Coronavirus vaccine update: SII will not alter AstraZeneca vaccine dose, Dr Reddy’s begins India trials of Sputnik V


The Serum Institute of India (SII) is likely to continue with its trials of the coronavirus vaccine developed by AstraZeneca and Oxford University in the same full dosage despite a lower dosage showing better efficacy in the UK. Meanwhile, the Indian drug controller has cleared the Covishield vaccine for further trials after a volunteer slapped a case on the makers claiming illness suffered due to the vaccination.

SII to continue with lower dose trials

According to a report in Reuters, an official of the Pune-based Serum Institute has said they will continue with their clinical trials of the AstraZeneca coronavirus vaccine in the same dosage. SII is conducting trials with the two full dose regimen of the coronavirus vaccine shot while some trials have shown a lower dose has shown better results.

AstraZeneca had earlier said its Covid-19 vaccine could be up to 90% effective if administered as a half dose followed by a full dose, although the results have been questioned by many as the altered trials were conducted only on a few thousand people.

On the other hand, the global trials with two full doses have shown 62% efficacy across volunteers in Britain and Brazil. SII has said there are no immediate plans to alter its trials in India.

Dr Reddy’s begins Phase 2/3 trials of Sputnik V

Dr. Reddy’s Laboratories Ltd. and the Russian Direct Investment Fund (RDIF) has announced commencement of adaptive Phase 2/3 clinical trials for Covid-19 vaccine Sputnik V in India after receiving necessary clearance from the Central Drugs Laboratory, Kasauli in Himachal Pradesh.

RDIF announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose and vaccine efficacy of over 95% 42 days after the first dose.

Currently, 40,000 volunteers are taking part in Phase 3 of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose and more than 19,000 with both the first and second doses of the vaccine.

SII vaccine trial probe

The Drugs Controller General of India (DCGI), which is probing the ‘adverse event’ during the SII trials of the AstraZeneca coronavirus vaccine, has said the illness suffered by a volunteer did not necessitate halting the trials.

The Centre said on Tuesday that the ‘adverse event’ will not affect the timelines of vaccine rollout in any manner.

A 40-year-old Chennai-based volunteer slapped a Rs 5 crore case on SII, AstraZeneca and others claiming he suffered neurological and psychological issues following the dose. SII filed a Rs 100 crore defamation suit against the volunteer and said there’s no proof to claim the illness was caused due to the vaccine dose.

No need to vaccinate all, says Centre

The Centre has said there may not be a need to vaccinate the country’s entire population against coronavirus if a critical mass of people are given a shot to break the chain of virus transmission. The government also clarified that it had never spoken about inoculating everyone.

“Our purpose is to break the chain of virus transmission. If we are able to vaccinate a critical mass of people and break the chain of transmission, then we may not have to vaccinate the entire population,” ICMR Director General Dr. Balram Bhargava said.

(With inputs from agencies)



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