Prepping for Next Winter, Experts Worry About Vaccine Hesitancy

WASHINGTON -- Leading government scientists and industry experts spoke here on Tuesday about the next COVID vaccine, rising vaccine hesitancy, and what the shots of the future might look like.

Choosing a vaccine for next winter is going to be a challenge, said Peter Marks, MD, PhD, director for the FDA's Center for Biologics Evaluation and Research (CBER), in comments at the World Vaccine Congress.

What's important, "first and foremost," is the vaccine's breadth, and second is its duration, he said. "I think people will get an annual vaccine if they think it's going to protect them broadly. Where we get into problems is when something is a mismatch and we don't have good protection."

It takes 2 to 3 months to manufacture mRNA vaccines. Which means the vaccine's composition will need to be decided sometime around June, Marks explained. Given that tight timeline, he said he doesn't expect the next shot to be "too different" from what's currently available.

Paul Burton, MD, PhD, chief medical officer for Moderna, said every effort should be made to match the vaccine to the virus "as closely as we can, but not let perfection be the enemy of the very good."

Marks said he's hopeful that the next vaccine will protect against severe disease and hospitalization, as it has in the past.

"In the event that the unthinkable happens, which is that some bizarre new reassortment [genetic recombination] occurs with SARS-Coronavirus-2, we'll be looking to the mRNA manufacturers to make something as fast as possible," Marks added.

Burton noted that RNA technology allows a manufacturer the "speed" and "agility" to "step in when things go awry."

As for the ideal vaccine of the future, it would be "nice someday to have a sterilizing vaccine or one that prevents transmission, but I'm not going to hold my breath, because I might become very blue," Marks said.

People have been looking to produce a vaccine to prevent influenza transmission for the last 10 years, and "we still don't have that one," he added.

'Erosion of Confidence in Vaccination'

The CBER director and the other panelists also spoke about what Marks called the "greatest catastrophe" of the pandemic: "the erosion of confidence in vaccination as a major public health tool."

Vaccine hesitancy, instead of waning with the pandemic, appears to be crossing over to other illnesses.

Penny Heaton, MD, Global Therapeutic Area Head for Vaccines at Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, pointed to 2022-2023 flu vaccine data which show that older adults are returning to pre-pandemic rates of flu vaccination, but for pregnant women and young children, "rates have dropped dramatically."

One issue is trust. She recalled a 2021 study that found that the countries with the highest rates of COVID vaccine uptake and the lowest number of deaths were places where the citizens had the most trust in their government.

Gregory Poland, MD, director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota and the panel's moderator, also highlighted research out of Denmark, which has the highest uptake of COVID-19 vaccines and also the highest trust in government.

When Danes were interviewed about vaccination, Poland said, "the response generally was, 'Well, if the government recommends it, why wouldn't we do it?' Which you can hardly imagine here in the U.S."

"But that is a process of decades of trust-building, which can be destroyed within minutes and was in the U.S.," he added.

Burton also commented on the degree of vaccine hesitancy in the U.S., noting that there are grand juries being established to investigate "the wrongdoings of vaccination."

And, Poland said, in parts of Utah, Idaho, and Florida, residents are trying to make it a misdemeanor for any pharmacist, nurse, or physician to administer a COVID vaccine.

"Right now, there are 88 bills in front of the local and state legislatures to roll back or outlaw any sort of mandate for any kind of vaccine under any condition," Poland added.

That kind of opposition seems unreal to Burton: "Three years ago, the number of deaths in this country was equivalent to 10 jumbo jets falling out of the sky every day and killing everyone -- three and a half thousand people," he said.

Even now, there are still too many people dying of the virus -- at around 350 a day, Burton said.

"I can't honestly believe that we are where we are," he added.

Rebuilding trust in a country as polarized as the U.S. is difficult, Heaton said, but, "I think that's where we have to start ... We have to roll up our sleeves and figure out how the people in these different groups make decisions," she said, speaking of different demographics -- urban areas versus rural, and people of different races and ethnicities.

"There aren't any easy answers," she added.

However, said Burton, loosely quoting Ashish Jha, MD, PhD, who said at a recent meeting of the Massachusetts Medical Society, "Healthcare providers, it really is time to pass that baton back from government agencies back to us as healthcare providers, to step up, step in, and get that trust back."

As for mandates, Marks said that while the U.S. needs a "reset," that isn't a solution.

"I'm past trying to argue with people who think vaccines are bad. I think we just have to take our case that 'This is something that can save your life,' to those who want to have their lives saved."

Isabel Oliver, MD, chief scientific advisor transition lead for the U.K. Health Security Agency, called the loss of trust in vaccines in the U.S. "an absolute tragedy."

While the same cannot be said of the United Kingdom -- booster uptake there has been over 65% -- it is important for countries to "work together," she said. "What happens in the U.S. will end up affecting the U.K. and other parts of the world."

The Next Vaccines

With regard to the next generation of vaccines, Burton spoke about a partnership between Moderna and Vertex focused on aerosolizing mRNA vaccines to treat cystic fibrosis.

Moderna is also working on a personalized cancer vaccine platform and plans to present its data at the American Association for Cancer Research annual meeting in mid-April.

Meanwhile, Heaton is excited about the potential for artificial intelligence and machine learning to "better understand the antigens that need to be included" in vaccines.

In addition, Janssen is "looking at things like circular RNA, where we can really start to engineer the duration of antigen expression more precisely, where we can even better fine-tune the immune response ... and include the type of immune response that we want," she said.

Heaton said she's also interested in moving beyond lipid nanoparticles to other methods of delivery that may be "potentially less reactogenic, potentially more immunogenic, potentially actually direct[ing] the exact immune response that we want."

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