U.S. Could Authorize Novavax Covid Vaccine—An MRNA Alternative—In February, CEO Says
Topline
Novavax’s Covid-19 vaccine, already obtainable to be used in 170 international locations and most well-known for being a non-mRNA vaccine various, could possibly be authorized to be used within the U.S. in February and in as much as 10 different international locations inside 90 days, CEO Stanley Erck told CNBC Monday.
Novavax’s Covid-19 vaccine could also be authorized by the U.S. Meals and Drug administration in February.
Justin Tallis/AFP by way of Getty Photos
Key Details
The Maryland-based biotechnology firm submitted its last knowledge packages to the U.S. Meals and Drug Administration on New Yr’s Eve, however gained’t be capable of request emergency use authorization till January 31, after which the corporate expects a call inside one month, Erck stated.
Erck stated the corporate expects its vaccine to be authorized to be used in a number of international locations over the following 90 days, because the vaccine has just lately been submitted to be used in Australia, Canada, New Zealand, Singapore, South Africa and the U.Okay., and with the World Well being Group.
The vaccine, which stimulates the immune system utilizing nanoparticles relatively than mRNA, may assist persuade people who find themselves skeptical of mRNA know-how to get vaccinated, Erck stated.
Key Background
Whereas mRNA vaccines immediate the physique’s cells into creating elements of the coronavirus that may set off the immune system, Novavax’s vaccine introduces a protein from the virus as a nanoparticle that can’t trigger sickness however stimulates antibody manufacturing. Novavax’s vaccine might be saved at room temperature, making it considerably simpler to distribute than mRNA vaccines, which should be refrigerated inside a specific vary. Scientific trials discovered Novavax’s two-dose vaccine to be 90% efficient towards the coronavirus, the WHO said. In November, Indonesia turned the first country to situation an emergency use authorization for the vaccine, which has since been made obtainable to be used in 170 international locations, Erck stated. Vaccine shipments are underway in Europe, Novavax announced Monday, with 27 million doses deliberate for supply within the first quarter of the yr and over 40 million within the second quarter. Novavax is contracted to ship about 2 billion doses of its vaccine worldwide, Erck stated.
What We Don’t Know
It stays unsure how Novavax’s vaccine stacks up towards the omicron variant, the WHO stated. Nonetheless, knowledge suggests a Novavax booster shot will increase antibody ranges towards omicron extra successfully than Pfizer or Moderna booster pictures.
What To Watch For
Novavax plans to start medical research of an omicron-targeted vaccine within the first quarter of 2022, said Gregory M. Glenn, president of analysis and growth for the corporate. Trials are additionally underway for a Novavax mixture vaccine for Covid and flu.
Tangent
Manufacturing issues had slowed Novavax’s entry onto the vaccine market, Bloomberg reported. Nonetheless, Novavax shares, which gained about 10% over the previous yr, had been up 4.16% on Monday afternoon, shortly after Erck advised CNBC he anticipated the vaccine to win emergency use authorization from 10 regulatory businesses inside 90 days.
Additional Studying
“Novavax CEO says its Covid vaccine could be cleared in multiple countries over next 90 days” (CNBC)
“Novavax Covid Vaccine Gives Antibody Response In opposition to Omicron, Information Suggests” (Forbes)
