The Bharat Biotech vaccine is more likely to work against newer strains such as the UK variant: Vardhan
With some congressional leaders expressing concern over the granting of approval to Bharat Biotech’s Covid-19 vaccine, Health Minister Harsh Vardhan said Sunday that Covaxin is more likely to work against newer variants of the virus, including the UK variant, and asked politicians not to. “Debunking well-established protocols backed by science” followed to pass the jab.
Some congressional leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, expressed serious concerns on Sunday about granting Covaxin approval for restricted use, saying it is “premature” and may prove dangerous.
Responding to them, Vardhan said that it is “a shame that someone politicizes such a critical issue.” Tagging Tharoor, Ramesh and Samajwadi Party Leader Akhilesh Yavad, the Health Minister said in a tweet: “… do not try to discredit the well-established science-backed protocols that are followed to approve # COVID19 vaccines. Wake up and realize that you are only discrediting yourself! “Vardhan said:” COVAXIN is more likely to work against newer variants such as variant N501Y (UK variant) and any other that may arise due to antigenic drift, as it contains immunogens (epitopes) from genes other than those of Spike protein. “SP President Yadav said that the Covid-19 vaccination program is a” sensitive process “and that the government should not treat it as a” cosmetic “event, as it is a matter of lives.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
ICMR Director General Balram Bhargava also said that Covaxin is based on an inactivated whole virus, which has the potential to target mutated coronavirus strains, including the UK variant, which was a major reason for giving it a conditional nod.
However, he said that so far there are no clear data on the efficacy of the vaccine.
The data generated so far demonstrate a strong immune response (both antibody and T-cell) and viral neutralization in vitro. The ongoing clinical trial is the largest trial involving 25,800 subjects, with 23,000 volunteers already enrolled, including subjects with comorbid conditions, and the vaccine has been shown to be safe to date, Bhargava said.
To further dispel apprehensions surrounding the Bharat Biotech vaccine, Vardhan said there were no seroconversions in those who received vaccines in the Phase II and Phase I clinical trials of Covaxin.
Seroconversion is the transition from the point of viral infection to the moment when antibodies to the virus are present in the blood.
“Our experience with inactivated vaccines that had no serious adverse effects was also seen in Phase II conducted among 380 study participants in the BBV152 trial at a follow-up of 21,280 person-days. No serious adverse events were observed. Only 7 percent of people who received a 6-microgram dose had mild symptoms, ”Vardhan said in another tweet.
“COVAXIN Phase I and II clinical trial data reveals that it not only produces neutralizing antibodies in all participants, but also sensitizes CD4 T cells that impart a long-lasting immune response,” Vardhan tweeted.
He said that globally approved vaccines based on genes encoding spike proteins have a protective efficacy of more than 90 percent.
“However, COVAXIN based on whole inactivated viruses has other antigenic epitopes in addition to the spike protein. Therefore, it is likely to have a similar protective efficacy reported for others, ”he said.
India’s drug regulator on Sunday approved Oxford’s Covishield Covid-19 vaccine, made by the Serum Institute, and indigenously developed Bharat Biotech’s Covaxin for emergency restricted use in the country, paving the way for a campaign of massive inoculation.
The Comptroller General of Drugs of India (DCGI) granted approval based on the recommendations of a Covid-19 Subject Matter Expert Committee (SEC) of the Central Drug Standards Control Organization (CDSCO).