Novavax’s COVID-19 vaccine has been approved by the FDA
On Wednesday, the FDA approved Novavax’s COVID-19 shot for immediate use, making it the fourth vaccine available in the United States.
The vaccination is now safe for individuals over the age of 18 to receive. The shot will be given in an initial set of two doses, spaced out every three weeks.
People who have been hesitant to have an mRNA vaccine may be more receptive to Novavax’s protein-based shot because of the distinct manufacturing method. However, around 77% of adults have previously had two doses of an mRNA shot, limiting the potential market size.
The U.S. is not short on doses from either of the Pfizer-BioNTech or Moderna vaccinations that have been available for more than a year, and those makers are already working with administration officials to design a variant-specific booster injection for the fall.
However, the vaccine is timed with a White House call to action to defend against a wave of severe infection from the omicron BA.4 and BA.5 subvariants by getting immunised and then getting a booster shot.
The Novavax vaccination “offers adults a choice” and increases the available COVID-19 vaccine stock in the US. According to Peter Marks, head of the FDA’s vaccine division, “the American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”
Studies on humans showed that the vaccination was 90% effective in preventing all three degrees of mild, moderate, and severe COVID-19. But, significantly, the experiments were undertaken before the omicron variant became prevalent.
The business has amended its FDA submission and now claims the vaccine has a “broad” response against the strains that are currently circulating.
To guard against the flu and for normal childhood immunizations against whooping cough and meningitis, Novavax use more conventional vaccine technology. The two-dose vaccine is more convenient to ship and use because it does not require special cold storage conditions.
During the early stages of the pandemic, Maryland-based Novavax was able to acquire a $1.8 billion contract from the Trump administration’s Operation Warp Speed to increase research and purchase up to 100 million doses.
Early this week, the Biden administration stated that they had purchased 3.2 million doses.
Due to manufacturing issues and difficulties scaling up production, Novavax missed its intended goal of submitting an application to the FDA for approval by May 2021. After missing the deadline in January 2022, it finally submitted its paperwork.
Current production of the vaccine is taking place in India’s Serum Institute, the largest vaccine manufacturer in the world.
A group appointed by the FDA recommended approval last month, but the agency’s assessment of the manufacturer’s procedures delayed the process.
This Thursday, the FDA stated that Novavax should complete quality testing “in the next few weeks.”
Vaccination campaigns can launch after receiving approval from the CDC. On July 19, the government will hold a meeting of its Advisory Committee on Immunization Practices.