HIGHLIGHTS: Will resume Covid-19 vaccine trials after DCGI nod, says Serum Institute
As many as 1,201 deaths reported in India during last 24 hours period pushed the death toll to 77,472. At present, the country has 9,58,316 active cases and 36,24,197 people who have been treated and discharged.
Unexpected side-effects after a drug has regulatory approval are rare, but the speed at which a COVID-19 vaccine is being pursued increases the risks of unforeseen conditions. (Reuters)
The Serum Institute of India (SII) Saturday said that phase 2 and 3 clinical trials of the Oxford-AstraZeneca COVID-19 vaccine candidate will resume after receiving a green signal from the Drugs Controller General of India (DCGI). Earlier in the day, AstraZeneca said it had resumed the clinical trials of the vaccine following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the firm said on Saturday.
Cautioning people against lowering their guard till an effective anti-coronavirus medicine is developed, Prime Minister Narendra Modi on Saturday came up with a slogan in Hindi to drive home his point. He said, ‘Jab tak dawai nahi, tab tak dhilai nahi’ (No carelessness till a medicine is found).
India reported nearly 1 lakh (97,570) coronavirus cases in the last 24 hours ending 8 am on Saturday. With this, the total tally went past the 46 lakh-mark to reach 46,59,985. Also, as many as 1,201 deaths reported during the same period pushed the death toll to 77,472. At present, the country has 9,58,316 active cases and 36,24,197 people who have been treated and discharged.
Globally, over 28 million have been affected while 915,356 have succumbed to the virus so far and as many as 19,215,800 have recovered. The United States continued to remain the worst-affected, followed by India and Brazil.
Delhi Metro resumes full services from today, nearly 47 lakh cases in India. Read highlights
A hospital worker pauses next to an ambulance outside of Kingsbrook Jewish Medical Center in Brooklyn, May 11, 2020. (Dave Sanders for The New York Times)
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Meanwhile, with the reopening of service on the Airport Express Line, the Delhi Metro resumed its full services from Saturday. Now the metro trains will run from 6 am to 11 PM on all lines, the Delhi Metro Rail Corporation (DMRC) said.
While an independent group of experts began investigating the severe illness in a participant that led to a halt on clinical trials of AstraZeneca’s coronavirus vaccine, the World Health Organisation said there was nothing to be discouraged about, since these kinds of incidents routinely happen during trials.
Meanwhile, the India trials of the vaccine, being carried out by Pune-based Serum Institute of India, have also been halted. Serum had, on Wednesday, claimed that the India trials would remain unaffected by AstraZeneca’s decision. However, it was issued a show-cause notice by the officer of the Drug Controller General of India, and on Thursday, Serum said it was putting a hold on India trials. Till now, 100 participants have been given the vaccine in India where combined phase-2 and phase-3 trials were approved last month. About 1,600 participants were planned to be enrolled for the complete trial.
In Geneva, WHO chief scientist Soumya Swaminathan said the AstraZeneca pause was not a setback, and nothing to be discouraged about. She said the incident just demonstrated that the process of vaccine development was not always a “fast and straight road”.
“I think this is good… perhaps a wake-up call or lesson for everyone to recognise that there are ups and downs in research, there are ups and downs in clinical development, and that we have to be prepared for those,” Swaminathan said.
“We need not be discouraged. Such things happen,” she said.