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International

Pfizer applies for emergency licence

November 21, 2020 05:37 AM

COURTESY HT NOV 21

Pfizer applies for emergency licence
Agencies

letters@hindustantimes.com

Washington : Pfizer Inc said it will apply to US health regulators on Friday for emergency use authorisation (EUA) of its Covid-19 vaccine, a major step toward providing protection against the coronavirus for a pandemic-weary world that has recorded over 1.3 million fatalities in over 10 months.

The application to the US Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing Covid-19 with no major safety concerns.

In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the UK and intend to submit similar information soon.

The companies expect the FDA to grant the EUA by mid-December and said they begin shipping doses almost immediately. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.

“Filing in the US represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer CEO Albert Bourla said.

An FDA advisory committee tentatively plans to meet on December 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change.

The European Union could also move quickly on the Pfizer-BioNTech vaccine, perhaps as soon as the second half of December, according to European Commission president Ursula von der Leyen.

The final trial data showed the vaccine provided a similar level of protection across different ages and ethnicities -- an encouraging result as the disease disproportionately hurts the elderly and minorities.

“The companies will be ready to distribute the vaccine candidate within hours after authorisation,” their statement on Friday said. But how much vaccine is available and when is a moving target, and initial supplies will be scarce and rationed. Recipients will need two doses, three weeks apart. Governments will also have to decide how the initial limited supplies are rationed out to anxiously awaiting people.

Hot on the heels of these companies is a vaccine developed by another American biotech firm, Moderna, which says its product is also about 94.5% effective. Final results and safety data are expected in the coming days or weeks. Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines.

Of dozens of drugmakers and research institutions racing to develop Covid-19 vaccines, the next late-stage data is expected to come from AstraZeneca Plc, which is working with the University of Oxford, in November or December. Johnson & Johnson said it expects to have data needed to seek US authorisation for its experimental vaccine by February. India does not yet have a deal with either Pfizer or Moderna, whose products are expected to be costlier and harder to store. It is likely to pin its hopes on the AstraZeneca vaccine, which has largely turned out to be safe, can be stored and distributed with relative ease and is being manufactured by the Serum Institute of India (SII), an Indian company.

Pfizer’s shares rose 2% and BioNTech climbed 5% on the news that a vaccine could soon be available, raising hopes for the end of a pandemic that has claimed more than a quarter of a million lives in the United States and over 1.3 million worldwide.

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