E-Paper
Covaxin may be administered without consent form, expert panel recommends
The expert panel has recommended that Covaxin can be taken off the clinical trial mode as results of phase 3 trial are available now.
Bharat Biotech's Covaxin can now be taken off the clinical trial mode, an expert panel of India's Central Drugs Standard Control Organisation(CDSCO) recommended on Wednesday, after Bharat Biotech submitted the initial results of the phase 3 trials of Covaxin which has been found to have around 81% efficacy against Covid-19.
The clinical trial mode in which Covaxin was being administered since January 16 stoked a lot of controversies as beneficiaries had to sign a consent form for taking the vaccine shot. The consent form was mandated as Covaxin got the emergency use approval based on the results of phase 2 as the results of phase 3 trial were awaited.
"The SEC reviewed the interim phase-three trial data of Covaxin on Wednesday after which it recommended emergency use authorisation to the vaccine while removing the condition of it being required to be administered under the clinical trial mode," PTI quoted a source as saying.
The recommendations have been sent to the Drugs Controller General of India (DCGI) who will take the final decision. Once it is taken off the clinical trial mode, beneficiaries won't have to sign the consent form.
"In case of any serious adverse events, vaccine recipients will be provided medically recognized standard of care in the government designated and authorized centers/hospitals. The compensation for the serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to the vaccine. The compensation will be determined by the ICMR Central Ethics Committee, as appropriate," the consent form said.
Reservations against Covaxin continued as Chhattisgarh health minister wrote to union health minister Harsh Vardhan requesting him to halt the supplies of the indigenous vaccine saying that there was no expiry date mentioned on the vial.
In the first phase of vaccination which started on January 16, Covaxin doses remained unter-utilised. But as the second phase commenced with PM Modi taking the shot of Covaxin and several ministers following the suit, vaccination picked up the pace.
Meanwhile, Bharat Biotech also published the preliminary results of phase 3 clinical trials. “Today is an important milestone in vaccine discovery, for science and our fight against coronavirus disease. With today’s results from our phase 3 clinical trials, we have now reported data on our Covid-19 vaccine from phase 1, 2, and 3 trials involving around 27,000 participants. Covaxin demonstrates a high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants,” Krishna Ella, Bharat Biotech’s chairman and managing director, said.
