Without a nasal vaccine, the U.S. edge in fighting Covid is on the line – POLITICO

India, Russia and Iran have authorized nasal vaccines. And while none of those have yet been proven to stop Covid transmission, officials say the U.S. could find itself at a global disadvantage, particularly if a deadlier variant emerges.

Intranasal vaccines vaccines that are variant-resistant those are critical tools to have in the toolbox for protecting Americans, not just for Covid but also for future pandemics and also for future biosecurity threats, Ashish Jha, the administrations Covid-19 response coordinator, told POLITICO.

Researchers working on nasal vaccines are hopeful that they could stop virus transmission by generating immunity against it in the nose and other parts of the upper respiratory system where the coronavirus enters the body. If that bears out in clinical trials, nasal vaccines would be superior to existing mRNA vaccines, which prevent severe disease but dont stop transmission.

Officials at the National Institute of Allergy and Infectious Diseases are attuned to the danger of failing to develop such a nasal vaccine since it would protect people in case of a more contagious and deadlier coronavirus variant, said Karin Bok, the acting deputy director for pandemic preparedness and emergency response at the agencys Vaccine Research Center.

The center has mapped the nasal and oral Covid vaccines in development in the U.S. 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 wont lead to a nasal Covid vaccine being approved in the U.S. anytime soon because funding for clinical trials and production is lacking.

Bok and Jha say the cost is high. If China were to develop a nasal vaccine capable of stopping Covid transmission, that could turn the tables on the current pandemic trajectory, which has the U.S. emerging and much of China stuck in lockdown.

Even though India, Iran, China and Russia havent proved their non-injectable vaccines stop transmission, the potential is there, experts said.

Countries where transmission is reduced are going to be healthier, are going to have stronger economies. And the U.S. needs to catch up, said Marty Moore, the founder and chief scientific officer of Meissa Vaccines, a small biotech company thats trying to develop a nasal vaccine in the U.S.

Many scientists believe the nose could hold the secret to stopping coronavirus transmission, but theres no consensus yet on whether nasal vaccines could be more effective than injectable ones, as evidence from clinical trials is necessary to prove it.

Disagreement in Congress about how to pay for additional aid or whether its needed, as well as disinterest from major drugmakers in spending their own money on something that may not be very profitable, could mean a foreign rival gets an advantage.

Writing in Science Immunology in July, Eric Topol, a professor of molecular medicine at Scripps Research, and Akiko Iwasaki, an immunobiology professor at Yale, endorsed the potential of a nasal vaccine to stop coronavirus transmission. Breaking the chain of transmission at the individual and population level will put us in a far better position to achieve containment of the virus, they wrote, adding that the prospect of achieving this with nasal vaccines is high.

They called for U.S. government support 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 that, but funding woes and pandemic fatigue have hampered its efforts.

Beyond effectiveness, a nasal vaccine could appeal to people who are squeamish about needles and to parents of young children who have mostly declined to get their kids inoculated. As of early October, only 9 percent of children ages 6 months to 5 years have gotten the shots, which were authorized by the FDA in June.

Outside of the government-funded research cited by Bok, two Washington University School of Medicine professors, David T. Curiel, a radiation oncologist, and Michael S. Diamond, a molecular microbiologist, invented the nasal vaccine authorized in India.

Curiel and Diamond told POLITICO they created it with the needs of the developing world in mind, given the lack of ultracold freezers needed to store mRNA vaccines. The two scientists licensed their vaccine to the Indian drugmaker Bharat Biotech, which tested it in clinical trials partially financed by the Indian government. They have also tried to solicit interest from large U.S. pharmaceutical companies about it and there was not as much excitement as we would have thought, Diamond said.

Their vaccine, named iNCOVACC in India, is based on an adenovirus that delivers the coronavirus spike protein.

Bharat Biotech tested it both as a primary vaccination series and as a booster for people who were vaccinated with injectable Covid shots available in India. The company said the clinical trials had successful results and that side effects were comparable to those from other Covid-19 vaccines, but it has not yet published the data in a peer-reviewed scientific journal.

The Indian drug regulator approved the two-dose vaccine, which comes in the form of nasal drops, for adults who have not had a previous Covid-19 shot, 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 financing vaccine development for epidemic threats, is developing a plan for nasal vaccine research projects.

For example, we are looking into whether nasal vaccines could be an option for our all-in-one coronavirus vaccine program funding the development of vaccines against both Covid-19 variants and other coronaviruses, said Melanie Saville, CEPIs executive director of vaccine research and development.

CEPI awarded nearly $5 million in seed funding to the Dutch company Intravacc for a nasal vaccine candidate that could work against multiple coronaviruses.

There are now 95 nasal vaccines under development around the world, according to health data company Airfinity. Six have reached the final Phase 3 in clinical trials.

But some scientists doubt that a nasal vaccine will be a game-changer.

William Haseltine, a former professor at Harvard Medical School with expertise in HIV/AIDS and genomics, believes that enthusiasm should be tempered about the potential of nasal vaccines to prevent infection, given that natural nasal exposure to the virus doesnt prevent people from getting reinfected.

Why in the world do you think that if you [spray] a vaccine up the nose you can do any better? he asked POLITICO.

Attempts to develop a nasal version of the AstraZeneca Covid-19 vaccine, the injectable version of which was widely used globally at the beginning of the vaccination campaign, experienced a setback after only a minority of participants in an early stage clinical trial showed some immune response in respiratory mucous membranes.

Haseltine argued that scientists still dont have a good understanding of nasal immunity and that government funding would be better directed to antiviral drugs that keep Covid-19 in check.

And Bok doesnt think any of the existing non-injectable vaccines 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 ones we have, she said.

Curiel and Diamond have licensed their vaccine for potential use in the U.S. to Pennsylvania-based biotech Ocugen.

The company is looking for both regulatory and financial support from the U.S. government to develop the vaccine as a booster, CEO Shankar Musunuri told POLITICO.

But without another Operation Warp Speed, there will be substantial delays in large-scale manufacturing, regulatory approval and distribution of a nasal vaccine, argued Topol and Iwasaki.

Iwasaki, who is working to develop a booster Covid-19 nasal vaccine, said she will probably 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.

Thats unlikely to happen.

Congress last month passed a short-term measure to continue funding the government until Dec. 16 without any additional money for Covid-19. The White House had asked for $8 billion to fund the next generation of vaccines and therapeutics, including nasal vaccines.

There is no plan B: If Congress does not fund this, it will not happen, Jha said. America will fall further behind China and other countries.

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Without a nasal vaccine, the U.S. edge in fighting Covid is on the line - POLITICO