Home English News Amid efficacy row, Covaxin gets thumbs-up from Lancet | India News

Amid efficacy row, Covaxin gets thumbs-up from Lancet | India News


HYDERABAD: Amid a raging controversy over the efficacy of Covaxin, India’s first indigenous Covid-19 vaccine, reputed medical journal the Lancet Infectious Diseases on Friday said the vaccine produced tolerable safety outcomes and enhanced immune responses in its Phase 1 trials.
With this, Covaxin has become the first Covid-19 vaccine from India to have its data published in Lancet, said Suchitra Ella, joint managing director of Bharat Biotech, which is developing the vaccine in association with the Indian Council for Medical Research and the National Institute of Virology, Pune.

“BBV152 (codename for Covaxin) induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response,” said the journal.
Covaxin was well tolerated in all dose groups, with no vaccine-related serious adverse events and the sole serious adverse event was not causally associated with the vaccine, the journal said.
According to biotech industry experts, any vaccine causes some discomfort like pain or fever but it is said to be tolerable when it is resolved without any treatment and is considered safe. A serious adverse side-effect is one which takes a lot of time and effort to treat and causes partial damage to the subject.
The biggest criticism against Covaxin was that none of its data was in the public domain when it was given emergency-use authorisation. Sources said Bharat Biotech is hoping to counter the critics with the Lancet piece.
Terming it as “international validation of Indian innovation”, Ella tweeted: “Extremely proud to announce Phase 1 clinical trial studies of Covaxin published in the most prestigious medical journal of The Lancet Infectious Diseases.”
Ella also said that 13,000 volunteers (out of 25,800) have been successfully administered the second dose of Covaxin in Phase 3 trials.
Lancet said all adverse events observed in the Phase 1 trials were mild or moderate and were more frequent after the first dose than the second. No significant differences were observed between the vaccinated and control groups, it added.
The most common adverse event was pain at the injection site, followed by headache, fatigue and fever. “The overall incidence of solicited local and systemic adverse events in this study was 14-21% in all vaccine-treated groups, which is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates,” it said.
As many as 44 unsolicited adverse events were reported by 24 (6%) of the 375 participants. The healthy volunteers, in the 18-55 years age group that were enrolled in the trials conducted in July-August 2020, were administered the two doses 14 days apart.
Of those enrolled, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only).
Apart from carrying Covaxin Phase 1 trial data, the Lancet carried another article saying that the indigenous Indian vaccine was a “welcome addition to the Covid-19 vaccine landscape”. But it also said that it would wait for Phase 3 trial results.
Pointing out that mathematical models indicate there will not be an adequate supply of vaccines available to cover the global population until 2023, the article said: “Bharat Biotech, experienced with developing and distributing vaccines to LMICs (low & middle-income countries) is poised to bridge the vaccine disparity gap using the well-established inactivated whole-virus vaccine platform.”
However, it said that until questions about BBV152’s efficacy and ability to subvert a Th2 response are answered by a more diverse multinational Phase 3 trial to comprehensively assess efficacy and long-term safety, “we will wait with cautious optimism on this vaccine candidate poised to bolster worldwide equitable access to Covid-19 prevention”.



Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

- Advertisment -

Most Popular

Congress joined hands with Badruddin Ajmal for ‘lust for power’: Amit Shah | India News

BORDUWA: Union home minister Amit Shah on Thursday attacked the Congress for joining forces with Badruddin Ajmal's AIUDF in Assam because of its...

Kangana Ranaut claims only she can do comedy: kangana ranaut claims only she can do comedy after sridevi trollers say that is comedy- कंगना...

कंगना रनौत को हिंदुस्‍तान की जनता ने सिनेमा की 'क्‍वीन' बनाया। लेकिन इन दिनों उनके तेवर 'अपने मुंह मियां मिट्ठू' वाले हैं। कंगना...

rakhi sawant post for salman khan: rakhi sawant heart touching post for salman khan after bigg boss 14 calls him her god brother- राखी...

'बिग बॉस 14' में अपने गेम से दर्शकों के साथ-साथ सलमान खान का दिल जीतने वालीं राखी सावंत ने इंस्टाग्राम पर एक पोस्ट...

Full Election Commission to visit West Bengal and Tamil Nadu again to review poll arrangements | India News

NEW DELHI: The full Election Commission -- comprising Chief Election Commissioner Sunil Arora and election commissioners Sushil Chandra and Rajiv Kumar -- will...

Recent Comments