AstraZeneca temporarily halts covid-19 vaccine trial 6:23
(CNN) -
Pharmaceutical giant AstraZeneca reported Tuesday that it halted global trials of its coronavirus vaccine due to an unexplained illness in one of the volunteers.
It is a standard precaution in vaccine trials aimed at ensuring that experimental vaccines do not cause serious reactions among participants.
"As part of the ongoing global randomized controlled trials of the Oxford coronavirus vaccine, our standard review process resulted in a pause in vaccination to allow review of safety data," the company said in a statement sent to CNN.
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The company is testing its vaccine, called the Oxford vaccine because it was developed with the British University of Oxford in Great Britain, in the United States, as well as the United Kingdom, Latin America, Asia, Europe and Africa.
"This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials," the statement added.
“In large trials, diseases will happen by chance, but they need to be independently reviewed for careful checking.
We are working to expedite the review of a single event to minimize any potential impact on the trial schedule.
We are committed to the safety of our participants and the highest standards of conduct in our trials.
Earlier Tuesday, AstraZeneca joined eight other companies in signing a pledge promising not to seek premature government approval for any coronavirus vaccine.
They vowed to wait until they had adequate data to show that any potential vaccine works safely.
"We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential covid-19 vaccines in accordance with high ethical standards and sound scientific principles," the statement read.
It was signed by the CEOs of AstraZeneca, BioNTech GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.
"We believe that this commitment will help ensure public confidence in the rigorous scientific and regulatory process by which vaccines for COVID-19 are evaluated and ultimately approved," they added.
AstraZeneca's vaccine is one of three coronavirus vaccines in late-stage phase 3 trials in the U.S. A Safety and Data Monitoring Board typically monitors trials for adverse events and may order pause or stop a trial, but AstraZeneca did not say who had stopped the trial.
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Common adverse events in vaccine trials include fever, headache, injection site pain, and muscle pain.
Regulators and companies alike have been working to ensure that people have confidence in the vaccine authorization process.
The US Food and Drug Administration (FDA) must grant an emergency use authorization or full approval to any vaccine before it can be distributed in the country.
President Donald Trump has repeatedly said that he believes that at least one of the vaccines could be ready before Election Day, November 3.
Most groups working on the vaccine say that's extremely unlikely, but BioNtech CEO and co-founder Ugur Sahin told CNN on Tuesday that he believes the vaccine his company is developing with Pfizer could be ready. for regulatory approval in mid-October.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said that it is technically possible that if a monitoring board sees strong evidence that a vaccine is working before a trial is completed, it might recommend that it be stopped. the trial so that more people can get the vaccine.
But Fauci said this is unlikely to happen before December.
However, discussions of early authorizations and reports of pressure from the White House to speed up a vaccine have concerned the public, as well as former FDA officials.
Former FDA Commissioner Dr. Robert Califf told CNN last week that he was concerned even before COVID-19 that Trump would pressure the FDA to make the decisions he wanted.
"One of the things that has kept me on hold for the last four years is that, literally, Trump could do this with any drug, device or vaccine anytime he wants," said Califf, who was commissioned from January 2016 through January 2018.
Fauci and FDA Commissioner Dr. Stephen Hahn have said they would not give in to political interference.
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