Politics, Checks and Balances, and Trust in COVID-19 Vaccines

A leader of a major pharmaceutical company says there is cause for optimism – and some bewilderment – as scientists fend off both political pressure and conflict of interest in their race to deliver therapies and vaccines against COVID-19.

Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron Pharmaceuticals, told an Academy audience that enough regulatory safeguards are in place to protect the public from an overly-rushed vaccine approval. But at the same time, he expressed puzzlement  at a pledge to “stand by science” made by the CEO’s of nine companies developing COVID-19 vaccines. The pledge, including a promise not to release a vaccine until it is safe and effective, was a response to President Trump’s recent suggestion that a vaccine could be ready by the election. Yancopoulous said regulators – not drug manufacturers themselves – must guard against conflict of interest.

Regeneron is developing an antibody treatment for COVID-19, and is now in phase 3 trials.

Another member of the panel, Dr. Swati Gupta, a leader of IAVI, the International AIDS Vaccine Initiative, was more supportive of the pharmaceutical CEOs.  “I think the pledge is a strong signal that they’re trying to resist pressure,” Gupta said. “They really highlighted their commitment to testing COVID-19 vaccines to the highest ethical standards and the highest scientific principles.”

Gupta added that the real safeguard would be the data. “We want to know that the vaccine works. And I think that we need to have the patience to let the data guide us and let the science guide us. When you’re in a middle of a pandemic, that’s not easy.”

Another panelist, Dr. Jacqueline Shea, COO of Inovio Pharmaceuticals, pointed out that COVID-19 is not just a problem for the United States. She said decisions about vaccine development, distribution, and acceptance must be made across international borders, and that significant challenges remain about how to make the vaccines affordable and accessible.

Dr. Nicholas Dirks, the President of the Academy, turned the attention to the recipients of the vaccine, and highlighted the importance of diversity, equity and inclusion.

“We found out very early on in the course of the pandemic in the United States that underrepresented minorities were not underrepresented when it came to infection and to the most dire effects of COVID-19,” Dirks said.

He spoke of bias and socioeconomic factors that contribute to differential impacts of the disease, and also of the importance of increasing diversity in clinical trials.  Dirks suggested that increased minority participation might help counter what polls show is a higher level of skepticism among Black Americans toward the expected vaccine.

Gupta, whose organization runs trials around the world, said a key to increasing diversity is to pursue very active engagement in consultation with community groups representing vulnerable populations. IAVI follows guidelines called Good Participatory Practices, developed by international NGOs to ensure the safety and trust of participants.

Dirks called for transparency about the science, especially by drug companies, to encourage public confidence. This came as questions remained about a temporary halt in the phase 3 clinical trial for AstraZeneca’s recombinant viral vector vaccine.  Hours earlier, Moderna, another vaccine front-runner, released the full protocol for its trial –  a move applauded by many scientists and public health experts.

Transparency in trial development is often complicated by differing opinion among scientists, Yancopoulos explained. He said scientists themselves often disagree about findings, and other complex issues, such as how to evaluate risk. He cited the case of a rare spinal inflammation that may have temporarily halted the AstraZeneca trial.

Dirks said that the scientific community is playing a critically important role not just in developing drugs, but in helping guard against undue political interference, and in monitoring outcomes. And he said the need for scientists to do a good job communicating with the public, and helping people understand the science of treatment and vaccination will soon be even more important. He emphasized  the Academy was committed to finding ways to help in that effort. “The communications problems are going to continue,” Dirks said. “I don’t think we’ve ever had a situation in which vaccines have been developed so quickly. We’re probably going to have multiple vaccines. There will be a lot of different information about each one, and it will be difficult for people to understand it all on their own.”

The Academy will continue to provide programming about COVID-19 in the coming months. Join us for our next virtual symposium, Preparing for Emerging Viral Diseases: Lessons from SARS-CoV-2 on Wednesday, September 30, 2020.