Five months after the novel coronavirus first reached America’s shores, a crash program to immunize the U.S. population is still in its earliest stages.
To be clear, there’s no guarantee a vaccine will work against SARS-CoV-2. Even if a vaccine is possible, developing, producing and distributing it takes time, money, coordinated effort by government, industry, and the medical community—and the cooperation of an increasingly traumatized and skeptical population.
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“You have a novel virus you’re trying to counteract with a novel vaccine strategy,” Paul Offit, chief of the division of infectious diseases at the Children’s Hospital of Philadelphia, told The Daily Beast. “What could go wrong?”
First step: develop a vaccine. Of the roughly 70 major novel-coronavirus vaccine candidates in development, the U.S. government has picked five for serious federal support. Following small-scale phase-one and phase-two testing this spring and early summer, large-scale phase-three trials are about to get underway.
At least one major vaccine candidate is under development in China, but it’s unclear whether and how quickly that vaccine could be available in the United States.
U.S. officials are cautiously optimistic that a vaccine could be ready by the end of the year, at which point a large-scale immunization effort would get underway and last through 2021.
That’s the best-case scenario. But a lot could go wrong. The leading vaccines might not work. Factories might not be able to produce enough doses to meet demand, especially considering the recent upward trend in infections in the United States.
Perhaps most alarmingly, a frustrated Trump administration could cut corners and push out an ineffective—or, worse, dangerous—vaccine. A skeptical public, stung by government screw-ups, could resist mass immunization. Especially if widespread immunization requires multiple vaccine roll-outs.
America’s anti-vaccine movement has raised the alarm over expedited coronavirus vaccine development.
The feds’ Operation Warp Speed, as it’s been dubbed, has tapped Moderna, a consortium of AstraZeneca and Oxford University, Johnson & Johnson, Merck and Pfizer to receive $13 billion in government funding. Officially, the goal is to produce 300 million doses of a vaccine by January 2021.
Anthony Fauci, the head of the National Institute for Allergy and Infectious Diseases, stressed that the January goal is “aspirational, but it’s certainly do-able.”
Testing can go only so fast, Fauci explained. “You need a few months at least of having vaccinated individuals getting exposed,” Fauci told reporters. “So let’s say it’s July, August, September, October. By November, you should have an efficacy signal.”
The main way to speed up the overall immunization program is to set up manufacturing plants for the leading vaccine candidates before they complete development. “Manufacturing has to start now,” Lola Eniola-Adefeso, a University of Michigan bio-engineer, told The Daily Beast.
The feds have set aside billions of dollars to pay for vaccine factories, knowing full well that many of the facilities could end up being useless if some—or all—of the vaccines prove to be ineffective. Moderna recently partnered with New Jersey-based medical-manufacturer Catalenta to produce up to 100 million doses of its vaccine.
Parallel development and production can be expensive and wasteful from a strictly financial point of view, but it’s also the best way to accelerate the overall immunization process. “All of that cuts months off,” Fauci said.
With parallel testing and manufacturing and a fair amount of luck, “you can have a significant number of doses available by the end of the year, the beginning of 2021,” Fauci said.
As it stands, Massachusetts-based Moderna appears to be ahead of other pharmas when it comes to developing a novel-coronavirus vaccine. Officials from Operation Warp Speed told reporters they expect Moderna to enter phase-three trials with its vaccine candidate as early as this week, likely making it the first of the leading developers to begin large-scale testing on human patients.
Moderna’s vaccine candidate, like Pfizer’s, is an mRNA vaccine that includes a synthetic version of the messenger-RNA that a virus uses to build its infectious proteins. Johnson & Johnson and the AstraZeneca-Oxford consortium are working on so-called “live vector vaccines” that include chemically weakened versions of the novel coronavirus.
Merck’s own candidate is unique. The company is using the same process to develop a SAR-CoV-2 vaccine that is used to develop its successful Ebola vaccine, building on non-human viruses.
Once a vaccine completes its phase-three trials and the Food and Drug Administration approves it for regular use, production can ramp up. Offit said he expects doctor’s offices, pharmacies, schools and hospitals to administer the vaccine, likely in two doses. The Trump administration insists that the vaccine will be cost-free for “vulnerable” Americans.
Authorities haven’t yet detailed who will get the vaccine first, but experts expect the most vulnerable groups to top the list. “We can imagine making seniors a high-priority population for it since they are most likely to get the sickest from infection,” Jennifer Reich, a University of Colorado sociologist who studies immunization, told The Daily Beast.
“We can also imagine setting priorities for essential workers, which could include health-care personnel, nursing-home staff or even grocery-store workers, religious leaders or teachers who are at risk,” Reich added. “How these decisions will be made, whether ACIP recommendations will be broadly adopted, and whether states and locales will agree remain unclear.”
ACIP is the Advisory Committee on Immunization Practices, a committee within the Centers for Disease Control and Prevention that advises the agency on vaccine-deployment.
There’s some risk that the FDA could bow to political pressure from the Trump administration and approve a vaccine before it’s ready, perhaps in the weeks leading up to the presidential election in November.
After all, the FDA caved to President Trump and other top Republicans and, in late March, approved hydroxychloroquine for emergency use as a treatment for COVID-19—this despite evidence that the drug not only didn’t work, but that it could also cause heart problems in some patients.
The FDA did not respond to a query before press time.
The FDA finally revoked hydroxychloroquine’s emergency approval in June. Offit described what happened with hydroxychloroquine as “bad news” for the possible, eventual coronavirus immunization effort. “If you put a vaccine out there and it’s not effective, you’re going to shake vaccine confidence in this country.”
“Since vaccines are given to people before they are sick, the last thing you want is to have people get adverse effects or death from the vaccine,” Eniola-Adefeso said. “Therefore, we have to balance speed with safety and efficacy.”
Now imagine running that risk more than once. After all, it’s possible—likely, even—that more than one company will develop a SARS-CoV-2 vaccine in coming months and the FDA will have to weigh how quickly to approve the vaccines for public use.
It’s possible that, in 2021, people will have several vaccines to choose from. It’s also possible these various vaccines won’t all work equally well.
“It is not clear where the active immunities resulting from different vaccines will be exactly the same,” Dmitry Korkin, a bioinformatics researcher at the Worcester Polytechnic Institute in Massachusetts, told The Daily Beast. “There are also questions [as to] whether different populations will be equally well responsive to the vaccines.”
Now assume that every aspect of the novel-coronavirus immunization program goes perfectly according to plan. One or more companies complete vaccine-testing by the end of the year. The FDA approves the vaccines only after the data clearly establish that the vaccines are safe and work. Americans dutifully head to their local pharmacy to get vaccinated. The vaccines’ effectiveness varies across different populations, but not so much as to make a meaningful difference in individuals’ immunity.
Even then, there are risks. “How long will the vaccine-induced immunity last is not clear,” Korkin explained. If a vaccine works, but doesn’t work for very long, then one major wave of immunizations might not be enough. The government, industry, the medical community and the public might have to repeat the whole process with all of its risks and complications.
Under the best of circumstances, Americans could be in for a long, messy immunization battle against the novel coronavirus—one lasting years or even decades.
