Government officials and companies have laid out highly ambitious plans for developing and making hundreds of millions of COVID-19 vaccine doses in an abbreviated timeframe.
But while scientists are working feverishly to bring an expedited product forward, medical marketers may have trouble promoting the vaccine to physicians and consumers, especially if its risk-benefit profile has not been vetted as fully as some would like, or is vulnerable to such a charge by the public.
1. The timeline
The first cause for skepticism involves the timeline itself. Delivering a 300 million-dose vaccine stockpile by the Jan. 1 deadline set by ex-pharma-exec-turned-national-vaccine-czar Monsef Slaoui last month – and echoed by biotechs like Moderna and big pharmas like Pfizer – will require upending almost everything we know about the vaccine paradigm.
“This vaccine would have to be developed at unprecedented speed, with unprecedented success in clinical trials to be able to move forward on the suggested timeline,” said Richard Hughes IV, who leads the vaccine team at consultancy Avalere. The record for developing an entirely new vaccine, the Ebola shot, is approximately five years, he pointed out.
Even arriving at a shot in 12 to 18 months is optimistic, Dr. Anthony Fauci, the nation’s top infectious diseases expert, has cautioned, as it would require ramping up discovery, testing, regulatory approval and manufacturing processes to heretofore unseen levels of pace and scale.
Seven vaccines have entered clinical trials, and Moderna’s candidate is anticipated to enter Phase 3 trials starting this July. There are various opportunities to shorten the testing timeframe, from evaluating a vaccine simultaneously in the lab and in animal models (parallel development) to holding a trial in a city where an outbreak is occurring (the stepped-wedge cluster).
These can shave off valuable time while generating a rigorous safety database. Meanwhile, manufacturers are ramping up to produce vaccine on multiple continents.
Those same shortcuts, however, could undermine public confidence. “For scientists and physicians, the term ‘warp speed’ should trigger concern,” wrote authors of a May 26 article in the Journal of the American Medical Assn., referring to Operation Warp Speed, the Trump White House’s vaccine development initiative. “Good science requires rigor, discipline, and deliberate caution.”
As co-author Arthur Caplan, a bioethicist at NYU Langone Medical Center, explained to the LA Times, “The basis for doubt could be that people think you didn’t do the research properly or the vaccine was not manufactured safely.”
2. A grim precedent
Those doubts would be intensified if cutting corners leads to lapses in safety or scientific rigor. Similarly, if industry puts a coronavirus shot in consumers’ hands that has insufficient potency or adverse effects, it could weaken public confidence in vaccines in general, fueling the argument that physicians and scientists can’t be trusted and giving a boost to the anti-vaccine movement.
In their JAMA article, Caplan and colleagues cited two examples in which the past serves as precedent. In 1955 five private manufacturers were contracted by the government to produce the Salk polio vaccine. The vaccine contained a dead polio virus that was just strong enough to prompt an immune response but not to cause the disease.
Cutter Laboratories, one of the contracted firms, distributed a vaccine that was contaminated with live poliovirus. The debacle resulted in 70,000 children who took the shot developing muscle weakness, 164 permanently paralyzed and 10 deaths.
“The legacy of this event is a regulatory landscape in which vaccines undergo thousands of tests to ensure their safety and effectiveness,” the authors wrote. Researchers ignore it at their peril.
Yet that’s exactly what happened in 1976, when President Gerald Ford called for vaccination of the country against the swine flu, at breakneck speed. The poorly conceived effort “failed in virtually every respect,” the JAMA article noted. One manufacturer, due to lax safety standards, produced an incorrect strain. Many children who took it failed to mount an immune response, and serious side effects emerged.
All this “added to the early momentum of the anti-vaccine movement,” the JAMA article reported. We can’t afford a repeat of those mistakes.
3. Phased rollout
If, due to distrust in the science or otherwise, a COVID-19 vaccine isn’t broadly accepted, fewer healthy people will take it. Lack of “herd immunity,” which is a safeguard against the virus’ spread, raises the risk for those who are immunocompromised and unable to get inoculated.
This brings us to the third aspect of a rushed COVID-19 vaccine that could complicate promotion – an expedited vaccine probably won’t become available to the general public right away. According to Hughes, immunization will proceed in two phases, with Phase 1 consisting of targeted immunization of priority populations and followed by everyone else in Phase 2.
As a proof point, he cited the Ebola vaccine, which was approved by the FDA last year. In that case, the Advisory Committee on Immunization Practices (ACIP), which typically advises the Centers for Disease Control and Prevention (CDC) on the use of vaccines, recommended use in priority populations first, like healthcare workers and first responders.
A COVID-19 vaccine, on the other hand, is more likely to be approved under a broad emergency use authorization (EUA), he said, rather than under a traditional license, given the sufficient public health need.
“[The Ebola shot] was a newly licensed product and [ACIP] focused on specific risk-based populations like healthcare workers, so if you think about an unlicensed product for COVID-19, that’s probably what we’re talking about,” said Hughes. In other words, mass vaccination of the general public is an unlikely scenario until standard product licensure and a broadened ACIP recommendation.
The public could be taken aback by lack of immediate access. “Consumers might be surprised by this initially, but later, once we do see this reach the general public,” Hughes said, “we are likely to see a need for education around the need to be vaccinated, especially if it is seasonal.”
By that time, the nation could be facing a second pandemic wave. “This is the big question,” said Hughes. “Are we able to reach Phase 2 before the fall and vaccinate the masses? I don’t think so. We might be in a position before the fall to do the EUA and see Phase 1 happen.”
4. Vaccine refusal
Finally, were a vaccine to become available, convincing the public to take it would not be an easy feat. Only about half of Americans say they would get a COVID-19 vaccine, per a recent poll from The Associated Press-NORC Center for Public Affairs Research. Thirty-one percent said they were on the fence, and 20% said they’d refrain.
Among Americans who say they’d refuse vaccination, seven in 10 worry about safety, according to the AP/NORC poll. About four in 10 say their main issue would be contracting COVID-19 from the shot itself (even though most of the leading vaccine candidates don’t contain the coronavirus itself) and three in 10 simply don’t fear getting seriously sick from coronavirus.
All of which makes for a tricky messaging assignment for medical marketers. If the “warp speed” effort falls short, their task will be to prevent the public from becoming even more jaded. On the other hand, if drug makers’ feverish efforts to come up with a vaccine succeed, lack of extensive safety data – or a substandard product – could hamper efforts to convince consumers.
Where does that leave us? It’s important for marketers to understand the reality of this two-stage roll-out now and to establish strategies for communication, urged Huges, especially for how prioritization decisions will be made and communicated in the early phase, as well as to prepare for when it’s available more broadly.
The authors of the JAMA piece called for study sponsors to clearly communicate clinical trial results, including adverse events, to the public, “to proactively address safety concerns.”
That said, fast-tracking development of a vaccine for a public health issue of the magnitude of SARS-CoV-2 is also cause for optimism. “There aren’t a lot of silver linings in a pandemic,” Hughes said.
For instance, we have neither an HIV vaccine nor one for RSV (respiratory syncytial virus) vaccine, two which we’ve spent decades chasing, he reminded us. Thus, the COVID-19 moonshot effort, “renews our appreciation for a vaccine and its ability to prevent disease and save lives.”