Task of Tracking COVID-19 Vaccine Safety Falls to Multiple Federal Agencies

By | November 18, 2020

Monitoring Covid-19 vaccines for safety issues will fall to a group of U.S. health agencies that also will have a hand in their rollout, a potential hurdle in persuading skeptics to get the shots, say former government officials who helped control an outbreak a decade ago.

The Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Veterans Affairs and other health agencies all have separate systems to track side effects and safety in people who get the first shots. But there are concerns the groups advising the agencies on all aspects of a vaccine may face public skepticism over their safety assessments at a time when vaccine hesitancy is a major concern.

“The same advisory committee that told them to get it are telling them it’s OK,” said Daniel Salmon, the director of vaccine safety for the National Vaccine Program Office during the 2009 H1N1 swine flu outbreak. “What are the optics of that?”

There’s also worry that a lack of unified oversight could make it more difficult to document and quickly act on safety issues. Meanwhile, the stalled presidential transition could complicate efforts even further, said Jesse Goodman, who led the FDA office that handled vaccines during the 2009 H1N1 outbreak.

“I am really worried that if there’s instability in leadership, or too much distraction, that in January a Biden administration could face an even more difficult situation,” said Goodman, now head of Georgetown University’s Center on Medical Product Access, Safety and Stewardship. That could affect “both the way the pandemic is accelerating and –when we do have a safe and efficacious vaccine — getting people to use it.”

Vaccines have generally been safe, though some high-profile missteps have helped fuel skepticism. For example, in 1976, some people who received a swine flu vaccine developed Guillain-Barre Syndrome, a disease that can cause paralysis. The Covid-19 vaccines will have only two months of safety data on hand — the FDA-mandated minimum — when they seek emergency authorization.

That means longer-term problems with the shots may not be seen until millions of Americans have already been vaccinated. The U.S., meanwhile, will be depending on monitoring programs tied to a range of different agencies to respond quickly to reports of side effects or safety issues.

Electronic Records

Some of the programs have been around for a few decades, others are new. It will be vital moving forward to make sense of all the data available as the vaccines are given out, said Grace Lee, who sits on the Advisory Committee on Immunization Practices for the U.S. Centers for Disease Control and Prevention, and leads the panel’s Covid-19 vaccine safety subgroup.

“The benefit of many of these systems is that they’re attached to electronic health records where we can go evaluate whether they’re real or not,” said Lee, a professor of pediatrics focusing on infectious diseases at Stanford University School of Medicine.

The subgroup includes three panel members and several consultants, including epidemiologists and immunologists from top universities. It is “laser-focused only on the safety issues,” Lee said. Her plan: the subgroup will meet weekly to assess potential signals of concerns from all the different safety monitoring programs.

Side effects can include minor annoyances, such as skin irritation where the needle went in or muscle soreness.Those are typically seen early in clinical trials, and will likely be noted in company requests for emergency approval.

Regular Updates

Lee’s group will be getting regular updates from systems that track federal health programs and private insurance claims. There is also a website, the Vaccine Adverse Event Reporting System, available to the general public to report issues, and those getting the first shots will also use smartphone apps that will help groups like Lee’s to keep a close watch for potential red flags.

People have heart attacks every day, and some may have a heart attack the day after they get a Covid-19 vaccine. That doesn’t mean a vaccine causes heart attacks, but the heightened anxiety around the virus will require a swift investigation if a link looks possible, said Salmon, who now is director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health.

“If we don’t have the data quickly, it can derail the vaccine program.” Salmon said. “It has to be rigorous and it has to be credible.”

Unified Group

Georgetown’s Goodman agrees. In 2009, when he was working with the FDA, “we had a unified safety working group that cut across the whole government,” he said. That group “took all of these databases and looked at them together and had government communication around them.”

The Trump administration folded the National Vaccine Program that Salmon worked under into the Office of Infectious Disease Policy and HIV/AIDS. During H1N1, the program fell under the Office of the Assistant Secretary for Health that at the time was led by Howard Koh. Much of the leadership the program took during H1N1 on vaccine safety is now falling to the CDC’s Advisory Committee on Immunization Practices.

ACIP is made up of “outstanding experts,” Koh said, but it doesn’t advise the entire Department of Health and Human Services that the CDC falls under.

“What we were charged to do was coordinate all of HHS,” Koh said. “You have to do that, especially in a time like then and now, when a new vaccine is being distributed on an urgent basis to tens of millions of people.”

Lee is aware of the concerns. But she said she remains comfortable the CDC’s immunization panel, through her subgroup, can do the necessary analysis within a couple days when the time comes. Lee led the H1N1 monitoring program for the Vaccine Safety Datalink, one of the handful of programs the government used to keep an eye on potential harmful effects.

“That really imprinted on me because I was just amazed at what we as a country could do when we all came together,” she said.

Warp Speed

The Trump administration has an overall budget of $18 billion for a multi-agency, coordinated effort called Operation Warp Speed to help develop, manufacture and distribute Covid-19 vaccines as well as drugs to treat the virus. The project has made little public mention of monitoring vaccine safety post-authorization.

Operation Warp Speed is working with the CDC to synchronize the systems involved in safety monitoring, Natalie Baldassarre, a spokeswoman for the Department of Health and Human Services, said in an email.

“We are committed to delivering a safe and effective vaccine to all Americans, and monitoring safety data following vaccine administration is a key step in the process,” she wrote.

Top Photo: A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market.

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