Vaccines of Bharat Biotech and Pune-based Serum Institute of India (SII) are being approved for restricted emergency use, says DCGI Chief Dr VG Somani.
DCGI is the country’s apex regulatory authority for medicinal products.
The Drugs Controller General of India (DCGI) on Sunday approved Covaxin and Covishield for restricted emergency use. While making the announcement, Dr VG Somani, DCGI Chief, said that recommendations of the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) have been accepted. “Vaccines of Bharat Biotech and Pune-based Serum Institute of India (SII) are being approved for restricted emergency use,” he said.
Somani said that the vaccines are 100 per cent safe and theirs is nothing to fear about its side effects. “Pain, mild fever, and allergy are some very common side effects of every vaccine. The DCGI will not approve vaccines if there is even a slightest of safety concern,” he said.
When asked to comment on rumours that the people may get impotent because of the vaccines, the DCGI chief said it is ‘absolute rubbish.’
#WATCH I We’ll 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: VG Somani,Drug Controller General of India pic.twitter.com/ZSQ8hU8gvw
“This is a very important decision and it will strengthen a spirited fight! DCGI’s approval of vaccines to two vaccines will accelerate the road to a healthier and COVID-19-free nation. Congratulations India and congratulations to our all hardworking scientists and innovators,” PM Modi said.
A decisive turning point to strengthen a spirited fight!
The prime minister said that every Indian will be proud because the two vaccines that have been granted emergency use authorisation by the DCGI are made in India. “This is a testimony to the eagerness of our scientific community to fulfill the dream of Aatmanirbhar Bharat.”
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.
Serum Institute of India CEO Adar Poonawalla said that Covishield is ready to roll out in the coming weeks. The SII had applied for emergency use authorisation for the vaccine on December 6.
Happy new year, everyone! All the risks @SerumInstIndia 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. pic.twitter.com/TcKh4bZIKK
Commenting on the development, Delhi AIIMS Director Dr Randeep Guleria said that there couldn’t be a better way to start the new year. “It is a great day for our country as both the vaccines that received emergency user approvals from the DCGI are made in India. They are easy to administer and very cost-effective. Vaccines should be rolled out in a very short period.
It’s important to understand that when we consider any vaccine, safety is paramount & therefore vaccine goes through various stages to make sure it’s safe,then only we come to human trials. All data is critically looked at by experts after which vaccine is approved:Director,AIIMS https://t.co/LroLBEbOIv
Guleria also emphasised that vaccines go through various tests and trials before being approved for human trials.
The Delhi AIIMS director also said that the Bharat Biotech vaccine will be used in an emergency situation. “Serum Institute of India already has 50 million doses available. They will easily provide doses required during the initial phase in which around 3 crore people will be vaccinated,” he said.
Approval clearly says ’emergency situation’ keeping in mind the circulating variant strains & at the same time, they have to continue the trial & get the data in. Once that data comes in, we’ll be more confident as far as safety and efficacy is concerned: Dr. Randeep Guleria https://t.co/1CuAFW0Cqi
The subject expert committee had earlier approved the restricted use of Covaxin in emergency situations. Covaxin is being indigenously developed by Bharat Biotech. The panel also cleared the emergency use authorisation application of the Serum Institute of India (SII). The SII has is developing Covishield in collaboration with AstraZeneca.
With this, India is all set to get at least two vaccines in the next few days. Also, there are two COVID-19 vaccines that are in advanced stages of development. Addressing a press conference in the national capital, Union Minister Prakash Javadekar said that India was the only country in the world where four COVID-19 vaccines were in the pipeline.
When asked to comment on people raising doubts over vaccines, the Union minister said that it is ‘effective.’ “It is being used by other countries as well. These vaccines are being introduced by proper tests and are being brought in because they are safe.”
Meanwhile, Union Health Minister Harsh Vardhan has appealed people to be misguided ‘rumours’ about the efficacy and safety of the coronavirus vaccines. “Every vaccine will be approved only after it fulfils all the protocol,” Vardhan said.