The United States Food and Drug Administration (FDA) has approved another vaccine maker to create a shot to help prevent COVID-19, with caveats.
Newsweek has reached out to Novavax for a statement over email Sunday during non-working hours.
Why It Matters
COVID-19, the disease is caused by the SARS-CoV-2 virus, swept through the world in early 2020, causing lockdowns, hospitalization spikes, and millions of deaths.
Over seven million people have died from COVID-19 globally since the start of the pandemic in 2020, according to the World Health Organization (WHO).
Out of the 7,095,349 deaths worldwide, 1,223,101 are in the US alone, the most recorded COVID-19 deaths of any country, according to WHO.
What To Know
Novavax’s vaccine – Adjuvanted -is approved only for those aged 65 and older or people aged 12 to 65 “who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19”, according to a letter from the FDA released Friday.
“We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.,” a press release from the company issued when they entered the vaccine for approval in April read.
This vaccine did previously have emergency approval by the FDA for use but can now be marketed in the U.S. for use, the letter said.
The approval comes amid Robert Kennedy Jr.’s appointment as United States Secretary of Health and Human Services. He has been outspoken about his distrust of medicinal treatments, including vaccines.
Novavax makes the only protein-based COVID-19 vaccine, which operates differently from other vaccines that use messenger RNA (mRNA).
Those mRNA vaccines prompt the patient to produce small amounts of virus to help create an immune response while the Adjuvanted has a protein spike to create the coupled with a Matrix-M adjuvant to prompt an immune response.
The company submitted its product for approval on April 1 along with Phase 3 clinical trial data, the press release said.
Development of the Novavax COVID-19 vaccine has been ongoing since 2020.
Data from the United States Centers for Disease Control and Prevention (CDC) shows that vaccines have had overall benefits including a decrease in hospitalization of about one third among adults with weakened immune systems.
What People Are Saying
Dr. Paul Offit, Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia told The New York Times: “I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive, and more feared.”
Michael Lin, MD PhD, Professor of Neurobiology & Bioengineering at Stanford University said in part on X, formerly Twitter: “Now the FDA added some odd condition that the vaccine is for those with conditions that increase risk of COVID complications. Given its better safety, it seems backward to put this on Novavax and not the RNA vaccines. But I’d hope you’d be allowed to self declare.”
What Happens Next
Now that the FDA has approved, the CDC will have to release guidance on usage. Additionally, Novavax is required to provide data on people who receive the vaccine, including rates of myocarditis.
Clinical trials of the vaccine are still being done for different age groups.
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