ArrowArtboardCreated with Sketch.Title ChevronTitle ChevronIcon FacebookIcon LinkedinIcon Mail ContactPath LayerIcon MailPositive ArrowIcon PrintIcon Twitter
Pharmaceuticals

Pfizer applies for US emergency use for COVID-19 vaccine

Company rushes enough doses for 25m people as it expects mid-December approval

Pfizer and German partner BioNTech say final trial results show their vaccine is 95% effective.   © Reuters

Pfizer Inc said on Friday it has applied to U.S. health regulators for emergency use authorization (EUA) of its COVID-19 vaccine, a major step toward providing protection against the new coronavirus for pandemic-weary Americans.

The application to the U.S. 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.

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.

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.

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

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.

(Reuters)

Sponsored Content

About Sponsored Content This content was commissioned by Nikkei's Global Business Bureau.

You have {{numberArticlesLeft}} free article{{numberArticlesLeft-plural}} left this monthThis is your last free article this month

Stay ahead with our exclusives on Asia;
the most dynamic market in the world.

Stay ahead with our exclusives on Asia

Get trusted insights from experts within Asia itself.

Get trusted insights from experts
within Asia itself.

Try 1 month for $0.99

You have {{numberArticlesLeft}} free article{{numberArticlesLeft-plural}} left this month

This is your last free article this month

Stay ahead with our exclusives on Asia; the most
dynamic market in the world
.

Get trusted insights from experts
within Asia itself.

Try 3 months for $9

Offer ends October 31st

Your trial period has expired

You need a subscription to...

  • Read all stories with unlimited access
  • Use our mobile and tablet apps
See all offers and subscribe

Your full access to Nikkei Asia has expired

You need a subscription to:

  • Read all stories with unlimited access
  • Use our mobile and tablet apps
See all offers
NAR on print phone, device, and tablet media

Nikkei Asian Review, now known as Nikkei Asia, will be the voice of the Asian Century.

Celebrate our next chapter
Free access for everyone - Sep. 30

Find out more