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    NVAX   US6700024010


Delayed Nasdaq  -  04:00 2022-06-30 pm EDT
51.43 USD   -0.81%
06/29Novavax to Participate in Vaccines and Related Biological Products Advisory Committee Review of COVID-19 Vaccines Strain Composition
06/29BioNTech, Pfizer to starting testing universal coronavirus vaccine in H2
06/29Taiwan to receive first doses of Novavax COVID vaccine this week
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Novavax Files in the European Union for Expanded Conditional Marketing Authorization of COVID-19 Vaccine as a Booster in Individuals Aged 18 and Over

05/23/2022 | 09:14am EDT

Novavax announced the submission of a request to the European Medicines Agency to expand the conditional marketing authorization (CMA) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) as a homologous and heterologous booster dose for individuals aged 18 and over.

This request for expanded CMA is supported by data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of NVX-CoV2373. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, NVX-CoV2373 induced a robust antibody response when used as a heterologous third booster dose.

Following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of NVX-CoV2373, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.

The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022.

Authorization in the U.S.

NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration (FDA). The U.S. FDA's Vaccines and Related Biological Products Advisory Committee will review NVX-CoV2373 COVID-19 Vaccine for active immunization against SARS-CoV-2 during a meeting scheduled for June 7, 2022.



T: (240) 268-2022

Email: ir@novavax.com

(C) 2022 Electronic News Publishing, source ENP Newswire

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Financials (USD)
Sales 2022 4 274 M - -
Net income 2022 1 935 M - -
Net cash 2022 2 508 M - -
P/E ratio 2022 2,19x
Yield 2022 -
Capitalization 4 018 M 4 018 M -
EV / Sales 2022 0,35x
EV / Sales 2023 0,20x
Nbr of Employees 1 541
Free-Float 98,8%
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Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 7
Last Close Price 51,43 $
Average target price 151,86 $
Spread / Average Target 195%
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Managers and Directors
Stanley C. Erck President, Chief Executive Officer & Director
James Patrick Kelly Chief Financial Officer, Treasurer & Executive VP
James F. Young Chairman
Gregory M. Glenn President-Research & Development
Biegie Lee Chief Information Officer & Senior Vice President
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