Novavax COVID vaccine heads to U.S. FDA advisory committee -Breaking
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© Reuters. FILE PHOTO – Vials labeled “VACCINE Coronavirus Covid-19” are shown in front of the Novavax logo. This illustration was taken on December 11, 2021. REUTERS/Dado Ruvic/IllustrationManas Mishra and Michael Erman
(Reuters] – Tuesday, U.S. Food and Drug Administration advisors will discuss whether they should recommend Novavax (NASDAQ) Inc’s COVID-19 vaccination for adults. The drugmaker believes it can be the vaccine of choice for some American vaccine skeptics.
Novavax shot, a traditional vaccine that uses technology from the past decades to fight diseases such as Hepatitis B or influenza is an older type.
It is aiming to establish a presence among the less than 25% of U.S. adults that have not been vaccinated. This includes those who don’t want to get a vaccine such as the Pfizer/BioNTech. Moderna (NASDAQ:) Inc shots based in groundbreaking messenger RNA(mRNA) technology.
Novavax Chief Commercial Officer John Trizzino stated that there are “still a substantial amount of people who are not yet vaccinated” in a press conference late last month. We’ll be seeing uptake among those who are either vaccine hesitant, or would prefer a different mRNA vaccine.
This demand hasn’t materialized in Europe where Novavax said that it might drive up vaccinations among the hesitant.
Novavax vaccine has been distributed to approximately 11.2.6 million people in Europe. But, around 221,000 doses were administered in Belgium since its launch in December.
According to the Department of Health and Human Services, the number of Novavax shot in America is expected to decrease in the short-term.
A spokesperson for HHS stated Monday that Novavax is cooperating with HHS “to receive limited quantities of vaccine and make those vaccines available to the American people” if shot approval is granted by FDA and is recommended by Centers for Disease Control and Prevention.
Novavax applied for U.S. approval in January. This was almost one year late than its original plan due to manufacturing and development problems. Serum Institute in India is producing the vaccine.
Novavax reported that 41 million doses of the drug were distributed in 41 countries during the quarter.
The FDA released briefing materials for Friday’s meeting, which included data that showed the vaccine could lower the risk of developing mild-to-severe diseases. Concerns were also raised about the possibility of myocarditis (heart inflammation) from the vaccine. Myocarditis is also a common condition after mRNA injections. It has been mostly observed in young men.
Novavax expected to achieve sales of between $4 billion-$5 billion for this year. According to Refinitiv, analysts expect lower sales.
Stewart Glickman, CFRA analyst, said, “Their pace must really improve in order to reach the lower end of this range.” He added that his company’s forecast relies on the risky sale to low income countries where orders might be delayed or decreased.
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