Ocugen-Bharat Biotech Vaccine Shows Efficacy Against B.1.617 Variant
As a massive COVID-19 surge continues to rage on throughout India, scientists and public health officials scramble to determine whether currently authorized vaccines in the country can provide a mitigation effect to this unprecedented spread. A new study published online has provided some hope, with researchers suggesting that the Covaxin vaccine, developed by Bharat Biotech and Pennsylvania-based Ocugen, could neutralize the SARS-CoV-2 variant leading the second wave in India.
On Saturday, a total of 346,786 new COVID-19 cases were recorded by India’s Ministry of Health and Welfare, exceeding the country’s record of the most significant number of new, daily infections reported by any other country.
Over the past few days, India has reported a mean of 331,000 new COVID-19 infections per day, a stark contrast to the fewer than 15,000 cases reported in early March of this year.
A relatively new, more transmissible strain of the virus that contains 2 mutations – E484Q and L452R – appears to be leading the recent surge in India. The prevalence of this variant, called B.1.617, has increased to up to 52% in sequenced blood samples this month. So far, up to 20 countries, including Australia, Germany, Ireland, Belgium, New Zealand, Singapore, Namibia, the U.K. and the U.S., have reported cases of B.1.617.
In India, there have been three authorized vaccines for COVID-19, including Russia’s Sputnik V, Bharat Biotech’s Covaxin, and the Indian-manufactured vaccine of AstraZeneca Covishield. The Indian government also discusses whether to authorize COVID-19 vaccines Pfizer, Moderna, and Johnson & Johnson.
A recent study published in the preprint server bioRxiv suggests Covaxin neutralizes the B.1.617, providing hope for the country currently taking the hardest hit from the novel coronavirus. In this study, the investigators examined the level of antibodies necessary to neutralize the infectious variance in serum samples from 17 individuals who have recovered from COVID-19. These are recovered patients were previously infected with variants B.1.1.7 (n=2), B.1.351(n=2), B.126.96.36.199(n=2) and B1 (n=11).
Findings were compared with data obtained from sera samples of patients who received Covaxin. The researchers found a similar neutralization capacity against B.1.617 in vaccinated people and those who had recovered from COVID-19. Results from this small study have not yet been peer reviewed.
On Monday morning, shares of Ocugen surged in pre-market trading after the White House said it will back India in fighting the country’s COVID-19 case spike. Stock in OCGN was up 16.3% by 7:30 am ET.
And on Sunday, the White House said the U.S. had found sources of specific raw material needed to manufacture the Covishield vaccine, developed by AstraZeneca with Oxford University, in India. This material will be made immediately available in the country.
On the U.S. front, Ocugen has struck a deal with Bharat to manage Covaxin’s commercialization in the states pending approval from U.S. regulators. Last week, an interim analysis of Phase III trial data showed the vaccine had a 78% efficacy against mild-to-moderate COVID-19 as well as a 100% efficacy against severe infection.
The efficacy of the vaccine against mild-to-moderate disease decreased from the initial 81% demonstrated in the first interim analysis. The findings are still promising and may continue to support bringing the vaccine to the U.S. market.
“We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date,” said Shankar Musunuri, Chairman and Chief Executive Officer of Ocugen, in a statement. “We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market.”