The trusted source for
healthcare information and
By Gary Evans, Medical Writer
While there is broad concern about the rapid pace and oversight of COVID-19 vaccine development, infection preventionists are ready to trust the time-honored protocols and process for safety and efficacy, says Connie Steed, MSN, RN, CIC, FAPIC, President of the Association of Professionals in Infection Control and Epidemiology (APIC).
“We need to trust that the medical system will follow the prescribed steps to ensure the safety and efficacy of the vaccine,” says Steed, director of infection prevention and control at Prisma Health in Greenville, SC. “I really can’t imagine our agencies — the Food and Drug Administration [FDA] and others — releasing a vaccine that isn’t safe.”
Peter Marks, MD, PhD, is director of the FDA Center for Biologics Evaluation and Research (CBER), which is responsible for ensuring the safety and effectiveness of vaccines and biological products. In a recent live stream interview, he expressed a personal stake in the safety issue.
“We will do what we need to do to get the appropriate safety data to make sure the deployment of any vaccine is safe,” Marks said. “Safety is what keeps me up at night.”
The review process for the COVID-19 vaccines in various trials will undergo the scrutiny of hundreds of FDA career officials working in such areas as biologics quality, biostatistics, epidemiology — undertaking a meticulous line-by-line review of submitted data, he said.
“We have the ability to do our own analysis and compare it to the company,” he says. “Perhaps there is a certain type of patient that the company included in the analysis that we don’t think should be included. We can leave those out and see if the end result is similar or different between the company’s and our own.”
The tone of Marks' comments and FDA guidelines suggest an emergency use authorization will be the first step for a vaccine rather than full licensure.
“We will look at the safety data sets that come in and we have made it clear that we want a median of two months of follow-up for any vaccine that [is submitted],” he said. “While it would be nice to have [longer], we have to balance the safety we get up front with the need to try to save lives with the vaccine. We have a virus that is killing some 1,000 people a day in the U.S. — so there is a balance there.”
The White House initially balked at this two-month follow-up period, continuing a pattern of political pressure to fast-track a vaccine which targets healthcare workers as priority one. However, the FDA held fast and the requirement remains in place in a recently issued vaccine guideline.
“We do have a crisis in in vaccine confidence now,” the FDA’s Marks said. “There are a lot of factors that have led to that, but our job at FDA is to do whatever we can through transparency and make it clear for one purpose only — to make sure we get a quality, safe and effective vaccine and people can see transparently that is what is happening here.”
A vaccine with 70% to 80% efficacy given to 70% to 80% of the population would give the country “a chance of having herd immunity,” he said. “But it is only going to happen if people have confidence enough to get vaccinated.”
For more on this story, see the next issue of Hospital Infection Control & Prevention.