Data and Safety Monitoring Board: Safeguards Behind COVID-19 Vaccines

key takeaways

  • A COVID-19 vaccine is undergoing expert scrutiny during development and before being authorized by the Food and Drug Administration.
  • At least two vaccine trials were paused and then restarted while experts reviewed side effects that occurred in patients to determine whether they indicated a problem with the vaccine.
  • The Black Physician Association and several state governors established their own independent vaccine review committees to review available data on the safety and efficacy of authorized COVID-19 vaccines.

In a short period of time, a lot has happened with the COVID-19 vaccine. Nine months after the pandemic began, Pfizer, BioNTech and Moderna’s vaccine candidates each received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Soon after, Johnson & Johnson’s vaccine received an EUA from the FDA. AstraZeneca, which also released some of the vaccine efficacy data, is preparing to apply for emergency use authorization from the FDA.

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While the developments are exciting, they are also scary for some. A VigorTip survey released in February 2021 found that 51% of Americans said they do not plan or are unsure about getting a COVID-19 vaccine. Among this group, concerns about side effects and concerns about efficacy were the most frequently cited reasons for not wanting to get vaccinated.

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One message that should allay public concerns, public health experts say, is that a vaccine accepted by the FDA for review for emergency use authorization could not have made so much progress without the oversight of a panel of scientists independent of the developing manufacturer. vaccine and government officials who will approve it. The scientists are appointed to the Data and Safety Monitoring Board (DSMB), which reviews clinical trials of drugs and vaccines.

“DSMB oversees emerging data to protect research subject safety and data integrity [clinical] Elliott Antman, MD, a senior physician specializing in cardiovascular medicine at Brigham and Women’s Hospital in Boston, Massachusetts, told VigorTip. “The members of the DSMB recommended whether the trial should continue as planned, whether it should be stopped because overwhelming evidence of benefit and harm has been seen, or whether investigators should modify the trial in some way.”

According to guidelines from the National Institute of Allergy and Infectious Diseases (NIAID) — the arm of the National Institutes of Health (NIH) that oversees the development of several COVID-19 vaccine candidates — an intervention could potentially affect participants Trials that pose a risk must have a DSMB.

What is DSMB?

NIAID defines the Data Safety Monitoring Board (DSMB) as “an independent committee responsible for reviewing interim safety and efficacy data and making recommendations regarding continuation, modification, or termination of the study.”

DSMB has been around for decades to review new drugs and vaccines, Matthew Wynia, MD, MPH, director of the Center for Bioethics and Humanities at the University of Colorado Anschutz Medical Campus, told VigorTip. “Protocols have been established to ensure the safety and efficacy of studies and the safety of clinical trial participants,” he said.

DSMB and COVID-19 vaccine candidates

AstraZeneca and Johnson & Johnson, the two companies working on a COVID-19 vaccine, suspended clinical trials after two patients, one participant in each trial, experienced serious side effects, on the advice of their DSMB. Two trials have now resumed, based on the monitoring committee’s determination of adverse events that did not indicate problems with the vaccine’s efficacy or safety. In AstraZeneca’s case, one participant developed an inflammatory response that may not be related to the vaccine. Johnson & Johnson did not disclose specific adverse events.

Both the Moderna and AstraZeneca vaccines are among several being developed with NIH funding. A single DSMB brings together all NIH-funded COVID-19 vaccines, and its chair is chosen by NIAID Director Anthony Fauci. The names of DSMB members have been kept secret, with the exception of the chairman (whose role was published online by his university, which was then removed). Secrecy of names helps protect DSMB members from corporate or government pressure.

Instead of getting funding for vaccine development from the U.S. government, Pfizer built its own DSMB. “The Data Monitoring Committee (DMC) consists of a chair and four additional members. We do not release the names of the DMC members,” Jessica Pitts, director of global media relations at Pfizer, told VigorTip by email. “Four members are highly regarded current or former professors of medicine with extensive experience in pediatric and adult infectious diseases and vaccine safety. One member is a respected statistician with extensive experience in vaccine trials. ”

DSMB reports to date

Moderna: On November 16, 2020, NIAID issued a press release regarding DSMB evaluating Moderna’s Phase 3 vaccine trial. “An interim review of data indicates that the vaccine is safe and effective in preventing symptomatic COVID-19 in adults,” the release said. “DSMB reports that the vaccine candidate is safe and well-tolerated, with a vaccine efficacy rate of 94.5 %.”

Pfizer and BioNTech: On November 18, 2020, a Pfizer press release stated that “to date, the data monitoring committee of this study has not reported any serious safety concerns related to the vaccine,” which is 95% effective.

What’s next?

Once the DSMB has completed its review, the FDA will assume responsibility for reviewing, evaluating, and determining whether the vaccine is safe and effective.

The FDA Advisory Committee met on December 17, 2020 to discuss the Moderna vaccine EUA and the Pfizer-BioNTech vaccine EUA on December 10. Both sessions are open to the public and broadcast on YouTube.

FDA does not have to accept the advisory committee’s recommendation, but it usually does. More specific safety and efficacy data reviewed by the DSMB will be made public at the advisory committee hearing.

The FDA issued an EUA for the Pfizer-BioNTech vaccine on December 11, 2020, the Moderna vaccine on December 18, 2020, and the Johnson & Johnson vaccine on February 27, 2021.

On August 23, 2021, the FDA fully approved the Pfizer-BioNTech COVID-19 vaccine for use in individuals 16 years of age and older.The vaccine will be sold under the name communicationis the first FDA-approved COVID-19 vaccine.

Pfizer’s COVID-19 vaccine is also the first approved for emergency use in children and adolescents ages 5 to 15.

On January 31, 2022, Moderna’s vaccine received full FDA approval.The vaccine will serve as Spike Wax, Authorized to adults 18 years of age and older.

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Typically, medical groups and state and local governments accept FDA decisions about vaccine effectiveness and safety, but the pandemic is an unusual time. Some health and government leaders are adding additional comments to help ease the public’s fears. The National Medical Association, which represents black doctors, announced that it had appointed an independent task force to review any drug or vaccine approved under an emergency use authorization.

On December 22, 2020, the National Medical Association’s COVID-19 Task Force issued a statement supporting the FDA’s EUA for the Pfizer-BioNTech and Moderna vaccines. The task force announced that it had reviewed clinical trial data and found consistent efficacy and safety and a sufficient number and percentage of black participants to be confident in health outcomes.

The governors of California and New York announced that they are organizing independent review panels for any COVID-19 vaccine authorized or approved by the FDA.

The New York task force unanimously endorsed the Pfizer-BioNTech vaccine on Dec. 10 and the Moderna vaccine on Dec. 18.

Washington, Nevada, and Oregon joined California in forming the Western States Scientific Safety Review Task Force, which announced support for the Pfizer-BioNTech vaccine on December 13, 2020 and Moderna’s vaccine on December 20, 2020 its comments.

The information in this article is current as of the date listed, which means that you may have updated information as you read this article. For the latest updates on COVID-19, visit our Coronavirus news page.