'Disgraceful to politicise such critical issue': Vardhan to oppn on Covid vaccine efficacy3 min read 03 Jan 2021, 07:47 PM IST
Regarding the phase 3 trials of Covaxin and the vaccine's available data so far, Harsh Vardhan said, 'There were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of COVAXIN clinical trials'
Calling out a number of opposition leaders, Vardhan said that it is disgraceful for anyone to politicise such a critical issue
Union Health Minister Harsh Vardhan on Sunday hit out at leaders of opposition parties for politicising emergency use approval for two Covid-19 vaccines in the country.
The comments came after the government on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute of India, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation.
However, some Congress leaders, including Anand Sharma, Tharoor and Jairam Ramesh, raised serious concerns over the grant of approval to Bharat Biotech's COVID-19 vaccine for restricted use, saying it is "premature" and can prove dangerous. Tharoor also said that Covaxin has not yet had Phase three trials.
Vardhan, in a series of tweets, backed Covaxin's emergency use approval. He said that vaccines approved globally are based on gene encoding spike proteins have protective efficacy of over 90%. However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein. So, it’s likely to have similar protective efficacy reported for others, the health minister said.
"COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) and any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein. Inactivated virus from NIV also had D614G mutation," he explained.
Regarding the phase 3 trials of Covaxin and the vaccine's available data so far, Vardhan added, "The data from COVAXIN Phase I & II clinical trials reveals that it not only produces neutralizing antibodies in all participants but also sensitises CD4 T lymphocytes that imparts durable immune response."
He also said, "There were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of COVAXIN clinical trials."
"Our experience with inactivated vaccines not having serious adverse events was also observed in Phase II done among 380 study participants in BBV152 trial in 21280 Person days follow up. No serious adverse events seen. Only 7% persons receiving 6 microgram dose had mild symptoms," Vardhan stated.
Meanwhile, Hyderabad-based vaccine manufacturer Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the phase 3 trial of its coronavirus vaccine candidate Covaxin.
"Phase-3 human clinical trials of Covaxin began mid-Nov, targetted to be done in 26,000 volunteers across India, this is India's first and only phase-3 efficacy study for Covid-19 vaccine, and largest phase-3 efficacy trial ever conducted for any vaccine in India," it added.
Bharat Biotech said that the Phase III human clinical trials of Covaxin began in mid-November. It is also the largest phase III efficacy trial ever conducted for any vaccine in the country, as per the statement.
Earlier in the day, Vardhan welcomed the emergency use approval for Oxford-AstraZeneca’s and Bharat Biotech’s vaccines against coronavirus and termed it a "watershed moment" in India's battle against COVID-19.
Calling these vaccines a fitting tribute to corona warriors, he expressed heartfelt gratitude to healthcare professionals and frontline workers for their efforts during these unprecedented times and congratulated all the scientists and researchers for their work.
Moreover, All India Institute of Medical Sciences (AIIMS) director Dr Randeep Guleria on Sunday said that the Covid-19 vaccine manufactured by Bharat Biotech will be used as a back-up for now.
He said that Bharat Biotech's vaccine can be used when "we're not sure how efficacious the Serum Institute vaccine is going to be."
"In an emergency situation when there is a sudden increase in cases and we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we're not sure how efficacious the Serum Institute vaccine is going to be," Guleria told news agency ANI.
With agency inputs
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