Bharat Biotech’s Entry to the Race to Vaccinate: COVAXIN

By Maya Spencer, Edited by Sami Morse and Maura McDonagh

The entire world is awaiting a COVID-19 vaccine – many have gone into trials, but only a few may make the market. Here’s what we know about one of the promising candidates.

The Indian Council of Medical Research and the National Institute of Virology, collaborating with Bharat Biotech, a private biotechnology company located in Hyderabad, have developed an inactivated vaccine to protect against SARS-CoV-2, dubbing it COVAXIN. This vaccine was produced through the isolation of a SARS-CoV-2 strain from an asymptomatic patient. After isolation and growing the isolate into colonies, vaccine developers then inactivate the strain of SARS-CoV-2 to make their final product. Given COVAXIN is an inactivated vaccine, administration must be conducted in two separate sittings to create a strong enough immune response for protection, which can pose issues with compliance. However, due to this same killed-virus status, the vaccine may be used on immune-compromised individuals, with nearly no chance of reactivation in patients.

Pre-clinical trials conducted on monkeys and hamsters were encouraging, eliciting immunogenicity and displaying safety, with no animal experiencing major side effects from vaccine administration in either study. In phase I and II clinical trials, researchers determined that COVAXIN was safe, and, although not released to the public yet, preliminary data proved encouraging enough for the Drugs Controller General of India to approve the progression to phase III clinical trials on October 23, 2020. This next set of trials are expected to have around 25,000 participants, ranging from 25 cities across India, a step up from phase I and II, which had 375 and 380 participants respectively.

Bharat originally promised a vaccine by August 2020, but changed their prospective release date. After walking the timeline back, Bharat Biotech Chairman Dr. Krishna Ella claimed that COVAXIN could potentially be available by early 2021, and that they are currently gearing up to generate 300 million doses of COVAXIN a year.

Although COVAXIN’s early results seem promising, Bharat Biotech has been criticized for their short initial timeline. Promising a vaccine in August--incredibly premature considering their trial dates--has caused health professionals to worry about rushing the vaccine process, and the potential risks that may follow. Adding to this concern, Bharat cut its phase II trial size in half, from a planned 750 volunteers to 380, citing high immunogenicity from their phase I trials. In spite of concerns, experts say that if data from their first clinical trials supports their claims, this would be a safe way to expedite the process to phase III.

Rajni Kant, a senior scientist at the Indian Council of Medical Research, stated that COVAXIN may be launched as early as February 2021, given their positive early returns. With phase III clinical trials launching this week, we’ll all be watching to see if it passes the rigorous standards set in place to bring a vaccine to market.

Results from ongoing research and the current understanding of COVID-19 are constantly evolving. This post contains information that was last updated on November 17, 2020.

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