Thursday, April 8, 2021

Concepcion, private sector eagerly await EUA for Covaxin


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Go Negosyo panel on Covaxin (from left): Amb. Shambhu Kumaran, Jopin Romero of A Dose of Hope, Presidential Advisor for Entrepreneurship Joey Concepcion, Amb. Ramon Bagatsing, Jr., Dr. Rache Ellas of Bharat Biotech, Deepu Bhatia of Ambica, Enrique Gonzalez of IP Biotech Inc.

THE business and entrepreneurial advocacy group Go Negosyo recently held a briefing with a number of private companies regarding the Covid-19 vaccine Covaxin, manufactured by India’s Bharat Biotech. Around one million doses of Covaxin are expected to be made available to the private sector beginning this April, according to the forecast of Presidential Adviser for Entrepreneurship and Go Negosyo founder Joey Concepcion.

“The Covaxin brand will be an option for the private sector, and this is definitely something to look forward to. It has an 81 percent efficacy rate from the interim results of its Phase 3 trial, apart from already being used by India’s top officials,” he pointed out.

Concepcion likewise noted that India is currently the largest vaccine manufacturer in the world right now, thus validating the country’s expertise in the field. “The thrust of the private sector is to secure these vaccines. The more vaccines we have, the more ready we are to implement the vaccine rollout, the more the game changes. We all want to open up the economy and prevent lockdowns; and vaccination is the only route we have to achieve this.”

Covaxin will be exclusively distributed to the private sector by Ambica and Family Vaccine and Specialty Clinics (FVSC — an IP Biotech company). An emergency use approval (EUA) was recently applied for on Covaxin’s behalf with the Food and Drug Administration (FDA).

Covaxin is an inactivated vaccine designed to combat critical stages of Covid-19. It can be stored at temperatures of 2 t0 8 degrees Celsius, is suitable for transportation to, and storage in countries of all climates, and is expected to provide up to one year immunity against Covid-19. Data from 25,800 participants who received a vaccine or placebo in 1:1 ratio further showed that the vaccine was well-tolerated. This trial, which was conducted with the Indian Council of Medical Research, is the largest Covid-19 vaccine trial conducted in India to date.


At least 40 countries have applied for procurement of Covaxin. Among these countries are the United States, Bahrain, Oman, Maldives, Mauritius, Sri Lanka, and the Philippines. “Given the strong ties that the Indian community has with the Philippines,” said Deepu Bhatia of Ambica, “We are confident that we have an ample allocation of doses from Bharat Biotech — with the possibility of receiving even more as the year progresses. Once the FDA grants the EUA, we expect to have the vials as early as April — and hopefully organizations such as Go Negosyo can help the vaccine reach more people.”



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