October 12, 2020, 1:35 pm Michael Devitt – Family physicians and others who attended the Academy’s Oct. 7 virtual Town Hall were treated to a timely discussion on the search for a COVID-19 vaccine.
Hosted by AAFP President Gary LeRoy, M.D.; and Senior Vice President for Health of the Public, Science and Interprofessional Activities Julie Wood, M.P.H. – and featuring Remy Brim, Ph.D., vice president of regulatory policy and strategy for BGR Group; and Jonathan Temte, M.D., Ph.D., associate dean for public health and community engagement at the University of Wisconsin School of Medicine and Public Health in Madison – the hourlong question-and-answer session touched on a range of topics, including the types of vaccines currently in development, vaccine safety and effectiveness, and how to address patient concerns.
“The AAFP wants to make sure you stay informed about the current state of the COVID-19 vaccine science, the process of vaccine development, including safety and approval, and what to consider in planning for potential vaccine distribution,” Wood explained.
Read on for highlights from the Town Hall, and watch a replay for the full discussion, including responses to audience questions.
Temte, who chaired the CDC’s Advisory Committee on Immunization Practices from 2012 to 2015, said that four vaccines are currently undergoing phase 3 clinical trials in the United States. Two are “entirely novel” and involve messenger RNA, the third vaccine uses a chimpanzee adenovirus, and the fourth vaccine uses a human adenovirus.
Brim explained that while most vaccines are developed over several years and involve multiple trials, the Project BioShield Act of 2004 created an emergency use authorization process that allows the FDA to deploy new or emerging medical products more quickly during a public health emergency.
In those situations, Brim said, the standard for EUA “is very different … Instead of demonstration of safety and effectiveness, it’s looking at the totality of evidence and if that is reasonable to believe that a product may be effective in treating the disease or condition, and that whatever we know about the potential benefits outweighs what we know about the risks, and all of that is considered within the context and the threat of the public health emergency.
“That’s a very different standard,” Brim continued. “That’s a completely different bar.”
Brim pointed to new guidance for vaccine manufacturers released by the FDA on Oct. 6 that outline the requirements for EUA of a COVID-19 vaccine. These requirements include a median follow-up duration of at least two months after completion of a full vaccination regimen to weigh the vaccine’s risks and benefits.
Temte also described his role as the AAFP liaison to the ACIP’s COVID-19 Vaccine Work Group.
The work group, Temte explained, does much of the “heavy lifting” for the ACIP in reviewing the medical literature, studying the available information and helping to develop policy options for the ACIP to consider.
As AAFP liaison, meanwhile, Temte represents the views of family physicians. In terms of implementing the ACIP’s recommendations, Temte said it is his role to see that the sensitivities and sensibilities of FPs and other primary care clinicians are taken into account.
As an example, Temte related that one of the four COVID-19 vaccines currently being studied has a storage requirement of -70 degrees Celsius. “It’s not something I have in my clinic, nor do any of my partners across the system have in their clinics, and so we really have to think carefully about how these vaccines are deployed, utilized and so on. I try and bring that reality to the group,” he said.
Temte delivered a blunt answer when asked about the effectiveness of any potential COVID-19 vaccines.
“Right now, we have not a clue as to how effective the vaccines are going to be, or how long that effectiveness will continue,” Temte said. The only way to determine long-term effectiveness, he added, will be to have patients vaccinated and observe the effects over time.
Temte noted that immunity to other coronaviruses tends to be transient, and reinfection from seasonal coronavirus occurs repeatedly over one’s lifetime. “The concern is that even with a safe and effective vaccine, we might be looking at a safe, effective vaccine that needs boosting on an annual or biannual basis, but we don’t know that yet,” he said.
Brim and Temte were asked about how the distrust some communities have toward the health care system could affect vaccine research.
“Not only is there historical distrust, but there’s a lot of political distrust right now,” Brim said. “This whole vaccine process has become very political.”
Brim added that many people do not understand how clinical trials work, which has not only contributed to distrust but also makes it critical that health care professionals establish trusting relationships with their patients.
“Talk to them in ways that resonate about the importance of vaccination, whether that’s for COVID-19 or any of the other conditions that we have great vaccines for,” Brim said.
Temte acknowledged that systemic and institutional racism may have discouraged some groups from participating in vaccine research.
“There is a huge amount of health inequity among both the Black and Latinx communities in the United States,” Temte said. “When you have communities that have traditionally faced racism and had traditionally had lower trust in the medical establishment, it’s really a challenge right now to bring this to the forefront.”
Temte emphasized that FPs should be frank with their patients about a COVID-19 vaccine and listen to their concerns. He also suggested that FPs get the vaccine themselves once it becomes available.
“I think our role is to set the example of being willing to receive the vaccine, being willing to tell our patients that we received the vaccine and, when the time comes, being willing to provide honest information to our patients on the vaccine, whether or not there are side effects,” Temte said. “Being very open and appropriate about that is our central role.”
Brim also said it will be important to educate patients on what health care professionals don’t know about the vaccine.
And he noted that while a COVID-19 vaccine is not currently available, an influenza vaccine is. As such, Temte considers now the perfect time for FPs to ensure their patients are vaccinated against influenza.
“We don’t know when the first COVID vaccines are going to be rolling out, but we will not have any data on coadministration for safety or efficacy, and so the best approach is to make sure that we get everybody vaccinated for influenza right now,” said Temte. “This is a great time to think about how we can get as many people vaccinated (for influenza) in preparation for getting as many people vaccinated for the coronavirus.”
Until a COVID-19 vaccine is available, Temte delivered a strong reminder on the importance of taking other safety measures, such as wearing a mask and practicing social distancing.
“This virus doesn’t select people based on political affiliation, it doesn’t select people based on where they live,” Temte said. “This is all over. It has gone across our entire country incredibly rapidly, and it’s going to continue to spread, and we’re going to have to work very carefully together. And even when the vaccines come out, that’s not going to be the end of it.
“Until we have this fully under control, it’s really going to be important to keep in mind that masking, distancing, handwashing, staying at home while sick, testing, isolation and quarantine are all things that actually work, and they work incredibly well if we’re willing to use them,” he continued.
LeRoy, who transitions to Board chair this week, closed the Town Hall by thanking AAFP members for allowing him to represent them.
“It’s been a pleasure. It’s been an incredible honor serving as your president,” LeRoy said. He added that despite the challenges posed by the pandemic, “I couldn’t think of a more important and impactful time to represent the specialty of family medicine.”
LeRoy also reminded viewers that the Academy has several efforts underway to encourage patients to catch up and stay up to date on their immunizations, and to receive the influenza vaccine. He directed members to visit the Academy’s COVID-19 microsite and a new webpage devoted to COVID-19 vaccine development.