Best American Institute for Health Research

The NIH said the results of two studies on the blood serum of people who have received Covaxin suggest that the vaccine generates antibodies that effectively neutralize the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS- CoV-2, first identified in the UK and India respectively.

The leading US institute for health research, which has a strong scientific collaboration with India, also said that an adjuvant developed with its funding contributed to the success of the highly effective Covaxin, which has been administered to around 25 million people. people to date in India and elsewhere.

Adjuvants are substances formulated as part of a vaccine to stimulate immune responses and improve the effectiveness of a vaccine.

Covaxin includes a deactivated form of SARS-CoV-2 which cannot replicate but still stimulates the immune system to make antibodies against the virus. Published results from a phase 2 trial of the vaccine indicate that it is safe and well tolerated, the NIH said, adding that safety data from a phase 3 trial of Covaxin will be available later this year.

“Meanwhile, unpublished interim results from the Phase 3 trial indicate that the vaccine has 78% efficacy against symptomatic disease, 100% efficacy against severe COVID-19, including hospitalization,” and 70% effectiveness against asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19, “he said.

“The results of two studies on the blood serum of people who have received Covaxin suggest that the vaccine generates antibodies that effectively neutralize the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, identified for the first time. in the UK and India, respectively, ”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), which is part of the NIH.

“I am pleased that a new vaccine adjuvant developed in the United States with support from 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 lab by biotechnology company ViroVax LLC of Lawrence, Kansas, with support from the NIAID Adjuvant Development Program.

Alhydroxiquim-II is the first adjuvant in an approved infectious disease vaccine to activate TLR7 and TLR8 receptors which play a vital role in the immune response to viruses.

In addition, the alum in Alhydroxiquim-II stimulates the immune system to search for an invading pathogen. Molecules that activate TLR receptors powerfully stimulate the immune system, but the side effects of Alhydroxiquim-II are mild, NIH said.

According to the NIH, the NIAID adjuvants program has supported the research of ViroVax founder and CEO ― Sunil David, MD, Ph.D. ― since 2009. His work has focused on finding new molecules that activate innate immune receptors. and develop them as adjuvants to vaccines.

The collaboration between Dr David and Bharat Biotech International Ltd. Hyderabad was initiated at a meeting in 2019 in India coordinated by the NIAID Office of Global Research under the auspices of the NIAID Indo-US Vaccine Action Program.

A delegation of five adjuvant researchers funded by NIAID, including Dr David; two members of the Allergy, Immunology and Transplantation Division of NIAID; and the representative of NIAID India, visited four major biotechnology companies to learn more about their work and discuss potential collaborations.

The delegation also attended a consultation in New Delhi co-organized by NIAID and the Indian Department of Biotechnology and hosted by the Indian National Institute of Immunology.

Among the scientific collaborations generated by these activities, Bharat Biotech signed a license agreement with Dr David to use Alhydroxiquim-II in their candidate vaccines. This license was extended during the COVID-19 pandemic to include Covaxin, which has received emergency use authorization in India and more than a dozen other countries.

“The company has conducted extensive safety studies of Alhydroxiquim-II and has undertaken the complex process of scaling up production of the adjuvant in accordance with good manufacturing practice standards. Bharat Biotech plans to produce approximately 700 million doses of Covaxin by the end of 2021, ”the NIH mentioned.

This story was posted from an agency feed with no text editing. Only the title has been changed.

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