From xxxxxx <[email protected]>
Subject Trump Administration Shut a Vaccine Safety Office Last Year. What's the Plan Now?
Date October 26, 2020 8:15 AM
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[The office was dedicated to the long-term safety of vaccines.
Experts say plans to track coronavirus vaccines are fragmented and
"behind the eight ball."] [[link removed]]

TRUMP ADMINISTRATION SHUT A VACCINE SAFETY OFFICE LAST YEAR. WHAT'S
THE PLAN NOW?  
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Carl Zimmer
October 23, 2020
New York Times
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_ The office was dedicated to the long-term safety of vaccines.
Experts say plans to track coronavirus vaccines are fragmented and
"behind the eight ball." _

President Trump and the Health and Human Services secretary, Alex M.
Azar II, who disbanded the National Vaccine Program Office last year.,
Al Drago for The New York Times

 

As the first coronavirus vaccines arrive in the coming year,
government researchers will face a monumental challenge: monitoring
the health of hundreds of millions of Americans to ensure the vaccines
don’t cause harm.

Purely by chance, thousands of vaccinated people will have heart
attacks, strokes and other illnesses shortly after the injections.
Sorting out whether the vaccines had anything to do with their
ailments will be a thorny problem, requiring a vast, coordinated
effort by state and federal agencies, hospitals, drug makers and
insurers to discern patterns in a flood of data. Findings will need to
be clearly communicated to a distrustful public swamped with
disinformation.

For now, Operation Warp Speed, created by the Trump administration to
spearhead development of coronavirus vaccines and treatments, is
focused on getting vaccines through clinical trials in record time and
manufacturing them quickly.

The next job will be to monitor the safety of vaccines once they’re
in widespread use. But the administration last year quietly disbanded
the office with the expertise for exactly this job, merging it into an
office focused on infectious diseases. Its elimination has left that
long-term safety effort for coronavirus vaccines fragmented among
federal agencies, with no central leadership, experts say.

“We’re behind the eight ball,” said Daniel Salmon, who served as
the director of vaccine safety in that office from 2007 to 2012,
overseeing coordination during the H1N1 flu pandemic in 2009. ”We
don’t even know who’s in charge.”

An H.H.S. spokesperson said that the vaccine office was not shuttered.
“The office was not ‘closed,’ but was merged with the Office of
Infectious Disease and HIV/AIDS Policy and was strengthened,” the
spokesperson said in a statement. “All the functions continue in
this new organizational structure.”

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

Scientists at the C.D.C. and the Food and Drug Administration have
decades of experience tracking the long-term safety of vaccines.
They’ve created powerful computer programs that can analyze large
databases.

“It’s like satellites looking at the weather,” said Dr. Bruce
Gellin, the president of the Sabin Vaccine Institute, who headed the
National Vaccine Program Office from 2002 to 2017.

But monitoring hundreds of millions of Americans who may get different
coronavirus vaccines from a variety of drug makers by summer is like
tracking a major storm beyond anything researchers have dealt with
before.

The closest parallel was in the spring of 2009, when a new strain of
H1N1 influenza emerged, and researchers raced to make a vaccine. From
October 2009 to January 2010, it was administered to over 82 million
people in the United States.

As the vaccine was developed, Dr. Gellin and other federal officials
and scientists organized a system to monitor the population for severe
side effects and to promptly share results with the public. Eleven
years later, it looks like the lessons of 2009 are being forgotten,
experts say.

“We got all these different agencies together, we created governance
around it, we created a regular monitoring plan, as well as a public
communication plan,” said Dr. Jesse Goodman, the F.D.A.’s chief
scientist during the H1N1 pandemic. “I think that something very
much like that is even more needed now. And, you know, we haven’t
yet seen that emerge.”

In the 1970s, the U.S. government set up large-scale programs to
monitor vaccine safety. There was a system
[[link removed]] for parents to report symptoms their
children experienced after getting a vaccine. It may get 50,000
reports from parents, doctors, hospitals and vaccine makers in a
typical year. But the tool has limits: People may not report symptoms
that should be investigated, or may see a connection to a vaccination
where none exists.

“People are vaccinated one day, and the next day they have some bad
medical event, and then they scratch their head and say, ‘Well, you
know, I was fine until this happened,’” Dr. Gellin said.

Dr. Bruce Gellin, who headed the the National Vaccine Program Office
for 15 years, appearing before the Senate in 2005. Chris
Greenberg/Getty Images

In 1990, the C.D.C. set up a new way to track vaccines that didn’t
depend on people coming forward. The agency worked with health care
organizations to get updates on people’s medical conditions. That
system now covers 12 million people. Researchers can use it to look
for clusters of symptoms that arise in people who get the same
vaccine.

When the H1N1 flu hit in 2009, Dr. Salmon recognized that these
methods didn’t track enough people to quickly pick up rare symptoms.
He reached out to researchers at Harvard to build a new system, which
came to be known as PRISM. Ten states supplied vaccination records,
and five health insurance companies shared anonymous information about
38 million members. PRISM then connected the two databases to track
insurance claims in the wake of vaccination. “That really gave us a
ton of data,” Dr. Salmon said.

The researchers could come up with a background rate of a host of
medical conditions. If the H1N1 vaccine was linked to cases that
matched the background rate, they could dismiss the symptoms as
ordinary. Only if they rose above the background rate would they be
considered unusual and warrant a closer look.

Scientists from various federal agencies gathered every two weeks to
share data and look for worrying clusters of symptoms. Every month,
outside experts reviewed the evidence and released public reports.
“Vaccine programs are contingent on trust,” Dr. Gellin said,
“and transparency is a huge element of that.”

The vast majority of reports turned out to have nothing to do with the
new vaccines. Just a handful of medical conditions required an
intensive review. The researchers noticed that some vaccinated people
developed a facial weakness called Bell’s palsy, for example, but
within two weeks they ruled out vaccines as the cause.

In the following years, as emerging viruses caused outbreaks of Ebola,
MERS and other diseases, experts called for more preparations for the
next pandemic. In 2016, President Barack Obama set up a global health
security office at the National Security Council. But in 2018, the
Trump administration disbanded that office, saying it was streamlining
bureaucratic bloat.

The next year, the National Vaccine Program Office met a similar fate.
Alex M. Azar II, the secretary of health and human services, said in a
letter to Senator Patty Murray, the ranking member of a health
subcommittee, that the merger, as part of a broader department
reorganization, would “increase operational efficiencies by
eliminating program redundancies and decreasing program costs.”

Read the Document
[[link removed]] The
Trump Administration last year shut down an office focused on the
long-term safety of vaccines.

The offices were merged “after a study by career staff who
recommended to the Assistant Secretary for Health that this was the
best way to improve the function of both offices by creating synergies
and eliminating stovepipes,” said Admiral Brett Giroir, assistant
secretary for health, in a brief statement. “I wholeheartedly
concurred with this recommendation because strengthening vaccine
effectiveness and confidence and ending the H.I.V. epidemic are two of
my most critical priorities. Anyone who is suggesting that we closed
this office has no clue what they’re talking about.”

But Dr. Nicole Lurie, who was assistant secretary for preparedness and
response at H.H.S. during the 2009 pandemic, said the loss of the
vaccine safety office was especially costly once the coronavirus
pandemic hit. “The coordinated leadership for stuff like this would
likely come from the National Vaccine Program Office,” she said.

Dr. Lurie, now an adviser at the Coalition for Epidemic Preparedness
Innovation, has been waiting along with other researchers, month after
month, for coordinated leadership to emerge from the federal
government on long-term vaccine safety. “There are a whole bunch of
people who were really concerned about this,” she said.

An F.D.A. official who declined to be identified said that in the
absence of the National Vaccine Program Office, F.D.A. and C.D.C.
staff members were relying on relationships they had built across the
agencies, meeting regularly to discuss their separate projects.

That leaderless effort concerns Dr. Lurie. “There’s no sort of
active coordination to bring all the information together,” she
said.

On Thursday, an expert from the C.D.C. and another from the F.D.A.
gave presentations about monitoring systems at a meeting of the
F.D.A.’s vaccine advisory committee. One system will use smartphone
apps to stay in touch with health and other essential workers after
their vaccinations. Another will look at a database of electronic
health records and insurance claims, and yet another will use Centers
for Medicare & Medicaid data to track people over 65.

Although each system may reveal important clues, they have limits that
worry outside experts. Dr. Steven Black, the co-director of the Global
Vaccine Data Network, observed that the Medicare system only registers
billing information, resulting in a time lag. “The patient has to
get into the hospital, leave the hospital and a bill needs to be
sent,” he said.

The other systems can provide safety information much faster, but
they’re small compared with the PRISM system, which now covers about
60 million people. The F.D.A. still uses PRISM for drug safety
research, but not for vaccines. Dr. Salmon is baffled that the agency
hasn’t tapped into it again. “Why would you not use that?” he
asked. (An agency spokeswoman said it might use PRISM in the future
should the need arise.)

The Hubert H. Humphrey building, which houses the Department of Health
and Human Services, reflected in a puddle. Stefani Reynolds for The
New York Times

The F.D.A. official said the agencies were still building lists of
symptoms they plan to track closely. The C.D.C.’s list includes
conditions like strokes and seizures. But it is also including
entirely new conditions the coronavirus causes, like Multisystem
Inflammatory Syndrome, which affects many organs at once.

The agencies are searching the scientific literature to estimate the
background rates of these outcomes. But Dr. Salmon warned that
lockdowns and other disruptions have made some conditions more common
and others less so. Comparing the health of vaccinated people with
that of people from before the pandemic may set off false alarms.

Dr. Salmon and other researchers are concerned that no overarching
plan for communicating findings to the public has emerged. The F.D.A.
official said the agency would post its updates on its website. A
C.D.C. committee will get safety data from the agencies and discuss
the results at public meetings.

But that may fall short of what’s needed to foster public
confidence. A poll
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earlier this month by Stat and The Harris Poll found that 58 percent
of Americans said they would get vaccinated as soon as a vaccine was
available, down from 69 percent in August.

The explosion of disinformation on social media will make clear
communication vital. “I think that preparing for Russian
disinformation campaigns should be part of preparing for the rollout
of a Covid vaccine,” said Steven Wilson, a political scientist at
Brandeis University.

Dr. Grace Lee, a professor at the Stanford University School of
Medicine and a member of the C.D.C. committee, agreed that such
preparations were urgent, but said they were beyond the committee’s
scope: “A national communication strategy and plan is much
needed.”

CARL ZIMMER writes the “Matter”
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thirteen books, including “She Has Her Mother's Laugh: The Powers,
Perversions, and Potential of Heredity.” @carlzimmer
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