Beneficiaries Reluctant to Sign Covaxin from Bharat Biotech’s Consent Form, Strike Rate Below 50%

Reportedly, on Day 1, only 99 Covaxin doses could be administered in Tamil Nadu out of the planned 600 for the first day. The following day, it had administered only 90 more doses for data available till 2.00 pm.

Bharat Biotech’s Covaxin beneficiaries are unwilling to sign the consent form, all three states- Bihar, Tamil Nadu and Telangana that administered the vaccines on January 16 have said. This led to a less than 50 percent strike rate in states on the first day of the world’s largest coronavirus inoculation drive.

The issue was raised by the states in the coordination meeting chaired by Union Health Minister Harsh Vardhan later on January 16, an Economic Times report stated.

Reportedly, on Day 1, only 99 Covaxin doses were administered in Tamil Nadu out of the planned 600 for the first day. The following day, it had administered 90 more doses till 2.00 pm. All 11 states, which agreed to administer Covaxin doses, have dedicated six vaccination centres as part of the drive and all of these centres are restricted to government hospitals.

Meanwhile, in Rajasthan 314 Covaxin doses were administered out of the planned 600. Even though no adverse event was reported from the vaccine in the state, reportedly, beneficiaries were still hesitant to take it. Rajasthan’s National Health Mission director Naresh Thakral told ET that translating the consent form to Hindi may have helped.

This comes after several politicians and experts have raised questions on the effectiveness of Covaxin as it is still under phase-3 clinical trials.

Bharat Biotech’s COVID-19 vaccine Covaxin, developed in collaboration with the Indian Council of Medical Research (ICMR), was granted restricted emergency use approval under the clinical trial mode. This means that people who receive the doses will have to sign a three-page informed consent form, and will also be monitored for any serious side effects.

Concerns over Covaxin, the locally-produced coronavirus vaccine

Experts have raised concerns over India’s emergency approval of a locally-produced coronavirus vaccine before the completion of trials.

The head of Bharat Biotech, which makes Covaxin, defended the approval process, but health experts warn it was rushed.

Health watchdog All India Drug Action Network said it was “shocked”.

It said that there were “intense concerns arising from the absence of the efficacy data” as well a lack of transparency that would “raise more questions than answers and likely will not reinforce faith in our scientific decision making bodies”.

The statement came after India’s Drugs Controller General, VG Somani, insisted Covaxin was “safe and provides a robust immune response”.

He added the vaccines had been approved for restricted use in “public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains“.

“The vaccines are 100% safe,” he said, adding that side effects such as “mild fever, pain, and allergy are common for every vaccine”.

The Resident Doctors’ Association (RDA) of the Ram Manohar Lohia Hospital in New Delhi had earlier requested the medical superintendent of the facility to administer SII’s coronavirus vaccine, Covishield, amid apprehensions about Covaxin.

The resident doctors were “a bit apprehensive” about Covaxin and may not participate in the immunization drive in large numbers, the association said in a letter.