(Tribune News Service) -- Novavax, a Gaithersburg, Md.-based pharmaceutical company, reported Monday, June 14 that its coronavirus vaccine was highly effective against COVID-19 infections after testing in about 30,000 people.
The trial included about 500 people followed by the University of Maryland School of Medicine, and the results from the United States and Mexico follow similar positive safety and efficacy results in Europe.
The company said it would seek emergency authorization to use the vaccine from the U.S. Food and Drug Administration as early as next month.
So, what’s different about this vaccine and who might benefit? We asked some university experts who worked on developing and testing it.
How effective is the vaccine?
Really effective, said Matthew Frieman, a professor of microbiology and immunology at the University of Maryland’s medical school whose research supports the vaccine.
The Phase 3 trial results showed it was 90.4% effective overall, 93% effective against predominately circulating variants and 100% effective in preventing hospitalization and deaths.
It also was 91% effective in high-risk populations such as those with other health conditions and those more likely to be exposed to an infection through work or social situations.
The university specifically included such people in the study, said Dr. Karen Kotloff, a principal investigator of the Maryland site at the university’s Center for Vaccine Development and Global Health.
What about side effects?
Kotloff said they were basically the same as other COVID vaccines, with soreness at the injection site being the main complaint followed by a temporary fatigue. There were no blood clots or heart issues attributed to the vaccine, unlike others, though issues could arise once the vaccine is given to millions more people.
How is it different from the other vaccines?
The Pfizer/BioNTech and Moderna vaccines use a bit of genetic material to deliver instructions to a person’s body to produce the coronavirus’ spike protein, which in turn induces antibody production to fight a real infection with the virus. Similarly, the Johnson & Johnson vaccine uses a harmless adenovirus to deliver instructions.
Novavax’s vaccine, Frieman said, uses a bit of the protein itself to induce virus-fighting antibodies.
“They just inject the protein into your arm rather than the mRNA vaccine that injects instructions,” he said. “It’s a much more traditional approach.”
What are the benefits of this vaccine?
The vaccine is a two-dose vaccine, like the mRNA vaccines, with shots delivered 21 days apart. But, Frieman noted, it does not require a deep freeze for storage like those vaccines.
That could make it more versatile to use on mobile vans and in other community settings, though not as simple as the one-dose Johnson & Johnson vaccine.
That vaccine, however, has something of an image issue, some officials have said, because it’s proven slightly less effective than other vaccines and its use was paused temporarily due to rare blood clotting. It also remains embroiled in controversy after an Emergent BioSolutions plant in Baltimore had to discard millions of doses contaminated in manufacturing.
Frieman said it’s the traditional development of the Novavax vaccine that may most appeal to Americans who don’t want the Johnson & Johnson or the mRNA vaccines, a type of vaccine studied for years but not authorized for use in people until the pandemic.
That may mean being a late-comer to market in the United States could prove something of a positive, picking up those hesitant to take other vaccines.
“Some people are against vaccines totally, or against the mRNA vaccines or the J&J vaccine, but maybe they’re more willing to get this traditional type of vaccine,” Frieman said. “Maybe it increases the number of vaccinations in some hesitant groups.”
How else might it be used?
The vaccine also could be used as a booster shot for Americans vaccinated with this or another vaccine down the line, Kotloff said.
But both Frieman and Kotloff thought most Novavax vaccine would be used in other countries where there is an estimated shortfall of 11 billion doses. Novavax said it expects to be able to produce 100 million doses a month by the end of September and 150 million doses a month by the end of the year.
What about variants going forward?
Frieman said variants remain a threat to those unvaccinated and potentially even those who already have gotten their doses of any vaccine, and the mutated strains could mean another wave of cases in the fall. However, he said, a fall surge likely wouldn’t be as big as last winter’s, particularly in places such as Maryland with higher vaccination rates than some other states.
The so-called Delta variant, first seen in India, is proving to be more contagious and dangerous than original strains and isn’t yet widespread enough in the United States for those with the Novavax vaccine to have encountered it.
Frieman continues to look at variants in the lab and in animals, and eventually the University of Maryland center could test new vaccines.
What’s next for vaccine testing?
The university’s center already has participated in a Phase 1 trial for the Pfizer vaccine and Phase 2 trials for the Moderna and Novavax vaccines, and is now testing the Moderna and Novavax vaccines in younger children.
As part of the adolescent Novavax study, the center is asking participants to swab their noses in an effort to determine whether they are not only protected from major illness from the virus, but if they are not actually being infected and potentially transmitting the virus to others. Kotloff said evidence so far suggests it’s far less likely for a vaccinated person to be passing infections, but the study will help put the issue to rest.
The center also is conducting a mix-and-match trial where people are given boosters with a vaccine different from the one they originally received. This study involves vaccines already authorized for use but could be amended later to include the Novavax vaccine.
“We still have a lot of questions to ask,” Kotloff said. “But the results today from Novavax were good. It was a good day.”
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