Oxford University resumes vaccine trial

Serum Institute gets nod to resume clinical trials of Oxford COVID-19 vaccine in India

The DCGI has asked SII to submit details of medication used in accordance with the protocol for the management of adverse events

An AstraZeneca spokesperson previously described the decision as a "routine action which has to happen whenever there is a potentially unexplained illness" in a trial.

The firm said in the statement that the committee had concluded its investigations and informed the British health authorities that it is safe to resume trials in the UK.

In a press release this afternoon confirming the resumption of the trials, Oxford University said the pause had given time for a "review of safety data by an independent safety review committee, and the national regulators". 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. Sources told the news agency that enrollment of new patients and other trial procedures for the pivotal United States trial was being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.

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The nasal spray comprises of strains of weakened flu genome or virus and genetic portion of the spike protein of coronavirus.

As pharmaceutical companies in the USA and around the world work with government agencies to build a reliable timeline toward offering the world a viable vaccine, we seem to be in a hypothetical tug-o-war, with President Trump's administration pulling the date back to sometime this year, and other experts - some scientific, some private - arguing for more time.

The vaccine candidate BNT162b2 aims to train the immune system to recognize and neutralize the novel coronavirus by using a chemical messenger RNA to mimic the surface of the virus. He was replying to a question on the status of COVID-19 vaccines in the country.

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Health Minister Jens Spahn echoed that stance, saying that only vaccines which have been tested on "thousands, ideally many thousands of volunteers in phase 3" would be approved. It stated that globally, some 18,000 individuals have received study vaccines as part of the trial.

Trials for AstraZeneca's COVID-19 vaccine had been restarted in the previous week after seeking permission from the Drugs Controller General of India (DCGI). Russian Federation then announced that it would conduct the trials on over 40,000 people to prove the safety and efficacy of the vaccine.

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