India Authorizes Covid-19 Vaccines Designed in US

Maria Elena Bottazzi, left, and Peter Hotez at the Center for Vaccine Development (Texas Children’s Hospital)

29 Dec. 2021. The government of India granted emergency clearance to two vaccines to prevent Covid-19 disease, both designed in U.S. research labs. The Drugs Controller General of India, or DCGI, yesterday authorized the Corbevax vaccine made by Biological E, a pharmaceutical company in Hyderabad India, designed by researchers at Texas Children’s Hospital Center and Baylor College of Medicine in Houston. DCGI also cleared the vaccine code-named NVX-CoV2373 made by biotechnology company Novavax Inc. in Gaithersburg, Maryland.

Corbevax is a project of the Center for Vaccine Development, a joint research center at Baylor Medicine and Texas Children’s Hospital. The vaccine is created as a low-cost protection against Covid-19 disease, produced with current drug manufacturing facilities, for lower resource regions of the world. The vaccine chemically resembles the receptor binding domain in the protein covering the SARS-CoV-2 viral spike, to induce an immune response against the virus, and contains an adjuvant that increases immune responses. Corbevax is given in two doses, 28 days apart.

“Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world,” says Maria Elena Bottazzi, co-director of the Center for Vaccine Development in a Texas Children’s statement. Bottazzi adds that Corbevax “will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production.”

Texas Children’s and Baylor license Corbevax to Biological E for clinical trials, manufacturing, and distribution. In two late-stage trials with adults in India, according to Biological E, Corbevax prevented symptomatic infections in more than 90 percent of cases of the original Wuhan strain of SARS-CoV-2, and 80 percent of cases from the delta variant. The company says the trials show Corbevax produces higher concentrations of neutralizing antibodies against the Wuhan strain and delta variant than the Covishield vaccine made by University of Oxford and drug maker AstraZeneca.

Still struggling with the delta variant

In addition, says Biological E, neutralizing antibodies from Corbevax diminished by 30 percent after six months, compared to 80 percent for most other Covid-19 vaccines. And recipients of Corbevax reported no serious adverse effects, as well as fewer adverse effects of any kind compared to Covishield.

While the U.S. and Europe are facing the emerging SARS-CoV-2 omicron variant, much of the rest of the world including India is still struggling with the delta variant. Peter Hotez, co-director of of the Center for Vaccine Development, says India’s authorization “is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant.”

Novavax’s NVX-CoV2373 is also a two-dose vaccine given 21 days apart, and made with a technology that generates nanoscale particles of synthetic proteins designed to resemble the genetic code of the SARS-CoV-2 viral spike that penetrates and infects host cells. The vaccine is combined with the company’s adjuvant called Matrix-M that boosts immune responses, allowing for lower doses of the primary vaccine.

Serum Institute of India licenses NVX-CoV2373 from Novavax and will distribute the vaccine in India under the brand name Covavax. NVX-CoV2373 is currently in late-stage clinical trials in the U.K., U.S., and Mexico showing efficacy rates of 90 percent. The vaccine, says Novavax, produces a strong immune response, is well-tolerated by recipients, and can be shipped and stored with normal refrigeration.

“No one is safe until everyone is safe,” says Novavax CEO Stanley Erck in a company statement, “and today’s authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country’s ongoing efforts to control the pandemic.”

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