FDA gives AstraZeneca the thumbs-up to restart PhIII Covid-19 vaccine trials, and J&J is preparing to resume its study
Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.
The FDA gave AstraZeneca the go-ahead to continue the trial stateside after concluding that it would be safe to press ahead, according to a company statement sent to Endpoints News. The green light comes roughly a month-and-a-half after the study had been voluntarily stopped. Regulators had been investigating two cases of a possible neurological side effect in the experimental vaccine, but appear satisfied with their findings.
The news on the AstraZeneca trial was first reported by the Wall Street Journal. The FDA did not find the vaccine was responsible for the side effects, according to the Journal, but could not rule out a link, either. Later on Friday, J&J announced that the independent DSMB had recommended resuming trial recruitment and following discussions with the FDA, J&J is now preparing to proceed.
“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” AstraZeneca CEO Pascal Soriot said in their statement. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
Going forward, researchers and clinicians at AstraZeneca trial sites will be required to inform volunteers of the cases and look out for any potential neurological events, such as numbness.
AstraZeneca’s vaccine had been on pace to receive authorization for emergency use before the end of year prior to the trial’s halt in September. The company remains 3rd in Endpoints News’ Covid-19 vaccine race tracker, behind only Pfizer and Moderna. With the US trial able to get back up and running, AstraZeneca says it’s anticipating to have the results of the study later this year, depending on the rate of infection in the trial sites’ communities.
The two cases studied by the agency include an instance in July when a patient developed what was thought to be transverse myelitis, a rare spinal inflammation disorder, but turned out to be multiple sclerosis unrelated to the vaccine. Then in September, another neurological event in a British patient also believed to be transverse myelitis caused the global trial halt.
Trials had already resumed in the UK, home of AstraZeneca’s headquarters, as well as Brazil, Japan, South Africa and India. The EMA initiated a rolling review of the vaccine at the start of October.
J&J had ordered a pause to its late-stage Covid-19 vaccine trials on Oct. 12 after an incident of a stroke, according to an earlier Washington Post report, though the illness was originally undisclosed. J&J said that there was no clear cause of the event and no evidence it was a result of its vaccine.
The company also noted it will not say whether or not that participant received an experimental vaccine dose or placebo in order to maintain the double-blindedness of the study.
Like AstraZeneca, J&J is researching an adenovirus vaccine, though the latter’s vaccine only requires a single dose. J&J is planning on recruiting 60,000 patients.
Reuters had previously reported that the AstraZeneca trial could resume this week, and Warp Speed chief Moncef Slaoui had told Bloomberg that he expected both to restart before the end of the week.
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