Covid-19 vaccine Covaxin Phase 3 Trial: No adverse effects after the first dose, says Gujarat hospital official

Coronavirus vaccine Covaxin update: Volunteers who have been administered dosage of Covaxin vaccine has not yet complained of any health issue or symptoms, said an official of a Gujarat-based hospital, which is conducting Phase 3 trial of the Covid-19 vaccine. Phase 3 trial of Covaxin, India’s first indigenous Covid-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), begun yesterday at Sola Civil Hospital, Ahmedabad.

According to Sola Civil Hospital Medical Superintendent Dr Parul Bhatt, more volunteers will be vaccinated today. Five volunteers have enrolled for the trial and were vaccinated from the 10 volunteers who approached them for the trial. She further informed that if any adverse reaction happens to the vaccine volunteers they will be treated at the hospital.

A total of 1,000 volunteers have been targeted, who will be vaccinated with 500 doses that arrived at the Gujarat facility on November 24 and has been stored at a temperature between 2 and 8 degree Celsius. Although the study design says volunteers of age group between 18 and 99 can be targeted, Bhatt added right now volunteers between 18 and 60 years of age have only been included.

Volunteers with comorbidities like heart diseases, hypertension, ischemic, diabetes can be included if they have had stable vitals in the past three months but the ones with autoimmune diseases cannot be. Also, anyone who had already been infected with Covid-19 infections once or had a family member suffering from it residing in the same household cannot be targeted.

The intramuscular vaccine shots will be administered to a participant, two times in 30 minutes interval onsite, followed by another dose in the next 24 hours. If no adverse reaction happens a follow-up dose will be given on day 15 and the fourth one on day 28, Bhatt said to The Indian Express.

Meanwhile, Prime Minister Narendra Modi is scheduled to visit Bharat Biotech’s facility at Genome Valley in Hyderabad on Saturday.