Washington: India's Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, effectively neutralizes both alpha and delta forms of the coronavirus, the US National Institutes of Health has said.
The NIH said the results of two studies of the blood serum of people who had received Covaxin showed that the vaccine produced antibodies that previously caused the B.1.17 (alpha) and B.1.617 (delta) variants of SARS-CoV-2 effectively neutralizes it. Identified in the UK and India respectively.
The top US health research institute, which has a history of strong scientific collaboration with India, also said that a subsidiary developed with its funding has contributed to the success of the highly effective Covaxin, which has been administered to nearly 25 million people so far Has been done In India and elsewhere.
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Adjuvants are substances that are formulated as part of a vaccine to boost the immune response and increase the effectiveness of the vaccine.
Covaxin contains a disabled form of SARS-CoV-2 that cannot replicate but still stimulates the immune system to make antibodies against the virus. The NIH said published results from a Phase II trial of the vaccine show it is safe and well-tolerated, with safety data from a Phase III trial of Covaxin becoming available later this year.
"Meanwhile, unpublished interim results from the Phase 3 trial indicate that the vaccine has 78 percent efficacy against symptomatic disease, 100 percent efficacy against severe COVID-19 including hospitalization, and against asymptomatic infection with SARS-CoV." It has 70 percent efficacy against 2. 2, the virus that causes COVID-19," it said.
"The results of two studies of blood serum from people receiving Covaxin showed that the vaccine produced antibodies that effectively neutralized the B.1.7 (alpha) and B.1.617 (delta) forms of SARS-CoV-2. which was first identified in the UK and India respectively," the NIH said.
Ending a global pandemic requires a global response, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
"I am delighted that a new vaccine Adjuvant developed in the US with the support of NIAID is part of an effective COVID-19 vaccine available to people in India," he said.
The adjuvant used in Covaxin, Alhydroxiquim-II, was discovered and tested in a laboratory by the biotech company ViroVax LLC of Lawrence, Kansas, with support from the NIAID Adjuvant Development Program.
Lhydroxyzyme-II is the first adjuvant in an authorized vaccine against an infectious disease that activates the receptors TLR7 and TLR8 that play important roles in the immune response to the virus.
In addition, the alum in Lhydroxyzyme-II stimulates the immune system to search for an invading pathogen. The NIH notes that molecules that activate TLR receptors potently stimulate the immune system, but the side effects of Alhydroxykim-II are mild.
According to the NIH, the NIAID Adjuvant Program has supported the research of Virovax's founder and CEO, Sunil David, MD, Ph.D., since 2009. Their work has focused on the discovery of novel molecules that activate and elicit innate immune receptors. As a vaccine adjuvant.
The collaboration between Dr. David from Hyderabad and Bharat Biotech International Limited was initiated during the 2019 meeting in India coordinated by the NIAID Office of Global Research under the aegis of NIAID's Indo-US Vaccine Action Program.
A delegation of five NIAID-funded assistant investigators, including Dr. David; two members of the NIAID Division of Allergy, Immunology, and Transplantation; and representatives of NIAID India visited four major biotechnology companies to learn about their work and discuss possible collaborations.
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The delegation also participated in a consultation co-organized by NIAID and India's Department of Biotechnology and organized by the National Institute of Immunology of India in New Delhi.
Amidst the scientific collaboration that started from these activities, Bharat Biotech signed a licensing agreement with Dr. David to use Elhydroxycim-II in its candidate vaccines. This license was expanded during the COVID-19 pandemic to include Covaxin, which has received emergency use authorization in India and more than a dozen other countries.
The NIH said, "The company conducted a comprehensive safety study of LHydroxycim-II and carried out the complex process of scaling up production of the adjuvant under good manufacturing practice standards. Bharat Biotech is expected to produce an estimated 700 million doses of Covaxin by the end of 2021. " said.
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