FDA decision on Novavax’s Covid shots could be delayed
As the Dutch Health Service Organization begins the Novavax vaccination programme on March 21st, 2022 in The Hague (Netherlands), a health worker prepares Novavax.
Patrick Van Katwijk | Getty Images
Changes must be reviewed by the Food and Drug Administration NovavaxAn agency spokesperson stated Wednesday that it will need to approve Covid-19’s manufacture process in order for it to authorize its use in the U.S.
After an extensive meeting, the FDA’s independent committee of vaccine experts voted Tuesday to endorse Novavax’s vaccine as safe and effective in preventing Covid.
After the endorsement of the panel, FDA quickly authorized Covid shots during the pandemic. Pfizer, Moderna Johnson & Johnson’sFDA approved vaccines on the day they were recommended by the committee. FDA approval of Novavax vaccine might take longer.
CNBC reported that the FDA stated in a statement that Novavax had informed them of modifications to their manufacturing process on June 3rd, days before the FDA was due to review the vaccine’s safety data and efficacy data.
CNBC’s Abby Capobianco stated that FDA would carefully examine the submission as well as any other information.
While the FDA does not have to agree with the recommendation of the committee, the FDA will normally do so. Capobianco indicated that Novavax will be approved by the FDA if the FDA considers the recommendations of the committee.
Novavax could start shipping US doses from India’s manufacturing partner Serum Institute of India with FDA approval. Before pharmacies and health-care professionals can start giving the shots, however, approval from the Centers for Disease Control and Prevention is required.
Novavax, which received $1.8 million from Operation Warp Speed as part of the U.S. government’s 2020 race for a Covid vaccine, was among the first participants. But, Novavax, a small Maryland biotech company, struggled to create a manufacturing base and clinical data was much later than Moderna and Pfizer, who rolled out their shots at breakneck speeds.
Novavax requested the FDA’s approval in February for its two dose vaccine. In April, Dr. Doran Fink (a top official in the FDA’s vaccine department) told CDC Advisors that Novavax’s application was “incredibly complicated” due to its clinical and manufacturing data.
Novavax released a statement saying that it had shared with FDA updated manufacturing data as soon as they became available.
Novavax is now rolling out the shots worldwide, even though the vaccine remains to be approved in the United States. More than 40 countries have approved the shots of Novavax, which is a biotech company. This includes Canada, Australia and Europe. The FDA’s vaccine department is headed by Dr. Peter Marks. He said that the U.S. adheres to high standards in vaccine regulation and doesn’t base decisions on approvals from other countries.
Marks told Tuesday’s FDA committee that “we take manufacturing very seriously.” We don’t compare ourselves to other countries in manufacturing. However, we believe that our standards are very high and this is why we’re frequently regarded as a top-tier manufacturing country, especially for vaccines.