If a vaccine is fast-tracked through an emergency use authorization rather than formally licensed by the Food and Drug Administration, that too could create bureaucratic hurdles. For example, Medicare doesn’t cover the costs of emergency-use drugs. So while the government intends to pay the cost of the vaccine and of supplies like syringes, hospitals would be on the hook for storage, scheduling, record keeping, and paying staff to actually give the injections. “Hospitals are not happy about that—at all,” Behlim says. A fix will likely have to come from Congress.
Another worry for hospitals: having to juggle multiple vaccines that are not interchangeable, especially after more become available in the future. “What they’re concerned about is: I get a vaccine now in November, and then another manufacturer launches in January, and then another manufacturer in March, and three more launch in May,” Behlim says. Immunization registries can record who got which vaccine, but hospitals and clinics will still have to decide which ones to stock and how much of each. One vaccine might be more effective, but another one easier to store. A third might be most effective in older people, while a fourth could have the advantage of requiring only a single dose. The more vaccines there are on the market, the harder vaccine management becomes.
In fact, with dozens of vaccines currently in clinical trials, the U.S. will very likely have multiple COVID-19 vaccines from multiple manufacturers next year. Two other vaccines are just behind Moderna’s and Pfizer/BioNTech’s mRNA vaccines, in Phase III clinical trials in the U.S. One of those is made by AstraZeneca and the other by Johnson & Johnson; both insert the genetic code for the coronavirus spike protein into a harmless virus.
These vaccines take slightly longer to manufacture, because they require growing viruses, and they are also a relatively new technology. But they do not have to be frozen, and Johnson & Johnson’s can be given in just a single dose. Close behind these two are more traditional vaccines that use proteins purified from the virus, which will likely have traditional storage requirements. Of course, clinical trials still need to be completed before scientists will know whether any of these vaccines are safe and effective. “Which vaccine or vaccines will prove the safest and the most effective and the most deployable? I think we don’t know yet. And that’s why having redundancy is good,” says Dan Barouch, a vaccine researcher at Harvard. (His lab is a collaborator on Johnson & Johnson’s vaccine.)
In the short run, speed is of the essence. But in the long run, these other characteristics—safety, effectiveness, and ease of use—will determine which vaccines get widely distributed. Julie Swann, who studies supply chains at North Carolina State University and who worked with the CDC during the 2009 flu pandemic, says she’s disappointed that the U.S. has put its weight behind these mRNA vaccines, which rely on new technology and whose handling imposes extra requirements on states and vaccine providers. It will be even harder to use them in developing countries. “There’s no way we can use this in some countries around the world,” she says.
The good news is that more deployable vaccines are moving fast through the pipeline too. The race to a vaccine has dominated hopes for an end to the pandemic. But the first COVID-19 vaccine may not ultimately be the most important COVID-19 vaccine.
We want to hear what you think about this article. Submit a letter to the editor or write to letters@theatlantic.com.
Source link