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Novavax confident Covid vaccine will receive FDA authorization in June after delays

Novavax (US.NVAXc) (DE.NVV1) is confident its Covid-19 vaccine will receive the endorsement of the Food and Drug Administration’s advisory committee early this summer, executives said this week. The FDA committee is scheduled to meet on June 7 to review Novavax’s submission. An endorsement from the committee, which is made up of independent experts, would mean the drug regulator is almost certain to quickly authorize the two-dose vaccine for use in the U.S. The vaccine would enter the U.S. market at a time when 76% of adults are already fully vaccinated. Novavax stock has dropped 13% this week due to uncertain demand for the shots and after the company missed Wall Street’s first-quarter earnings and revenue expectations. Although Novavax maintained its 2022 sales guidance of $4 billion to $5 billion, CFO Jim Kelly said the company has not yet received an order from COVAX, the international alliance that procures shots for poorer nations. It’s unclear how much COVAX may order, Kelly said, which could put downward pressure on the sales guidance.

novavax confident covid vaccine will receive fda authorization in june after delays 2022

Novavax (DE.NVV1) (US.NVAXC), eficienta 80% a propriului vaccin anti-Covid la segmentul de varsta 12 - 17 ani

Vaccinul dezvoltat de Novavax este o alternativa la variantele mRNA produse de Pfizer (US.PFE) (DE.PFE) si Moderna (US.MRNA) (DE.0QF) si a fost autorizat deja in Regatul Unit, Germania, Noua Zeelanda, Filipine, India, Australia si Coreea de Sud.

novavax says covid 19 shot 80 effective adolescent study 02 102022

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Britain approves Novavax (DE.NVV1) Covid-19 vaccine as fifth in country

Britain has approved Novavax’s Covid-19 vaccine for use in those 18 years of age and older, the country’s medicines regulator said on Thursday, bringing a fifth coronavirus shot to its roster amidst the rapid spread of the Omicron variant. The vaccine, Nuvaxovid, was approved as a first and second dose as it met the required safety, quality and effectiveness standards, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The British approval for Nuvaxovid comes days after the drugmaker filed for U.S. authorization of the vaccine following months of struggles with development and manufacturing problems, and follows a German backing earlier in the day.