AstraZeneca, Bharat Biotech Vaccines Nab Emergency Approval in India

by Ruchi Jhonsa
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India, a country with the second-highest number of infections globally, becomes third after the UK and Argentina to grant emergency approval to the COVID-19 vaccine jointly developed by AstraZeneca and the University of Oxford. It is a huge moment for the country, which just witnessed 150,000 deaths from the SARS-CoV-2 infection. The country is expected to begin a massive immunization program next week and hopes to immunize 300 million people free of charge in the first six to eight months of this year.

The approval for AstraZeneca’s vaccine was announced in concurrence with another approval for the homegrown vaccine by Bharat Biotech called Covaxin. Dr. V.G. Somani, the drug controller general of India, said the Central Drugs Standard Control Organization, India’s pharmaceutical regulator, granted the approval after careful examination of the data, which came from Phase 2 and 3 trials conducted by SII on 1600 participants. The data derived from this small study was found to be “comparable” with the data from overseas studies.

The Oxford-AstraZeneca vaccine, known as Covishield in India, is being produced locally by the Serum Institute of India, the world’s largest vaccine manufacturer. Following a pact signed by the company with AstraZeneca, the producer has readied around 40 million doses till now for the world. This is lesser than the promised volume of 400 million doses by the end of the year. But with $300 million support from the Bill and Melinda Gates Foundation and some of its own funds, SII is geared to produce 100 million doses per month by February. Of all the doses produced, SII has pledged 50% of its production for India.


How Will Vaccines Be Distributed To Such a Large Population?

In a country of 1.3 billion people, the problem of distribution is pertinent. However, India is expected to derive experience from its existing vaccination programs such as nationwide polio vaccination and newborn immunization campaigns that already reach about 55 million people a year, administering 390 million free vaccines against a dozen diseases.

The country also boasts of an electronic system, Co-WIN, which it uses to keep track of stocks and distribution of the vaccine. This software will assist the program managers across all levels through automated session allocation for pre-registered beneficiaries, their verification, and a digital certificate will be generated upon successful completion of the vaccine schedule.

For the coronavirus vaccine campaign, the national government has requested states to prepare strategies. According to the health ministry, about 96,000 healthcare workers have been trained to administer the vaccine. On January 2nd, the country conducted a dry run at 116 sites to check the best way to vaccinate people against COVID-19 and plug any loopholes in logistics and training ahead of the vaccination drive. As many of the vaccinations are accompanied by mild to severe side effects, the dry run will also focus on managing these events following immunization.


Who Will Get the Vaccine First?

The first wave of vaccination in the country will begin this month and will run until March. This wave will cover 300 million people. The first 30 million inoculated will be healthcare providers, police, and other frontline workers. The remaining 270 million people will include people over 50 and those who have conditions that might make them vulnerable to the virus. The rest 1 billion people will be inoculated as and when the vaccine is made available.


Why is AstraZeneca’s Vaccine Better for a Country Like India?

The UK drugmaker’s vaccine was found to be 62% effective with two full shots and 90% effective with a half and a full dose. This efficacy is comparable to and higher than some of the existing vaccinations for other diseases. However, it is lower than much-touted vaccines produced by the US drug makers, Moderna and Pfizer, which are 90% efficacious. Despite that, AstraZeneca’s vaccine is much favorable in an Indian setting for two reasons. It is easy to store and easy to transport. The vaccine can be stored at 2-8 degrees Celsius in a normal refrigerator and does not require special cooling equipment for transportation. This is important for a country where a big percentage of the population lives in rural areas with bare minimum facilities for vaccine storage.

Related Article: COVID-19: Oxford/AstraZeneca’s DNA Vaccine Scores Emergency Use Approval in the UK

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