Novavax Says Its Covid Vaccine Is 90% Effective, Plans To Submit Data To FDA In Q3 – –

Novavax Says Its Covid Vaccine Is 90% Effective, Plans To Submit Data To FDA In Q3 – –

Biotech company Novavax said on Monday that its Covid-19 vaccine was found to be 90.4% safe and effective in a phase three clinical trial involving nearly 30,000 participants in the United States and Mexico.
What’s more, the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants, Novavax said. The company said it plans to file an application for authorization with the Food and Drug Administration in the third quarter of this year.

The advanced stage trial “confirms that NVX-CoV2373 offers an encouraging safety and tolerance profile,” said Dr. Gregory Glenn, president of research and development for Novavax, in a press release. “These data show high and consistent levels of efficacy and reaffirm the vaccine’s ability to prevent COVID-19 as part of the virus’s ongoing genetic evolution. “

The analysis assessed 77 confirmed Covid infections among the 29,960 trial participants. Novavax said 63 cases of Covid were seen in the placebo group compared to 14 cases seen in the group that received its two-dose vaccine. This resulted in an estimated vaccine efficacy of 90.4%, he said.

The vaccine also appears to be well tolerated, according to the company. The most common side effects were fatigue, headaches, muscle aches and pain at the injection site, which typically didn’t last more than two or three days, the company said.

All of the Covid hospitalizations in the trial occurred in the placebo group, the company said.

Novavax said the vaccine appears to be effective against some variants, including the Alpha variant, first identified in the UK. About 65% of the cases for which sequence data was available were variants of concern, the company said.

If Novavax’s vaccine is cleared by the FDA, it would follow three Covid-19 injections already approved for emergency use in the United States from Pfizer-BioNTech, Moderna and Johnson & Johnson.

The new data comes as federal officials say the United States has more than enough doses of the Covid vaccine to finish vaccinating the entire American population. As of Sunday, more than 173 million Americans had received at least one dose of a Covid-19 vaccine, according to data compiled by the Centers for Disease Control and Prevention.

It is possible that the United States will end up giving doses of the Novavax vaccine.

The Biden administration has already pledged to donate at least 20 million doses of Covid vaccines produced by Pfizer-BioNTech, Moderna and J&J as well as 60 million doses of AstraZeneca vaccines, the use of which does not has not yet been authorized in the United States.

Earlier this month, the White House announced it was lifting restrictions under the Defense Production Act that prioritized the United States for vaccines developed by AstraZeneca, Sanofi and Novavax.

Novavax said Monday it remains on track to achieve a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the fourth quarter of 2021.


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