Drug companies seek to reassure public amid Trump vaccine push
Drug companies are seeking to reassure the public that coronavirus vaccine approval will be based on science, not politics, as the push for a vaccine intensifies and President Trump floats the idea of pre-Election Day approval.
The rare statement issued Tuesday by nine pharmaceutical companies working on potential coronavirus vaccines, pledging to “stand with science,” illustrated the fears about politicization of the vaccine approval process with the election approaching.
“The existence of the statement is an acknowledgement that there are real concerns over the politicization of the FDA’s approval process,” said Rachel Sachs, a Food and Drug Administration (FDA) expert at Washington University in St. Louis.
During a news conference Monday, Trump raised the idea of a “very big surprise coming up” on a vaccine, while also saying it will be “very safe and very effective.”
“We’re going to have a vaccine very soon. Maybe even before a very special date. You know what date I’m talking about,” he said.
Trump has previously put pressure on the FDA. He tweeted last month that the “deep state” at the agency was slowing down work on vaccines and treatments until after the election.
Tuesday’s statement by vaccine manufacturers Pfizer, Moderna and AstraZeneca was therefore welcomed by experts as an added safeguard against potential political influence.
The companies vowed they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
Sachs, who said the statement was a step in the right direction, noted that there was still some concerning wiggle room, given that the companies did not specify which requirements they would meet.
For example, the FDA has said a vaccine should be effective in at least 50 percent of people to be approved, but Sachs noted that statements have left open the possibility that an emergency authorization might be issued with a lower standard. She added that there could also be clearer commitments to making data from the clinical trials widely accessible to the public before any authorization is given.
Adding to the vaccine buildup ahead of the election, Pfizer CEO Albert Bourla on Tuesday repeated his prediction that the company’s vaccine could have results back from the trial by the end of October, a faster timeline than the one experts have laid out.
“Right now, our model, our base case, predicts that we will have an answer by the end of October,” he said on NBC, adding there is a 60 percent chance of hitting that timeline.
It is impossible to know exactly when clinical trials will report their results. The trials work by giving the potential vaccine to one group of people and a placebo to another. Participants then go about their lives until enough time has passed to compare whether significantly fewer people in the vaccinated group contracted the coronavirus compared with the placebo group. But the time it takes to get that answer depends on how long it happens to take for enough people to become infected.
Anthony Fauci, the government’s top infectious diseases expert, said on CNN last week that it is “unlikely, not impossible” to have the results of a trial in October.
“I think most of the people feel it’s going to be November, December,” he said.
Fauci also downplayed concerns about political interference.
“The FDA has been very explicit that they are going to make a decision based on the data as it comes in,” he said.
FDA Commissioner Stephen Hahn has been seeking to offer reassurances that an approval decision will not be based on politics.
“FDA’s professional staff will only authorize or approve a #COVID19 vaccine if it meets the high standards that Americans expect for safety and effectiveness,” Hahn tweeted Tuesday.
But fears about his ability to stand up to political pressure grew last month when he overstated the benefits of the coronavirus treatment known as convalescent plasma while standing next to Trump at a White House press conference. Hahn backtracked the next day after widespread criticism.
Scott Gottlieb, Trump’s former FDA commissioner, said Tuesday on CNBC that he expects an emergency authorization could be issued to allow the vaccine to be used first for “certain high-risk groups,” which could include the elderly or health care workers.
“But the likelihood that that’s going to come in October is very low, extremely low,” he added, saying it would likely be “at least” November.
Once a vaccine is authorized, it will take several months for everyone in the country to receive the shots due to the immense logistical challenges around vaccinating more than 300 million people, though high-risk groups are likely to get priority.
Illustrating the skepticism among the public, an NPR-PBS NewsHour-Marist poll last month found that 35 percent of Americans said they would not take a coronavirus vaccine.
Sen. Kamala Harris (Calif.), the Democratic vice presidential nominee, raised concerns about the politicization of a vaccine in a CNN interview last week, saying a “credible” source would have to vouch for a vaccine, not just Trump, for her to take it.
She said she worries experts will be “muzzled” in a vaccine push “because [Trump’s] looking at an election coming up in less than 60 days, and he’s grasping for whatever he can get to pretend that he’s been a leader on this issue when he’s not.”
Bourla, the Pfizer CEO, said Tuesday that the pledge from drugmakers was driven by “increasing public concerns” about the vaccine process.
Asked about Trump’s comments the previous day about having a vaccine before a “special date,” Bourla declined to respond directly.
“I don’t want to comment on what the president says,” Bourla said.