Novavax, the little Maryland-based company that has been struggling for months to bring a promising protein-based COVID-19 vaccine to market, announced a setback yesterday in its quest for an Emergency Use Authorization (EUA) in the US, sending its share prices deteriorate today. The US government has ordered Novavax to quit making the vaccine in the US and said it won’t offer the company more funding until it passes stringent Food and Drug Administration (FDA) manufacturing requirements, such as making sure every batch of the vaccine contains the alike potency.
The US government has recently received instructions [us] To prioritize alignment “with FDA methods to ensure consistency in manufacturing,” the company wrote in a quarterly report presented yesterday. The government also noted that [it] It won’t fund additional US manufacturing” until the company does.
Meeting FDA testing requirements “only takes time. This interaction with [the U.S. government] is part of the average course of business,” company spokeswoman Amy Speck wrote in an email to SciencesInsiders today. “We persevere to work with the US Food and Drug Administration and the US government to finalize our package of files for the EUA as quickly as conceivable.”
Novavax’s big North American trial in June produced results on par with RNA vaccines, with 90% efficacy against COVID-19 symptoms and 100% efficacy against temperate to severe disease. The company has struggled with manufacturing issues, but said in June that it plans to file with the Food and Drug Administration for an EUA in the third quarter. Yesterday, I pushed that plan into the fourth quarter. New York times Anonymous Biden administration sources said it was not clear if or when the vaccine would be authorized in the United States, which funded the company with $1.75 billion to develop and manufacture the vaccine.
Despite the setback in the United States, where contractors manufacture the vaccine in North Carolina and Texas, Novavax is pressing ahead with manufacturing in other countries. The company also announced yesterday that it, along with its partner Serum Institute of India, has applied for EUAs in India, the Philippines and Indonesia – the first filings of its considerate. This month it also expects to file an application for emergency use with the World Health Organization, a prerequisite for export to many countries.
“Manufacturing in the United States is divide from the manufacturing network that manufactures the doses intended for it.” [the rest of the world]. “There should be no effect on this show,” Speak wrote.
Novavax has agreed to supply more than 1 billion doses of its vaccine to countries around the world, including 350 million doses that will be provided to destitute countries through the COVID-19 Vaccine Global Access Facility. On August 4, the company also terminated a pre-purchase agreement with the European Union for up to 200 million doses. It says it will conclude the emergency authorization request there and in the UK in the third quarter.
Novavax stock is down 20% today, to $190. But some stock analysts have shrugged off the US manufacturing news, saying the myopic focus on the US ignores the vaccine’s quality, cravings and market for it globally.
“We believe the company has [needed] Analytical assays are on hand as the application process has been initiated to various regulators who should have similar requirements [to FDA]Analyst Charles Duncan of Cantor Fitzgerald wrote in a note to investors today.
Mayank Mamtani of B. Riley Securities says the US news “doesn’t matter given the crucial need for the Novavax vaccine in markets where they have a clear regulatory path.”
Mamtani anticipates that the Novavax dose will play an significant role in the United States as a booster for currently authorized vaccines. Yesterday the company released the results of a clinical study of a booster dose of its vaccine, given to participants from its big North American trial about 6 months following the second dose. The third hit quadrupled the participants’ neutralizing antibody levels.