer to get the COVID-19 vaccine shipped out so that it might be managed to the most vulnerable by patients by Monday or Tuesday. Pfizer plans to make ready almost 6.4 million doses for the United States in the first round in late December. Because two injections required per single person, so the above doses are enough for three million people, out of a total United States population of 330 million.

How some of the Coronavirus vaccines compare?

Company Type Doses How Effective Storage Cost per dose
Oxford Uni-AstraZeneca Viral vector
(genetically modified virus)
X2 62-90% Regular fridge temperature $4
Moderna RNA
(part of virus genetic code)
X2 95% -20C up to 6 months $33
Pfizer-BioNTech RNA X2 95% -70C $20
(Sputnik V)
Viral vector X2 92% Regular fridge temperature
(in dry form)

Source: Respective Drug Companies and WHO

Federal officials for CDC say the twenty-one million healthcare workers of the country should remain on the priority along with the three million elderly nationals living in long-term care homes. However, there is less settlement on how states should distribute it to other groups in the country. Almost eighty-seven million essential workers of the nation expected to be in the queue for the vaccination dose. Whereas, it is up to the administration of states to decide which industries to prioritize.

According to officials, the groups at low risk expected to vaccinate in the spring of 2021. Another COVID-19 vaccine developed by Moderna and the National Institutes of Health, also looking for approval from the officials in the United States. Like the Pfizer COVID-19 vaccine, it requires a second round of jabs.

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