With the first coronavirus vaccine coming next year, government researchers will face a major challenge: monitoring the health of millions of Americans to ensure that these vaccines do no harm.
By pure chance, thousands of vaccinated people will have heart attacks, strokes and other illnesses soon after the injection. Sorting out whether these vaccines have anything to do with their illnesses will be a thorn problem, requiring a huge, coordinated effort by state and federal agencies, hospitals, drug manufacturers and insurance companies to find patterns in the flood of data. The findings will need to be clearly communicated to unreliable people full of disinformation.
For now, Operation Operation Speed Speed, developed for the development of coronavirus vaccines and treatments by Tra Operation Administration, focuses on obtaining and producing vaccines through record clinical trials.
The next job will be to monitor the safety of vaccines once they are widely used. But the administration last year quietly waived office fees with mastery for this work. Its abolition leaves federal agencies with long-term safety efforts for coronavirus vaccines, experts say.
“We are eight balls behind,” said Daniel Salmon, who served as director of vaccine safety at Office Fees from 2007 to 2012, overseeing coordination during the 2009 H1N1 flu pandemic. ”
H.H.S. The spokesman declined to answer detailed questions about why the vaccine office, which was established in 1987, was closed or how health agencies were planning to find out the safety of vaccines when millions of people are being injected. In a brief statement, he said the pace of operations was linked to “synchronizing IT systems” with the Centers for Disease Control and Prevention to monitor vaccine safety data.
Scientists at the CDC and the Food and Drug Administration have decades of experience in long-term safety of vaccines. They have created powerful computer programs that can analyze large databases.
“It’s like weather-watching satellites,” said Dr. Sabin, president of the Vaccine Institute, who led the Office Fees of the National Vaccine Program from 2002 to 2017. Said Bruce Galen.
But observing that by the summer millions of Americans could get different coronavirus vaccines from different drug manufacturers is like tracking a storm bigger than anything researchers have done before.
The closest parallel was in the spring of 2009, when a new strain of H1N1 influenza emerged, and researchers rushed to develop a vaccine. October From October 2009 to January 2010, it operated more than 82 million people in the United States.
As the vaccine developed, Dr. Jelin and other federal officials and scientists set up a system to monitor the population for serious side effects and to share the immediate results with the public. Eleven years later, the 2009 lessons seem to have been forgotten, experts say.
“We’ve got all these different agencies together, we’ve got a regime around it, we’ve got a regular monitoring plan, as well as a public communications plan,” said Dr. Jesse Goodman, the FDA’s chief scientist during the H1N1 epidemic. There are also. “I think something like this is needed more now. And, you know, we haven’t seen it emerge yet. ”
In the 1970s, U.S. The government organized large-scale programs to monitor vaccine safety. There was a system for parents to report the symptoms their children experienced after being vaccinated. It can get 50,000 reports from parents, doctors, hospitals and vaccine manufacturers in a normal year. But the tool has limitations: people can’t report symptoms that should be investigated, or see connections with vaccinations where nothing is.
“People are vaccinated one day, and the next day they have a bad medical event, and then they scratch their heads and say, ‘Well, you know, I was fine until that happened.’
In 1990, the CDC introduced a new way of tracking vaccines that was not based on the people who came forward. The agency worked with health care organizations to get updates about people’s medical conditions. That system now covers 12 million people. Researchers can use it to detect clusters of symptoms that arise in people receiving the same vaccine.
When the H1N1 flu came in 2009, Dr. Salmon recognized that these methods did not track enough people to quickly select rare symptoms. He reached out to Harvard researchers to create a new system known as PRISM. Ten states provided vaccination records, and five health insurance companies shared anonymous information about 38 million members. PRISM then connected the two databases to find out the insurance claims following the vaccination. “It really gave us a ton of data,” Dr. Said Salmon.
Researchers may come up with a background rate of a number of medical conditions. If the H1N1 vaccine is associated with cases that match the background rate, they may rule out symptoms as normal. Only if they rise above the background rate will they be considered unusual and a close look guaranteed.
Scientists from various federal agencies met every two weeks to share data and find disturbing clusters of symptoms. Each month, outside experts reviewed the evidence and released public reports. “Vaccine programs are contingent on trust,” Dr. Ge. “And transparency is a huge element,” Jelly said.
Most reports have nothing to do with the new vaccine. Only a few medical conditions require intensive review. The researchers noted that some vaccinated people developed facial weakness called bell paralysis, for example, but within two weeks they rejected the vaccine as a cause.
In subsequent years, Ebola, MERS and other diseases caused by the e-virus spread, experts called for more preparations for the next epidemic. In 2016, President Barack Obama established the Office of Global Health Security at the National Security Council. But in 2018, the Trump administration said it was streamlining bureaucracy.
The following year, the National Vaccine Program Office Fees received a similar fate. Secretary of Health and Human Services Alex M. Azar II, in a letter to Senator Patti Murray, a ranking member of the Health Subcommittee, said the merger, as part of the restructuring of the expanded department, would “increase operational efficiency. Eliminate program redundancies and reduce program costs.”
Dr .. Nicole Lurie, J.H.H.S. In an assistant secretary for preparedness and response during the 2009 epidemic, he said the damage to the vaccine safety office was particularly costly due to the one-time coronavirus epidemic. “Integrated leadership for this type of content will probably come from the National Vaccine Program Office Fees.”
Dr. Lurie, now a consultant at the General Assembly Preparation Innovation for Allied, is waiting, along with other researchers, months later for coordinated leadership from the federal government on long-term vaccine safety. “There’s a whole bunch of people who were really concerned about this,” he said.
An FDA official, who declined to be identified, said that in the absence of a National Vaccine Program fee, members of the FDA and CDC staff, depending on the relationships formed between the agencies, met regularly to discuss their separate projects.
Those leaderless efforts Lury worries. “There is no active integration to bring all the information together,” he said.
On Thursday, an expert from the CDC and another FDA made presentations about monitoring systems at a meeting of the FDA’s vaccine advisory committee. A system will use smartphone apps to stay in touch with health and other essential workers after a vaccination. Another will look at a database of electronic health records and insurance claims, and another will use Medicare and Medicaid data centers to track more than 65 people.
Although each system can reveal important signals, they have limitations that concern outside experts. Co-director of the Global Vaccine Data Network, Dr. Steven Blake observed that the Medicare system only registers billing information, resulting in time delays. “The patient has to be admitted to the hospital, leave the hospital and send the bill,” he said.
Other systems can provide security information much faster, but it is smaller than the PRISM system, which now covers about 60 million people. The FDA still uses PRISM for drug safety research, but not for vaccines. Dr. Salmon is surprised that the agency has not re-taped it. “Why don’t you use it?” He asked. (A spokesman for the agency said it could use PRISM in the future if the need arises.)
The FDA official said agencies are still compiling a list of features that they plan to track closely. The CDC’s list includes situations such as stroke and seizures. But it also involves completely new conditions for coronavirus causes such as multisystem inflammatory syndrome, which affects many organs at once.
Agency agencies are searching the scientific literature to estimate the background rate of these results. But Dr Salmon warned that downtown and other disruptions had normalized some conditions and made others less so. Comparing the health of vaccinated people with those before the epidemic can turn off false alarms.
Dr. Sal. Salmon and other researchers are concerned that no significant plan has been devised to make the findings public. The agency will post its updates on its website, an FDA official said. The CDC committee will obtain the safety data of the agencies and discuss the result in public meetings.
But it can be less than what is needed to boost people’s confidence. A poll conducted by the State and Harris Poll earlier this month found that 58 per cent of Americans said they would be vaccinated as soon as they were vaccinated, down from 69 per cent in August.
Clear communication will become important with the explosion of scattering on social media. “I think the preparation for the Russian dissolution campaign should be part of the preparation for the rollout of the covid vaccine,” said Steven Wilson, a political scientist at Brandes University.
Dr. Stanford University School of Medicine Professor of Medicine and a member of the CDC Committee. Grace Lee agreed that such preparations are urgent, but said they are beyond the scope of the committee: “National communications strategy and planning are very much needed.”
