The world’s largest COVID-19 vaccination program in India will launch on 13 January, signaling an early rollout, with cases surging to over 10 million and a surge in a new virus strain.
Health Minister Rajesh Bhushan said on Tuesday that the covid-19 vaccine will be deployed within 10 days of receiving emergency use approval. “We are ready to deploy COVID-19 vaccines within 10 days of the issuance of an emergency authorization based on feedback. But the government will only decide on the exact date of the vaccination program rollout, ”Bhushan said at a press conference.
On January 3, the regulator authorized the emergency use of two vaccines, Covishield and Covaxin.
Last week, the Ministry of Health conducted a nationwide immunization simulation program at 285 sites as part of a validation of end-to-end operations and mechanisms to ensure a smooth process. … The government announced it will use the digital Co-WIN platform to provide real-time information on vaccine stocks, storage temperatures, and individual tracking of vaccine recipients.
The deployment plan was presented to reporters as the number of cases jumped to 10.36 million on Tuesday and the number of deaths to 151,057.
India, the largest hotspot after the United States, has reported 16,375 new cases and 201 deaths in the past 24 hours. It is alarming that the number of people infected with the new virulent strain, first reported in the UK, has reached 71 in India.
Bhushan said the vaccine will be refrigerated and digitally tracked during transit – from the manufacturer to the main vaccine store, the national vaccine store, the district vaccine store, and the primary health center.
There are four main vaccine stores in Karnal, Mumbai, Calcutta, and Chennai, from where vaccines will be distributed in bulk to 37 government stores. All major, regional, and district stores will have temperature sensors, Bhushan said, and temperature information will be uploaded in real-time from the store to a central server.
Once the vaccine arrives at the district store, beneficiaries will be required to register, based on which the district judge will order vaccines, Bhushan said. However, there is no need for healthcare professionals and ordinary workers to register as their contact details will be retrieved from a mass database uploaded to the healthcare management system. vaccine.
This system will also allow beneficiaries to create a unique health identifier. “After two doses, a QR code certificate will also be generated that can be saved in the government’s DigiLocker app,” he said.
In the event of a negative reaction, a notification is provided in real-time. Other features include text messaging in 12 languages, a 24/7 hotline, and chatbot support. To date, over 90,000 users have been trained in over 700 districts.
Meanwhile, Dr. Balram Bhargava, CEO of the Indian Council for Medical Research (ICMR), said on Tuesday that safety, efficacy, and immunogenicity data are only needed for vaccine approval. in a non-emergency situation.
This is in our legal position: in a pandemic situation, limited use is envisaged based on safety and immunogenicity data. While phase 3 is still ongoing, the immunogenicity data from phase 2 clinical trials serve as a surrogate for efficacy, ”Bhargava said.
The Clinical Trials Registry (CTR) 2019 Clinical Trials Rule provides for the review of phase 2 results for approval. The Committee of Specialized Experts guides India’s Chief Medicines Officer in the decision-making process on restricted use in an emergency, ”he said.
ICMR, led by Bhargava, is co-developer of Covaxin with Bharat Biotech International Ltd. The regulatory body has been criticized for approving Covaxin for emergency use despite incomplete Phase 3 data. Bhargava said Serum Institute’s Covishield is safe and immunogenic, and the data shows it is on par with the AstraZeneca version.