Experts generally agree it will be a heavy lift for the pharmaceutical industry to develop and fully test a safe novel coronavirus vaccine before the end of the year—to say nothing of developing and testing one before the U.S. presidential election on Nov. 3.
But even if, by some miracle of science, a safe and effective vaccine were ready in the next couple of months, many Americans might not be able to get their hands on it.
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That’s because the two vaccines that are most likely to complete large-scale Phase 3 trials—the last step before possible FDA approval—first are also the hardest to distribute. Unlike most other vaccines, they both require refrigeration. And right now it looks like many potential distribution sites will lack the necessary tools to stash them for the foreseeable future.
Of course, first a vaccine has to clear safety hurdles—without being sabotaged by a perception, legitimate or otherwise, of undue political interference.
“The timeline hinges completely on the results of the Phase 3 clinical trials,” Cynthia Liu, a scientific information manager with the Ohio-based Chemical Abstracts Service, told The Daily Beast.
That hasn’t stopped President Donald Trump from making big promises. Trump said as recently as Friday that a vaccine might be available “sometime during the month of October.”
Some members of Trump’s administration have shown signs of bowing to the president’s push to hurry up already, even as they have also promised to follow the science. As McClatchy reported, on Aug, 27, CDC Director Robert Redfield sent a letter to governors "urgently" asking them to expedite applications for vaccine distribution facilities and waive any requirements that might prevent them from being “fully operational" by Nov. 1. (The New York Times has also reported on documents suggesting vaccination priority may be given to the elderly, essential workers, and communities of color, among other at-risk groups.)
On Aug. 30, FDA Commissioner Stephen Hahn told The Financial Times he was willing to consider granting emergency authorization for a vaccine before Phase 3 trials are done.
Redfield’s letter and Hahn’s statement drew rebukes from some scientists and health officials. “The credibility of the FDA and the CDC is shot,” Jeffrey Klausner, a professor of medicine and public health at UCLA who previously worked at the CDC, told The Daily Beast.
Democratic vice presidential nominee Sen. Kamala Harris went so far as to say she “would not trust” Trump when it comes to approving and distributing a vaccine.
Hahn, for one, has done some damage control. “I can tell you our decision at FDA will not be made on any other criteria than the science and data associated with these clinical trials," he told CBS News.
Moncef Slaoui, a top adviser to Operation Warp Speed, the White House’s $13-billion vaccine initiative, also pushed back against the idea of rushing a vaccine, saying there was “no intent” by the FDA to approve a vaccine before the end of Phase 3 trials.
“We may have enough vaccine by the end of the year to immunize probably, I would say, between 20 and 25 million people,” Saloui told National Public Radio. “And then we will ramp up the manufacturing of vaccine doses to be able to, based on our plans, have enough vaccine to immunize the U.S. population by the middle of 2021.”
The problem is that widespread deployment most likely will require extensive new infrastructure that’s only beginning to be built. The two vaccines that officials say are farthest along in development, “Vaccine A” from New York-base pharma Pfizer and “Vaccine B” from Moderna in Massachusetts, are both so-called “messenger-RNA” vaccines that must remain cold in order to be effective.
These mRNA vaccines work by introducing to a patient’s immune system a genetically engineered nanoparticle that encourages the production of coronavirus-fighting antibodies. MRNA is a new technology, and no vaccines using this tech have been approved yet. Unlike older-style vaccines that involve less genetic engineering, it’s possible to speed up development of an mRNA vaccine. That’s the advantage of the technology.
The disadvantage is that it’s “unstable,” as Paul Offit, chief of the division of infectious diseases at the Children's Hospital of Philadelphia, previously told The Daily Beast. To counteract that instability, testers in laboratory settings store an mRNA vaccine at temperatures as cold as -110 degrees Fahrenheit. Moderna executives have argued that their Vaccine B should be stable at just four degrees below zero. Neither Moderna nor Pfizer responded to requests for comment.
Hospitals generally possess extremely cold, industrial-style refrigerators that can keep an mRNA vaccine at the required temperature, whether it’s four below zero or a hundred below zero. But many of the facilities that eventually would administer a vaccine—pharmacies and doctor’s offices, for example—lack that high-end equipment.
An mRNA vaccine can go bad in a day’s time if stored in the warmer temperature of a cheap, consumer-style refrigerator. “These storage conditions would make traditional office or pharmacy administration very difficult,” analysts at SVB Leerink, a Boston investment bank specializing in health care, stated on Aug. 27.
Because it might be impractical for a large number of sites to keep stocks of an mRNA vaccine on hand, health-care workers may have to organize large, intensive “one-day vaccination events” at hospitals and labs, the analysts explained. “But this would still only cover a fraction of the healthy population,” they noted. Relying on one-time events would limit how fast, and how widely, authorities could deploy a vaccine, regardless of its effectiveness.
And if you live in a small town far from a hospital or lab—well, given the federal government’s failures on testing and other COVID initiatives, it’s hard to have a ton of confidence. Klausner, for one, proposed enlisting the National Guard in the effort. “We need supply and logistics coordination and we need vaccine delivery sites,” he said.
Now imagine that a conventional vaccine, rather than one of the mRNA candidates, gets FDA approval—or emergency authorization—first. That could upend expectations, and render moot what little progress officials have made on the deployment of a vaccine they believed would require intensive refrigeration.
It’s possible, in other words, that we’re expecting the wrong vaccine.
That uncertainty is unavoidable, Anthony Alberg, a University of South Carolina epidemiologist, told The Daily Beast. After all, we just don’t know what the various Phase 3 trials are going to turn up. “The detailed protocol required for a coordinated national rollout of a SARS-CoV-2 [novel coronavirus] vaccine is not possible to generate in the absence of detailed data from a randomized controlled trial that demonstrated efficacy in protecting against infection and also demonstrated safety,” he said.
This is why vaccines take time.
So yes, the Trump administration’s apparent impatience to approve a vaccine, possibly before Phase 3 trials are even over, is a red flag from a health perspective. Side effects could do tremendous harm and set back the cause in a country with a long history of vaccine skepticism.
But botching the science and botching distribution are entirely separate issues. And experts warned the United States could be on a path to doing both.
“Developing a safe and effective vaccine is critical, but not necessarily the most important step,” Klausner said. “Once we have a vaccine, it’s going to be difficult and require a tremendous amount of coordination to implement vaccination.”
“I don’t see that we are adequately preparing for that,” he added.
