India’s 2 coronavirus vaccines get final approval for emergency use

Publish: 7:24 PM, January 3, 2021 | Update: 7:24 PM, January 3, 2021

NEW DELHI,  – India today gave final approval to Covishield and Covaxin, the two coronavirus vaccines, manufactured by Serum Institute of India and Bharat Biotech Ltd respectively for “emergency use” to fight against coronavirus.

The Drugs Controller General of India (DCGI), the country’s drug regulatory authority, formally announced the final approval for the Oxford-AstraZeneca and Bharat Biotech vaccines against coronavirus disease (Covid-19) this morning.

The DCGI, however, gave nod to Cadila Healthcare Ltd to conduct Phase-III Clinical Trial Protocol.

M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses. All these vaccines have to be stored at 2-8° C, according to a statement issued by the union health ministry this morning.

On Saturday evening, the subject expert committee (SEC) under Central Drugs Standard Control Organisation (CDSCO) had recommended Oxford-AstraZeneca’s vaccinefor emergency use and Covaxin for restricted use.

The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics and internal medicine.

With the DCGI’s final approval, the vaccination drive will start anytime soon, hinted the drug regulatory head V G Somani recently.

Immediately after the announcement by the DCGI, Prime Minister Narendra Modi said, “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India.”

He hailed the scientific community to fulfil the dream of an “Aatmanirbhar Bharat”, at the root of which is care and compassion.

Covaxin is the indigenous vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

VG Somani, Drug Controller General of India, claimed that the vaccines are “110 percent safe despite some side affects like mild fever, pain and allergy, which are common for any vaccines”.

“We’ll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” VG Somaniadded.

Meanwhile, India has conducted a countrywide vaccine dry-run drillat selected sites on Saturday for administering the COVID19 vaccine.

This dry run drive spread across 125 districts is covering all States/UTs having adequate representation of urban and rural districts along with hard-to-reach areas, the ministry sources said.

As the country readies for the COVID-19 vaccine roll-out, the government is planning to vaccinate 30 crore people in India against Coronavirus in the next six to eight months, starting with the frontline workers.

According to recommendations of National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), the vaccine will first be given to around one crore healthcare workers in both government and private hospitals, two crore frontline workers and people above 50 years of age.

The two crore frontline workers included state and central police department, armed forces, home guard, disaster management and civil defense organisation, prison staff, municipal workers and revenue officials engaged in COVID-19 containment, surveillance.