Pfizer ‘Within Days’ of Seeking Emergency Use for COVID-19 Vaccine

Joanna Estrada
November 21, 2020

Pfizer and its German partner BioNTech will submit their emergency authorization request of their COVID-19 vaccine candidate to the FDA today.

This effectiveness was also consistent across age groups - essential given the vulnerability of the elderly - as well as ethnicities and gender.

The companies say they will now apply for authorisation for emergency use of the jab in the US.

Echoing the positive message, EU Commission chief Ursula von der Leyen said the bloc could approve both vaccines "as early as the second half of December".

"If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively", Sahin was quoted as saying by the agency.

Pfizer and BioNTech have concluded the Phase III study of their mRNA-based Covid-19 vaccine candidate, BNT162b2, which showed 95% efficacy rate and met all primary efficacy endpoints.

Dr. Peter Chin-Hong, an infectious disease specialist at UC San Francisco, said the symptoms typically appear in the first few hours after vaccination and resolve within 24 to 36 hours.

The Pfizer-BioNTech vaccine - and Moderna's shots - are made with brand-new technology.

Henry said overall; they are excited that there might be two vaccines available within months or even weeks.

The FDA has held such meetings in the past on multiple products, but Moderna has said it expects final results from its vaccine trial in about a week or two. After that USA drug major Moderna also claimed that its Covid-19 vaccine candidate found to have an efficacy of 94.5 per cent against the virus.

Instead, these most successful coronavirus vaccines inject people with RNA from the virus.

Japan was also on "maximum alert" after logging a record 2,000 daily infections with almost 500 in the capital Tokyo alone, though no immediate restrictions were planned.

The bloc struck the deal with CureVac this week to secure the supply of up to 405 million doses, of which 180 million are optional. It also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius.

After the review, the FDA then will decide whether to grant an "emergency use authorization", a quicker version of the normal FDA approval.

But they did notice headaches and fatigue in about 2% of volunteers given the vaccine, although older people seemed to experience minimal side effects.

The emergency authorization process allows drugs and vaccines targeting Covid-19 to reach Americans much faster than through standard approval channels.

"These are extraordinary results, and the safety data look good", said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

On November 16, Moderna said early analysis of its vaccine trial showed that it is 94.5% effective at preventing the virus.

Asked what assurances he had been given by the medicines regulator - the MHRA - over how long its process takes, he said: "It is absolutely a question for them how long they take, I'm not going to pre-judge that at all". Johnson & Johnson said it is on track to deliver data this year. Pfizer only recently began testing the vaccine in children as young as 12.

Health authorities say vaccines, and the protection they provide if enough people receive injections, will be key to allowing people to return to schools, workplaces and other establishments.

Other reports by Click Lancashire

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