Americans may soon get a new COVID-19 vaccine option -- shots made with a more tried-and-true technology than today’s versions.
Novavax received approval from the Food and Drug Administration for its COVID-19 vaccine Wednesday.
It’s late in the pandemic for a new choice, but the company is hoping to find a niche among some of the unvaccinated millions who might agree to a more traditional kind of shot -- a protein vaccine — and also to become a top choice for boosters, regardless of which type people got first. Only about half of vaccinated adults have gotten a booster.
So what exactly is Novavax and what should you know about the vaccine? Here's a breakdown.
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What is the Novavax vaccine and how is it different?
The Novavax vaccine trains the body to fight the coronavirus by delivering copies of its outer coating, the spike protein. Those spike copies are grown in insect cells, purified and packaged into nanoparticles that to the immune system resemble a virus, said Novavax research chief Dr. Gregory Glenn.
Then an immune-boosting ingredient, or adjuvant, that's made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong response.
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“It’s basically a soap bubble. It’s made of stuff that you find in root beer,” Glenn said. “When an immune cell sees that, it becomes quite activated. ... We supercharge the immune response.”
Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases.
It’s a very different approach than the Pfizer and Moderna shots. Those so-called mRNA vaccines have saved countless lives and changed the course of the pandemic but still, some people are uncomfortable with the new technology that delivers genetic instructions for the body to make its own spike copies. A third U.S. option, from Johnson & Johnson, isn't as widely used.
Who did the FDA approve Novavax vaccines for?
For now, the FDA authorized Novavax's initial two-dose series for people 18 and older.
“I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Commissioner Dr. Robert Califf said in a statement.
What still needs to happen before shots could begin?
Before shots begin, the Centers for Disease Control and Prevention must recommend how they should be used, a decision expected next week.
Novavax CEO Stanley Erck told The Associated Press that he expected the U.S. to expand use of the vaccine beyond unvaccinated adults fairly quickly.
Where is Novavax authorized currently?
The vaccine is already available for use in at least 170 countries.
The European Medicines Agency gave Novavax’s two-dose COVID-19 vaccine for adults the green light in December; the shot has also been cleared by Indonesia, Australia and the World Health Organization, among others.
European regulators recently cleared the Novavax vaccine to be used as young as age 12, and several countries have authorized booster doses of its original vaccine.
Earlier manufacturing difficulties held up the vaccine, although Erck said those have been solved and Novavax can meet global demand. Much of the company's vaccine, including doses for the U.S., are being produced by the Serum Institute of India, the world's largest vaccine manufacturer.
How effective is the vaccine?
Like the other vaccines used in the U.S., the Novavax shots have proved highly effective at preventing COVID-19's most severe outcomes.
Earlier in the pandemic, large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. When the delta variant emerged last summer, Novavax reported a booster dose revved up virus-fighting antibodies that could tackle that mutant.
The Novavax vaccine was tested long before the omicron variant struck. But last month, the company released data showing a booster dose promised a strong immune response even against omicron's newest relatives — preliminary evidence that several of the FDA's scientific advisers called compelling.
Still, U.S. regulators are planning for a fall booster campaign using Pfizer and Moderna shots that better target omicron subtypes — and Novavax also has begun testing updated shots. Erck said the company could have updated doses available late in the year.
What are the side effects of Novavax?
Typical vaccine reactions were mild, including arm pain and fatigue. But FDA did warn about the possibility of a rare risk, heart inflammation, that also has been seen with the Pfizer and Moderna vaccines.
According to the company, "serious and severe adverse events were low in number and balanced between vaccine and placebo groups" during clinical trials.
The company notes that the most common reactions were headache, nausea or vomiting, pain at the injection site, fatigues and muscle pain.
