The fourth vaccination to be made accessible in the US, but one that employs a different technology than prior approvals, was given an emergency use license by the U.S. Food and Drug Administration (FDA) on Wednesday for those ages 18 and older.
The vaccine may be useful in preventing COVID-19 and will be offered as a two-dose main series for adults, spaced three weeks apart, according to a statement from the FDA. Its recognized and prospective benefits outweigh its risks for adults.
The CDC Director will ultimately decide whether to approve the advisory committee’s recommendation before the vaccine is authorized for nationwide administration. The Advisory Committee on Immunization Practices at the U.S. Centers for Disease Control and Prevention (CDC) is scheduled to meet on July 19 to provide input on the vaccine.
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The United States government said earlier this week that it had obtained 3.2 million doses of the Novavax vaccine, which it intends to distribute when the business completes quality testing in the following few weeks.
Over two-thirds of Americans have received all recommended vaccinations from Moderna, Pfizer-BioNTech, or Johnson & Johnson.
Health officials in the United States are hoping that patients who have chosen not to get the vaccines produced by Pfizer and Moderna, which are based on the ground-breaking messenger RNA (mRNA) technology, will choose Novavax’s protein-based injection instead.
The vaccine is based on a technique that has been used for decades to fight illnesses including hepatitis B and influenza. It has previously received approval in Europe.
FDA Commissioner Robert Califf stated in a statement that “today’s authorisation provides individuals in the United States who have not yet received a COVID-19 vaccination another alternative that fulfills the FDA’s strict criteria.”
Novavax increased its focus on developing nations as a result of the poor demand for the injection in Europe, where just 242,000 doses had been provided since its introduction in December.
Due to development and production issues, the company’s original application for U.S. authorisation of the shot was over a year late, making it a late arrival in the country’s market for COVID-19 vaccinations.
This year’s sales are expected to reach between $4 billion and $5 billion, according to Novavax. Refinitiv reports that analysts anticipate sales to be at the lower end of that range.
(With help from organizations)
