Fast Tracking COVID-19 Vaccine 4 Aspects Can Complicate Your Promotions-News-MM & M

Government officials and companies have come up with very ambitious plans to develop and manufacture hundreds of millions of COVID-19 vaccines within a simplified time frame.

However, while scientists are enthusiastic about pushing out priority products, their risk and benefit profiles, in particular, have not been adequately vetted as some would like, or such vulnerabilities have been compromised. If vulnerable, medical marketers may have difficulty promoting the vaccine to doctors and consumers Public claims.

1. Timeline

The first source of skepticism concerns the timeline itself. Delivered 300 million vaccine stocks by January 1 deadline Set by former Pharma Executive Turned National Vaccine Scissor Monsef Slaui last month and echoed by biotechnology including: Moderna A major pharmaceutical company Pfizer – We need to defeat almost everything we know about the vaccine paradigm.

“This vaccine must be developed at an unprecedented speed, and in order to move forward in the proposed timeline, it must have unprecedented success in clinical trials,” said the vaccine team at Consultant Avaler. Headed Richard Hughes IV said. He noted that the development record for the all-new vaccine, Ebola Shot, is about five years old.

It’s optimistic to arrive all at once in 12 to 18 months. Dr. Anthony Fauci, the country’s top infectious disease expert, warns that discovery, testing, regulatory approvals, and manufacturing processes need to be strengthened at an unprecedented pace. scale.

Seven vaccines are in clinical trials, and Moderna candidates are expected to enter Phase 3 trials this July. From the simultaneous evaluation of vaccines in the lab and the animal model (parallel development) to conducting the tests in the cities where the outbreaks occur (graded wedge clusters), there are various opportunities to shorten the test period.

These can save valuable time while generating a strict safety database. Meanwhile, manufacturers are setting up to produce vaccines on multiple continents.

However, these same shortcuts can undermine public confidence. “For scientists and doctors, the term “warp rate” should cause concern,” he wrote. May 26 article author In Journal of American Medical Assun., Trump White House Vaccine Development Initiative, referring to Operation Warp Speed. “Good science requires rigor, discipline, and careful attention.”

Arthur Caplan, a bioethicist at NYU Langone Medical Center, co-authored LA Times“The rationale for doubt may be that people think you didn’t do the research properly or the vaccine wasn’t manufactured safely.”

2. Severe precedent

These questions will be compounded if cornering leads to a lack of safety or scientific rigor. Similarly, if shots consume coronavirus in the hands of consumers with insufficient potency or adverse effects, it generally undermines public confidence in the vaccine, fueling protests that doctors and scientists cannot trust it, and the anti-vaccine movement.

their Jama The article, Kaplan and colleagues gave two examples where the past serves as a precedent. In 1955, five private manufacturers were commissioned by the government to manufacture soak polio vaccines. The vaccine contained dead poliovirus, which was strong enough to stimulate an immune response, but did not cause disease.

One of the contractors, Cutter Labs, distributed vaccines contaminated with live poliovirus. As a result of the blunder, 70,000 children were shot and weakened, 164 were permanently paralyzed, and 10 died.

“The legacy of this event is a regulatory situation in which vaccines undergo thousands of tests to ensure their safety and efficacy,” the author writes. Researchers risk it and ignore it.

But that’s exactly what happened in 1976 when President Gerald Ford drastically demanded a national vaccination against swine flu. Inadequately thought efforts “failed in virtually every way”, Jama The article pointed out. Due to loose safety standards, one manufacturer produced incorrect stocks. Many of the children who took it failed to mount an immune response and had serious side effects.

All this “increases the initial momentum of the anti-vaccine movement.” Jama The article was reported. We cannot afford to repeat these mistakes.

3. Step by step disclosure

If the COVID-19 vaccine is not widely accepted, for example due to distrust of science, healthy people will be less likely to get it. The lack of “herd immunity”, a precaution against the spread of the virus, increases the risk to people who have weakened immunity and cannot be vaccinated.

This leads to the third aspect of the rushed COVID-19 vaccine, which can complicate promotion. Prompt vaccines will probably not be readily available to the general public. According to Hughes, vaccination proceeds in two phases, phase 1 consisting of targeted vaccinations in a priority population, followed by everyone in phase 2.

As proof, he cited the Ebola vaccine, which was approved by the FDA last year. In that case, the Advisory Committee on Immunization Practices (ACIP), which usually advises the Centers for Vaccination (CDC) on the use of vaccines, first recommends its use in priority populations such as health care workers and first responders. ..

Meanwhile, the COVID-19 vaccine is likely to be approved under the Wide Area Emergency Use License (EUA) rather than under a conventional license given the need for adequate public health, he said.

“[The Ebola shot] Is a newly licensed product, [ACIP] It’s probably what we’re talking about when thinking about COVID-19 unlicensed products, because we’re focusing on specific risk-based populations like healthcare professionals,” Hughes said. In other words, mass vaccination of the public is a unlikely scenario, even with standard product licenses and broad ACIP recommendations.

Citizens will be surprised at the lack of immediate access. “Consumers may be surprised at first, but seeing it reach the general public later is likely to show a need for education about the need for vaccination.

By that time, the country may be facing a second pandemic wave. “This is a big problem,” Hughes said. “Is it possible to reach Phase 2 and vaccinate the public before the fall? I don’t think so. We carry out the EUA before the fall and see Phase 1 occur It will be.”

4. Vaccine refusal

Finally, as vaccines become available, it is not easy to persuade the public to accept them. Only about half of Americans these days say they will get the COVID-19 vaccine poll From the NORC Center for Associated Press PR research. 31% said they were on the fence and 20% said they would refrain.

According to AP/NORC research, 7 out of 10 Americans who refuse to vaccinate are worried about safety. Approximately 4 out of 10 say the main problem is to transmit COVID-19 from the shot itself (most of the major vaccine candidates do not contain coronavirus itself), 3 in 10 Is not afraid to be seriously ill with the coronavirus.

All of this is a tricky messaging quota for healthcare marketers. If “warp speed” efforts are inadequate, their task is to prevent further public frustration. On the other hand, if pharmaceutical companies’ enthusiastic efforts to come up with vaccines succeed, the lack of extensive safety data or substandard products can hinder their efforts to persuade consumers.

Where does it leave us? It’s important for marketers to understand the current state of the two-step rollout and establish a communication strategy. In particular, he urged Huges to prepare how the prioritization decisions were made and communicated in the early stages, and when. More widely available.

Author of Jama This work required sponsors to clearly communicate the results of clinical trials, including adverse events “to proactively address safety concerns.”

Rapid development of vaccines against SARS-CoV-2 public health problems of scale is the cause of optimism. “There isn’t much silver lining in a pandemic,” Hughes said.

For example, there is no HIV vaccine or RSV (respiratory syncytial virus) vaccine. Two of them have been tracked for decades. Therefore, the efforts of COVID-19 Moonshot “renew our appreciation for the vaccine and its ability to prevent disease and save lives.”