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After EMA Recommendation, Novavax’s COVID-19 Vaccine Nears Rollout in Europe Feedzy

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In less than a week, Novavax has clinched a second major win in its bid to expand the reach of its COVID-19 vaccine.

The European Medicines Agency (EMA) on Monday blessed Novavax’s shot, Nuvaxovid, with a recommendation for conditional marketing authorization in the European Union. The news comes just a few days after the vaccine, also known as NVX-CoV2373, won emergency use listing from The World Health Organization (WHO), teeing up shipments to the agency’s equitable vaccine access scheme COVAX.

The shot will carry the Nuvaxovid name if it’s authorized in Europe. Elsewhere, the vaccine has been authorized under the Covovax moniker.

Prior to the thumbs up from WHO, Novavax and its manufacturing partner Serum Institute of India won their world-first authorization in Indonesia. Meanwhile, Novavax’s Japanese partner Takeda has filed the vaccine in country under the name TAK-019. Novavax has also submitted regulatory filings in the U.K., Australia and Canada. In the U.S., the company has run into delays, but it still aims to file by the end of 2021.

RELATED: Novavax struggling to meet quality standards in COVID-19 vaccine production push: report

With an EMA recommendation in hand, Novavax expects conditional marketing authorization to arrive “imminently,” the company said in a release. The thumbs up would make Nuvaxovid the first protein-based COVID-19 vaccine available in Europe, the company pointed out.

The vaccine is a two-dose, recombinant protein-based shot, which is co-formulated with Novavax’s Matrix-M adjuvant to enhance immune response. In a phase 3 trial, the vaccine cut the risk of moderate-to-severe COVID by 100%, with an overall efficacy against the disease of 90.4%, according to data published last week in the New England Journal of Medicine.

The EMA’s recommendation follows a positive opinion from the agency’s Committee for Medicinal Products for Human Use (CHMP), which relied on a speedy review of “the totality” of manufacturing, preclinical and clinical trial data on the vaccine.

Back in August, Novavax forged an advance purchase agreement with the European Commission for up to 200 million doses of the company’s vaccine. Under the deal, Novavax will work in tandem with its established manufacturing partner Serum Institute of India. SII is expected to supply initial doses in the E.U., which will later be “supplemented with data from additional manufacturing sites in Novavax’ global supply chain.”

Novavax is expected to start delivering vaccine doses to Europe in the first quarter of 2022, Reuters reported on Monday, citing an EU source.

Source: fiercepharma.com

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Inside the Catalent FDA Citation Said to Trigger Novo Nordisk’s Wegovy Supply Hiccup FiercePharma: Pharma

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Inside the Catalent FDA citation said to trigger Novo Nordisk’s Wegovy supply hiccup
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Tue, 01/18/2022 – 09:39

Article: fiercepharma.com

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Despite a recent surge in the omicron variant of COVID-19, area fitness centers are busy as many people made New Year’s resolutions to get in shape and get their health back on track.

Original Source: standardspeaker.com

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