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Novavax applies for FDA approval of its COVID-19 vaccine

15 June 2021
2 min.
Novavax applies for FDA approval of its COVID-19 vaccine

Vaccine approval application

Novavax will be another major international supplier of vaccines against COVID-19, as trials of its NVX-CoV2373 vaccine have shown an overall effectiveness of 90.4% with good tolerability. Novavax expects coronavirus vaccination to be annual.

US biotechnology company Novavax (NVAX) on Monday published the final results of a large-scale test of its vaccine NVX-CoV2373 against COVID-19 involving 29,960 volunteers from the US and Mexico.

The results were better than experts and Wall Street experts expected. The Novavax vaccine showed 100% protection against hospitalizations and deaths, 100% protection against less dangerous strains of COVID-19, and 93% protection against predominantly circulating strains, with heavier tolerability.

The overall efficacy of the Novavax vaccine was 90.4%, with the company noting good tolerability and side-effects were similar to those seen with existing COVID-19 vaccines. The COVID-19 vaccine Novavax is a more traditional type of vaccine than those currently available. It contains a real version of the viral spike protein, which cannot cause disease but can directly trigger the immune system.

Vaccine manufacturers' promotions

On the back of the news, Novavax shares initially rose 9.5% on Monday, but ended the trading day down almost 1%.

Shares of Pfizer (PFE), BioNTech (BNTX)and Moderna (MRNA) on Monday reacted with significant declines of -1.3%, -7.5% and 5.2% respectively.

Novavax shares are up 86.3% since the start of 2021, after jumping more than 2,700% in 2020. Further gains in Novavax shares will require US Food and Drug Administration (FDA) approval for widespread use of the NVX-CoV2373 vaccine, as well as reports of major supply deals and confirmation that the COVID-19 vaccination will be annual.

Novavax said it intends to apply for FDA and other regulatory approvals in the 3rd quarter and remains committed to achieving production capacity of 100 million doses per month by the end of the third quarter. By the end of 2021, that figure should rise to 150 million doses per month.

While some countries, such as the US, have already purchased the necessary doses to vaccinate their entire population, many others have yet to do so.

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