By Anne Blythe
To trust or not to trust a COVID-19 vaccine.
That is a question many are weighing amid the political rhetoric and shifting timelines on when a vaccine could be ready and widely distributed.
It can be mind-boggling to keep up with the latest on vaccine development and frustrating to sort through differing declarations and determine their accuracy amid a heated campaign in the middle of a pandemic that, according to public health officials, is nowhere near petering out.
Now North Carolina public health advocates and scientists in federal agencies are working to increase confidence in whatever vaccine gets rolled out first.
Initially, President Donald Trump said a vaccine might be available before Election Day even though scientists, researchers in government agencies and his own advisers disputed such a timeline. Then on Oct. 7, in a video posted to his Twitter account, Trump acknowledged that a vaccine was more likely after the election.
Whatever the timeline, North Carolina and other states have been mapping out plans for who would be first up for inoculation if a safe and effective one becomes available and how it would be distributed.
Who’s on first?
“Health care providers at high risk for exposure and who are vital to the initial COVID vaccine administration efforts and staff in long term care will be prioritized first,” the DHHS plan states.
The next group would include residents in nursing homes and long-term care facilities, people over 65 and staff working in congregate living settings such as migrant farm camps, prisons and jails, and shelters for the homeless.
The numbers and the research point to the fact that many of these workers carry COVID from their communities to the places where they work, even as they don’t show symptoms.
Anyone with two or more chronic conditions that have been identified by the CDC will be high on the list as well as communities of color and other historically marginalized populations.
The plan was developed with the assistance of a COVID-19 Vaccine Advisory Committee that was convened by the North Carolina Institute of Medicine outside of the department.
“The committee was composed of a broad range of leaders, including from those populations most significantly affected by COVID-19, including racial and ethnicity groups, health care, public health and academia, who worked diligently over the past month in order to fully address equity, inequalities and health issues that are driving the pandemic and creating mistrust,” Michelle Ries, interim director of the North Carolina Institute of Medicine, said in a statement issued Oct. 16, when the draft plan was presented to the public.
Building trust amid rhetoric
With all the pandemic-related rhetoric in a presidential election year that has generated an energetic get out the vote campaign, health care advocates are mounting campaigns of their own: Building public trust in a vaccine not yet available.
“Vaccine hesitancy is expected to be high, especially among historically marginalized people who are highly represented in prioritized populations, so public communication efforts will focus on building a foundation of trust,” the DHHS plan states.
There has been a lingering mistrust of institutional medicine among Black people for decades. In North Carolina, they often cite a state-sanctioned eugenics program, which sterilized nearly 7,600 men and women from 1929 to 1974, and the Tuskegee Syphilis Study in which adequate treatment for the sexually transmitted disease was withheld from a group of infected poor Black men.
A recently released poll from the Kaiser Family Foundation and The Undefeated, an ESPN website that covers how race, sports and culture intersect, found that nearly “half of Black adults say they would not want to get a coronavirus vaccine if it was deemed safe by scientists and freely available, with safety concerns and distrust cited as the top reasons.”
Charlene Green, president of Old North State Medical Society, founded in 1887 to further the interests of Black physicians, said it will be important to include established leaders from communities of color involved with the distribution plan.
“Since early 2020, Old North State Medical Society testing team has been focusing on efficient and effective ways of testing the vulnerable population for this aggressive and lethal COVID-19 virus, as well as promoting culturally sensitive education and messaging,” Green said in a statement. “Trust is the key to success.”
The National Medical Association, a 125-year-old organization representing some 50,000 African American physicians and their patients, announced in September it had formed a COVID-19 Task Force to “take the politics out of vaccine development.”
Leon McDougle, association president, wrote in a Sept. 21 statement raising questions about numerous steps the FDA has taken during the pandemic, that the task force “will be positioned to provide timely recommendations to physicians and the community about future emergency use authorizations by the FDA for COVID-19 vaccines.”
How FDA authorization should work
What happens after a vaccine company submits a request for emergency-use authorization has been the subject of several recent Duke University webinars with former FDA commissioners and FDA career scientists contributing to the panels.
With all the back and forth about the rush to develop a COVID-19 vaccine, federal agencies with far more career scientists than political appointees, drug companies and the independent panels that review their work will have to open the windows wide on their decision-making processes in the coming weeks and months, the panelists have said.
“I think some people understandably have some nervousness about the speed of vaccine development for COVID being about cutting corners, which it’s not,” said Mark McClellan, a Duke University professor and former Food and Drug Administration commissioner.
Recently, McClellan laid out the process through which a COVID-19 vaccine could gain emergency use authorization from the FDA, noting the many checks and balances that should happen if science, not politics, drives the decision-making.
“Where the emergency use authorization comes in is it gives the FDA an ability to be flexible,” McClellan said. “Not just to approve a product or not, and potentially make it available to everyone, but to approve a product when they have enough evidence on safety and effectiveness to conclude it’s OK to use it for a select group of people who are at very, relatively high risk and who could benefit the most from a new vaccine.”
There are data safety monitoring boards and there also should be an FDA process that includes public meetings with independent advisers on the vaccines, McClellan said. The FDA would present its views on what the organization makes of the data and a decision would follow.
“Before there’s any actual use, the Centers for Disease Control and its advisory committee on immunization practices would also provide guidance on how and whom the vaccine should be used based on the FDA’s regulatory decision,” McClellan said. “First, we’re going to have to see a safe and effective vaccine based on data of tens of thousands of patients, both safety data for at least a few months.”
‘Cacophony’ and ‘blah, blah, blah vaccine’
Most of the serious events associated with the vaccine generally occur within the first six weeks, McClellan added, stressing the importance of having as much safety follow-up data as possible.
There was a kerfuffle between the White House and FDA in late September and early October about the agency’s plan to post new guidelines making clear that vaccine developers must monitor half the clinical trial participants for at least two months before seeking emergency use authorization.
Such a timeline made it highly unlikely even before some of the recent trial pauses that a vaccine would be available by Election Day, prompting a tweet from Trump: “Just another political hit job! @SteveFDA”
Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, participated in a Duke-Margolis Center for Health Policy webinar led by McClellan in early September where he stressed how important it would be to keep politics out of vaccine development.
During what was billed as a “fireside chat” about how the FDA would ensure vaccines are safe and effective, Marks, a career scientist at the FDA who is not a political appointee, pointed to scars on his forehead marking a childhood bout with chicken pox and measles, just two weeks apart, to illustrate the importance of people having confidence in vaccines.
“Vaccines are a victim of their own success,” Marks said. “For those who have never suffered through chicken pox and measles, … people don’t understand that people actually died from measles. They don’t understand that smallpox killed a lot of people and that polio maimed a lot of people. So the power of vaccines has been underappreciated.”
Now, the FDA has an opportunity, Marks said, to make people understand vaccines can make a tremendous difference — if the public has the confidence in them.
“From my perspective we need to be absolutely transparent,” Marks said. “We need to be as forthcoming with data as we possibly can be. From my perspective, short of trade-secret manufacturing information, we’re going to encourage the manufacturers to be absolutely transparent with data.
“It’s just absolutely critical that we put aside all of the noise that we’ve been hearing, there’s all sorts of cacophony about blah, blah, blah, vaccine, blah, blah, bad, blah, blah, blah,” Marks added. “That cacophony needs to go away. We need to understand that there are scientists here at FDA … these people are so committed that what comes through this process is safe enough for their own families and they want it to be safe for everyone’s family just like for their own.”
As a possible nod toward more transparency, Stephen Hahn, head of the FDA, announced on Twitter this week that the Vaccines and Related Biological Products Advisory Committee would air its Thursday meeting on YouTube and did.
“We expect a robust discussion about #COVID19 vaccine development. This committee is made up of scientific & public health experts, external to FDA, who have extensive expertise in infectious diseases, immunology, pediatrics, biostatistics, & more,” Hahn added. “We look forward to hearing from these external scientific and public health experts about their thoughts on the meeting topics. This discussion will add to our own expectations as laid out in our recent #COVID19 vaccine guidances.”