AstraZeneca Covid Vaccine Trial Resumption In US Not Yet Known; UK Trial Resumed
British drug major AstraZeneca, which had halted the trial of coronavirus vaccine AZD1222 last week, has resumed the trial in the U.K, while it is still not certain when the company will start its US trial again.
The company said it will continue to work with other global health authorities and be guided as to when other clinical trials can resume.
In the U.K, clinical trials for the AstraZeneca Oxford coronavirus vaccine have resumed following confirmation by the Medicines Health Regulatory Authority or MHRA that it was safe to do so.
The potential vaccine, AZD1222, is being developed by the pharmaceutical giant in partnership with Oxford University, and its spin-out company, Vaccitech. It is in phase III development in the U.S., UK, Brazil, and South Africa with additional trials planned to start in Japan and Russia.
It was on September 6 that the company voluntarily paused all global trials following a potentially unexplained illness in a U.K. volunteer, to allow review of safety data by independent committees, and international regulators.
In its latest statement, AstraZeneca said the UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.
AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information.
The company will update all trial investigators and participants with the relevant information, which will be disclosed on global clinical registries.
In July, AstraZeneca had revealed that the ongoing phase I/II study of AZD1222 was showing good immune responses against the SARS-CoV-2 virus in all participants.
The voluntary pause in the trials following an adverse reaction in a trial participant is said to be a routine action to maintain the integrity of the trials.
Recently, a group of Covid-19 vaccine developers, including AstraZeneca, Johnson & Johnson, Merck & Co, and Moderna, among others, announced a historic pledge to uphold the integrity of the scientific process in developing and testing potential vaccines for COVID-19.
As of this writing, the U.S. has recorded 6,519,979 cases of COVID-19 and 194,079 deaths, according to the Johns Hopkins University database. Globally, the cases were 29,006,033 including 924,105 deaths.
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