Advanced phase clinical trials for the AstraZeneca and Oxford University coronavirus vaccine were resumed in the UK after they had been suspended six days earlier due to suspected possible adverse reactions.
AstraZeneca reported this Saturday of the resumption in a statement explaining it was made after confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.
“The UK committee concluded its investigations and recommended to the MHRA that it is safe to resume trials in the UK,” the brief states.
This possible vaccine, considered one of the most advanced developed worldwide, is in the final stages of clinical trials before receiving authorization from regulatory bodies to proceed with immunizing the population.
The company and the University of Oxford, the two sponsors of the trial, indicated that they are unable to release further medical details, although they mentioned that they will inform all investigators and trial participants of the relevant data, which will be disclosed in global clinical registries. .
Global trials had been temporarily suspended on September 6 to allow review of safety data by independent committees and international regulators.
The FDA could speed up approval of the coronavirus vaccine, but experts warn of the dangerous consequences this would bring.
AstraZeneca did not disclose any information about the possible side effect, other than calling it “a potentially unexplained illness.”
A spokesperson for AstraZeneca confirmed that the pause in vaccinations includes studies in the United States and other countries.
Late last month, AstraZeneca began recruiting 30,000 people in the United States for its largest trial of the vaccine. She is also testing the vaccine, developed by the University of Oxford, in thousands of people in Britain, and in smaller-scale studies in Brazil and South Africa.
The distribution debate is starting to be seen around the world, especially by the WHO who want to make sure that the poorest countries are not left out of these conversations.
Two other vaccines are in the final stages of testing in the United States: one produced by Moderna Inc. and the other by Pfizer and the German laboratory BioNTech. Those two vaccines work differently than AstraZeneca’s, and the studies have already recruited two-thirds of the volunteers needed.
During the third and final stages of the trials, researchers look for any hints of possible side effects that may have gone unnoticed in previous patient research. Due to their large size, studies are considered the most important phase of research to record less common side effects and establish safety margins.
The trials also allow for efficacy to be assessed by tracking who gets sick and who doesn’t among patients who received the vaccine or a placebo.
The federal government has said it will be free to low-income people and medical personnel.