Covaxin phase 3 trial data now with FDA; envoy awaits start of negotiations for supply

FILE PHOTO: Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech’s COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. REUTERS/Adnan Abidi

MANILA, Philippines — Indian vaccine maker Bharat Biotech submitted the interim data from phase 3 trials of its COVID-19 jab to the Food and Drug Administration (FDA) on Tuesday evening, India’s ambassador to the Philippines disclosed Wednesday.

Ambassador Shambhu Kumaran also expressed eagerness to begin negotiations with the Philippine government for the supply of Bharat Biotech’s Covaxin.

India’s biotech firm applied for an emergency use authorization (EUA) of Covaxin in January. However, FDA Director-General Eric Domingo said in February that the company has yet to submit documents from clinical trials for its anti-coronavirus drug.

“I am not sure why we have not started negotiations. I hope that we can start tomorrow. We are ready. The company is ready. I believe that there was perhaps a degree of patience on the Philippine side because the phase 3 data have not been shared, but I am happy to share with you and your viewers that the interim data was shared last evening with the FDA,” Kumaran said in an interview with ABS-CBN News Channel.

The Philippines and India are in talks for the supply of at least eight million doses of Covaxin, according to Kumaran.

He said Bharat Biotech “has had one or two representations with the FDA for the supply of the vaccines but the commercial negotiations which involve signing of a term sheet and eventually moving into a contract are still pending.”

Bharat Biotech earlier revealed that preliminary data from phase 3 trials for the Covaxin showed it has an efficacy rate of 81 percent.

In the same interview, Kumaran shared that India has vaccinated two million individuals against COVID-19 on Tuesday alone. He said the government of India is looking at vaccinating 300 million individuals by August.

“At the moment, what we are working on is 300 million vaccinated by August yet we crossed the milestone of two million vaccinations a day. So there’s been a slow ramping up. Last week we reached one million a day. Yesterday was the first time we reached two million a day,” Kumaran said.

“The idea is we would hit about 300 million vaccinations by August. That is an ambitious target but very much achievable because the prime minister, as you noted, has led from the front right from the beginning… from enforcing a strict lockdown to easing it out, to guiding the process, to encouraging an economic revival in India, to supporting the efforts for self-reliance,” he further said.

KGA