India is fighting the COVID-19 pandemic with two indigenous vaccines at the front - Covishield and Covaxin and the country is aiming to vaccinate the eligible people within this year. While carpeting the foreign-made vaccines, the government has been in the state of addressing the concerns of the people over the vaccines. Bharat Biotech, the maker of Covaxin, has now revealed the final study over the vaccine's efficacy.
The Hyderabad-based pharmaceutical company has on Saturday unveiled the safety and efficacy data of phase 3 clinical trials of Covaxin. The final analysis has come weeks after several people had demanded the maker to release the details of the efficacy as the vaccine was surfaced with controversies. According to Bharat Biotech, Covaxin was found to have an efficacy of 77.8% against symptomatic COVID-19.
The study was made through 25,798 participants and it is yet to be peer-reviewed. Bharat Biotech has said that Covaxin has 93.4% efficacy against severe symptomatic COVID-19, 63.6% protection against asymptomatic COVID-19, and 65.2% protection against the Delta variant, which has been declared as the variant of concern. In a statement, Bharat Biotech said, "Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events."
The maker has said that the vaccination was well tolerated with an overall incidence of adverse events observed over a median of 146 days that was lower than that observed with other COVID-19 vaccines. On the front of side effects, the company said that the most frequent adverse effect was a headache, followed by fever, fatigue, and myalgia. It has said that such incidences and events were below 1% in both groups.
Bharat Biotech has also said that no vaccine has so far reported efficacy against asymptomatic infection in a randomized controlled trial. It has further added that the clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow-up booster doses.
Bharat Biotech Managing Director Dr Krishna Ella said, "The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development." The reports say that additional clinical trials are currently underway to study the safety and efficacy of the vaccine for children between the age of 2 and 18.
ICMR Director Dr Balram Bhargava said, "Covaxin will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly SARS-CoV-2 virus. I am also pleased to see that Covaxin works well against all variant strains of SARS-CoV-2. The successful development of Covaxin has consolidated the position of Indian academia and industry in the global arena."
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