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Pfizer, BioNTech Seek Full FDA Approval For Covid Vaccine; Shares Pop

Investors2021-05-07

Pfizer and BioNTech asked for full Food and Drug Administration approval of their Covid vaccine on Friday, leading BioNTech stock to pop.

The vaccine is already authorized for emergency use in people ages 16 and older. But if approved, the vaccine could stay on the market after the pandemic ends. The companies could also market directly to consumers and change the price.

"Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the (application) submission is an important cornerstone of achieving long-term herd immunity and containing Covid-19 in the future," BioNTech Chief Executive Ugur Sahin said in a written statement.

In morning trading on today's stock market, BioNTech stock jumped 5.6% near 177.40. Pfizer stock rose 0.9% near 39.60.

BioNTech Stock Pops On FDA Submission

Pfizer and BioNTech gained emergency authorization for their Covid vaccine in December. At that time, the FDA said it would require at least six months of follow-up data in vaccinated volunteers before considering a full approval.

The data submitted Friday to the FDA include the most recent analysis from Phase 3 testing. The companies' observed the vaccine's safety and effectiveness for up to six months after the second dose, Pfizer and BioNTech said in a news release.

"We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months," Pfizer Chief Executive Albert Bourla said in a written statement.

Next, the FDA must decide whether the accept or reject the application. Then, the agency will set a date to review it. That could also stoke BioNTech stock.

Vaccine Shares Recover

The news Friday was a breath of fresh air for BioNTech stock.

Earlier this week, shares were under pressure after President Joe Biden and his administration voiced support for waiving patent rights for Covid vaccines. The goal is to help other countries make their own vaccines. BioNTech stock lost nearly 20% this week, as of Thursday's close.

On Thursday, though, German Chancellor Angela Merkel opposed waiving patent protection for vaccines. That helped BioNTech, which is based in Mainz, Germany, pare much deeper losses. At one point, BioNTech stock was off by 15%.

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评论22

  • MLL1010
    ·2021-05-10
    Good news or bad news?
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  • HLPA
    ·2021-05-08
    Great for PFE
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    收起
    • PEHPEH
      GoOd
      2021-05-09
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  • Mich77
    ·2021-05-08
    like n share
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    收起
    • Mich77
      nice
      2021-05-08
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  • Khoo12
    ·2021-05-08
    Yes
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  • Teckbee
    ·2021-05-08
    👏
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  • Ericlam
    ·2021-05-08
    Go Pfizer 
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    收起
    • T2C
      Ya
      2021-05-08
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    • Ericlam
      Nice
      2021-05-08
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    • WayneLo
      Nice and please reply my comment 🙂
      2021-05-08
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  • Yappy
    ·2021-05-08
    Well done[强] 
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    • Ericlam
      Nice
      2021-05-08
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  • Huazai
    ·2021-05-08
    Real or not 
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    收起
    • Huazai
      [Miser]
      2021-05-08
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    • jiajia321
      Maybw
      2021-05-08
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  • tss
    ·2021-05-08
    Most of the people in the world is already taking the vaccine before this approval
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    • Ericlam
      Nice
      2021-05-08
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    • yujie
      US only approved them for “emergency use” so now Pfizer wants full FDA approval
      2021-05-08
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  • Whyeloon
    ·2021-05-08
    Yes, finally.....now to save the world
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    收起
    • ISSEY1413
      hahahaha are you sure?
      2021-05-08
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    • Ericlam
      Nice
      2021-05-08
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  • Naaaiiviv
    ·2021-05-08
    Like 
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    收起
  • HLPA
    ·2021-05-08
    Good
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    收起
    • Ericlam
      Nice
      2021-05-08
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  • athenaang
    ·2021-05-08
    Nicree
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    收起
    • Ericlam
      Nice
      2021-05-08
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  • EVKY
    ·2021-05-07
    Hope market rout is over
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    收起
  • IAmThankful
    ·2021-05-07
    Wow
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    收起
    • CocoPosh
      [Miser]
      2021-05-07
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    • IAmThankful
      [Miser]
      2021-05-07
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  • CocoPosh
    ·2021-05-07
    Wow
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    收起
    • IAmThankful
      [Miser]
      2021-05-07
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    • CocoPosh
      [Miser]
      2021-05-07
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  • JS64
    ·2021-05-07
    Nice
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  • JaniceZhu
    ·2021-05-07
    Keep watching
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    收起
    • Bluem
      oo
      2021-05-07
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  • Guotiao
    ·2021-05-07
    Yeah, German Chancellor saves the day [开心] 
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  • bokeng
    ·2021-05-07
    Like
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