The U.S. could soon have a new COVID vaccine on the market but this one will be different from the others.
Novavax asked the Food and Drug Administration to authorize its COVID-19 vaccine for adults in late-January and that application remains under review, but the company recently released data surrounding a new trial that could target both flu and COVID at the same time.
So what exactly is Novavax and what should you know about the vaccine? Here's a breakdown.
What is the Novavax vaccine and how is it different?
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The Novavax vaccine differs from Pfizer and Moderna's mRNA vaccines in that it relies on an older technology that’s been used for years to make shots for diseases like influenza and pertussis. The Maryland-based Novavax drugmaker uses genetic engineering to grow harmless copies of the coronavirus spike protein in insect cells. Scientists then extract and purify the protein and then mix in an immune-boosting chemical.
For certain groups of people — particularly young men — the mRNA vaccines carry a slightly elevated risk of a heart condition called myocarditis. Novavax's vaccine has not been linked to myocarditis.
But in addition, the company is also in clinical trials of a version of its vaccine that would target both COVID and flu at the same time. The company said its first phase of the trial showed the potential for triggering an antibody response to both viruses, though further study is needed. A second phase of the trial is set to begin "by the end of 2022."
"We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza," Dr. Gregory M. Glenn, president of research and development for Novavax, said in a statement. "We're encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19."
Neither version of the vaccine has been authorized for use in the U.S.
When could authorization come?
In a statement to NBC Chicago Monday, the company said a meeting could be scheduled "in the near future."
"We continue to have a productive dialogue with the FDA as they review data and we answer inquiries related to clinical and manufacturing data as expected," Novavax said in its statement. "We look forward to scheduling our VRBPAC meeting in the near future as indicated by the FDA."
If cleared for emergency use in the United States, it would provide an alternative to the popular mRNA-based shots from Pfizer-BioNTech and Moderna.
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.
Japan’s health ministry on Tuesday formally approved Novavax's COVID-19 vaccine, a fourth foreign-developed tool to combat the infections as the country sees signs of a resurgence led by a subvariant of fast-spreading omicron.
What are the side effects of Novavax?
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.
What are the potential issues?
Novavax has run into repeated production problems and mainly relies on other factories to make its vaccine. It has delayed delivery of its shots to numerous countries in Europe and despite pledges to make 250 million doses available to COVAX, not a single vaccine has been shared with the U.N.-backed effort to distribute shots to poorer countries.