Trials of a leading candidate for the COVID-19 vaccine being produced by pharmaceutical company AstraZeneca remain on hold in the U.S. But human testing of the vaccine has resumed in at least five other countries, leading to some experts to question whether the caution of US regulators is the country’s ability to access one of the most promising vaccine candidates.
On Thursday, the European Medicines Agency, the European Union’s medicine regulator, announced that it had begun what is known as a “continuous review” of AstraZeneca’s COVID-19 vaccine. This means that the regulator will begin to analyze data from vaccine trials even before those studies are complete and a formal application for approval is submitted. The process will allow the agency to expedite its possible approval of the vaccine.
The ongoing delay in the US trial is due to the US Food and Drug Administration expanding its review of safety data to include evidence from other vaccine trials that used the same underlying technology, according to a Reuters report.
which is working with the FDA to restart the US arm of the [vaccine] trial. AstraZeneca vaccine trials were halted around the world on September 6 after a volunteer in the UK developed a serious medical condition. The volunteer, a woman, was reported to have developed severe neurological symptoms that may have been associated with transverse myelitis, an inflammation of the spinal cord that can be caused by an immune response.
AstraZeneca CEO Pascal Soriot also revealed that trials in the UK had stopped once before, in July, when another volunteer also developed severe neurological symptoms. It was later discovered that she had undiagnosed multiple sclerosis.
“We work in a regulated environment to ensure the safety of our volunteers and comply with all requests and regulatory requirements,” said Andrew Pollard, a researcher at the Jenner Institute in Oxford, who developed the COVID-19 vaccine and oversees its testing abroad. . . the United States. In a sentence.
Vaccine skeptics
Six out of 10 Americans said they would not rush to get a COVID-19 vaccine as soon as the FDA approved one, according to an Axios / Ipsos survey released last month. That compares with three out of four who said they would receive a vaccine once it was available globally, according to another Ipsos survey released in August.
But the growing gap between the FDA and other global regulators may mean that the United States will not be in a position to approve the AstraZeneca vaccine as soon as other countries. The large 30,000-person clinical trial of the vaccine AstraZeneca is running in the US It had only been underway for about a week when the trials were discontinued. And while Soriot initially said the delay would not delay the company’s projections of having a vaccine ready for FDA approval before the end of the year, that timeline is now in question.
Meanwhile, two of AstraZeneca’s main rivals in the race to be the first to bring a COVID-19 vaccine to market, pharmaceutical giant Pfizer and biotech company Moderna, have large-scale clinical trials in the United States. On going. Pfizer has said it should have enough data from its study to seek regulator approval by the end of this month.
