Novavax COVID vaccine heads to U.S. FDA advisory committee
By Michael Erman and Manas Mishra
(Reuters) – Advisers to the U.S. Meals and Drug Administration on Tuesday will think about whether or not to advocate Novavax Inc’s COVID-19 vaccine for adults, which the drugmaker hopes can change into the shot of selection amongst some American vaccine skeptics.
Novavax’s shot is a extra conventional kind of vaccine using expertise that has been used for many years to fight illnesses together with Hepatitis B and influenza.
The corporate is hoping to achieve a foothold throughout the lower than one-quarter of U.S. adults who’ve but to be vaccinated, significantly those that don’t need to obtain a vaccine just like the Pfizer/BioNTech or Moderna Inc pictures primarily based on groundbreaking messenger RNA (mRNA) expertise.
“There are nonetheless a considerable variety of individuals that aren’t but vaccinated,” Novavax Chief Business Officer John Trizzino mentioned in a media briefing late final month. “I believe we’ll see uptake in these those that have both been vaccine hesitant or have a desire for one thing aside from mRNA vaccine.”
That demand has not materialized in Europe, the place Novavax additionally mentioned it might drive up vaccination among the many hesitant.
Round 12.6 million doses of Novavax’s vaccine have been distributed within the European Union, however solely round 220,000 doses of the two-shot inoculation have been administered there because it was launched in December.
The variety of Novavax pictures out there in america is prone to be restricted within the close to time period, in response to the Division of Well being and Human Companies (HHS).
An HHS spokesperson mentioned on Monday it’s coordinating with Novavax “to obtain a restricted amount of vaccine and can make that vaccine out there to the American public” if the shot is allowed by the FDA and really useful by the Facilities for Illness Management and Prevention.
Novavax filed for U.S. authorization in late January, virtually a yr behind its unique plan, following improvement and manufacturing issues. The vaccine can also be being made by Serum Institute of India.
About 41 million doses have been delivered in 41 nations within the first quarter, Novavax mentioned.
In briefing paperwork ready for the assembly and launched on Friday, the FDA mentioned knowledge confirmed it might cut back the probabilities of mild-to-severe illness. It additionally raised considerations in regards to the danger of coronary heart irritation referred to as myocarditis from the vaccine, a situation that has additionally been noticed after mRNA vaccinations, primarily in younger males.
Novavax projected between $4 billion to $5 billion in gross sales this yr. Analysts anticipate gross sales on the decrease finish of that vary, in response to Refinitiv.
“Their pacing has to actually enhance simply to succeed in the low finish of the vary,” mentioned CFRA analyst Stewart Glickman, including that the corporate forecast will depend on dangerous gross sales to low-income nations, the place orders could also be delayed or lowered.
(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Enhancing by Caroline Humer and Invoice Berkrot)
