U.S. Vaccine Safety System Still Has Gaps


By JoNel Aleccia, Kaiser Well being Information

Monday, Might 03, 2021 (Kaiser Information) — The fast detection of an ultra-rare blood clotting response in some covid-19 vaccine recipients confirmed the facility of a federal warning system for vaccine issues of safety, however consultants fear that blind spots in this system may hamper detection of different sudden unintended effects.

Earlier than the pandemic started, the Meals and Drug Administration had scaled again a program it used efficiently to trace antagonistic occasions throughout and after the 2009 H1N1 influenza pandemic, and the company continues to be ramping up its alternative, stated Dr. Robert Chen, scientific director of the Brighton Collaboration, a nonprofit international vaccine security community.

“It’s purely unhealthy luck they had been in between techniques when covid hit,” stated Chen, who helped create the prevailing U.S. vaccine security techniques throughout almost 30 years on the Facilities for Illness Management and Prevention.

FDA officers acknowledged that some knowledge evaluation gained’t begin for weeks or months, however stated the federal government is expecting vaccine reactions with “state-of-the-art” techniques.

“FDA and CDC have sturdy security and effectiveness surveillance techniques in place to watch COVID-19 vaccines licensed for emergency use within the U.S.,” Abby Capobianco, an FDA spokesperson, wrote in an electronic mail.

No query, the nation’s vaccine surveillance system carried out as anticipated this spring when it recognized uncommon circumstances of blood clots mixed with low platelet counts in 15 individuals who had obtained Johnson & Johnson’s one-shot covid vaccine, stated Dr. Jesse Goodman, a former chief scientist with the FDA. Three individuals died.

“The excellent news for a really uncommon occasion is it should pop up on VAERS,” Goodman stated on a name with reporters, referring to the Vaccine Antagonistic Occasion Reporting System collectively run by the FDA and CDC since 1990.

However different probably harmful, unanticipated reactions to vaccines might not be so apparent in VAERS, a system that’s believed to overlook many potential unintended effects — or within the nation’s extra monitoring techniques, together with the Vaccine Security Datalink and the CDC’s new phone-based monitoring program, v-safe.


“It’s fairly a hodgepodge of various techniques of accumulating knowledge,” stated Dr. Katherine Yih, a biologist and epidemiologist who focuses on vaccine surveillance at Harvard Pilgrim Well being Care. “It’s value stating that it’s inferior to it might be.”

The Vaccine Security Datalink, although extremely regarded, didn’t embody sufficient vaccinations inside its knowledge from 9 hospital techniques protecting 12 million individuals to catch the J&J problem, CDC officers stated. And enrollment in v-safe has been lower than anticipated, with about 6 million individuals enrolled by the tip of March, simply 6.4% of those that had been vaccinated at that time.

That implies that, at a time when about 100 million People have been totally vaccinated in opposition to covid, the U.S. continues to depend on a patchwork community of vaccine monitoring techniques that will fail to watch a big sufficient swath of the inhabitants, consultants advised KHN.

“I’m very involved about this,” stated Goodman, who additionally led the FDA’s Heart for Biologics Analysis and Analysis, or CBER, and is now a professor of infectious illnesses at Georgetown College. “I feel we must be seeing that reporting on all of those vaccines. It was promised 4 months in the past that it was occurring.”

The three vaccines in use within the U.S. — produced by Pfizer, Moderna and Johnson & Johnson — had been proven to be secure and efficient throughout clinical trials of tens of hundreds of volunteers.

However even the very best trials aren’t giant sufficient to seize all issues, particularly uncommon ones, in the event that they happen solely in sure teams or exterior a particular timeframe. It’s vital to trace unintended effects as soon as vaccines are distributed all through the inhabitants — an effort referred to as pharmacovigilance — to make sure not solely security, but additionally public confidence.

Vaccine security consultants stated they had been involved that the FDA scaled again a system referred to as the Publish-Licensure Speedy Immunization Security Monitoring community, or PRISM, lengthy thought to be a workhorse of surveillance.

“Previous to PRISM, I felt like we had been form of at nighttime ages,” Steve Anderson, director of the FDA’s Workplace of Biostatistics and Epidemiology, stated at a 2016 workshop. “When PRISM got here alongside, for us it was actually a recreation changer.”


PRISM linked 4 giant well being plans in several elements of the nation with eight state immunization registries. In the course of the H1N1 pandemic, it detected indicators for 3 antagonistic occasions presumably linked to the vaccines and was used to rule out the 2 that weren’t associated and the one, Guillain-Barré syndrome, that was.

The system included information from almost 40 million individuals, stated Daniel Salmon, former director of vaccine security on the Nationwide Vaccine Program Workplace. Having a big quantity of information of vaccinated individuals “actually drives your skill to determine what’s occurring,” he stated.

PRISM, which was repurposed for drug security, now accommodates knowledge from about 60 million individuals, nevertheless it has not been used to trace vaccine reactions in the course of the covid pandemic, stated Salmon, who oversaw security monitoring for the H1N1 vaccine.

“With PRISM, we examined it in a disaster and it operated for a decade,” he stated. “I used to be actually stunned when it wasn’t used for covid. That was why we constructed it.”

A more recent system, referred to as the Biologics Effectiveness and Security System, or BEST, was began in 2017, however solely just lately started monitoring knowledge weekly for 15 pre-specified antagonistic occasions amongst Medicare recipients. It is going to be expanded to incorporate business databases beginning by the tip of June, based on Capobianco, the FDA spokesperson.

A seek for doable circumstances of the uncommon situation linked to the J&J vaccine started in mid-April and might be expanded within the subsequent few weeks, she added.

FDA officers stated PRISM’s capabilities have been integrated into BEST, which may look at knowledge from 100 million individuals. Specialists advised KHN that it has not been used extensively to watch post-vaccination results, however Capobianco stated: “We disagree.”

“BEST is constructed as a state-of-the-art lively surveillance system,” she wrote.

The priority is that officers have leaned closely on VAERS, a “passive” system that depends on experiences from sufferers and well being care suppliers to flag points after vaccination that will or might not be associated to the photographs. A sturdy “lively” surveillance system can search giant volumes of affected person care information to match charges of antagonistic occasions in individuals who obtained vaccines with those that didn’t.


As well as, some vaccine security consultants level to an absence of clear authority within the space. The Trump administration shut down the NVPO, a federal workplace with experience in monitoring vaccine security, merging it right into a authorities company centered on infectious illnesses.

Consequently, monitoring of covid vaccine security is fragmented amongst federal businesses, stated Salmon, who now directs the Institute for Vaccine Security on the Johns Hopkins Bloomberg College of Public Well being.

“There is no such thing as a single particular person in cost,” he stated. “You might want to have any person in cost.”

Biden administration officers have praised the nation’s vaccine monitoring system, declaring that it flagged the Johnson & Johnson issues inside weeks of the vaccine’s rollout. Federal officers paused distribution to evaluate extra circumstances and subsequent steps. (They had been helped by the truth that European regulators had discovered comparable issues in one other vaccine.)

“VAERS carried out precisely as meant on this case,” stated Dr. Tom Shimabukuro, head of the CDC’s COVID-19 Vaccine Process Drive.

That’s true, stated Dr. Steven Black, co-director of the World Vaccine Information Community. Nonetheless, he famous, there’s room for enchancment, significantly extra funding and higher collaboration.

“It is a safeguard for our inhabitants,” Black stated. “Whether or not it’s for the flu vaccines or the covid vaccines, it’s worthwhile to have a viable and robust system. Simply because we expect they’re secure doesn’t imply you don’t want techniques in place to again up that opinion.”

WebMD Information from Kaiser Well being Information

©2013-2020 Henry J. Kaiser Household Basis. All rights reserved.

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