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81% interim efficacy data boosts Bharat Biotech's hopes of Covaxin exports

Bharat Biotech said another interim analysis and a final one is expected in the weeks ahead, which will give a more robust picture of Covaxin's efficacy.

March 03, 2021 / 07:23 PM IST
PM Narendra Modi was given a shot of Bharat Biotech's Covaxin on March 1. (Image: Twitter/@DDNewslive)

PM Narendra Modi was given a shot of Bharat Biotech's Covaxin on March 1. (Image: Twitter/@DDNewslive)

Bharat Biotech’s COVID-19 vaccine Covaxin has shown 81 percent efficacy in the first interim analysis of Phase-3 trials, the company said, giving a shot in the arm for the Indian firm that is eyeing exports and hopes to join the World Health Organization’s COVAX programme for vaccination in poor and middle-income countries.

With this announcement on March 3, Bharat Biotech has pulled off its second coup in three days. Earlier, Prime Minister Narendra Modi took a jab of made-in-India Covaxin in full media glare, which is expected to encourage people to participate in India’s massive vaccination programme.

The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 percent.

The Hyderabad-based company said it would share the second interim analysis based on 87 cases, and the final analysis from 130 cases in coming weeks. This will give a more robust picture on the efficacy of the vaccine.

Bharat Biotech Chairman and Managing Director Krishna Ella recently expressed his desire to be part of the COVAX Facility. The COVAX programme is already committed to delivering 237 million doses of AstraZenca’s vaccine to 142 countries in the next three months.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Bharat Biotech has started signing bilateral deals to supply Covaxin. On February 26, it said it had signed an agreement with Brazil for supply of 20 million doses of its COVID-19 vaccine Covaxin.

The deliveries are expected to begin during Q2 and Q3 2021, but lack of efficacy data has been a stumbling block.

Brazilian prosecutors have sought immediate suspension of purchases of India’s Covaxin as the vaccine didn't have phase-3 efficacy data, Reuters reported.

Moneycontrol reported that France is also looking to import Covaxin.

Bharat Biotech on Wednesday said that more than 40 countries globally have expressed their interest in Covaxin.

"These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity," the company said.

The other advantages of Covaxin include the time-tested inactivated platform that is found to be effective against mutating strains. Unlike other vaccines that use one of prominent protein on the virus as antigen, which is prone to lose efficacy if the virus mutates. Inactivated vaccines are based on whole virion which is more stable and offers much broader protection.

Covaxin is also stable at 2 to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

The company also says that it has a 28-day open vial policy as a unique product characteristic, reducing vaccine wastage by approximately 10-30 percent.

In addition, Covaxin has government's firm backing from begining.  The vaccine has been approved for restricted emergency use under clinical trial mode in January, despite criticism of not having efficacy data. Covaxin has been showcased as the success story of Modi's Atmanirbhar.  Bharat Bitoech developed the Covaxin based on strain isolated and shared by the government's Indian Council of Medical Research (ICMR)'s the National Institute of Virology.

Ella recently said the company was ramping capacity to 40 million doses, with its third facility entering production. Now those capacities may not be sufficient for the company.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.

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