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A safe and effective COVID-19 vaccine could help healthcare workers on the pandemic’s front lines. Getty Images
  • Nine vaccine makers released a joint pledge to listen to the science in their development of COVID-19 vaccines.
  • The companies that signed the pledge include AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.
  • In a survey, 72 percent of Republicans and 82 percent of Democrats thought the process was driven more by politics than science.

Nine vaccine makers signed a joint pledge holding themselves to “high ethical standards and sound scientific principles” in the development and testing of potential vaccines for COVID-19.

They also pledged to apply for government approval of a vaccine only “after demonstrating safety and efficacy through a Phase 3 clinical study.”

The companies that signed the pledge include AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.

This statement comes as President Donald Trump continues to push for quick approval of a vaccine against the coronavirus that causes COVID-19.

“We are going to have a vaccine very soon, maybe even before a special date. You know what date I’m talking about,” he said at a press briefing on Monday according to CNN referencing Election Day on November 3.

Trump’s comments and others made by top U.S. health officials have raised concerns that a COVID-19 vaccine may be rushed for political reasons.

Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn said in an interview with the Financial Times that the agency could consider an emergency use authorization for a COVID-19 vaccine before phase 3 clinical trials are complete.

However, he said it is up to the vaccine developers to apply for this authorization.

Herschel Nachlis, PhD, a research assistant professor of government and a policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth College, notes that political pressure on the FDA is not uncommon.

“Regulatory decisions are often combinations of both policy and politics,” he said, “and this time will be no different.”

However, he says the vaccine makers seem to understand the need for COVID-19 vaccine decisions to be based on the quality of the data and the integrity of the regulatory processes.

“An important feature of the pledge is that firms are saying that they will not be pressured into submitting bad data, or into submitting data that does not show evidence of vaccines’ safety and efficacy, to the FDA,” he said.

Peter Loge, an associate professor of media and public affairs at The George Washington University, says that it is in the vaccine makers’ best interest to insist on a rigorous review of their vaccines.

“Real cures cost real money [for pharmaceutical companies] to develop,” he said. “If there is no national or international standard for safe and effective treatments, companies that spend the resources to get it right will quickly lose market share to companies that don’t bother to ensure their claims are true.”

The nine vaccine makers’ news release called their pledge “historic” because it is unusual for competing companies to work together.

However, Loge says this collaboration is no substitute for independent federal regulation.

Public health observers should be “worried that industry self-regulation could make independent review even tougher,” he said. “The [vaccine makers’] pledge is probably good for public health, but there’s a reason the FDA exists.”

Pfizer and BioNTech, AstraZeneca and the University of Oxford, and Moderna and the U.S. National Institute of Allergy and Infectious Diseases have candidate vaccines in late-stage, phase 3 trials. Johnson & Johnson plans to start its phase 3 trial later this month.

These studies will enroll thousands of volunteers and are the only way to know whether a COVID-19 vaccine is both safe and effective.

Volunteers will receive either the candidate vaccine or an inactive placebo, with some of the vaccines requiring two doses spaced weeks apart. Researchers then have to wait for participants to be exposed to the virus, which takes time.

So it’s unlikely the phase 3 trials will be completed before Election Day. But vaccine makers may have enough data to apply for emergency use authorization (EUA) of their vaccine, an option they included in their pledge.

An EUA is reserved for public health emergencies — like a pandemic. It still requires FDA review of the clinical trial data, but the agency only has to decide that a vaccine has likely benefit. This is a lower threshold than is needed for conventional approval.

After Trump pushed hydroxychloroquine, a decades-old malaria drug, as a treatment for COVID-19, the FDA issued an EUA for this and the related chloroquine. The agency later revoked this authorization due to lack of benefits and a growing number of cases of serious side effects.

More recently, the FDA issued an EUA for convalescent plasma after Trump touted the treatment as a breakthrough. Evidence of its effectiveness, though, is inconclusive and a panel convened by the National Institutes for Health said there was not enough evidence for this approval.

The FDA’s Hahn further muddied the waters by overstating the results of studies looking at this treatment.

Nachlis co-authored a recent article in the journal JAMA looking at how lessons from the FDA’s missteps with the hydroxychloroquine EUA could be applied to make the review of a COVID-19 vaccine more transparent.

“Some people worry… that the EUA review standard itself is quite vague, as are EUA standards for transparency,” said Nachlis, “and that’s why in both the short and long term it may be important for the FDA to both clarify EUA review and transparency processes and standards.”

Tobias Gerhard, PhD, an associate professor of pharmacy practice and administration at the Rutgers Ernest Mario School of Pharmacy, is less concerned about whether vaccine approval occurs through the EUA or conventional route, and more about whether the data used to make that decision is publicly available.

“An emergency use authorization — or standard approval — in the absence of publicly available data or based on unconvincing data would be extremely problematic,” he said, “and would likely cause great harm to the ongoing COVID-19 response and to public health.”

Even if the FDA issues an EUA for a COVID-19 vaccine, drug makers will still need to continue monitoring people who have been given the vaccine to make sure it is safe.

While mild effects — such as irritation or soreness at the site of injection — often show up in smaller trials, more rare adverse events may not be detected until tens of thousands of people have received a vaccine.

One COVID-19 vaccine trial — a collaboration between AstraZeneca and the University of Oxford — has already been put on hold after a participant in the United Kingdom was diagnosed with transverse myelitis, according to the New York Times.

This inflammatory condition affects the spinal cord and can be triggered by a viral infection. It is not known if this diagnosis is directly linked to AstraZeneca’s vaccine.

These kinds of holds are not uncommon for clinical trials — that’s why studies are continuously monitored by data and safety monitoring boards, a group of independent nongovernmental scientists and researchers.

But health economist Joshua P. Cohen, PhD, wrote on Twitter that this “snag” highlights the need to not rush a vaccine.

“Perhaps this dose of reality makes people understand the possible obstacles that occur,” he wrote. “But also that it’s not helpful for politicians to ‘promise a vaccine by year’s end.’ Better to wait and see.”

The FDA has scheduled a public meeting of its Vaccines and Related Biological Products Advisory Committee on October 22, less than 2 weeks before Election Day. During this meeting, the agency will share some of the data collected from phase 3 trials.

This meeting may alleviate some of the public’s concerns about a politicized vaccine approval process, something that was on sharp display in a recent STAT-Harris survey.

In the survey, 72 percent of Republicans and 82 percent of Democrats thought the process was driven more by politics than science.

In addition, 80 percent of Republicans and 85 percent of Democrats said they would be concerned about the safety of a vaccine if it was approved quickly.

In making their pledge, vaccine makers appear to be responding to some of the public’s concerns.

Pfizer CEO Albert Bourla said on NBC’s Today show on Tuesday that the pledge to maintain high ethical standards for vaccines stems from “increasing public concerns about the processes we are using to develop these vaccines, and even more importantly, the processes that would be used to evaluate these vaccines.”

Loge says getting the process right this time is not just about addressing the COVID-19 pandemic, but about what happens in the future.

“A rushed vaccine that is unsafe is a terrible, terrible idea,” he said. “More people will die, and public trust in government, science, and industry will slide. That means the next time there is a pandemic — and there will be a next time — it will be even harder to respond.”

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