Former Commissioners Support FDA on Vaccines
A panel of three former FDA commissioners told the Milken Institute 2020 Future of Health Summit that FDA has been acting properly to oversee the development of Covid-19 vaccines. Former commissioners Robert Califf, Mark McClellan, and Margaret Hamburg appeared in a 12/8 online discussion that centered on the agency’s role in Covid-19 vaccine development generally and also its role in other aspects of the pandemic.
“They’ve been doing the right thing with the Pfizer vaccine,” Califf said, when asked about the U.S. being behind the UK in approving a vaccine. “FDA is the only agency to do an independent analysis of the raw data.”
Hamburg noted that the U.S. is not racing against other countries, but rather against the virus, and the difference of a few days or weeks won’t matter. “Even if you have the safest and most effective vaccine,” she said, “it won’t matter if people don’t have confidence in it.”
Asked about the Trump administration’s decision not to buy additional doses of the Pfizer vaccine, Califf said the key issue is not how much vaccine we get initially but rather how it is distributed.
“We (the U.S.) are not safe until the whole world is safe,” Hamburg added. “I was surprised that we declined additional Pfizer vaccine but now we just have to keep moving forward and remember that there are other vaccines in the pipeline.”
The panelists expressed approval that the incoming Biden administration has indicated plans to rejoin the world community on health issues. “It’s in our own self-interest to help the lower-income countries,” Califf said.
The panelists were asked about political pressure on FDA. McClellan said it is “very reassuring how robust the FDA processes are. They can’t just approve something politically.” He said it will be important to learn from what went well and what didn’t go well in the Covid-19 pandemic to better prepare for future public health challenges.
Califf noted that while industry, patient groups, and other stakeholders are always ready to criticize the agency, “when the chips are down, they come to FDA’s support.”
Asked what more needs to be done to assure people of vaccine safety, the panelists pointed to the briefing paper that came out in advance of an advisory committee meeting on the Pfizer product and the meeting itself. McClellan also said that agencies and organizations other than FDA must be involved in public education campaigns.
The panelists said there are some significant side effects to the vaccines that people need to be aware of. And Hamburg cautioned that some people will link unrelated health issues such as heart problems or miscarriages in vaccinated people to the vaccine.
Califf stressed the importance of post-marketing vaccine studies and efforts to inform clinicians so they can work with their patients.