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Vaccine Maker Awarded Approval for COVID-19 Vaccine
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Shares of Valneva SE traded 8.5% higher after the company reported that the U.K.'s MHRA has granted Conditional Marketing Authorization for its inactivated whole-virus COVID-19 vaccine candidate called VLA2001 for primary immunization in adults between 18 and 50 years old.

Specialty vaccine developer Valneva SE (VALN:NASDAQ; VLA:FRA), which concentrates its work on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that "the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for its inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age."

The company advised that the MHRA has determined that that VLA2001 has successfully met all the necessary standards for safety, quality and effectiveness.

The company's CEO Thomas Lingelbach stated, "We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence. VLA2001 is the only inactivated whole virus COVID-19 vaccine approved in the U.K., and this authorization could pave the way for the availability of an alternative vaccine solution for the U.K. population."

"We continue to receive messages every day from people who are looking for a more traditional vaccine approach. We believe that this new approval could also lead to additional marketing authorizations in other regions of the world.," Lingelbach added.

The company noted that this latest new marketing authorization follows the emergency use authorization of VLA2001 issued by the Bahraini NHRA last month. The firm advised that the vaccine candidate has been submitted to the European Medicines Agency (EMA) for approval and is now undergoing a rolling review process. Valneva added that it is presently engaged in discussions with the government in Scotland for as many as 25,000 doses for use by frontline medical workers.

The company explained that "VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe." The vaccine is designed and formulated to prevent symptomatic infection and transmission of COVID-19 during the ongoing pandemic as well as for booster and routine vaccinations and potentially for new future variants.

The firm indicated that "VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018."

Valneva is a specialty vaccine company based in Saint Herblain, France that concentrates is effort on developing and commercializing preventative vaccines targeted for infectious diseases. The firm has previously been successful in developing and commercializing two vaccines for preventing Japanese encephalitis (IXIARO®) and cholera (DUKORAL®) and is using that expertise to advance a broad range of other vaccine candidates through clinical development. The company is now investigating vaccine candidates to address Lyme disease (Phase 2), the chikungunya virus (Phase 3), COVID-19 (Phase 3), Clostridium difficile (c diff.) (Phase 2) and the Zika virus (Phase 2).

Valneva began the day with a market cap of around $1.8 billion with approximately 53.89 million shares outstanding. VALN shares opened about 9% higher today at $36.39 (+$2.96, +8.85%) over yesterday's $33.43 closing price/ The stock has traded today between $34.76 and $40.70 per share and is currently trading at $36.26 (+$2.83, +8.47%).

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