Maharashtra all set for vaccination drive with Covaxin shots

Covaxin has been indigenously developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The vaccine is yet to complete late-stage human clinical trials in India and no efficacy data has yet been made public. A vaccine in trial mode requires special monitoring and follow-up.

“We conducted training on the procedure of vaccination from 7.30pm until night on Thursday in all these centres. These medical colleges are properly equipped to monitor beneficiaries for any adverse event. Although the vaccine is safe for use,” said state immunisation officer Dr DN Patil.

As per the Union health ministry’s guidelines, issued on Thursday, each vial of Covaxin can give one shot to 20 people. The 0.5ml whitish translucent dose is administered intramuscularly and can be stored between 2-8 degrees centigrade just like Covishield. Its shelf life is six months.

“We have to vaccinate 100 people a day to start with as our stock is small,” said Dr Lalit Sankhe from JJ hospital. All six centres, where Covaxin will be used, are expected to immunise 600 people on Saturday.

On Friday, JJ hospital was busy setting up its vaccination centre, given that they were informed on a short notice. On Wednesday, the hospital was informed that it would run a vaccination centre, and accordingly, training was conducted on Thursday night. The hospital also runs an immunisation clinic for influenza, yellow fever, rabies and several other vaccines. “Today we ran a dry run of the entire vaccination process. The arrangements are almost ready and we can start on Saturday,” Sankhe said.

A written consent from beneficiaries is essential for vaccines to be taken. On Friday evening, state officials held a video conference with all six centres to explain the process of obtaining consent among other logistical issues. Covaxin will be administered under restricted use under an open-label trial.

On Friday, the All India Peoples Science Network (ALPSN) issued a statement, questioning the Centre’s decision to procure over 55 lakh Covaxin doses from Bharat Biotech. Each person will require two doses. “Inoculation of 28 lakh persons cannot be considered a ‘trial’ by any stretch of imagination, especially when phase-III trials for Covaxin are already underway, involving around 26,000 volunteers,” the AIPSN said.

“Clinical trials should require informed consent or refusal by Covaxin recipients after being made fully aware of conditions imposed by the CDCSO and the absence of phase-III efficacy data,” the network added.

The AIPSN has demanded special protocol for Covaxin administration, including both consent and refusal data.

Dr Prashant Howal, one of the immunisation officers, said: “We have not been told to individually inform each beneficiary that Covaxin is under a phase III trial. But all that information is mentioned on the consent form and we will give each beneficiary enough time to go through it,” he said.

Dr Anil Pachrekar, a physician in Dharavi, informed that most doctors in his area are eager to get their vaccine jabs of either Covaxin or Covishield. “We have seen the virus’s spread in Dharavi and the extent of havoc it can create. Therefore, most of us will go for vaccination,” he added.