According to Novavax, the Covid vaccine is 90% effective and will be submitted to the FDA in the third quarter.

The woman has a small bottle with the “Coronavirus COVID-19 Vaccine” sticker and the medical syringe label in front of the displayed Novavax logo in this figure, taken on October 30, 2020.

Daddle Bitch | Reuters

Biotechnology company Novavax On Monday, the Covid-19 vaccine was shown to be safe and overall 90.4% effective in a phase 3 clinical trial involving approximately 30,000 participants across the United States and Mexico.

In addition, the double-dose vaccine was found to be 100% effective in preventing moderate and severe diseases and 93% effective against some mutants, Novavax said. The company said it plans to apply for approval from the Food and Drug Administration in the third quarter of this year.

In late-stage trials, “We have confirmed that NVX-CoV2373 provides a promising tolerability and safety profile,” said Dr. Gregory Glenn, Head of Research and Development at Novavax, in a press release. “These data show a consistently high level of efficacy, reaffirming the vaccine’s ability to prevent COVID-19 during the ongoing genetic evolution of the virus.”

The analysis evaluated 77 confirmed Covid infections among the 29,960 participants in the study. Novavax said 63 Covids were observed in the placebo group, compared with 14 in the double-vaccinated group. As a result, 90.4% of vaccine efficacy was estimated.

According to the company, the vaccine is well tolerated. The most common side effects were fatigue, headaches, muscle aches, and pain at the injection site, which usually lasted only a few days, the company said.

According to the company, all Covid hospitalizations in the trial occurred in the placebo group.

According to Novavax, this vaccine appears to be effective against some variants, including the Alpha variant first identified in the United Kingdom. Approximately 65% ​​of cases for which sequence data were available were variants of concern.

If the Novavax vaccine is approved by the FDA, it will follow three Covid-19 shots (BioNTech, Moderna, Johnson & Johnson) that have already been approved for emergency use in the United States by Pfizer.

New data comes because federal officials state that the United States has enough Covid vaccine to complete vaccination of the entire US population. As of Sunday, more than 173 million Americans have been vaccinated with at least one Covid-19 vaccine, according to data compiled by the US Centers for Disease Control and Prevention.

The United States may end up donating a dose of Novavax vaccine.

The Biden administration has already promised to donate at least 20 million Covid vaccines manufactured by Pfizer-BioNTech, Moderna and J & J, and 60 million AstraZeneca vaccines not yet approved for use in the United States.

Earlier this month, the White House announced that it would lift restrictions as part of the Defense Production Act, which prioritizes vaccines developed by AstraZeneca, Sanofi and Novabax over the United States.

Novavax said on Monday that it expects to reach 100 million monthly production capacity by the end of the third quarter and 150 million monthly production capacity by the fourth quarter of 2021.

According to Novavax, the Covid vaccine is 90% effective and will be submitted to the FDA in the third quarter.

Source link According to Novavax, the Covid vaccine is 90% effective and will be submitted to the FDA in the third quarter.

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