The Food and Drug Administration has authorized use of the two-dose Novavax COVID-19 vaccine for adults 18 and over, making it the fourth vaccine to be made available since the pandemic began nearly two years ago.
The Novavax shots offer an alternative for vaccine holdouts who have resisted the mRNA vaccines from Pfizer and Moderna over safety concerns. The company’s application for emergency use authorization has been in the works since January and was recommended by the agency’s panel of experts over a month ago.
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“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” said FDA Commissioner Robert Califf.
Novavax was plagued by production setbacks early on, despite massive government investment of $1.6 billion under former President Donald Trump’s multibillion-dollar initiative Operation Warp Speed, an all-out federal effort to speed the development and distribution of vaccines and treatments for COVID-19. The Maryland-based company had long worked on vaccines for viruses such as MERS, Zika, and Ebola but had never brought one to market.
Novavax also struggled to meet FDA quality and purity standards early on. Federal regulators typically look for a level of vaccine purity of at least 90% to ensure that there are few contaminants and outside products in the doses that could cause negative adverse reactions. Novavax’s purity levels hovered around 70%, according to an October 2021 Politico report.
Still, the two-dose regiment proved 90.4% effective in preventing mild, moderate, or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 cases in the placebo group. The shots were 100% effective against symptomatic disease and death. The vaccine has also proven capable of preventing infection for the alpha, beta, and gamma strains of the virus. But the clinical studies occurred before the omicron wave last winter, and the FDA lacks data to show its effectiveness against that variant and its offshoots.
“The FDA’s medical and scientific experts have determined that the vaccine meets the FDA’s high standards for safety and effectiveness for emergency use authorization,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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.”
The Novavax vaccine relies on protein-based technology similar to what is used to create the flu, hepatitis B, and shingles vaccines. Researchers constructed a spike protein using insect cells similar to the one on the coronavirus pathogen that binds to cells and infects people. Specifically, the genetic material used to create the spike protein was developed in the lab and then injected into a virus known as the baculovirus that infects insects. The baculovirus, containing genetic instructions to create the spike protein, infects cells taken from the fall armyworm moth. Scientists harvested the spike proteins that proliferate in moth cells and filter out the cellular debris. They add a substance to the vaccine nanoparticles called an adjuvant, in this case derived from soapbark tree extract, which turbocharges the immune reaction to the spike protein.
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The Novavax vaccine was billed early on as a boon for the federal campaign to vaccinate hesitant people who distrusted the speed at which mRNA vaccines were developed. Many people thought that a truly safe and effective vaccine would take much more time and rounds of trials, just as vaccines for other diseases have, so a vaccine using tried and true technology may be welcome to those skeptical of the Pfizer and Moderna jabs.
