The FDA’s vaccine advisory committee voted in favor of Novavax’s (NVAX) COVID-19 vaccine for use in adults, paving the way for the company to get its first product authorized in the U.S.
But the day-long meeting raised a number of concerns presented by Novavax’s late entry to the vaccine field.
Before any data was even presented, questions were raised by committee members about the need to authorize yet another COVID-19 vaccine, as demand has waned in the U.S., and about the manufacturing struggles Novavax — which relied on contract manufacturers— faced from the start.
FDA’s Dr. Peter Marks noted that even with three other vaccines available, and with 89% of adults receiving at least one dose, there remained some unmet need. In particular, Marks noted, there are those who are not comfortable with mRNA vaccines, and the Johnson & Johnson (JNJ) vaccine has faced some concerns over associated risks of blood clots.
“Anything we can do to make people more comfortable … is something we feel we are compelled to do,” Marks said in support of weighing Novavax’s application.
But some panelists questioned whether or not a primary course application was useful rather than using the vaccine as a booster.
Novavax chief medical officer Dr. Filip Dubovsky noted, “One in 10 Americans has yet to be vaccinated, and we haven’t given up on them.”
Novavax also faced concerns over reports of heart inflammation, or myocarditis, that had also been linked to mRNA vaccines like Pfizer (PFE)/ BioNTech (BNTX) and Moderna (MRNA).
Experts noted that the link to myocarditis only occurred after the real-world data for the mRNA vaccines came in, so there was no indication of the risk at the time. In addition, the Novavax vaccine is being reviewed after a year of such data, which means there was already reason to look for it and find it when it does occur.
But Dr. Paul Offit, a vaccine expert and director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the reason behind the heart inflammations is necessary to understand.
He said it was important “so that we can use that knowledge to make safer vaccines for a disease that is going to be with us for decades if not longer.”
To that end, one of the co-creators of the mRNA vaccine told Yahoo Finance Tuesday, in a separate interview, that new findings will soon be published about what could be causing it.
Manufacturing woes
The early manufacturing struggles of the biotech continue to overshadow its global distribution, which currently largely relies on the Serum Institute of India for global doses, as well as Takeda (TAK) for Japan’s doses and SK Bioscience for South Korea’s.
The FDA highlighted the issues in its presentation, saying that manufacturing data was still under review, and that the data from clinical stage trials through today vary widely as the sources changed.
In a statement to Yahoo Finance, Novavax said they had recently provided updated manufacturing information to the FDA.
“Novavax submitted its CMC data package on December 31 and applied for EUA on January 31 of this year. Since then, the company has continued to share relevant data with the FDA related to their review of the EUA application with updated manufacturing data as it has become available. On June 3, Novavax submitted an amendment with updated manufacturing information for the EUA to the FDA for review,” according to the statement.
Throughout the meeting Tuesday, there was no reference to a U.S. plant, or plans for U.S. production.
Could that delay the process for Novavax? In a statement to Yahoo Finance, the FDA seemed to indicate it would not.
“FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use. The decision to grant an EUA will also take into consideration the discussion of clinical data and voting outcome of the June 7 VRBPAC meeting,” the statement said.
The committee voted 21-0, with one abstention, to recommend use, and the company now awaits the FDA’s decision. The next step is the CDC’s advisory meeting to decide whether or not to recommend use, followed by a decision from the CDC.
The company’s stock was halted throughout the day Tuesday, even as the vote was cast prior to the closing bell.
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