Coronavirus: Covid-19 vaccine trial pause shows it's no 'rush job'

Grant Boone
September 12, 2020

Speaking further about Sputnik-V, Dmitriev said, "We've frequently discussed potential risks that new technologies may pose, as well as comparing these risks with Sputnik-V vaccine, which is based on a well-studied platform that uses human adenoviral vectors, something that has been proven to be safe and effective".

An independent committee was drafted in to review safety, in what the company and the World Health Organization described as a routine step.

On August 11, Russian Federation became the first worldwide to register the vaccine against the coronavirus which was named Sputnik V The preparation was developed by the Gamaleya National Research Centre and passed clinical trials in June-July.

"The independent review process has concluded and following the recommendations of both the independent safety review committee and the United Kingdom regulator, the MHRA, the trials will recommence in the United Kingdom".

Though it would not disclose information about the patient's illness for reasons of participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause in testing.

In a statement, the university said 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". All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.

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What Happened: The WHO official said that the vaccine trial delay was good and a "wake-up call or a lesson for everyone to recognize the fact that there are ups and downs in research", CNBC reported Thursday.

The AZD1222 vaccine uses a weakened version of a common cold-causing adenovirus engineered to code for the spike protein that the Covid-19 coronavirus uses to invade cells.

Swaminathan says early data in human vaccine candidates so far has been "quite promising", showing the shots trigger an immune response.

On September 9, ANI first reported that DCGI issued a show-cause notice to Serum Institute for not pausing the ongoing clinical trial of the COVID-19 vaccine. On the 2nd September, it was reported that "A new arm of the ongoing global clinical trials of the ChAdOx1 nCoV-19 vaccine led by AstraZeneca has launched in the United States to assess safety, efficacy and immunogenicity of the vaccine for the prevention of COVID-19".

The United States Centers for Disease Control and Prevention notified all 50 states on August 27 to get ready to distribute two COVID-19 vaccines starting late October.

Speaking on Monday, on LBC's new phone-in Call the Cabinet, Health Secretary Matt Hancock said the Government has secured 30 million doses of the vaccine from AstraZeneca.

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