The Trump administration closed its vaccine safety office last year. What are your plans now?

When the first coronavirus vaccine arrives next year, government researchers will face the major challenge of monitoring the health of hundreds of millions of Americans to make sure the vaccine is harmless.

Coincidentally, thousands of vaccinated people will have a heart attack, stroke, or other illness immediately after the injection. Categorizing whether vaccines are associated with their illness is a daunting task and is extensively coordinated by state and federal agencies, hospitals, pharmaceutical and insurance companies to identify flood patterns of data. It requires a lot of effort. The findings need to be clearly communicated to the disinformation-filled and distrustful public.

For now, Operation Warp Speed, created by the Trump administration to lead the development of coronavirus vaccines and treatments, has decided to obtain vaccines through clinical trials at record speeds and to manufacture them quickly. I’m focusing.

The next task is to monitor the safety of the vaccine once it has been widely used. But last year, the administration quietly disbanded the office with the expertise of this very job and integrated it into an infectious disease-focused office. Experts say the elimination has fragmented the long-term safety efforts of the coronavirus vaccine among federal agencies, eliminating central leadership.

“We are behind eight balls,” said Daniel Salmon, director of vaccine safety at the office from 2007 to 2012. Oversaw coordination during the 2009 H1N1 influenza pandemic. .. “

An HHS spokesman said the vaccine office was not closed. “The office was not’closed’, but was integrated and strengthened with the Infectious Diseases and HIV / AIDS Policy Department,” a spokeswoman said in a statement. “All functionality will continue in this new organizational structure.”

In a brief statement, another spokesperson said Operation Warp Speed ​​is working closely with the US Centers for Disease Control and Prevention to “synchronize IT systems” involved in monitoring vaccine safety data. Said.

CDC and Food and Drug Administration scientists have decades of experience tracking the long-term safety of vaccines. They have created a powerful computer program that can analyze large databases.

“It’s like a satellite watching the weather,” said Dr. Bruce Gellin, director of the Sabin Vaccine Institute, which headed the National Vaccine Program Office from 2002 to 2017.

But monitoring hundreds of millions of Americans who could get different coronavirus vaccines from different pharmaceutical companies by the summer is like tracking a storm that researchers have never dealt with. Thing.

The closest is in the spring of 2009, when a new strain of H1N1 flu emerged and researchers competed to make a vaccine. From October 2009 to January 2010, it was administered to more than 82 million people in the United States.

As the vaccine was developed, Dr. Gellin and other federal authorities and scientists organized a system to monitor the population for serious side effects and quickly share the results with the general public. Eleven years later, experts say the lessons of 2009 seem to be forgotten.

“We have brought together all of these different institutions, created governance around them, and created regular surveillance and public communication plans,” said Dr. Jesse Goodman, FDA’s lead scientist during the H1N1 pandemic. Said. “I think we need more of that now, and as you know, we haven’t seen it appear yet.”

In the 1970s, the US government launched a large program to monitor vaccine safety.was system To report the symptoms that parents experienced in their children after vaccination. Generally, there can be 50,000 reports from parents, doctors, hospitals and vaccine manufacturers in a year. However, there are limits to the tools. People may not report any symptoms to investigate, or they may see an association with vaccination in the absence of anything.

“One day people were vaccinated, and the next day some bad medical event happened, scratching their heads and saying,’Well, I was fine until this happened,'” said Dr. Gerin.

In 1990, the CDC set up a new way to track positive people-independent vaccines. The agency worked with medical institutions to get the latest information on people’s medical conditions. The system currently covers 12 million people. Researchers can use it to look for clusters of symptoms that occur in people who have been vaccinated with the same vaccine.

When the H1N1 flu epidemic occurred in 2009, Dr. Salmon realized that these methods could not track enough people to quickly detect rare symptoms. He contacted Harvard researchers to build a new system that became known as PRISM. Ten states provided vaccination records and five health insurance companies shared anonymous information about approximately 38 million members. PRISM then connected the two databases to track post-vaccination claims. “It really gave us a lot of data,” said Dr. Salmon.

Researchers have been able to come up with background rates for many medical conditions. If the H1N1 vaccine is associated with cases that match the background rate, they can dismiss the symptoms as usual. Only if they exceed the background rate are they considered anomalous and should be scrutinized.

Scientists from various federal agencies met every two weeks to share data and look for clusters of worried symptoms. Each month, outside experts reviewed the evidence and published a public report. “Vaccine programs are subject to trust, and transparency is a big factor,” said Dr. Gellin.

Most of the reports turned out to have nothing to do with the new vaccine. Only a handful of medical conditions required an intensive review. Researchers, for example, found that some vaccinated people developed a facial weakness called Bell’s palsy, but within two weeks they excluded it because of the vaccine.

The following year, a new virus caused the outbreak of Ebola, MERS, and other illnesses, and experts called for further preparation for the next pandemic. In 2016, President Barack Obama established the Global Health Security Office at the National Security Council. However, in 2018, the Trump administration disbanded its office, saying it was rationalizing bureaucratic expansion.

The following year, the National Vaccine Program Office followed a similar fate. Secretary of Health and Welfare Alex M. Hazard II said in a letter to Senator Patty Murray, a ranking member of the Health Subcommittee, that the merger would “work by abolishing” as part of a broader sector restructuring. Increase efficiency. ” Program redundancy and program cost reduction. “

Admiral Brett Guilloyle, Deputy Secretary of Health, advised the Assistant Secretary of Health that this is the best way to create synergies and improve the functioning of both stations by eliminating stovepipes. As a result of the investigation by the two offices, the two offices have been integrated. ” With a simple statement. “I sincerely agreed with this recommendation because strengthening vaccine efficacy and confidence and ending the HIV epidemic are two of my most important priorities. Anyone who suggests a closure has no idea what they are talking about. “

However, Dr. Nicole Lurie, assistant secretary for preparation and response at HHS during the 2009 pandemic, said the loss of the Vaccine Safety Agency would be particularly costly in the event of a coronavirus pandemic. “Coordinated leadership for something like this will probably come from the National Vaccine Program Office,” she said.

Dr. Lurie, now an adviser to the Coalition for Infectious Disease Control Innovation, waits with other researchers every month for federal-coordinated leadership on long-term vaccine safety. “Many people are really worried about this,” she said.

FDA officials who refused to identify are dependent on the relationships they have built between institutions because there is no National Vaccine Program Office, and FDA and CDC staff meet regularly to discuss separate projects. I said there is.

Its leaderless efforts relate to Dr. Lurie. “There is no positive coordination to put all the information together,” she said.

On Thursday, a CDC expert and another FDA expert gave a presentation on the monitoring system at a meeting of the FDA’s Vaccine Advisory Board. One system uses a smartphone app to stay in touch with post-vaccination health and other important workers. Another looks at electronic health records and claims databases, and yet another uses the Medicare & Medicaid data center to track people over the age of 65.

Each system may reveal important clues, but it has the limits of worrying about outside experts. Dr. Steven Black, co-director of the Global Vaccine Data Network, observed that the Medicare system only registers billing information, resulting in a time lag. “Patients need to be hospitalized, discharged, and billed,” he said.

Other systems can provide safety information much faster, but are smaller than the PRISM system, which currently covers about 60 million people. The FDA still uses PRISM for drug safety research, but not for vaccines. Dr. Salmon is confused that the agency is not using it again. “Why don’t you use it?” He asked. (A spokeswoman for the agency said he may use PRISM in the future if the need arises.)

FDA officials said authorities are still preparing a list of symptoms to be closely tracked. The CDC list includes conditions such as strokes and seizures. However, it also contains a whole new condition caused by the coronavirus. For example, multi-organ inflammatory syndrome, which affects many organs at once.

The institution is searching the scientific literature to estimate the background rate of these results. However, Dr. Salmon warned that blockades and other turmoil have made some conditions more common and others less common. Comparing the health status of vaccinated people with the health status of pre-pandemic people can lead to false alarms.

Dr. Salmon and other researchers are concerned that there is no comprehensive plan to disseminate the findings to the public. FDA officials said the FDA would post the update on its website. The CDC Committee will obtain safety data from the agency and discuss the results at a public meeting.

But that may not be what it takes to foster public trust. A Voting According to Stat and Harris Poll earlier this month, 58% of Americans said they would be vaccinated as soon as the vaccine became available, down from 69% in August.

The explosion of disinformation on social media will require clear communication. “I think the preparation for the Russian disinformation campaign should be part of the preparation for the deployment of the Covid vaccine,” said Stephen Wilson, a political scientist at Brandeis University.

Dr. Grace Lee, a professor at Stanford University School of Medicine and a member of the CDC Commission, agreed that such preparations were urgent, but said they were beyond the scope of the Commission. “There is a great need for national communication strategies and plans.”