AstraZeneca Will Resume Vaccine Trials After Concerning Pause
Pharmaceutical giant AstraZeneca announced Saturday that its phase three coronavirus vaccine trial is back in business.
“Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so,” the company said in a media release.
“On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume,” AstraZeneca said.
The company did not address the status of drug trials outside of Britain.
“The vaccine’s phase three trial is looking to include 50,000 participants in both the U.K. and the United States,” the Washington Examiner reported.
“AstraZeneca is one of three companies, including Moderna and Pfizer, that have phase three trials underway in the U.S.”
In a media release published Wednesday, AstraZeneca said the trials were paused due to an “unexplained illness” in the U.K.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
The company said in its latest release that it “cannot disclose further medical information,” adding: “All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.”
The pause in the trial took place after a participant developed an inflammation of the spinal cord, a person familiar with the situation told The New York Times.
The source said that “a volunteer in the U.K. trial had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections,” The Times reported.
At the time of the pause, it was unclear if the vaccine was linked to the inflammation.
White House adviser Dr. Scott Atlas told Fox Business that the pause was an indication of proper procedure.
“This is one of the reasons why clinical trials are done. This is an indication that the trials are being done safely. Things happen during trials; that’s part of the reason why we can’t totally predict exactly when things will be available,” he said.
Atlas said pauses in a vaccine trial are not “anything unexpected.”
“As they said, it is routine and these are investigated,” he explained. “That’s exactly why we are doing the trials. People should be assured by this.”
“We have 200,000 people almost have died already, and people are inciting fear into people about the vaccine,” he said. “I think this is really unconscionable. Frankly, I hate to say it, they are killing people by doing that.
“We have people who are high risk, they need the vaccine, and when this vaccine is available and we’re on track to have it available before the end of the year. But, again, the timing is unpredictable really with accuracy because it depends on the events that occur during the clinical trial.”
White House press secretary Kayleigh McEnany had said in a briefing Wednesday that the pause indicated “the science is guiding the way here,” according to a White House transcript.
“There are still two American vaccines in phase three clinical trials showing great promise. But, you know, AstraZeneca — what is happening there is showing that the science is guiding the way on a vaccine, which is what Dr. Fauci, others like Alex Azar and the president have said all along,” she said.
McEnany said the Trump administration seeks to have a vaccine ready by the end of the year.
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