U.S. Food and Drug Administration consultants on Tuesday voted overwhelmingly in favor of the company granting Novavax Inc’s COVID-19 vaccine for adults, which pharmaceutical companies hope will be a viable option. among some anti-American advocates.
A group of outdoor immunization experts held a 21-0 election and a refusal for immunization support for 18-year-olds went up.
If the FDA follows that advice and authorizes the shooting, it will be the fourth-largest COVID vaccine available for use in adults in the United States.
Novavax is a traditional herbal remedy that has been used for decades to fight infections including hepatitis B and influenza.
Novavax in Maryland expects support from around 27 million U.S. adults to be vaccinated, mostly those who do not want to be vaccinated based on Pfizer / BioNTech or Moderna Inc. messenger RNA (mRNA). ) technology.
FDA officials agree that having a protein-based injection similar to that developed by Novavax may help improve immunity acceptance among those who are reluctant.
“We have a problem with getting very serious vaccines in the United States,” FDA official Peter Marks told the team.
He added, “Anything we can do to bring peace of mind so that people can accept these life-saving pharmaceutical products is something we feel we are forced to do.”
The demand has not yet been fulfilled in Europe, where Novavax also said it could promote immunization among the reluctant.
About 12.6 million Novavax vaccines are distributed in the European Union, but only about 220 000 doses of inoculation have been put in place since it was released in December.
The Novavax population in the United States is likely to end soon, according to the Department of Health and Human Services (HHS).
A HHS spokeswoman said Monday that Novavax was planning to “get enough of the vaccine and that it would make Americans more vaccinated” if the FDA authorized the shotgun and the Centers for Disease Control and Prevention supported.
Novavax filed for U.S. license in late January, almost a year after its original plan, following development and manufacturing problems.
The vaccine is also manufactured by the Serum Institute of India.
About 41 million drugs were delivered in 41 countries in the first quarter, Novavax said.
In a statement prepared for the meeting and released Friday, the FDA said data showed it could reduce the chances of mild to severe disease.
It raised concerns about the risk of inflammation of the heart called myocarditis from the vaccine, and this condition is seen after mRNA injection, mainly in young men.
Novavax COVID vaccine approved for use by US FDA panel – SABC Report
Source link Novavax COVID vaccine approved for use by US FDA panel – SABC Report