[ad_1]
Novavax, based in Gaithersburg, Md., Announced a setback this week in its quest for emergency use authorization from the United States Food and Drug Administration for its COVID-19 vaccine.
Alyssa Schukar / Redux
By Meredith Wadman
Novavax, the small Maryland-based company that has struggled for months to bring its promising protein-based COVID-19 vaccine to market, yesterday announced a setback in its quest for an Emergency Use Clearance (EUA) in the United States, sending its stock price dropping today. The U.S. government has ordered Novavax to stop manufacturing vaccines in the U.S. and said it will no longer offer the company manufacturing funding until it meets stringent manufacturing requirements. the Food and Drug Administration (FDA), such as ensuring that each batch of vaccine has the same potency.
“The US government recently asked [us] prioritize alignment “with FDA methods to ensure manufacturing consistency, the company wrote in a quarterly report filed yesterday. The government “further indicated that [it] will not fund additional manufacturing in the United States ”until the company has done so.
Meeting FDA testing requirements “just takes time. This interaction with [the U.S. government] is part of the normal course of business, ”wrote company spokesperson Amy Speak in an email to ScienceInitiated today. “We continue to work with the FDA and the US government to finalize our EUA application package as quickly as possible.”
Related
The large North American trial of Novavax in June produced efficacy results comparable to those of messenger RNA vaccines, with 90% efficacy against symptomatic COVID-19 and 100% efficacy against moderate and severe disease . The company faced manufacturing issues, but said in June that it planned to file an EUA application with the FDA in the third quarter. Yesterday he pushed that plan back to the fourth quarter. The New York Times Anonymous sources from the Biden administration reported saying it is not clear if or when the vaccine will be authorized in the United States, which has funded the company with $ 1.75 billion to develop and manufacture its vaccine.
Despite its setback in the United States, where contractors manufacture the vaccine in North Carolina and Texas, Novavax continues to manufacture in other countries. The company also announced yesterday that it had filed, together with its partner, the Serum Institute of India, USA in India, the Philippines and Indonesia, its first such filings. It also plans this month to file an emergency use request with the World Health Organization, which is a prerequisite for exports to many countries.
“Manufacturing in the United States is separate from the manufacturing network that manufactures doses for [the rest of the world]. There should be no impact on this supply, ”Speak wrote.
Novavax has agreed to deliver more than a billion doses of its vaccine to countries around the world, including 350 million doses to be delivered to the poorest countries through the Global COVID-19 Vaccine Access Facility. The company also finalized on August 4 an early purchase agreement with the European Union for up to 200 million doses. He says he will complete his emergency clearance application there and in the UK in the third quarter.
Novavax stock fell 20% today, to $ 190. But some stock analysts have ignored the news of manufacturing in the United States, saying a myopic focus on the United States overlooks the quality of the vaccine and the intense desire and market for it around the world.
“We believe that the company has the [needed] analytical testing in hand as it kicked off the process of submitting to various regulatory bodies that are expected to have similar requirements [to FDA]Cantor Fitzgerald analyst Charles Duncan wrote in a note to investors today.
Mayank Mamtani of B. Riley Securities said the US news “does not matter given the urgent need for the Novavax vaccine in markets where they have a clear regulatory path.”
Mamtani expects the Novavax vaccine to play an important role in the United States as a booster for currently licensed vaccines. The company yesterday published the results of a clinical study of a booster dose of its vaccine, given to participants in its large North American trial about 6 months after their second dose. The third jab quadrupled the participants’ neutralizing antibody levels.
[ad_2]
Source link