Novavax COVID vaccine heads to U.S. FDA advisory committee

[June 07, 2022]  By Michael Erman and Manas Mishra

(Reuters) - Advisers to the U.S. Food and Drug Administration on Tuesday will consider whether to recommend Novavax Inc's COVID-19 vaccine for adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.

Novavax's shot is a more traditional type of vaccine employing technology that has been used for decades to combat diseases including Hepatitis B and influenza.

The company is hoping to gain a foothold within the less than one-quarter of U.S. adults who have yet to be vaccinated, particularly those who do not want to receive a vaccine like the Pfizer/BioNTech or Moderna Inc shots based on groundbreaking messenger RNA (mRNA) technology.

"There are still a substantial number of people that are not yet vaccinated," Novavax Chief Commercial Officer John Trizzino said in a media briefing late last month. "I think we'll see uptake in those people that have either been vaccine hesitant or have a preference for something other than mRNA vaccine."

That demand has not materialized in Europe, where Novavax also said it could drive up vaccination among the hesitant.

Around 12.6 million doses of Novavax's vaccine have been distributed in the European Union, but only around 220,000 doses of the two-shot inoculation have been administered there since it was launched in December.

The number of Novavax shots available in the United States is likely to be limited in the near term, according to the Department of Health and Human Services (HHS).

An HHS spokesperson said on Monday it is coordinating with Novavax "to receive a limited quantity of vaccine and will make that vaccine available to the American public" if the shot is authorized by the FDA and recommended by the Centers for Disease Control and Prevention.

Vials labelled "VACCINE Coronavirus COVID-19" and a syringe are seen in front of a displayed Novavax logo in this illustration taken December 11, 2021. REUTERS/Dado Ruvic/Illustration

Novavax filed for U.S. authorization in late January, almost a year behind its original plan, following development and manufacturing problems. The vaccine is also being made by Serum Institute of India.

About 41 million doses were delivered in 41 countries in the first quarter, Novavax said.

In briefing documents prepared for the meeting and released on Friday, the FDA said data showed it could reduce the chances of mild-to-severe disease. It also raised concerns about the risk of heart inflammation called myocarditis from the vaccine, a condition that has also been observed after mRNA vaccinations, primarily in young men.

Novavax projected between $4 billion to $5 billion in sales this year. Analysts expect sales at the lower end of that range, according to Refinitiv.

"Their pacing has to really improve just to reach the low end of the range," said CFRA analyst Stewart Glickman, adding that the company forecast depends on risky sales to low-income countries, where orders may be delayed or reduced.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Caroline Humer and Bill Berkrot)

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