7580 people witnessed adverse reactions across India in first phase: Govt

Hyderabad: A total of 7580 people witnessed Adverse Event Following Immunization (AEFI) till January 31.Twelve people have died. However, the government has categorically mentioned that the deaths are not causally related to vaccination.

"These deaths were investigated and examined by the experts and as per current evidence, none of these deaths have a causal relationship with the COVID-19 vaccination. In addition, measures have been put in place like availability of anaphylaxis kits at each vaccination site, immediate referral to AEFI management center and observation of vaccine recipients for 30 minutes at session site for any adverse events so as to take timely corrective measure" said Harsh Vardhan-Minister of Health and family welfare.

India's Central Drugs Standards Control Organization (CDSCO) has granted permission to manufacture both Covishield and Covaxin as per New Drugs and Clinical Trials Rules, 2019. Currently, these two vaccinations have been rolled out.

What is AEFI?

Adverse Event Following Immunization (AEFI) is any untoward medical occurrence which follows immunization and may not necessarily have a causal relationship with the vaccine.

According to case studies, the symptoms people are witnessing are anxiety, vertigo, giddiness, dizziness, fever, pain, rashes, and headache which are self-limiting and all people have recovered. This is monitored through the AEFI surveillance system.

Currently, the prioritized groups which comprise of Health Care Workers, Front Line Workers, persons above the age of 50 years, and persons below 50 years with associated comorbidities, are being given priority in vaccination.

Why was Covaxin granted approval despite non –completion of Phase III trials

Bharat Biotech developed 'Covaxin' has the potential to target mutated coronavirus including the United Kingdom (UK) strain. The data submitted by the company has demonstrated a strong immune response (both in antibody as well as T cell) and in-vitro viral neutralization, the ministry of Health and family said.

Covaxin though in its Phase III of the trial has been approved by the government for restricted use in an emergency situation. This means an individual can opt for Covaxin after giving written consent to be part of the phase III trials.

The permission to rollout Covaxin for restricted use in an emergency situation in clinical trial mode was granted after the advice of Subject Expert Committee. But the approval came with a list of conditions. Bharat Biotech is required to submit safety data on Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter to CDSCO.

"In case of any serious adverse events, vaccine recipient will be provided a medically recognized standard of care in a government-designated hospital. And the compensation for the adverse event will be paid by the company if the SAE is proven to be related to the vaccine. And if the vaccine recipient develops symptoms of COVID-19, he/she will be provided treatment in a government hospital," Ashwini Kumar Choubey, Minister of State for health and family welfare, told Rajya Sabha in a written reply.

This is beside the guarantee that the vaccine recipient needs to be provided treatment in a government recognized hospital if serious adverse effect surface.