MUMBAI: With the Drugs Controller General of India granting emergency-use approval to two vaccines on January 3, the debate among medical professionals now is which one would they take, if given a choice.
Most doctors, including KEM Hospital dean Dr Hemant Deshmukh, said that Covishield, developed by Oxford-AstraZeneca and manufactured by Serum Institute of India, would be their preferred vaccine since Covaxin‘s efficacy data is not available yet.
Incidentally, KEM was one of the sites where the Oxford vaccine Covishield trial was conducted. “The reason is simple. The vaccination of participants, even with the second dose, is over in Covishield and people are in the observational stage. Whereas Covaxin participants are still getting the vaccine,” said Dr Deshmukh. “Covaxin may be a better vaccine than Covishield afterall and preferred even as it’s an inactivated one, but we wouldn’t know anything till the efficacy, immunogenicity and safety data is all out.”
Covaxin is being developed by Bharat Biotech and the Indian Council of Medical Research (ICMR).
Covaxin’s approval has kicked up a strong reaction from the country’s scientific and medical fraternity who have questioned the go-ahead in the absence of efficacy data from phase III clinical trial that is still underway.The phase III trial that was started in November is supposed to recruit 25,800 participants across 25 centres of which 24,000 have been recruited.
ICMR head Dr Balram Bhargava on Tuesday said that the restricted-use approval was granted looking at the data on animal studies and safety data of phase I and II trials conducted with 375 and 380 participants, respectively. He also said that more than 24,000 participants have been given the first dose, and over 5,000 the second dose with no adverse effects.
Interestingly, Covishield’s complete immunogenicity (ability to generate an immune response) data on 1,600 Indian participants enrolled for the phase II/III clinical trial too is not yet complete as data for only 400 has been evaluated. Dr Deshmukh, however, said there was the UK trial data to fall back on.
Intensivist Dr Rahul Pandit, also a member of the state task force, said that the government has clearly spelt out that Covishield was the primary vaccine and most likely will be rolled out first. “The drug controller has granted it a restricted emergency use in clinical trial mode approval, meaning those receiving it need to give consent and will be followed up.”
On Tuesday, when VK Paul, chairman of National Expert Group on Vaccine Administration for Covid-19 and a member NITI Aayog, was asked which vaccine would be preferred during a press meet in Delhi, he only said, “I will take the vaccine which the ministry of health will specify for me.” Incidentally, AIIMS director Dr Randeep Guleria had said that the Bharat Biotech vaccine could be used as a backup, a statement that was opposed by the company’s chairman Dr Krishna Ella who said that Covaxin was “one of the vaccines and not a backup”.
Interestingly, even as the vaccine war rages on, state and civic officials are clueless about what may arrive in the next 10 days.
State immunisation officer Dr D Patil said that the Centre has not communicated the specific vaccine type yet. Suresh Kakani, BMC’s additional municipal commissioner, said they have been told only one vaccine brand would be supplied by the Centre at one given point since two doses would have to be administered 28-30 days apart.