India, Russia and Iran have approved nasal vaccines. And while none of these have been proven to stop the transmission of Covid, officials say the US could be at a disadvantage globally, especially if a more deadly strain emerges.
“Intranasal vaccines – vaccines that are resistant to variants – are critical tools to have in the toolbox to protect Americans not only from Covid, but also from future pandemics and also from future biosecurity threats,” said Ashish Jha, the government’s Covid-19 response. coordinator, told POLITICS.
Researchers working on nasal vaccines are hopeful that they can stop the transmission of viruses by generating immunity against them in the nose and other parts of the upper respiratory tract where the coronavirus enters the body. If shown in clinical trials, nasal vaccines would be superior to existing mRNA vaccines, preventing serious illness but not stopping transmission.
Officials at the National Institute of Allergy and Infectious Diseases are aware of the danger of such a nasal vaccine not being developed as it would protect people in the event of a more contagious and deadly strain of the coronavirus, said Karin Bok, the acting deputy director for pandemic preparedness and emergency response at the agency’s Vaccine Research Center.
The center has mapped the nasal and oral Covid vaccines under development in the US and abroad. It is also testing nasal versions of the Moderna vaccine and two other types of injectable Covid-19 vaccines in monkeys, Bok said. But that probably won’t see a nasal Covid vaccine approved in the US anytime soon, as funding for clinical trials and manufacturing is lacking.
Bok and Jha say the cost is high. If China were to develop a nasal vaccine that could stop Covid transmission, it could turn the tables on the current pandemic trajectory, with the US on the rise and much of China stuck.
While India, Iran, China and Russia have not proven their non-injectable vaccines stop transmission, the potential is there, experts say.
“Countries where transmission is reduced will be healthier and have stronger economies. And the US needs to catch up,” said Marty Moore, the founder and scientific director of Meissa Vaccines, a small biotech company trying to develop a nasal vaccine in the US.
Many scientists believe the nose could be the secret to stopping coronavirus transmission, but there’s no consensus yet on whether nasal vaccines could be more effective than injectables, as evidence from clinical trials is needed to prove it.
Disagreements in Congress about how additional aid should be paid for or whether it is needed, as well as disinterest from major drug makers to spend their own money on something that may not be very profitable, could mean a foreign rival gains an advantage.
To write in scientific immunology in July, Eric Topol, professor of molecular medicine at Scripps Research, and Akiko Iwasaki, professor of immunobiology at Yale, endorsed the potential of a nasal vaccine to halt coronavirus transmission. “Breaking the chain of transmission at the individual and population level will put us in a much better position to contain the virus,” they wrote, adding that “the prospect of achieving this with nasal vaccines is great.”
They called for the support of the US government in developing Operation Warp Speed 2.0, modeled on the initiative that created the first Covid-19 vaccines in record time. The Biden administration is working on it, but is funding affliction and pandemic fatigue have hindered his efforts.
In addition to its effectiveness, a nasal vaccine may appeal to people who are squeamish about needles and to parents of young children who have mostly refused to have their children vaccinated. As of early October, only 9 percent of children ages 6 months to 5 years have received the injections, which were approved by the FDA in June.
American technology in India
Beyond the government-funded research Bok cites, two Washington University School of Medicine professors, David T. Curiel, a radiation oncologist, and Michael S. Diamond, a molecular microbiologist, invented the nasal vaccine used in India has been approved.
Curiel and Diamond told POLITICO they made it with the needs of the developing world in mind, given the lack of ultra-cold freezers needed to store mRNA vaccines. The two scientists licensed their vaccine to Indian drugmaker Bharat Biotech, who tested it in clinical trials funded in part by the Indian government. They also tried to spark interest from major US drug companies “and there wasn’t as much excitement as we thought,” Diamond said.
Their vaccine, called iNCOVACC in India, is based on an adenovirus that supplies the coronavirus spike protein.
Bharat Biotech tested it both as a primary vaccination series and as a booster for people vaccinated with Covid injectable shots available in India. The company said its clinical trials had “successful results” and that side effects were similar to those of other Covid-19 vaccines, but it has not yet published the data in a peer-reviewed scientific journal.
The Indian drug regulator has approved the two-dose vaccine, which comes in the form of nasal drops, for adults who have not had a Covid-19 shot before, Bharat Biotech said. The company has the right to sell it in India and most of the rest of Asia and Africa.
Elsewhere, the Coalition for Epidemic Preparedness Innovations, a global partnership that funds vaccine development for epidemic threats, is developing a plan for nasal vaccine research projects.
“For example, we are investigating whether nasal vaccines could be an option for our all-in-one coronavirus vaccine program that funds the development of vaccines against both Covid-19 variants and other coronaviruses,” said Melanie Saville, CEPI’s executive director of vaccines. research and development.
CEPIA awarded nearly $5 million in seed funding to Dutch company Intravacc for a nasal vaccine candidate that could work against multiple coronaviruses.
There are now 95 nasal vaccines in development around the world, according to health data company Airfinity. Six have reached the final phase 3 of clinical trials.
But some scientists doubt a nasal vaccine will be a game-changer.
William Haseltine, a former Harvard Medical School professor with expertise in HIV/AIDS and genomics, believes that enthusiasm for the potential of nasal vaccines to prevent infection should be tempered, as natural nasal exposure to the virus does not prevent people from being re-infected.
“Why in the world do you think that if you… [spray] a vaccine in the nose… you can do better?” he asked POLITICS.
Attempts to develop a nasal version of the AstraZeneca Covid-19 vaccine, the injectable version of which was widely used worldwide at the beginning of the vaccination campaign, experienced a setback after only a minority of participants in an early-stage clinical trial showed any immune response in the mucous membranes of the airways.
Haseltine argued that scientists still don’t have a good understanding of nasal immunity and that government funding would be better spent on antiviral drugs that control Covid-19.
And Bok doesn’t think any of the existing non-injectable vaccines will stop Covid-19 transmission. “I would be very surprised if India or China licensed it with data proving that an intranasal vaccine is better than the one we have,” she said.
Curiel and Diamond have licensed their vaccine for possible use in the US to Pennsylvania-based biotech Ocugen.
The company is seeking both regulatory and financial support from the US government to develop the vaccine as a booster, CEO Shankar Musunuri told POLITICO.
But without another Operation Warp Speed, there will be significant delays in the large-scale production, regulatory approval and distribution of a nasal vaccine, Topol and Iwasaki argued.
Iwasaki, who is developing a booster Covid-19 nasal vaccine, said she will likely need tens of millions of dollars to test it in clinical trials. “Just trying to do this as a small academic lab is very different from a Warp Speed,” she told POLITICO.
Congress passed last month a short-term measure to continue to fund the government until December 16 without additional money for Covid-19. The White House had asked for $8 billion to fund next-generation vaccines and therapies, including nasal vaccines.
“There is no plan B. If Congress doesn’t fund this, it won’t happen,” Jha said. “America will fall further behind China and other countries.”