LOS ANGELES — With 13 COVID-19 vaccines in use around the world, pharmaceutical companies are exploring second-generation technology that could change how doses are administered and distributed.
These vaccines could be taken orally as a capsule that could be swallowed, as a tablet that dissolves under the tongue or as a nasal spray. Such formulations would not require refrigeration, nor would they need health care workers to administer them.
The efforts are in early stages with no guarantee of success. Research and development costs are steep, and only a small number of companies — none with a vaccine currently authorized for use — are exploring these alternate methods. The work may seem like a gamble but could play a critical role in ending the pandemic.
“It is encouraging to see manufacturers pursue easier-to-administer formulas of the vaccine,” said Esther Krofah, executive director of the Milken Institute’s FasterCures. “We need to have a global focus, and not just a domestic focus.”
With 22% of its population vaccinated, the Unites States has administered more doses than any other country in the world, and data show that high-income countries have been more effective in distributing doses than low-income countries.
“The United States can’t be safe if the rest of the world is not safe,” said Bruce Innis with PATH, a nonprofit working in 70 countries to ensure global healthcare equity. “At a time in the country when the lens of equity is applied to everything, we can’t feel good about getting a vaccine if that isn’t happening everywhere.”
Current vaccines need syringes and refrigeration. These requirements present logistical challenges if the SARS-Cov-2 virus is to be eradicated.
The Moderna and Pfizer vaccines require ultra-cold storage or dry ice. The Johnson & Johnson vaccine, which has been put on hold while officials study reports of very rare but dangerous blood clots, can be stored in temperatures just above freezing.
According to FasterCures, which is tracking 326 COVID-19 treatments and 252 vaccines, five companies are developing oral vaccines, and two — ImmunityBio and Vaxart — have progressed to Phase 1 clinical trials.
Thirteen companies are working on intranasal sprays, and five are in early clinical trials.
“We should not underestimate how challenging it is to create the right vaccine formulations that will generate an effective immune response,” Krofah said.
Dr. William Schaffner, an infectious disease expert at Vanderbilt University and the medical director of the National Foundation for Infectious Diseases, said he is impressed that two companies are in Phase 1 trials.
“People have been looking to create an oral vaccine for a long time without a whole lot of success,” Schaffner said. “This is exciting, novel and distinctive.”
Other experts are taking a wait-and-see approach.
“Phase 1 is a long, long way from having a product,” Dr. Paul Offit, with the Children’s Hospital of Philadelphia, said in an email, adding that there is no downside for the FDA to approve early studies.
ImmunityBio, based in El Segundo, is the only company to be simultaneously testing both injectable and oral versions of its vaccine, according to FasterCures data. ImmunityBio’s chairman and chief executive, Dr. Patrick Soon-Shiong, also owns The Times.
The vaccine developed by ImmunityBio is different from the vaccines developed by Moderna, Pfizer and Johnson & Johnson. Those vaccines prompt the immune system to generate antibodies against the virus’ spike protein. The ImmunityBio vaccine, however, is designed to induce antibodies against not just the spike protein on the outside of the virus but also a different protein on the inside of the virus.
Because the inside protein is less likely to mutate than the spike protein, the vaccine could potentially be more effective against coronavirus variants, experts say.