India's COVID-19 vaccine developed by Bharat Biotech is safe, reveals preliminary results
By Lokmat English Desk | Published: August 14, 2020 03:19 PM2020-08-14T15:19:06+5:302020-08-14T15:19:06+5:30
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Covaxin, the COVID-19 vaccine developed by Bharat Biotech and the ICMR, is safe, according to preliminary results of the Phase 1 clinical trials, according to a report by The Economic Times.
Hyderabad-based Bharat Biotech is developing the vaccine candidate in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV)
The vaccine is safe. We have not observed any adverse events in any of the volunteers at our site,” said Savita Verma, the principal investigator who is leading the trial at PGI, Rohtak, told the publication.
Investigators are collecting blood samples to test the immunogenicity of the vaccine, and expect to complete the Phase 1 trials by the end of August, the report said.
While volunteers are being administered with the second dose, investigators are collecting blood samples which will test the immunogenicity of the vaccine.
“As of now we know that it is safe. The second step is to know how effective the vaccine is for which we have started collecting the samples,” added Verma. The investigators are expecting to finish the Phase I by August end.
“We are in the process of giving a second dose to the healthy volunteers and so far, we have not seen anything unusual event in patients.
It is safe,” said Sanjay Rai, principal investigator at All India Institute of Medical Sciences, Delhi. AIIMS had recruited 16 volunteers for testing the Bharat Biotech vaccine.
As the race to secure vaccines begins, the government is keeping a close eye on developments. Covaxin is India’s first vaccine candidate and is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The vaccine is developed from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.
Once the safety data from all 12 sites shows desirable results, the company will approach the Drug Controller General of India for conducting Phase II trials. “If all goes well, the vaccine may be available in the first half of next year,” said another investigator, on the condition of anonymity.
