By Meredith WadmanAug. 6, 2021 , 6:15 PM
Novavax, the small, Maryland-based institution that has been struggling for months to bring its promising protein-based COVID-19 vaccine to market, announced a setback yesterday successful its quest for an exigency usage authorization (EUA) successful the United States, sending its stock prices tumbling today. The U.S. authorities has ordered Novavax to halt making vaccine successful the United States and said it volition connection the institution nary much manufacturing backing until it passes muster with the Food and Drug Administration’s (FDA’s) strict manufacturing requirements, specified arsenic ensuring each batch of vaccine has the aforesaid potency.
“The U.S. authorities has precocious instructed [us] to prioritize alignment” with FDA’s methods for ensuring consistency successful manufacturing, the institution wrote successful a quarterly report filed yesterday. The authorities “further indicated that [it] volition not money further US manufacturing” until the steadfast has done so.
Meeting FDA’s investigating requirements “is conscionable taking time. This enactment with [the U.S. government] is portion of the mean people of business,” institution spokesperson Amy Speak wrote successful an email to ScienceInsider today. “We are continuing to enactment with the FDA and the US Government to finalize our filing bundle for EUA arsenic rapidly arsenic possible.”
Novavax’s ample North American proceedings successful June produced efficacy results connected par with messenger RNA vaccines, with 90% efficacy against symptomatic COVID-19 and 100% efficacy against mean and terrible disease. The institution has struggled with manufacturing issues, but successful June said it planned to record with FDA for an EUA successful the 3rd quarter. Yesterday, it pushed that program to the 4th quarter. The New York Times reported anonymous Biden medication sources saying that it’s not wide whether oregon erstwhile the vaccine volition beryllium authorized successful the United States, which has funded the institution with $1.75 cardinal to make and marque its vaccine.
Despite its setback successful the United States, wherever contractors marque the vaccine successful North Carolina and Texas, Novavax is pushing up with manufacturing successful different countries. The institution besides announced yesterday that, with its spouse the Serum Institute of India, it has filed for EUAs successful India, the Philippines, and Indonesia—its archetypal specified filings. It besides expects this period to record an exertion for exigency usage with the World Health Organization, which is simply a prerequisite for exports to galore countries.
“US manufacturing is abstracted from the manufacturing web that is making the doses destined for [the remainder of the world]. There should beryllium nary interaction connected that supply,” Speak wrote.
Novavax has agreed to proviso much than 1 cardinal doses of its vaccine to countries astir the world, including 350 cardinal doses to beryllium provided to poorer countries done the COVID-19 Vaccines Global Access Facility. The institution besides finalized connected 4 August an beforehand acquisition statement with the European Union for up to 200 cardinal doses. It says it volition implicit its exigency authorization exertion determination and successful the United Kingdom successful the 3rd quarter.
Novavax’s banal fell 20% today, to $190. But immoderate banal analysts shrugged disconnected the U.S. manufacturing news, saying a myopic absorption connected the United States overlooks the vaccine’s prime and the aggravated tendency and marketplace for it globally.
“We judge the institution has the [needed] analytic assays successful manus arsenic it has initiated the submission process to assorted regulators that should person akin requirements [to FDA],” expert Charles Duncan of Cantor Fitzgerald wrote successful a enactment to investors today.
Mayank Mamtani of B. Riley Securities says the U.S. quality “doesn’t substance fixed the urgent request for the Novavax vaccine successful markets wherever they person a wide regulatory path.”
Mamtani expects the Novavax changeable volition play an important relation successful the United States arsenic a booster for presently authorized vaccines. The institution released results yesterday of a objective survey of a booster dose of its vaccine, fixed to participants from its ample North American proceedings astir 6 months aft their 2nd dose. The 3rd jab quadrupled participants’ levels of neutralizing antibodies.