Clinical efficacy of vaccine yet to be established, reads recipients' consent form

New Delhi: "In phase 1 and phase 2 clinical trials, COVAXINTM has demonstrated the ability to produce antibodies against COVID 19. However, the clinical efficacy of COVAXIN is yet to be established and it is still being studied in phase 3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covie 19 need not be followed," states the consent form to be filled by the recipients of the vaccine.

Sumitra Deb Roy, health journalist at Times of India, has shared the consent form in her Twitter handle.

Here's the full consent form that beneficiaries of Covaxin would have to sign if they wish to take the vaccine. They will also be given factsheet & AEFI form.State says for those unwilling to take Covaxin,there's no other vaccine waiting ! @AnantBhan @malini_aisola pic.twitter.com/zX00AmzIgg

— Sumitra Deb Roy (@SumitraRoyTOI) January 16, 2021

The government has approved two made in India vaccines – Oxford – AstraZeneca's Covishield and Bharat Biotech's Covaxin for emergency use authorisation.

Covishield vaccine is being touted as one of the most promising vaccines which are slower but cheaper. Astrazenca vaccine was approved by UK regulator based on interim safety and efficacy data from large phase 3 trials due monitoring for at least 60 days after the second dose.

In India, the approval was given based on safety and immunogenicity tested in India on a smaller number of participants and safety and efficacy data from large trials of over 24,000 participants in three foreign countries.

However, Covaxin was given approval by Drugs Controller General of India without any efficacy data. The approval was solely based on a small number of participants studied during phase 1 and phase 2 trials. The vaccine efficacy is studied only during a phase 3 trial.

The people will either receive a Covishield vaccine or Covaxin but cannot choose one over the other. If people find that a vaccination site provide only Covaxin they can choose not to get vaccinated.

Hence, the question over the meaning of consent is being raised widely.

People at the vaccine sites offering Covaxin are required to take an informed consent from each recipient before immunisation.

"In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in the government designated and authorized centers/hospitals," the consent form reads.

Meanwhile, activist Saket Gokhale has file a writ petition in Bombay High Court where in he states that the efficacy data submitted by the company has not been made public and contends that there is a great possibility of harm to the life of members of the general public that are being administered with the Covaxin.

Meanwhile, the government has said that the pregnant women may not take the jab for now.