No info to CDSCO about specific severe adverse event linked to Covid-19 vaccines: MoS Health

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has not received information about any specific severe adverse event causally linked to administration of COVID-19 vaccines, the Rajya Sabha was informed on Tuesday.

India''s drugs regulator has approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country.

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Common adverse events which have been reported from COVID-19 vaccines approved for restricted use in emergency situation include headache, rash, chills, myalgia, fatigue, fever, dizziness, inflammation and pain, swelling or redness at the site of injection, erythema, pruritus and others, Minister of State for Health Ashwini Choubey said in a written reply to a question.

On the authority liable for any adversity faced by a patient who has been administered COVID-19 vaccines, Choubey said the firms are 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.

"As per Rule 82 of New Drugs and Clinical Trials Rules, 2019, the manufacturers are responsible for reporting of serious unexpected adverse reactions related to the drugs including COVID-19 vaccine to the Central Licensing Authority i.e. Drugs Controller General (India)," he said.

The CDSCO, in consultation with the Subject Expert Committee, has approved the protocol for rolling out the Whole Virion Inactivated coronavirus vaccine (BBV152) in clinical trial mode along with a factsheet, informed consent form, and adverse event form.

"As per the approval, in case of any serious adverse events, vaccine recipients will be provided a medically recognized standard of care in the government designated and authorized centers and hospitals.

"The compensation for the serious adverse event will be paid by the sponsor (BBIL) if the SAE is proven to be causally related to the vaccine. If any vaccine recipient develops symptoms of COVID-19, vaccine recipient will be provided a medically recognized standard of care in the government designated and authorized centers/hospitals," Choubey said.

On whether severe adverse events have been reported in relation to any COVID-19 vaccines currently being developed and or manufactured in India, Choubey said AEFI are categorized as ''minor'', ''severe'' and ''serious'' and various vaccines are given market authorization or restricted emergency use authorization by the national regulator only after their safety is established in pre-clinical and clinical trials.

"The National Coordination Centre-Pharmacovigilance Programme of India (NCC– PvPI)/Central Drugs Standard Control Organisation has not received information about any specific severe adverse events causally linked to administration of COVID-19 vaccines," he said.

On whether the COVID-19 vaccines being administered guarantee complete protection against all strains and variations of the virus, Choubey said in case of proposal of Bharat Biotech, during consultation and evaluation, the SEC of CDSCO noted that the Whole virion inactivated coronavirus vaccine has the potential to target mutated strains.

Regarding apprehensions about emergency approval for locally produced vaccine for COVID-19, Choubey said market authorization or restricted emergency use authorization are given by the national regulator based on well-established procedures and recommendation of the SEC which consists of domain knowledge experts.

Hence, such approvals are based on scientific evidence and data submitted before the regulator, he underlined.

Specific communication strategies involving multiple stakeholders both within and outside Government are being used by the Central and state governments to address vaccine hesitancy and to promptly rectify misinformation, if any, the union minister of state for health said.

He further said a communication strategy has been prepared to raise awareness about COVID-19 vaccines and address misinformation against vaccination.

The strategy aims to disseminate factual information about the vaccines and the vaccination process. This is being done through multimedia platforms and to reach out to the last mile the community leaders and influencers are being engaged, Choubey said.

The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) has been established, which provides guidance on all aspects of COVID-19 vaccination including prioritization of population groups, procurement and inventory management, vaccine selection, vaccine delivery and tracking mechanism.

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