United States approves Pfizer-BioNTech vaccine as 6th country

White House tells FDA to ‘approve vaccine or quit’, Peru suspends trials of Chinese vaccine

Agence France-Presse . Washington | Published: 10:39, Dec 12,2020 | Updated: 00:35, Dec 13,2020

 
 

The US green lighted the Pfizer-BioNTech COVID-19 vaccine late Friday, paving the way for millions of vulnerable people to receive their shots in the world’s hardest-hit country.

President Donald Trump immediately released a video on Twitter, where he hailed the news as a ‘medical miracle’ and said the first immunisations would take place ‘in less than 24 hours.’

It comes as infections across America soar as never before, with the grim milestone of 300,000 confirmed deaths fast approaching.

The US is now the sixth country to approve the two-dose regimen, after Britain, Bahrain, Canada, Saudi Arabia and Mexico.

US president Donald  Trump’s White House reportedly told the head of the country’s drug regulator to approve Pfizer-BioNTech’s COVID vaccine by the end of Friday or resign, after indications the first immunisations were imminent.

The threat reported by The Washington Post came on the same day Trump tweeted that the US Food and Drug Administration was a ‘big, old, slow turtle’ and told its commissioner, Stephen Hahn, to ‘Get

the dam(n) vaccines out NOW.’

The Post reported that White House chief of Staff Mark Meadows had delivered the resignation threat to Hahn.

The report followed comments by the country’s health secretary earlier in the day that the United States could start injecting the first Americans with the Pfizer-BioNTech vaccine by Monday.

Alex Azar told news channels that final details were being ironed out, after an expert committee voted to green light the two-dose regimen for people aged 16 and over on an emergency basis.

Trump’s interference threatens to re-insert politics into the scientific process, and came as the FDA was working out last minute details with Pfizer, including a fact sheet about the vaccine for doctors.

The FDA has also said it will include a warning label to advise people with a known history of severe allergies to avoid getting immunized for the time being.

Trump’s intervention reinserts politics into the scientific process, which some experts have said could undermine vaccine confidence.

The US is seeking to inoculate 20 million people this month alone, with long-term care facility residents and health care workers at the front of the line.

The government also said Friday that it is buying 100 million more doses of the Moderna vaccine candidate, amid reports the government passed on the opportunity to secure more supply of the Pfizer jab.

The purchase brings its total supply of Moderna doses to 200 million, enough to immunise 100 million people with the two-shot regimen that could be approved as early as next week.

Mexico’s health regulator on Friday granted emergency authorisation to the Pfizer-BioNTech coronavirus vaccine, deputy health minister Hugo Lopez-Gatell said.

‘Mexico is the fourth country whose health regulatory agency, Cofepris, has granted emergency use authorization to the Pfizer-BioNTech vaccine,’ he told a news conference.

The Mexican government announced this week that it would begin vaccinations against the coronavirus at the end of December, with a first batch of 250,000 doses to immunise 125,000 people, since the vaccine requires two shots.

Peru has temporarily suspended clinical trials of a COVID vaccine made by Chinese drug giant Sinopharm after detecting neurological problems in one of its test volunteers.

The National Institute of Health said Friday that it had decided to interrupt the trial after a volunteer had difficulty moving their arms, according to local media.

‘Several days ago we signalled, as we are required, to the regulatory authorities that one of our participants (in trials) presented neurological symptoms which could correspond to a condition called Guillain-Barre syndrome,’ said chief researcher German Malaga in comments to the press. 

Guillain-Barre syndrome is a rare and non-contagious disorder which affects the movement of the arms and legs. Peru declared a temporary health emergency in five regions in June last year following multiple cases.

Want stories like this in your inbox?

Sign up to exclusive daily email

Advertisement

 

Advertisement

images