Bharat Biotech, a Hyderabad-based pharmaceutical company, released the results of phase 3 trials of its coronavirus vaccine Covaxin on Wednesday, stating that the efficacy of India's first homemade vaccine is 81 percent. In the ongoing vaccination campaign, the 'Made-in-India' vaccine is being used alongside the Covishield vaccine from the Serum Institute of India (SII). Covaxin was given to many lawmakers, including Prime Minister Narendra Modi, who had received the first dose of their Covid-19 vaccine.
"The phase 3 study enrolled 25,800 people aged 18 to 98, including 2,433 people over 60 and 4,500 people with comorbidities." The first incidence 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 is the primary endpoint of phase 3 clinical trial. Bharat Biotech announced on February 23 that it would release interim efficacy results for the Covaxin phase 3 trial within the next two weeks.
Bharat Biotech's CMD Krishna Ella said after the phase 3 trial results were released that Covaxin not only protects against Covid-19 but also offers substantial immunity against new and rapidly evolving variants. "Covaxin exhibits a strong clinical efficacy pattern against COVID-19, as well as substantial immunogenicity against rapidly evolving variants," Ella explained.
The government was ridiculed for approving the vaccine for emergency use in January despite the lack of phase 3 trial results. The ICMR then stated that restricted use in emergencies was granted based on immunogenicity data obtained from phase 2 clinical trials, and that the Clinical Trials Rule 2019 requires phase 2 results to be used as a guide for approval.
Covaxin will be shipped to Mongolia, Myanmar, Sri Lanka, the Philippines, Bahrain, Oman, the Maldives, and Mauritius, and clinical trials in these countries will begin soon, according to the company's website. The vaccine does not need sub-zero storage, according to the company's website, which may be advantageous for countries with hot climates.
It's a vaccine that doesn't require sub-zero freezing, doesn't require reconstitution, and comes in ready-to-use liquid form in multi-dose vials that's safe at 2-8°C.
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