Coronavirus: Serum Institute, Bharat Biotech vaccines 110% safe, says DCGI after emergency approval
Union Health Minister Harsh Vardhan said the approval was a ‘watershed moment’ in India’s fight against the coronavirus crisis.
The Drugs Controller General of India on Sunday said that the coronavirus vaccines developed by Bharat Biotech and Serum Institute, which have been granted emergency use authorisation in the country, are 110% safe, ANI reported. Meanwhile, the Centre and World Health Organization welcomed the clearance granted to the vaccines.
The Serum Institute is the local maker of Covishield, the vaccine developed by Oxford University and pharmaceuticals company AstraZeneca. Bharat Biotech has manufactured India’s first indigenous vaccine candidate Covaxin in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
DCGI chief VG Somani held a press briefing at 11 am to make the announcement. He told reporters after the briefing that the vaccines wouldn’t have been approved if even the slightest safety concerns existed. “Some side effects like mild fever, pain and allergy are common for every vaccine,” he said in response to a question about possible side effects of the vaccine.
Union Health Minister Harsh Vardhan, on the other hand, said that the clearance to the two vaccines was a “watershed moment” in India’s fight against the coronavirus crisis. “These vaccines are a fitting tribute to our corona warriors!” he tweeted. “My heartfelt gratitude to all healthcare professionals and frontline workers for their exemplary efforts during these unprecedented times. Congratulations to all the scientists and researchers for their untiring efforts.”
The health minister added that the government had set up a strong supply chain to ensure the quick and equitable distribution of the vaccines. “Urge all citizens to entrust the stringent protocols followed for ensuring safety, efficacy and immunogenicity of the approved vaccines,” he said.
Serum Institute of India Chief Executive Officer Adar Poonawalla said the risks taken by his firm had finally paid off. “Happy new year, everyone!” he said in a tweet. “COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks,” he added.
Bharat Biotech said the approval was a “great milestone” for India, PTI reported. “While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most,” the company’s Managing Director Krishna Ella said. “Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”
Poonam Khetrapal Singh, WHO South-East Asia’s regional director, said India’s approval to the two vaccines will help strengthen efforts to combat the pandemic in the region. “The use of vaccine in prioritised populations, along with continued implementations of other public health measures and community participation will be important in reducing the impact of COVID-19,” she said in a statement.
All India Institute of Medical Sciences Director Randeep Guleria said it was a great day for the country, ANI reported. “It’s a very good way to start the new year,” he added. “Both the vaccines are made in India. They are cost-effective and easy to administer. We should, in a very short period, start rolling out vaccine.”
Guleria also sought to provide an assurance about the safety of the vaccines. “It’s important to understand that when we consider any vaccine, safety is paramount and therefore vaccine goes through various stages to make sure it’s safe, then only we come to human trials,” he was quoted as saying by the news agency. “All data is critically looked at by experts after which vaccine is approved.”
Union Home Minister Amit Shah also celebrated the “momentous achievement for India”. “I salute our very talented and hardworking scientists for making India proud,” he tweeted. Shah also thanked the country’s frontline health workers.
Earlier in the day, Prime Minister Narendra Modi had said that the clearance to the vaccines was a “decisive turning point” in coronavirus containment efforts. “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India,” he had added.
The Congress, meanwhile, raised questions about the decision to grant emergency approval to Covaxin before the completion of phase-3 trials. Rajya Sabha MP Anand Sharma said that the matter of granting authorisation to the vaccine use needed to be taken carefully as no country had done away with the mandatory phase 3 trials and verification of data.
Senior Congress leader Jairam Ramesh asked the Centre to clarify why internationally-accepted protocols on phase 3 trials were being modified. His colleague Shashi Tharoor also tweeted saying that the “approval was premature and could be dangerous”.
India on Sunday registered 18,177 new coronavirus cases, taking its tally to 1,03,23,965. The new cases were 4.7% lower than Saturday. The country’s toll rose by 217 to 1,49,435. The number of active cases stood at 2,47,220, while the recoveries reached 99,27,310.