AstraZeneca resumes United Kingdom trials of COVID-19 vaccine halted by patient illness

Rules regarding the Covid 19 vaccine

Last month, Pfizer and BioNTech shared additional Phase 1 safety and immunogenicity data from their ongoing US study of the vaccine candidate, which has advanced into Phase 2/3 evaluation.

"On Sunday [06/09/2020] our standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators".

During the pause, there were reviews of safety data by independent committees and global regulators, AstraZeneca said.

AstraZeneca and the University of Oxford, as the trial sponsor, can not disclose further medical information.

The statement came in response to AstraZeneca's announcement that vaccine trials have resumed in the UK.

The expansion announcement comes less than a week after the CEOs of the major coronavirus vaccine developers made a joint pledge to avoid applying for FDA approval, even for emergency use, until certain safety and efficacy standards are met.

Rules regarding the Covid 19 vaccine

The results of clinical trials in our country are moving on the right path, with all tests being successful so far. One of those women in the United Kingdom experienced neurological symptoms consistent with a serious spinal inflammatory disorder called transverse myelitis, STAT News reported earlier this week. Prominent among those are Oxford-AstraZeneca, Bharat Biotech's COVAXIN, China's Sinovac, Moderna, Novavax and China's CanSino. At the time, AstraZeneca described it as a "routine" pause in the case of "an unexplained illness".

In a statement, Oxford University said: "In large trials such as this one, it was expected that some participants will become unwell".

Pharma company AstraZeneca's India partner Serum Institute said it will also restart the trials once the Drug Controller General of India (DGCI) gives the nod.

He also added that people who were sent to high-risk places in the country and those who came from overseas including health workers, diplomats and other employees were given the vaccine doses.

Pfizer also submitted a proposal to the FDA on Saturday (12 September) that would see its late stage trial expanded, including up to 44,000 participants.

"We have evidence that delivering influenza vaccines via a nasal spray can protect people against flu as well as help to reduce the transmission of the disease", said Dr. Chris Chiu of Imperial, who is leading the research.

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