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Why Novavax Stock Slipped Thursday

Motley Fool2021-09-10

(Update: Sept 10, 2021 at 04:14 a.m. ET)

Authorization of the company's COVID-19 vaccine in India appears to have hit a speed bump.

Key Points

  • A report stated that the Indian government has requested additional data for Novavax's COVID-19 vaccine candidate before it can grant Emergency Use Authorization.
  • EUA for the vaccine in India was originally expected in October but will now be pushed back.
  • The delay isn't a huge blow for Novavax with the company's bigger opportunities in developed markets.

What happened

Shares of Novavax were slipping 2.6% lower as of 3:25 p.m. EDT on Thursday. The decline came following a report by The Economic Times that the Indian government has requested additional data from Novavax's partner, Serum Institute of India (SII), for COVID-19 vaccine candidate NVX-CoV2373 (which is called Covovax in India).

So what

SII filed for Emergency Use Authorization (EUA) in India for Covovax in August. This submission was based on data from international clinical studies. An official with the country's drug regulatory agency has asked for data from a clinical trial of the vaccine conducted in India, according toThe Economic Times article.

The problem is that SII likely won't be able to submit data from the clinical studies of Covovax in India until next month. SII CEO Adar Poonawalla stated in August that his organization hoped that the COVID-19 vaccine would be launched in India in October for adults and in the first quarter of 2022 for children. That timeline will now be pushed back.

This delay isn't a huge blow for Novavax, as evidenced by the relatively small drop in thevaccine stock. The company's biggest opportunities are in developed markets including the U.S. and Europe.

Now what

Novavax expects to file for EUA for NVX-CoV2373 in the United Kingdom within the next few weeks. That filing should be quickly followed by submissions in Australia, New Zealand, and the European Union. The company remains on track to file for U.S. EUA in the fourth quarter of 2021.

Novavax fell over 2% in premarket trading.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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Comment18

  • W00dy
    ·2021-09-11
    Like pls, thanks
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  • bernardtayet
    ·2021-09-11
    It is a knee jerk response. The stock holds great potential. Monitor n accumulate. 
    Reply
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  • Deonc
    ·2021-09-11
    ok
    Reply
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    • Deonc
      done. tq
      2021-09-12
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    • hpt
      Ok
      2021-09-12
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    • Deonc
      ???
      2021-09-11
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  • FrickL
    ·2021-09-11
    Oh oh…. 
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  • lewisleeks
    ·2021-09-11
    [Surprised] [Surprised] 
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  • CYKuan
    ·2021-09-11
    Novavax is one of the important and safer vaccine with less long term genetic side effect as compared to other mRNA vaccines available. For sure the stock price will rocket when it get approved in the near future in several big country 
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    • CYKuan
      plan, monitor and execute??
      2021-09-12
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    • Frosty4ever
      tempting to buy more
      2021-09-12
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  • Ciboy
    ·2021-09-11
    Good buy?
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  • seojun
    ·2021-09-11
    Oh no!!! Please approve the vaccine
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  • LST3
    ·2021-09-11
    Good 
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  • Imeeng
    ·2021-09-10
    Buy At dip?
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  • Lamborghini1
    ·2021-09-10
    Ok
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  • PorkChopRice
    ·2021-09-10
    This company is operationally crap, how can they keep messing up the filling for regulatory reviews?! They have not received a single emergency authorisation use anywhere in the world even thought their vaccine is effective. Time is running out otherwise others will get there before they do... [流淚] [流淚] [流淚] 
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    • sunshine138
      Stan has no more hair to pull for the stress
      Omgosh
      2021-09-10
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  • CIG
    ·2021-09-10
    Roti prata, keep flipping.
    Reply
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    • seojunReplying toCIG
      really
      2021-09-11
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    • CIG
      lots of development outsiders won't know.
      2021-09-10
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    • sunshine138
      A good vaccine under bad hands.
      Flip flop till burned.
      FDA EUA should be filed moon ago
      2021-09-10
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  • Ck38
    ·2021-09-10
    Pls like
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  • Mml
    ·2021-09-10
    Good
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  • Desmondsim
    ·2021-09-10
    Like
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    • Mml
      Done
      2021-09-10
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  • ETCH
    ·2021-09-10
    Time is running out for market share
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  • Chororo
    ·2021-09-10
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    • Chororo
      2021-09-10
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    • ETCH
      ?
      2021-09-10
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