Congress leaders on Sunday expressed concerns over the permission granted for restricted use of the coronavirus vaccine developed by Bharat Biotech, even as the pharmaceutical company was yet to complete phase 3 trials, PTI reported.
Rajya Sabha MP Anand Sharma said that the matter of granting authorisation to the vaccine use needs to be taken carefully as no country has done away with the mandatory phase 3 trials and verification of data. “The Health Ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of frontline workers who will be vaccinated under the restricted category,” Sharma, who heads the Parliamentary panel on Home Affairs, told PTI.
Earlier on Sunday, Drugs Controller General of India chief VG Somani announced the approval for restricted emergency use of Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin shots.
Covaxin is the country’s first indigenous vaccine developed by Bharat Biotech, a company based in Hyderabad, with backing from the Indian Council of Medical Research and the National Institute of Virology. However, not much is known about the safety and efficacy of this vaccine in clinical trials.
Somani said Bharat Biotech’s vaccine generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, hamsters, and that the firm conducted challenge studies on non-human primates. He further said that the Phase I and II clinical trials of the vaccine were conducted approximately on 800 subjects and it was found to be safe. Following this, the Phase III efficacy trial was initiated in the country in 25,800 volunteers and till date 22,500 participants have been vaccinated, and it has proved to be safe as per the available data, Somani said. However, the data that has reportedly been submitted to the drug controller, is not in the public domain.
Referring to Somani’s statement, Sharma said that it was puzzling and that the government must reveal the final data of global efficacy trials, according to PTI.
Another senior Congress leader, Jairam Ramesh, also raised concerns and asked Union Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials were being modified.
The party’s Lok Sabha MP Shashi Tharoor also tweeted saying that the “approval was premature and could be dangerous”.
On Saturday, a government-appointed panel of experts had recommended granting of permission for the two vaccines, following which the DCGI gave the final nod on Sunday.