AstraZeneca COVID-19 vaccine trial in USA remains on hold

AstraZeneca Resumes Its COVID-19 Vaccine Trials In The U.K.

AstraZeneca Resumes Its COVID-19 Vaccine Trials In The U.K.

The World Health Organisation described the decision to suspend trials of the highly-promising AstraZeneca and Oxford University vaccine, after one volunteer fell ill, as a "wake up call".

This COVID-19 vaccine, dubbed AZD1222, aka ChAdOx1 nCoV-19, is being developed in association with biopharmaceutical company AstraZeneca and is one of several now in late-stage Phase 3 trials. "In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety". Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord. It too had "paused" clinical trials in India, albeit a day after AZ announced similar action globally.

Days later, the company resumed human testing of the vaccine candidate in the UK.

"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 worldwide regulators", the company said, adding, "The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume".

In this instance, a rapid review by the MHRA led to a recommendation the trials be restarted. It said it would work with health authorities "across the world" and "be guided" as to when other clinical trials can resume.

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"AstraZeneca and the University of Oxford, as the trial sponsor, can not disclose further medical information", AstraZeneca said in a statement. Three candidates are in advanced stage of Phase I/II/III trials, and more than four are in the advanced pre-clinical development stage, he said.

Hassan Valley, an epidemiologist from La Trobe University, suggests rather than this transitory pause being a cause for concern it should instead offer reassurance that this vaccine trial is being conducted using optimal safety precautions.

Pfizer's coronavirus vaccine could be distributed to Americans before the end of the year if found to be safe and effective, CEO Albert Bourla said Sunday. "The investigators need to go through the process of trying to work out what may have happened in this situation before progressing with this trial". Being alert to potential adverse reactions with any new vaccine is part of the process, he explained.

"This new agreement could help us vaccinate millions of people across the country, as well as help create a United Kingdom vaccine manufacturing facility to speed up access to a potential Covid-19 candidate and boost the country's resilience against future pandemics", said Britain's Business Secretary Alok Sharma.

"No date has been fixed for the vaccine launch, it may be ready by the first quarter of 2021", said Mr Vardhan.

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