Hyderabad-based pharmaceutical company Bharat Biotech on Wednesday released its results of phase 3 trials of its coronavirus vaccine Covaxin, outlining that the efficacy of the India’s first homemade vaccine is 81 per cent.
The ‘Made-in-India’ vaccine is being administered currently along with Serum Institute of India’s (SII) Covishield in the ongoing vaccination drive. Several lawmakers including the Prime Minister Narendra Modi, who have received the first dose of their Covid-19 vaccine, have received Covaxin.
Bharat Biotech said that the clinical trial in third phase involved 25,800 participants, making it the largest ever trial conducted in India. The phase 3 trials were conducted in partnership with Indian Council of Medical Research (ICMR).
“The phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline,” a statement from the company said.
On February 23, Bharat Biotech said that it will release its interim efficacy data for the phase 3 trial of Covaxin within the next two weeks.
After the release of the phase 3 trials data, Bharat Biotech’s CMD Krishna Ella said that Covaxin not only protects against Covid-19 but also provides significant immunity against new and rapidly emerging variants. “Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” said Ella.
Suchitra Ella, Bharat Biotech’s joint managing director, thanked every volunteer and said that the milestone would not have been achieved without the relentless commitment of every volunteer involved. Suchitra Ella said, “I want to thank every one of the participants, who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery.”
“We could not have achieved this public-private partnership milestone without the relentless commitment of those involved,” she further added.
The lack of phase 3 trial data had led criticism against the government for granting emergency use approval to the vaccine back in January. The ICMR had then said that restricted use in emergency has been granted based on immunogenicity data which was generated based on phase 2 clinical trials and had said that the Clinical Trials Rule 2019 allows considering phase 2 results to guide for approval.
Mongolia, Myanmar, Sri Lanka, Philippines, Bahrain, Oman, Maldives and Mauritius will receive supplies of Covaxin and the company’s website says that clinical trials in these nations will also begin soon. The company’s website also outlines that the vaccine does not require any sub-zero storage, which could prove beneficial for countries with hot climates. “It is a vaccine with no sub-zero storage, no reconstitution requirement, and ready to use liquid presentation in multi-dose vials, stable at 2-8°C,” Bharat Biotech said. Hindustan Times