Novavax Covid Vaccine seeks FDA Approval

Novavax, Inc., a biotechnology company, has submitted a request to the FDA to grant Emergency Use Authorization (EUA) to their own Covid vaccine. The Novavax Covid vaccine, NVX-CoV2373, is a protein-based Covid-19 vaccine meant for vaccination in individuals 18 years and above. This is coming after Pfizer filed approval request for the first-ever vaccine for children under 5 years.

Novavax submitted the request after the vaccine proved safe, with an efficacy of close to 90% in two large clinical trials. The pivotal Phase 3 clinical trials conducted by Novavax – PREVENT-19, which involved over 30,000 participants in the US and Mexico. The other trial involved 15,000 participants in the UK.

In both trials, the vaccine showed efficacy and common side effects such as headache, nausea or vomiting, myalgia, injection site pain, fatigue and malaise. Novavax is also carrying out booster study before they roll out the third doses of the vaccine, and also study on the vaccine for younger individuals between the ages 12-17.

They produced the Novavax Covid Vaccine using recombinant nanoparticle technology. The vaccine contains purified protein antigen, just as the one on the surface of SARS-CoV-2 (the spike protein). When a person receives the vaccine, the immune system sees it as a foreign agent and deploys the T cells and antibodies against it. Eventually, when the vaccinated person encounters SARS-CoV-2, the immune system will recognise the spike protein on the virus and attack it.

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It also has an adjuvant, a saponin-based Matrix-M to enhance immune response and increase antibodies that neutralise the virus.

It is available as a ready-to-use liquid formulation. The vial contains ten doses of the vaccine. For the vaccination, two 0.5 ml doses are given intramuscularly (muscles of the upper arm) 21 days apart. The storage temperature is between 2 to 8° C.

According to Novavax, they have the partnership to make sure the vaccine is available worldwide, with an existing partnership with Serum Institute of India, the largest manufacturer of vaccine, by volume in the world

In December 2021, European Medicines Agency granted conditional marketing authorization to Novavax’s COVID-19 vaccine Nuvaxovid (NVX-CoV2373). The EMA’s human medicines committee (CHMP) evaluated the data and concluded that it met the EU’s conditions in terms of efficacy, quality, and safety.

It became the fifth vaccine approved by the EU for protection against Covid-19.

On 3rd Feb. 2022, Novavax announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine in the Great Britain. It is the first-ever protein based Covid vaccine in the United Kingdom.

India, South Korea, and Australia have already approved the vaccine for emergency use.

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Sources

https://ir.novavax.com/2022-01-31-Novavax-Submits-Request-to-the-U-S-FDA-for-Emergency-Use-Authorization-of-COVID-19-Vaccine
https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu

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