Manas Dasgupta
NEW DELHI, Jan 3: India will have two vaccines to fight against Coronavirus with the Drug Controller General of India on Sunday giving the final nod for emergency use of both Covishield developed by Oxford University-AstraZeneca and being manufactured by the Serum Institute of India and Covaxin developed indigenously by Bharat Biotech.
“After adequate examination, Central Drugs Standard Control Organisation (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,” the drug controller V G Somani said. He said the permission had also been granted to Ahmedabad-based Cadila Healthcare to conduct Phase III clinical trial of the vaccine being developed by it.
The authorities also ruled out any safety concern of the two vaccines though these might have some minor side effects like mild fever or allergy, common for any vaccine.
The Subject Expert Committee (SEC) of the DGCI had recommended approval for emergency use of Covishield on January 1 and Covaxin on Saturday and the two vaccines were only waiting for the customary final nod from the DCGI before the country can roll out its massive immunization programme to counter the spread of the disease that has crippled the normal life and hit its economy.
According to the medical experts, both the approved vaccines need to be administered in two doses and stored at temperatures between 2 and 8 degrees Celsius.
Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use.” Replying to queries at a media conference on the potential risks the vaccines might pose, he 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 in a series of tweets said:
“A decisive turning point to strengthen a spirited fight!
DCGI granting approval to vaccines of
@SerumInstIndia and @BharatBiotech
accelerates the road to a healthier and COVID-free nation.
Congratulations India.
Congratulations to our hardworking scientists and innovators.”
“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 fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”
Underlining the country’s gratefulness to the Corona warriors, Modi said, “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.”
The Union Home Minister Amit Shah hailed the approval granted by the DGCI to the two vaccines and said, “A momentous achievement for India!DCGI has granted approval to COVID vaccines of the Serum Institute of India and Bharat Biotech. I salute our very talented and hardworking scientists for making India proud. Congratulations to Prime Minister Shri Narendra Modiji for striving towards a COVID free India. Visionary leadership can make a huge difference. Time and again, we have seen a New India eager to innovate and help the humanity during crisis. The approval to Made in India vaccines will prove to be a game changer in boosting Prime Minister Narendra Modi’s vision of an Aatmanirbhar Bharat. We heartily thank our scientists, doctors, medical staff, security personnel and all Corona warriors who dedicatedly served humanity during these testing times. Nation will always remain grateful to them for their selfless service towards mankind.”
Terming it a “watershed moment” in India’s fight against the pandemic, the union health minister Harsh Vardhan said, “A watershed moment in India’s famed battle against Covid-19 under leadership of PM Modi. Our wait for the vaccine is over with Covishield from Serum Institute of India and Covaxin from Bharat Biotech approved for emergency use in India.”
All India Institute of Medical Sciences (AIIMS) director Randeep Guleria said “it is a great day for the country and a good way to start the new year.” He also said indigenously developed Covaxin – one of the two vaccines approved – could be used as backup.
“It’s a great day for our country and it’s a very good way to start the new year. Both the vaccines are made in India. They are cost-effective & easy to administer. We should, in a very short period, start rolling out vaccines,” said Guleria.
He said that the vaccine developed by Bharat Biotech would be used as backup. “In an emergency situation when there is a sudden increase in cases & we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we’re not sure how efficacious the Serum Institute vaccine is going to be,” said Guleria.
“Initially, Serum Institute vaccine will be given. They already have 50 million doses available & they’ll be able to give that in the initial phase where we’ll vaccinate around 3 Cr people. Gradually, we’ll build on it & by the time Bharat Biotech data will also be available,” he added.
Welcoming the DCGI 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 said.
On Saturday, select hospitals across the country conducted a dry run as a rehearsal before rolling out the inoculation programme to identify any administrative lacunae in effectively implementing the scheme that the people of the country are anxiously waiting for the last 10 months or so since the pandemic broke out and the people were locked in. 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.
According to official sources, the Pune-based Serum Institute of India (SII), has manufactured Covishield, the Indian variant of the AZD1222 vaccine developed by Oxford University and AstraZeneca, and already stockpiled some 50 million doses. As such, the rollout can begin fairly quickly.
The other vaccine that has got emergency use authorisation, Covaxin manufactured by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), could take a few days or weeks to be available.
In the United States and United Kingdom, the first shots were administered within 1-2 days of the Pfizer-BioNTech and Moderna vaccines receiving regulatory approval. In India too, the process is likely to be very fast. While no concrete timelines have been announced it, it can be reasonably expected that the mass vaccination programme will begin within a fortnight.
First, the entire vaccination drive will be voluntary. The government has already announced that first in line will be 30 million (3 crore) workers in the forefront of India’s battle against the virus, including one crore healthcare workers and two crore frontline workers. Health Minister Harsh Vardhan had announced on Saturday (January 2) that the vaccine would be administered to them for free. Also receiving the vaccine in the first phase will be a third priority group – consisting of some 27 crore persons above age 50, and persons below age 50, but with associated comorbidities. Details of the first phase immunization programme were being finalized, he said.
Following is the text of the press statement issued by the DCGI granting approval to the two vaccines for emergency use:
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd.
The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
M/s Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%. Further, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies. After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.
M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally.
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.
The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue.
M/s Cadila Healthcare Ltd., has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee.
M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C.
After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trial.
