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FDA Panel Endorses Novavax’s Coronavirus Vaccine

US Food and Drug Authority (FDA) has unanimously decided to approve a protein-based Novavax Coronavirus vaccine on Tuesday

FDA Panel Endorses Protein-based Novavax’s Coronavirus Vaccine

On Tuesday, the vaccine advisory committee (VRBPAC) of the Food and Drug Administration (FDA) backed a COVID-19 vaccine from Novavax, which would become the fourth Coronavirus dose approved in the United States. Moreover, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 – 0 with one abstention. They proposed that the FDA permit emergency use authorization (EUA) for the vaccine for adults eighteen and older.

Novavax’s protein-based Covid-19 vaccine would be the fourth vaccine to win approval in the United States, following the vaccines from Pfizer/BioNTech, Johnson & Johnson, and Moderna. Moreover, the vaccine is probable to win approval by June, projected M. Nielsen Hobbs, an expert for Informa Pharma Intelligence. On the other hand, many firms are reading about next-generation Coronavirus vaccines; the Novavax vaccine is not so much a new competitor as a much-delayed preliminary competitor as part of Operation Warp Speed.

Additionally, the U.S. Centers for Disease Control and Prevention (CDC) must choose to back the vaccine before it becomes widely available countrywide. Peter Marks, the FDA official, advised the advisory panel that the vaccine dose could offer the option for those who are hesitant to receive a vaccination shot as it is not made from new messenger RNA (mRNA) technology such as Moderna and Pfizer’s shots.

Novavax Primary Vaccine Key Background

In clinical trials, the two-shot primary vaccine of Novavax was found to be ninety percent effective against mild, moderate, or severe Coronavirus infection. As a result, the firm scored $1.6 billion in funding from the Operation Warp Speed of the Trump government in July 2020, but it faced difficulties. On the other hand, many nations, such as the Philippines, Australia, Indonesia, the United Kingdom, and South Korea.

FDA Panel Endorses Novavax’s Coronavirus Vaccine
FDA Panel Endorses Protein-based Novavax’s Coronavirus Vaccine
Source: Web

The FDA advisory committee came some days after the drug agency warned of a likely risk of two categories of heart inflammation – pericarditis and myocarditis – associated with the Novavax vaccine. Heart inflammation cases occurred after patients received Moderna and Pfizer’s coronavirus vaccines. In a Friday statement, Novavax stated that it believed there was inadequate evidence to create a causal relationship between the heart inflammation and its COVID vaccine.

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