Bulletin
Investor Alert

New York Markets Close in:

Oct. 17, 2020, 10:29 a.m. EDT

Pfizer could know if COVID-19 vaccine candidate is effective by end of October

new
Watchlist Relevance
LEARN MORE

Want to see how this story relates to your watchlist?

Just add items to create a watchlist now:

  • X
    Pfizer Inc. (PFE)
  • X
    BioNTech SE ADR (BNTX)
  • X
    S&P 500 Index (SPX)

or Cancel Already have a watchlist? Log In

Tomi Kilgore

Shares of Pfizer Inc. rallied to a 7-week high Friday, after the drug maker said it is on track to know whether its potential COVID-19 vaccine is effective by the end of October, and currently expects to apply for Emergency Use Authorization by the second half of November.

Pfizer /zigman2/quotes/202877789/composite PFE -0.69% , which is developing its vaccine candidate with Germany-based biotechnology company BioNTech S.E. /zigman2/quotes/214419716/composite BNTX +2.88% , said before it can apply for the EUA, it will have to prove the vaccine is safe.

To do so, the Food and Drug Administration requires two months of safety data on half of the trial participants following the final dose of the vaccine.

“Based on current trail enrollment and dosing pace, we estimate we will reach this milestone in the third week of November,” Chief Executive Albert Bourla wrote in an open letter posted on its website Thursday. He said he wrote the letter to clear up any confusion regarding the development and approval of the vaccine candidate.

Don’t miss : Trump’s vaccine czar says the first vaccine should be submitted for emergency authorization around Thanksgiving .

Pfizer’s stock surged 3.8% to $37.95, the highest close since Aug. 26, while BioNTech shares rallied 4.1% to a 2-month high.

Once the vaccine candidate is indicated to be effective and safe, Pfizer said another requirement will be to submit manufacturing data showing the “quality and consistency” of the vaccine that will be produced. The company said it expects to have that manufacturing data ready before the safety milestone is reached.

“So let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla wrote. “All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency .”

Pfizer’s stock has lost 3.1% year to date through Thursday, while BioNTech shares have nearly tripled (up 177.7%). In comparison, the S&P 500 index /zigman2/quotes/210599714/realtime SPX -0.07% has gained 7.8% this year.

/zigman2/quotes/202877789/composite
US : U.S.: NYSE
$ 36.25
-0.25 -0.69%
Volume: 16.14M
Jan. 21, 2021 12:47p
P/E Ratio
23.48
Dividend Yield
4.30%
Market Cap
$202.88 billion
Rev. per Employee
$586,070
loading...
/zigman2/quotes/214419716/composite
US : U.S.: Nasdaq
$ 106.21
+2.97 +2.88%
Volume: 1.35M
Jan. 21, 2021 12:47p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$24.86 billion
Rev. per Employee
$92,777
loading...
/zigman2/quotes/210599714/realtime
US : S&P US
3,849.26
-2.59 -0.07%
Volume: 1.21B
Jan. 21, 2021 12:47p
loading...

This Story has 0 Comments
Be the first to comment
More News In
Industries

Story Conversation

Commenting FAQs »
Link to MarketWatch's Slice.