1 Review on COVAXIN Vaccine
Covaxin recently received emergency usage approval from the World Health Organization. Two dosages of Covaxin, COVID-19's native vaccine in India, provide 77.8 percent protection against disease symptoms and do not pose any severe health risks, according to an interim report of its phase 3 trial, which was published in The Lancet on Friday.
Covaxin is an inactivated complete virus vaccine created in Hyderabad by Bharat Biotech. It has recently received an emergency use authorization by the World Health Organization (WHO) for individuals aged 18 and over.
The results of the phase 3 trial show that Covaxin produces a strong antibody response, with no serious adverse events related to vaccination or deaths reported among participants in the test, the researchers of the study stated.
The majority of adverse reactions, such as fatigue, headache, fever, and pain in the injection site, were not severe and occurred within the first seven days after vaccination, according to the doctors.
It is given in two doses, 28 days apart. It can be kept and carried at 2- 8 degrees Celsius.
The study ran from November 16 through May 17 this year, with those aged 18 and older randomly allocated to receive two doses or an uninvolved placebo.
Researchers "recorded 24 positive cases among 8,471 people in the vaccine group and 106 positive cases among 8,502 people in the placebo group, suggesting an overall vaccine efficacy of 77.8 percent," The authors wrote.
They also pointed out that the study is only preliminary and that further research using larger samples is required to assess the efficacy of this treatment against severe illness and hospitalization.
The participants deemed to have a high risk of contracting COVID-19 were prioritized, with 2,750 participants over 60 years old. At any age, five thousand seven hundred twenty-four people had at least one medical condition, like diabetes, cardiovascular disease, or obesity.
This study was conducted using participants from different geographical locations across 25 hospitals in India.
Researchers conducted an efficiency study based on 130 laboratories that confirmed COVID-19 positive RT-PCRs from 16973 initially seronegative participants.
These cases were documented within two weeks of participants receiving their second dose.
The trial also showed that Covaxin was well-tolerated by all participants in the trial, with 12 percent of the vaccine and placebo groups reporting adverse reactions.
"The peer-review of Covaxin phase III clinical trial data in The Lancet, an authoritative voice in global medicine, validates our commitment to data transparency and meeting the stringent peer-review standards of world-leading medical journals," said Bharat Biotech Chairman Krishna Ella.
"The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published COVID-19 vaccines in the world," Mr. Ella said.
The authors of Bharat Biotech and the National Institute of Virology, Indian Council of Medical Research (NIV-ICMR), Pune, observed that there was not a statistically or clinically significant distinction in serious adverse events among groups, and there were no instances of deaths due to vaccines.