New Delhi: Late-phase trials of the Oxford-AstraZeneca vaccine, known as Covishield in India, are well underway in the country with no major adverse side-effects being reported so far, ThePrint has learnt.
Covishield vaccine trials in India are being carried out by the Pune-based Serum Institute of India (SII) at multiple sites. They are currently in Phase 2 and Phase 3, which means they are being administered among large groups of human subjects.
“The trial is running smoothly, some have received their second doses also,” said a top scientist associated with the trial, adding, “Very few people have developed fevers after the dose, but this is a mild reaction and nothing to get alarmed about.”
During the ongoing seven-month-long study, the vaccine’s safety and efficacy will be tested among 1,600 participants across 17 trial sites in India.
On 9 September, the vaccine trials were halted after one of the participants in the UK developed an “unexplained illness”, suspected to be an adverse effect of the vaccine. On 10 September, the Drugs Controller General of India (DCGI) sent SII a showcause notice, following which trials were stopped in India too.
The trials were resumed in the UK on 12 September after a go-ahead from the country’s regulator Medicines Health Regulatory Authority, and they were back on track in India within the same week. Two weeks later, officials from three sites said the vaccine seems “safe” and has shown no adverse effects so far.
In an email response to ThePrint, an official spokesperson of the SII said, “At this point, there is no comment from Serum Institute of India. We will wait for the trial results to come out.”
‘No adverse effects so far’
The Oxford-AstraZeneca Covishield vaccine is among the front-runners in the race for immunity against the novel coronavirus, which has infected over 3.4 crore people worldwide, 63 lakh of them in India. Globally, the study involves at least 30,000 participants from the UK, South Africa, Brazil and India.
“We expect to finish enrolling all the participants within the next two months, after which we’ll monitor them and check for the vaccine’s efficacy. But so far, we haven’t seen any side-effects,” said one of the principal investigators (PI) from a trial site in Maharashtra.
Another PI from a centre in a northern state said, “It’s safe. We’ve administered just the first dose so far but it seems to be going well.”
Some participants have experienced a fever, but the investigators said it is considered a common and mild side-effect of vaccines.
The race to develop an effective vaccine against Covid-19 has produced over 190 candidates across the world, 41 of which are under clinical evaluation, while others are at the preclinical stage (which don’t involve human subjects).
Apart from the SII’s Covishield, two vaccine candidates from India have crossed the preclinical stage and are in phases 1 and 2 of clinical trials — Covaxin by Bharat Biotech and the Indian Council of Medical Research (ICMR), and ZyCoV-D by the Gujarat-based Zydus Cadila.
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