New Delhi : The Serum Institute of India (SII) is all set to restart its phase two and three clinical trials for
the COVID-19 vaccine after getting the nod from the Drugs Controller General of India (DCGI).
The SII had sought permission from the DGCI to restart the re-enrollment procedure for COVID-19
vaccine which is being developed by AstraZeneca and Oxford University following the Data Safety
Monitoring Board (DSMB) recommendations.
“You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB,
India as per already approved protocol and the provisions laid down under New Drugs and Clinical
Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as
extra care during screening, additional information in the informed consent and close monitoring for
similar events during the study follow-up,” the DCGI said in its letter to the Serum Institute.
On September 8, AstraZeneca had announced that it “voluntarily paused” the phase 3 clinical human
trials of its vaccine candidate ‘Covishield’ after one of the volunteers got ill.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our
standard review process was triggered and we voluntarily paused vaccination to allow a review of safety
data by an independent committee,” the pharma major had said in a statement.
The vaccine trial was put on hold in the US, Brazil and the United Kingdom but the trials have now
resumed in the UK.
According to reports, the DSMB has allowed Serum Institute to restart the vaccine trials on three
conditions: first, all relevant participant information must be recorded. Second, the additional safety
monitory plans must be devised by SII for volunteers participating in trials and lastly the contact numbers
of all participants must be recorded in case of an emergency.
However, In a major concern, India’s coronavirus COVID-19 tally galloped past 50 lakh, just 11 days
after it crossed 40 lakh, with 90,123 new cases of infections being reported in a day, while recoveries
surged to 39,42,360 on Wednesday.
The Union Health Ministry’s 8 AM data showed that total coronavirus cases mounted to 50,20,359,
while the death toll climbed to 82,066 with a record 1,290 people succumbing to the disease in a span of
24 hours.
India’s COVID-19 cases jumped from 10 lakh to 20 lakh in 21 days. Then it took 16 more days to race
past 30 lakh, 13 days more to cross the 40-lakh mark and 11 days to go past 50 lakh. It took 110 days
for the COVID-19 cases in the country to reach one lakh while it had taken 59 days more to go past the
10-lakh post.
The COVID-19 case fatality rate due to the coronavirus infection further dropped at 1.63 per cent.
There are 9,95,933 active cases of COVID-19 in the country which comprises 19.84 per cent of the
total caseload, the data stated.
According to the ICMR, a cumulative total of 5,94,29,115 samples have been tested up to September
15 with 11,16,842 samples being tested on Tuesday.
A total of 1,290 new deaths have been reported including 515 from Maharashtra, 216 from Karnataka,
113 from Uttar Pradesh, 90 from Punjab, 69 from Andhra Pradesh, 68 from Tamil Nadu , 59 from
West Bengal and 36 from Delhi.
A total of 82,066 deaths have been reported so far in the country includes 30,409 from Maharashtra
followed by 8,502 from Tamil Nadu, 7,481 from Karnataka, 5,041 from Andhra Pradesh, 4,806 from
Delhi, 4,604 from Uttar Pradesh, 4,062 from West Bengal, 3,244 from Gujarat, 2,514 from Punjab and
1,820 from Madhya Pradesh.
The health ministry stressed that more than 70 per cent of the deaths occurred due to comorbidities.
“Our figures are being reconciled with the Indian Council of Medical Research,” the Health Ministry said
on its website, adding that state-wise distribution of figures is subject to further verification and
reconciliation.
