Initial Approvals, Launch of Vaccination Program

In September 2020, India's Health minister Harsh Vardhan stated that the country planned to approve and begin distribution of a vaccine by the first quarter of 2021. The first recipients were to be 30 million health workers directly dealing with COVID patients.
On 1 January 2021, the Drug Controller General of India (DCGI) approved emergency use of the Oxford–AstraZeneca vaccine (local trade name "Covishield"). On 2 January, the DCGI also granted an interim emergency use authorisation to BBV152 (trade name "Covaxin"), a domestic vaccine developed by Bharat Biotech in association with the Indian Council of Medical Research and National Institute of Virology. This approval was met with some concern, as the vaccine had not then completed phase 3 clinical trials. Due to this status, those receiving Covaxin were required to sign a consent form, while some states chose to relegate Covaxin to a "buffer stock" and primarily distribute Covishield.
India began its vaccination program on 16 January 2021, operating 3,006 vaccination centres on the onset. Each vaccination centre will offer either Covishield or Covaxin, but not both. 165,714 people were vaccinated on the first day of availability. Difficulties in uploading beneficiary lists at some sites caused delays. In the first three days, 631,417 people were vaccinated. Of these, 0.18% reported side-effects and nine people (0.002%) were admitted to hospitals for observation and treatment. Within those first days, there were concerns about low turnout, due to a combination of vaccine safety concerns, technical problems with the software used, and misinformation. The first phase of the rollout involved health workers and frontline workers including police, paramilitary forces, sanitation workers, and disaster management volunteers. By 1 March, only 14 million healthcare and frontline workers had been vaccinated, falling short of the original goal of 30 million.
Second phase
The next phase of the vaccine rollout covered all residents over the age of 60, residents between the ages of 45 and 60 with one or more qualifying comorbidities, and any health care or frontline worker that did not receive a dose during phase 1. Online registration began on 1 March via the Aarogya Setu app and Co-WIN ("Winning over COVID-19") website. Amid the beginnings of a major second wave of infections in the country, vaccine exports were suspended in March 2021, and the government ordered 110 million Covishield doses from SII. The company aims to produce 100 million doses per month, but by May 2021 its production capacity was only 60–70 million doses. Following the conclusion of its trial, the DCGI issued a standard emergency use authorisation to Covaxin on 11 March 2021.
From 1 April, eligibility was extended to all residents over the age of 45. On 8 April, Prime Minister Narendra Modi called for a four-day Teeka Utsav ("Vaccine Festival") from 11 to 14 April, with a goal to increase the pace of the program by vaccinating as many eligible residents as possible. By the end of the Utsav, India had reached a total of over 111 million vaccine doses to-date.
Third phase, Sputnik V approval
On 12 April, the DCGI approved Russia's Sputnik V vaccine for emergency use in India. A phase 3 trial had been conducted in the country in September 2020, which showed 91.6% efficacy. The local distributor Dr. Reddy's Laboratories stated that it planned to have the vaccine available in India by late-May 2021.
On 19 April, it was announced that the next phase of the vaccine program would begin on 1 May, extending eligibility to all residents over the age of 18. Under phase 3, individual stakeholders were also given more flexibility in how they conduct the vaccine program. As part of this plan, only half of the vaccines procured by the Central Drugs Laboratory from manufacturers would be distributed by the central government. This supply would go to government-run clinics and be offered free-of-charge to residents 45 and over and priority workers, and siphoned off to states based on factors such as the number of active cases and how quickly they are administering vaccines. The remainder would be offered to individual states and purchased on the open market (including private hospitals), which would be able to serve residents over the age of 18.
Registration for the next phase began on 28 April; a single-day record of nearly 13.3 million people registered. Due to supply issues, several states, including Delhi, Gujarat and Madhya Pradesh announced that they would delay their wider rollouts of vaccines to later in the month.
The initial shipment of 150,000 Sputnik V doses arrived on 1 May, and began to be administered on 14 May. An estimated 156 million doses is expected between August and December; initially, doses will be sourced from Russia, but domestic production is expected to begin by August 2021.
On 13 May, the DCGI approved phase 2 and phase 3 trials of Covaxin on children 2–18. On 14 May, health officials projected that based on the anticipated approval of additional vaccine options, it could receive at least 2.17 billion more vaccine doses from August to December 2021. On 25 May, India exceeded 200 million vaccine doses administered in total. On 3 June, the Ministry of Health and Family Welfare pre-ordered 300 million doses of a potential fourth vaccine, Corbevax, which is undergoing phase 3 clinical trials.
Regards,
Adina
Submit your manuscript at: https://www.longdom.org/submissions/infectious-diseases-preventive-medicine.html