The consent form sent by the Centre for recipients of Covaxin does not mention that the data on the efficacy of the homegrown vaccine against Covid-19 is still pending, health department officials said.
Recipients of Covaxin, which is still undergoing Phase III trial, have to sign the form before they are administered doses of the vaccine.
The state health department will distribute copies of the forms to teaching hospitals where Covaxin shots are likely to be administered from Tuesday. The four venues in Calcutta selected so far are the Calcutta Medical College and Hospital, School of Tropical Medicine, SSKM Hospital and the RG Kar Medical College and Hospital.
The consent form mentions that the recipient has read the Covaxin information sheet or been told about the content and has understood the “benefits and risks of the vaccination”.
It says the recipient will be “entitled to medical management and compensation for serious adverse events related to the administration of this vaccine”.
“We will send the forms to the venues where Covaxin doses will be administered, mostly likely from Tuesday. Prospective recipients will be given copies of the form on reaching the vaccination site. They will get time to read it. The jab will be given only if one signs the form,” an official of the health department said.
The form, the official said, does not mention that efficacy data of Covaxin is still not available.
An immunologist attached to a research institute under the central government told Metro that the form should clearly mention that Phase III trial results of Covaxin are pending.
“The Phase III trial data, still unavailable, will show whether the vaccine will work against the disease for a considerable point of time. If consent is being taken before administering the vaccine, the recipients should be told clearly that the Phase III trial results are pending. The form should also mention phone numbers which a recipient can call if some serious adverse events develop after getting the jab,” said the immunologist, who did not want to be named.
The fact sheet supplied with Covaxin mentions that the vaccine is undergoing efficacy trials. “A Phase III efficacy study is ongoing in 25,800 participants and administered with first dose of vaccination with Covaxin, no vaccine related adverse events were observed,” the document states.
An official of the state health department said that the form, in English, was recently sent by the Centre. The state government will translate it into Bengali and other languages.
Metro had on January 24 reported that the Centre had told state health department officials in a video conference that Covaxin recipients would have to sign a consent form before they are administered the doses.
Recipients of Covishield, the other Covid vaccine granted emergency use approval in India, do not have to sign any consent form.
Bengal has received 1.6 lakh Covaxin doses so far.
The department has decided to conduct extensive awareness campaigns so that refusal to get Covaxin doses does not become a worrying point for them.
“There are plans to run awareness campaigns through seminars, WhatsApp messages, and by involving different professional organisations, prior to the initiation of and during the Covaxin vaccination programme. The purpose is to remove the misconceptions and to allay anxiety surrounding Covaxin,” said Santanu Kumar Tripathi, former head of clinical pharmacology at the School of Tropical Medicine, who is a member of a committee formed by the state health department for Covid-19 vaccination.
Frontline workers
The health department also decided on Friday to begin vaccination of frontline workers from next week. So far only healthcare workers have been inoculated.
“Among the frontline workers, police, municipal workers and revenue officials in the district magistrate’s office will be given priority,” said an official of the state health department.
The inoculation of frontline workers will continue simultaneously with that of healthcare workers. “We will not wait for all healthcare workers to be vaccinated before we begin to vaccinate frontline workers. Frontline workers too will be called to the sites to receive doses from next week,” said the official.