The FDA’s Vaccines and Related Biological Products Advisory Committee is set to review clinical data on June 7 and potentially suggest approval of NVX-CoV2373.
Plagued by a slow rollout of its COVID-19 vaccine overseas, Maryland-based Novavax is seeing a ray of sunshine in the United States. The U.S. Food and Drug Administration‘s Vaccines and Related Biological Products Advisory Committee is set to review clinical data on June 7 and potentially suggest approval of NVX-CoV2373, a recombinant, adjuvanted COVID-19 vaccine currently marketed overseas as Nuvaxovid.
NVX-CoV2373 would be the first protein-based COVID-19 vaccine to be reviewed by VRBPAC in the U.S. Stanley C. Erck, president and CEO of Novavax, said the company believes NVX-CoV2373 can play a significant role in reducing COVID-19 infections.
“We believe our vaccine, built on a well-understood protein-based vaccine platform, can play a part in fulfilling this need. We look forward to a productive VRBPAC meeting and will continue to work with the FDA throughout the review process,” Erck said in a statement.
In January, Novavax announced it had submitted a request for Emergency Use Authorization of NVX-CoV2373. But, much like the rollout to other countries where the Novavax vaccine has been authorized, the EUA review process could take a while.
Earlier this year, officials with the FDA said the review for authorization in the U.S. could take longer than anticipated due to an “incredibly complex review process.” The officials said the vaccine’s clinical data and manufacturing process would have to be thoroughly reviewed before an Emergency Use Authorization can be granted to Novavax.
Overseas, the Novavax vaccine has been greenlit by the World Health Organization for use against the ongoing pandemic. Earlier this month, John Trizzino, chief commercial officer of Novavax, said the vaccine is now available in 170 countries. He also stressed that the company has “sufficient manufacturing capacity” to meet demands for the medication.
“We believe that our protein-based vaccines storage attributes, efficacy and safety, make it ideal for most settings, including those where standard cold chain is preferred. With significant progress made in our commercial launch, we believe we are well positioned to continue this execution through the remainder of 2022 and beyond,” Trizzino said during a conference call earlier this month.
However, as BioSpace previously reported, the company has not been able to supply what it has promised. In February, the company said it intended to deliver approximately 80 million doses during the first quarter of the year. But in its quarterly financial report, the company stated it has only delivered about 42 million doses.
Novavax is hoping that its more traditional vaccine approach will find footing in the U.S. among those who are hesitant to receive one of the mRNA-based vaccines. Clinical data has been positive, and Kaiser Health News noted that the Novavax vaccine has typically seen fewer side effects than its mRNA counterparts. The company also believes that its vaccine could serve the U.S. market as an optimal booster vaccine.
In April, the company initiated a study of its vaccine as a potential booster for pediatric patients ages 12 to 17. Currently, the only vaccine authorized in the U.S. for that age group is the Pfizer and BioNTech-developed mRNA vaccine.
Novavax reported that Nuvaxovid generated $704 million in revenue during those first three months of the business year in its quarterly financial report. The vaccine is the company’s first commercial revenue source. Novavax reiterated its 2022 revenue guidance to between $4 billion and $5 billion based on the first-quarter sales.
