India’s first COVID-19 vaccines get DCGI approval for emergency use
The Drug Controller General of India (DCGI) on Sunday approved the emergency use of both Oxford-AstraZeneca’s Covishield and Bharat Biotech’s Covaxin for immunisation against Covid-19 in India. Addressing the media, the DCGI said, “After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of Serum Institute and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to Cadila Healthcare for the conduct of Phase III clinical trial.”
On January 1, Covishield was recommended for emergency use whereas Covaxin was recommended for restricted use on January 2.
Drug Controller General of India VG Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use”. Replying to queries on the potential risks the vaccines might pose, Somani said, “We will never approve anything if there’s slightest of safety concern. Vaccines are 110 % safe. Some side effects like mild fever, pain & allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish.”
Soon after the DCGI nod, Prime Minister Narendra Modi tweeted: “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”
“We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives,” PM Modi added.
Welcoming the decision, SII CEO Adar Poonawalla wrote, “Happy new year, everyone! All the risks SII took with stockpiling the vaccine have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”
Dr. Poonam Khetrapal Singh, regional director WHO South East Asia Region said that WHO has welcomed the first emergency use authorization given to COVID 19 vaccine in the WHO South East Asia region. “The use of vaccine in prioritized populations along with continued implementation of the other public health measures and community participation will be important in reducing the impact of COVID 19,” Dr. Singh.
Regional director, World Health Organization (WHO), South East Asia Region, Dr Poonam Khetrapal Singh said that WHO has also welcomed the first emergency use authorisation given to COVID 19 vaccine in the WHO South East Asia region. “The use of vaccine in prioritized populations along with continued implementation of the other public health measures and community participation will be important in reducing the impact of COVID-19,” Singh added.
On Saturday, select hospitals across the country conducted an inoculation dry run. The nationwide rehearsal was to understand the best way to administer the vaccine and plug loopholes in logistics and training. India, which has more than one crore three lakh cases of infection, will conduct the largest vaccination drive in the world.
While reviewing the dry run in Delhi’s GTB hospital on Saturday, Health Minister Harsh Vardhan said the vaccines would be administered free of cost to priority groups in the first phase on India’s inoculation drive. This includes one crore healthcare workers and two crore frontline workers. Vardhan said the details of the second phase, in July, which will include vaccines for 27 crore more beneficiaries, is being worked out.
Source: The Indian Express