FDA advisory committee recommends Novavax vaccine for use in adults

The FDA’s Vaccine Advisory Committee has voted in favor of Novavax’s COVID-19 vaccine (NVAX) for use in adults, paving the way for the company to obtain its first authorized product in the U.S.

But the day-long meeting raised a number of concerns raised by Novavax’s late entry into the vaccine field.

Before any data was even presented, committee members raised questions about the need to authorize yet another COVID-19 vaccine as demand has waned in the US, and about the manufacturing difficulties that Novavax – which relied on contract manufacturers – faced from the beginning.

The Doctor. Peter Marks of the FDA noted that even with three other vaccines available, and with 89% of adults receiving at least one dose, there were still some unmet needs. In particular, Marks noted, there are those who are uncomfortable with mRNA vaccines, and the Johnson & Johnson (JNJ) vaccine has faced some concerns about the associated risks of blood clots.

Photo by: STRF/STAR MAX/IPx 2021 29/01/21 Novavax says its two-dose vaccine for COVID-19 shows an 89.3% efficacy rate in a large Phase 3 clinical trial and was highly effective against a variant first identified in the UK. STAR MAX Photo: Novavax logo and COVID-19 virus images photographed on Apple devices.

“Anything we can do to make people more comfortable… is something we feel we are obligated to do,” said Marks in support of Novavax’s assessment of the order.

But some panelists questioned whether or not a primary course application was helpful, rather than using the vaccine as a booster.

Novavax medical director Dr. Filip Dubovsky, noted, “One in 10 Americans still hasn’t been vaccinated and we haven’t given up on them.”

Novavax has also faced concerns over reports of cardiac inflammation, or myocarditis, which have also been associated with mRNA vaccines such as Pfizer (PFE) / BioNTech (BNTX) and Moderna (MRNA).

Experts noted that the link to myocarditis only occurred after real-world data for the mRNA vaccines arrived, so there was no indication of risk at the time. Furthermore, 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 occurs.

But Dr. Paul Offit, a vaccine expert and director of the Center for Vaccine Education at Children’s Hospital of Pennsylvania, said it is necessary to understand the reason behind heart inflammation.

He said it was important “so that we can use this knowledge to make safer vaccines for a disease that will be with us for decades, if not longer.”

To that end, one of the co-creators of the mRNA vaccine told Yahoo Finance on Tuesday in a separate interview that new findings will be published soon about what could be causing this.

manufacturing issues

The biotechnology’s early manufacturing difficulties continue to overshadow its global distribution, which currently relies heavily on the Serum Institute of India for global doses, as well as Takeda (TAK) for doses from Japan and SK Bioscience for South Korea.

The FDA highlighted the issues in its presentation, saying manufacturing data was still being reviewed and that data from clinical trials in today’s phase varies widely as sources change.

In a statement to Yahoo Finance, Novavax said it had recently provided updated manufacturing information to the FDA.

“Novavax submitted its CMC data packet on December 31st and requested US on January 31st of this year. Since then, the company has continued to share relevant data with the FDA related to the review of the US application with updated manufacturing data as June 3, Novavax submitted an amendment with updated US manufacturing information to the FDA for review,” according to the statement.

Throughout Tuesday’s meeting, there was no reference to a US factory or US production plans.

Could this delay Novavax’s lawsuit? In a statement to Yahoo Finance, the FDA appeared to indicate no.

“The FDA will carefully review this and any additional information presented by the company as part of its ongoing evaluation and prior to authorizing the vaccine for emergency use. The decision to award a EUA will also take into account the discussion of clinical data and the outcome of the vote to June 7 VRBPAC meeting,” the statement said.

The committee voted 21 to 0, with one abstention, to recommend use, and the company is now awaiting the FDA’s decision. The next step is the CDC advisory meeting to decide whether or not to recommend use, followed by a CDC decision.

The company’s shares froze throughout the day on Tuesday, even as the vote was taken before the closing bell.

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