A panel of foreign vaccine specialists voted 21-0 on one vaccination for those 18 years and older after discussing whether the benefits of shooting outweigh the risks, including the rare occurrence of heart attack that may be associated with the vaccine.U.S. Food and Drug Administration advisers on Tuesday voted strongly to recommend that the organization approve the vaccine NovavaxInc’s COVID-19 for use in adults, a drug manufacturer who hopes to be a favorite of some who doubt the American vaccine.
If the FDA follows the recommendation and approves the shot, it will be the fourth COVID drug available for use in adults in the United States. The FDA approved the previous COVID seizures during the panel voting days, with immediate distribution following.
Novavax timeline is unclear
Novavax Commercial CEO John Trizzino said the organization was still reviewing detailed documents on its production processes launched last week. “We hope to have a product in the US at our warehouse by the end of June,” he said in an interview, adding that the company plans to send millions of volumes made by its partner, the Serum Institute of India, soon after approval.
The Novavax shot, which is already available in more than 40 countries, is a traditional vaccine that has been used for decades to fight diseases such as the flu. Novavax based in Maryland hopes to gain a foothold among the estimated 27 million American adults yet to be vaccinated, especially those who do not want to receive a vaccine such as Pfizer / BioNTech or Moderna shooting based on messenger RNA technology. “We have a problem with the adoption of the most difficult vaccine in the United States,” FDA official Peter Marks told the panel.
“Anything we can do to make people more comfortable to accept these life-saving medical products is something we feel compelled to do,” he added. However, that need did not materialize in Europe, with Novavax. he said it could increase vaccination of skeptics. About 12.6 million vaccines have been distributed in the European Union, but about 220,000 doses of double vaccines have been given since its launch in December.
A spokesman for the Department of Health and Human Services (HHS) noted that the supply could be limited in the near future. Before taking pictures, the FDA must approve the vaccine and the Centers for Disease Control and Prevention (CDC) needs to be screened. turn on its use. HHS said in a statement Monday that it was working with Novavax to “get a smaller vaccine and will make the vaccine available to the American public” once those measures are completed. The CDC panel may consider the Novavax rifle by the end of next week. Novavax applied for accreditation in the US in late January, about a year after his initial plan, following development and manufacturing problems.
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