India: Covid Vaccination Drive

The Union Health Ministry confirmed on August 25th 2021 that over 59.55 crore vaccine doses against Covid-19 have been provided to States and Union Territories till now cumulatively. This announcement has surely emphasized the fact that India is now moving towards better days in terms of vaccination penetration and safety. A reassurance to the different stakeholders and investors that the Indian economy will be back on track soon.

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India began administration of COVID-19 vaccines on 16th January 2021. India initially approved the Oxford–AstraZeneca vaccine (manufactured under license by Serum Institute of India under the trade name Covishield) and Covaxin (a vaccine developed locally by Bharat Biotech). They have since been joined by the Sputnik V (manufactured under license by Dr. Reddy’s Laboratories, with additional production from Serum Institute of India being started in September, Moderna vaccines, Johnson & Johnson vaccine and ZyCoV-D (a vaccine locally developed by Zydus Cadila) and other vaccine candidates undergoing local clinical trials.

Initial approvals, launch of vaccination programme

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 1st January 2021, the Drug Controller General of India (DCGI) approved emergency use of the Oxford–AstraZeneca vaccine (local trade name “Covishield”). On 2nd 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.

COVID-19 vaccination rolled out in AIIMS, New Delhi, India on 16 January 2021

India began its vaccination programme on 16th 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 1st 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 years 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 1st 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 authorization to Covaxin on 11th March 2021.

From 1st April, eligibility was extended to all residents over the age of 45 years. On 8th April, Prime Minister Narendra Modi called for a four-day Teeka Utsav (“Vaccine Festival”) from 11th to 14th 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 12th 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 19th April, it was announced that the next phase of the vaccination programme would begin on 1st 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 vaccination programme. 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 years.

Registration for the next phase began on 28th 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 1st May, and began to be administered on 14th May. An estimated 156 million doses are expected between August and December; initially, doses will be sourced from Russia, but domestic production is expected to begin by August 2021.

On 13th May, the DCGI approved phase 2 and phase 3 trials of Covaxin on children 2–18 years. On 14th 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 25th May, India exceeded 200 million vaccine doses administered in total. On 3rd 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.

On 23rd May the union government allowed walk-in registrations for vaccination throughout the country; a health worker at the vaccination centre would register the recipient in the Co-win vaccination database. The government claimed in an affidavit to the Supreme Court that as of June 23 about 78% of vaccines had been administered via walk-in registration.

Return to centralized procurement

On 31st May, an affidavit was issued in the Supreme Court of India requesting a review of the central government’s vaccine distribution strategy, suggesting that the decision to only offer doses at no charge to priority workers and residents over the age of 45 was “prima facie arbitrary and irrational”.

On 7th June, Prime Minister Modi announced that India would migrate back to centralized procurement of vaccines by 21st June. In an address, Modi stated that multiple chief ministers had requested that the central government reconsider its new distribution strategy, and reinstate the system it had used prior to May. As before, the centre will procure up to 75% of the country’s vaccine supplies from manufacturers in bulk, and distribute them to states at no additional charge. Vaccines would now be offered at no charge for those in the 18–44 years age group. Private hospitals will still be responsible for the remaining 25% of procurement, but fees for appointments are now capped at ₹150 (US$2.10).

On 21st June, the day these changes took effect, approximately 8,270,000 doses were administered—India’s largest single-day total to date. The states of Madhya Pradesh and Karnataka had the highest local totals.

On 23rd June, India surpassed over 300 million vaccine doses administered in total. On 28th June, India overtook the United States in total vaccine doses administered. On 29th June, the DCGI approved the Moderna vaccine (which is being imported by Cipla) for emergency use.

500 million mark, Johnson & Johnson Covid-19 vaccine approval and New record

On 6th August 2021, India crossed the 500 million doses milestone within 6 months from the onset of the vaccination program.

On 7th August 2021, the Drug Controller General of India (DCGI) approved emergency use of the Johnson and Johnson single-dose vaccine. On 16 Aug 2021, India administered around 8.81 million doses of COVID-19 vaccines, achieving the highest single-day record and overtaking its own previous record of 8.61 million doses, by 16 August the cumulative doses had surpassed the 55 million mark.

ZyCoV-D approval and Vaccination for ages 12-17 years

On 20th August 2021, India granted emergency use approval to the world’s first DNA based COVID-19 vaccine, ZyCoV-D manufactured by Zydus Cadila for adults and children aged 12 years and above. The vaccine is administered using a needle-free applicator. With all these developments, it is believed that India is in better place now, in terms of increasing the vaccination penetration and is also better prepared for the fight against the

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