Can Novavax’s more traditional vaccine win over skeptics?

In this image provided by the Serum Institute of India, vials of freshly manufactured Novavax COVID-19 vaccines wait to be labeled in 2022, in Pune, India. The U.S. Food and Drug Administration is evaluating a more traditional kind of vaccine made by Novavax, which the company hopes can win over unvaccinated people and become a top choice for boosters. (Serum Institute of India for Novavax via AP)

Combined ShapeCaption
In this image provided by the Serum Institute of India, vials of freshly manufactured Novavax COVID-19 vaccines wait to be labeled in 2022, in Pune, India. The U.S. Food and Drug Administration is evaluating a more traditional kind of vaccine made by Novavax, which the company hopes can win over unvaccinated people and become a top choice for boosters. (Serum Institute of India for Novavax via AP)

An option to sometimes controversial mRNA vaccines, Novavax needs FDA approval before it can be administered in the U.S.

Over 15 million doses of COVID-19 vaccines have gone into the arms of Georgians. But not many lately.

With a third of adults in Georgia remaining unvaccinated or partially vaccinated, could a more traditional vaccine persuade the holdouts to roll up their sleeves?

That question could soon be set to the test. On Tuesday, the Food and Drug Administration’s advisory panel is scheduled to review vaccine data for a COVID vaccine that would be new to the U.S., made by Novavax. You can watch the meeting here.

Novavax’s vaccine relies on technology similar to seasonal flu vaccines and routine childhood immunizations such as whooping cough and meningitis. The Novavax vaccine also does not need special refrigeration like other COVID vaccines.

Some experts say people who were hesitant to take the Moderna or Pfizer shots might be willing to accept the more conventional Novavax vaccine. Both Moderna and Pfizer use a molecule called messenger RNA (mRNA), which is newer technology.

The Novavax vaccine is now authorized for use in many other countries and is shown to be highly effective in clinical trials, but it remains to be seen what role it might play in Georgia and the U.S., both awash in vaccine supply.

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How Novavax’s shot holds up against omicron and its subvariants is likely to be a big topic of discussion for the FDA. In a study of nearly 30,000 people in the U.S. and Mexico, the vaccine’s efficacy was about 90%, but these studies were conducted before the more contagious omicron and its subvariants started widely circulating.

And although the company is skeptical about the need to modify its shot, Novavax recently began testing an omicron-targeted vaccine.

If the FDA issues an emergency use authorization to Novavax and the CDC signs off on it, it would provide the U.S. with another vaccine option after Johnson & Johnson’s shot was sidelined by the CDC over safety concerns. Novavax also could play an important role as a booster.

But experts are not overly optimistic many minds will be changed among those who refuse to get a shot.

“Maybe there is a good group of people who decide this is OK, more like a traditional vaccine,” said Dr. Andrew Reisman, a Gainesville doctor and former president of the Medical Association of Georgia. “But who knows, there are some people who just don’t want the vaccine and they won’t want this one either.”

Demand for COVID vaccines has waned considerably over the past several months. After a little uptick in vaccinations earlier this year, any interest in a shot among Reisman’s unvaccinated patients came to a screeching halt. Even so, if Novavax gets authorized, he said he plans to discuss this option with his unvaccinated patients.

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Unlike the mRNA vaccines, which were developed using new technology, Novavax uses a time-tested method of growing and harvesting virus proteins — the same process that’s already used to make other vaccines including influenza and HPV. Protein-based vaccines have a strong track record of safety and mild side effects.

While the mRNA vaccines work by sending instructions to host cells in the body for making copies of a spike protein that can trigger the immune system, the Novavax vaccine takes a different approach. The company grows harmless copies of the coronavirus spike protein in insect or moth cells. Scientists then extract and purify the proteins and add in an “adjuvant” — an immune-boosting ingredient — to improve the body’s response to the vaccine. When the vaccine is injected, it stimulates the immune system to produce antibodies and T-cells to fight off the virus.

The difference in how Novavax is made may ease fears some people have about the mRNA vaccines. Some worry they’ll cause side effects that won’t show up for years. Others worry they’ll interfere with their fertility, although there’s currently no evidence of that. And then there are more outrageous conspiracy theories, such as the vaccine carrying a microchip so the government can track people.

Another factor that could make Novavax more attractive to some holdouts: The vaccine was not developed using cell lines derived from aborted fetal tissue, which is a routine practice in pharmaceutical research. The mRNA vaccines were developed using these cell lines, but the vaccines themselves do not contain any fetal cells.

Well over a year since COVID vaccines started going into arms, COVID vaccines are still highly protective at warding off severe disease and hospitalization. But the protection offered by the two-dose mRNA vaccines has been found to wane over time.

Ashley Kirzinger, director of Survey Methodology and associate director of Public Opinion and Survey Research for the Kaiser Family Foundation, said early on during the vaccination rollout that there were a fair number of people who had “legitimate concerns” about mRNA vaccines and its side effects.

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“But those questions have been answered,” said Kirzinger. Most Americans eventually got vaccinated. She doesn’t foresee a more traditional vaccine swaying those who remain unvaccinated.

“I worry now that attitudes toward COVID vaccines have become so entrenched in partisanship and identity that it doesn’t matter what type of vaccine it is anymore,” she said.

Combined ShapeCaption
Scientists work on the vaccine purification process as they design updates to the Novavax's COVID-19 shots in the company's research laboratory on May 24, 2022, in Gaithersburg, Md. The U.S. Food and Drug Administration is deciding whether to authorize use of Novavax’s more traditional kind of COVID-19 vaccine, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang)

Credit: Angie Wang

Scientists work on the vaccine purification process as they design updates to the Novavax's COVID-19 shots in the company's research laboratory on May 24, 2022, in Gaithersburg, Md. The U.S. Food and Drug Administration is deciding whether to authorize use of Novavax’s more traditional kind of COVID-19 vaccine, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang)

Credit: Angie Wang

Combined ShapeCaption
Scientists work on the vaccine purification process as they design updates to the Novavax's COVID-19 shots in the company's research laboratory on May 24, 2022, in Gaithersburg, Md. The U.S. Food and Drug Administration is deciding whether to authorize use of Novavax’s more traditional kind of COVID-19 vaccine, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang)

Credit: Angie Wang

Credit: Angie Wang

About a quarter of American adults remain unvaccinated for COVID, including one in six who say they will “definitely not get the vaccine,” according to an April survey by the Kaiser Family Foundation.

For those who have not been vaccinated Kirzinger said, “they don’t see COVID as a threat, they say, ‘I am not scared of COVID,’ so why would they get vaccinated now?” Many by now have had and survived COVID.

Logan Boss, public information officer for the Northwest Health District in Georgia, which includes Paulding, Bartow and Floyd counties, said while they are monitoring Novavax to see if gets the green light from the FDA and CDC, he doesn’t expect it to be “any sort of game-changer.” He said health departments in the 10-county district might not even offer it at health clinics in the district if it were authorized.

In the Northwest Health District, Boss said, “demand is almost zero right now and has been for several months.”

But with the number of COVID cases rising again, it has become clear coronavirus variants can slip past some of the immunity provided by vaccines and prior infections. Experts say new vaccines and updating existing vaccines are key to ultimately quelling the pandemic.

“More options and broader distribution of more vaccines will hopefully alleviate the public health crisis we continue to deal with today,” said Professor Baozhong Wang at Georgia State’s Institute for Biomedical Sciences.


Upcoming FDA meetings in June

The FDA advisory panel is planning to meet several times to discuss COVID vaccines in June. Here’s a look at the tentative schedule:

Tuesday: FDA advisory panel is scheduled to meet to discuss Novavax’s request for an emergency use authorization (EUA) for its COVID vaccine for adults.

June 14: Moderna’s EUA request for COVID vaccine for children 6 through 17.

June 15: Moderna’s EUA request for COVID vaccine for 6 months through 5 years of age and Pfizer-BioNTech’s EUA request for COVID vaccine for 6 months through 4 years of age.

June 28: Discussion on proposals to update existing COVID vaccines so they work better against coronavirus variants.