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COVID Vaccine Study Pauses For Safety Review

coronavirus vaccine

This story was updated Sept. 10, 2020 with details about the volunteer's condition.

Sept. 9, 2020 -- The late-stage clinical trials for AstraZeneca’s COVID-19 vaccine candidate have been paused to look into one patient’s illness.

The company is investigating whether a vaccine volunteer has an illness that is related to the shot and is a side effect, according to The Associated Press. A “standard review process has been triggered, leading to the voluntary pause of vaccination across all trials,” according to a statement from the company on Wednesday. An independent committee will review the safety data for the “single event of an unexplained illness” in a clinical trial in the UK, the company said.

According to STAT, the volunteer is a woman who has symptoms consistent with transverse myelitis. The rare spinal cord inflammation can lead to pain, sensory problems and leg weakness, among other symptoms. The website said the revelations came from AstraZeneca during a private call with shareholders.

The woman is in the hospital and expected to be released soon. The company has not publicly confirmed the details of the volunteer’s condition. 

AstraZeneca said it will follow the independent committee’s guidance in terms of restarting trials, and hopes to keep the trial timeline on track.

“At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” Pascal Soriot, CEO of AstraZeneca, said in the statement.

The company’s late-stage trials of the vaccine, called AZD1222, were started in the UK, Brazil and South Africa first. The U.S. trial started in late August at 62 sites across the country, according to ClinicalTrials.gov, with the goal of enrolling 30,000 participants. Some sites aren’t yet enrolling patients.

The vaccine is included in Operation Warp Speed, a partnership with the Department of Health and Human Services, the FDA and other federal agencies. Its goal is to deliver 300 million doses of a safe, effective vaccine by January 2021. Hopes are high for a vaccine to help end the global coronavirus pandemic, which has been going on for 9 months.

Temporary holds on medical studies aren’t unusual, the AP reported. Companies are mandated to investigate serious reactions or unexpected illnesses as part of safety requirements. Phase 3 trials are intended to catch any side effects that weren’t detected in earlier research phases due to the large number of patients enrolled.

The pause occurred on the same day that AstraZeneca and eight other biopharmaceutical companies pledged to “stand with science” in the COVID-19 vaccine development process. They issued the statement to address concerns that a vaccine could be approved before clinical trials show safety and efficacy.

“In large clinical trials, illnesses will happen by chance and must be independently reviewed,” according to the AstraZeneca statement. “We are committed to the safety of our participants and the highest standards of conduct in our trials.”

WebMD Health News Brief Reviewed by Brunilda Nazario, MD on September 09, 2020

Sources

Associated Press, “AstraZeneca COVID-19 vaccine study paused after one illness.”

AstraZeneca, “Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trial temporary pause.”

STAT, “AstraZeneca Covid-19 vaccine study put on hold due to suspected advere reaction in participant in the UK.”

ClinicalTrials.gov, “Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults.”

AstraZeneca, “Biopharma leaders unite to stand with science.”

National Institutes of Health: Transverse Myelitis Fact Sheet.

The Guardian: “Oxford Covid Vaccine Suspension Trial: what happens next?”

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