Novavax says its Covid vaccine is 90% effective, plans to submit data to FDA in third quarter
- Biotech firm Novavax said its Covid-19 vaccine was shown to be safe and 90.4% effective overall during a phase three clinical test .
- It said it plans to file for authorization with the FDA within the third quarter.
- With an abundance of vaccines already available within the us , it’s possible that the govt would donate the Novavax doses to other countries.
Biotech firm Novavax said Monday its Covid-19 vaccine was shown to be safe and 90.4% effective overall during a phase three clinical test of nearly 30,000 participants across the us and Mexico.
Additionally, it said the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants. the corporate said it plans to file for authorization with the Food and Drug Administration within the third quarter.
The late-stage trial “confirms that NVX-CoV2373 offers an encouraging tolerability and safety profile,” Dr. Gregory Glenn, Novavax’s president of research and development, said during a handout . “These data show consistent, high levels of efficacy and reaffirm the power of the vaccine to stop COVID-19 amid ongoing genetic evolution of the virus.”
The company’s shares jumped by quite 9% in premarket trading. The stock was up by about 1% in intraday trading.
With an abundance of vaccines already available within the us , it’s possible that the govt would donate the Novavax doses to other countries.
Novavax CEO Stanley Erck told CNBC the corporate also expects to ascertain an outsized market within the U.S. for booster shots. That’s because researchers are starting to see levels of antibodies wane after 6 to 12 months, he said.
“It’s clear that we’re all getting to need one boost then maybe on an annual basis or some period,” he said during an interview with “Squawk on the Street” on Monday.
The company’s analysis evaluated 77 confirmed Covid infections among the trial’s 29,960 participants. Novavax said 63 cases of Covid were observed within the placebo group versus 14 cases observed within the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 90.4%, it said.
The vaccine also seemed to be well-tolerated, consistent with the corporate . the foremost common side effects were fatigue, headache, muscle pain and pain at the injection site, which usually lasted no quite two or three days, the corporate said.
All Covid hospitalizations within the trial occurred within the placebo group, the corporate said.
Novavax said the vaccine appears to be effective against some variants, including the Alpha variant, first identified within the U.K. About 65% of the cases where sequence data was available were variants of concern, the corporate said.
If Novavax’s vaccine is permitted by the FDA, it might follow three Covid-19 shots already approved for emergency use within the U.S. from Pfizer-BioNTech, Moderna and Johnson & Johnson.
The new data comes as federal officials say the U.S. has quite enough doses of Covid vaccines to end vaccinating the whole American population. As of Sunday, quite 173 million Americans have had a minimum of one dose of a Covid-19 vaccine, consistent with data compiled by the Centers for Disease Control and Prevention.
The Biden administration has already committed to donating a minimum of 20 million doses of Covid vaccines produced by Pfizer-BioNTech, Moderna and J&J also as 60 million doses of AstraZeneca’s vaccine, which has not yet been authorized to be used within the U.S.
Earlier this month, the White House announced it had been lifting restrictions as a part of the Defense Production Act that gave the U.S. priority for vaccines developed by AstraZeneca, Sanofi and Novavax.
Erck said Monday the company’s supply of vaccine doses within the U.S. might be directed to COVAX, the WHO-backed immunization program, and places like India, where the virus is rapidly circulating.
Novavax said Monday it remains on target to succeed in manufacturing capacity of 100 million doses per month by the top of the third quarter and 150 million doses per month by the fourth quarter of 2021.