BackBahrain approves emergency use of Bharat Biotech's Covid-19 vaccine Covaxin
The World Health Organization (WHO) granted emergency approval to Covaxin earlier this month
PremiumBahrain’s National Health Regulatory Authority has approved the emergency use of India’s indigenously developed Covid-19 vaccine Covaxin, said the Indian Embassy in Bahrain on Friday.
“Bahrain’s National Health Regulatory Authority @NHRABahrain approves the emergency use of India’s indigenously developed Covid-19 vaccination, Covaxin by Bharat Biotech," the embassy said in a tweet.
Covaxin, an inactivated whole virus vaccine, recently received emergency use approval from the World Health Organization (WHO) for people aged 18 and above.
Earlier on 10 November, Hong Kong and Vietnam also joined the list of nations that have approved the jab. The Made in India vaccine has also received a nod from the US, UK, Switzerland.
Covaxin efficacy
An interim analysis of Covaxin's phase 3 trial data published in The Lancet has revealed that two doses of the vaccine offer 77.8% protection against symptomatic Covid-19 and present no serious safety concerns.
The phase 3 trial findings indicate that Covaxin induces a robust antibody response with no severe vaccine-related adverse events or deaths reported among the trial participants, the authors of the study said.
The majority of the adverse events, including headache, fatigue, fever, and pain at the injection site, were mild and occurred within seven days of vaccination, they explained.
The vaccine is administered in a two-dose regimen, 28 days apart, and can be stored and transported between 2-8 degrees Celsius.
The trial took place from 16 November last year to 17 May this year, with participants aged 18 and older randomly assigned to receive two doses of the vaccine or a placebo.
The 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%", the authors said.
They also noted that the data is preliminary and more research with a larger sample size is needed to determine efficacy against severe disease and hospitalisation.
Participants considered to be at risk of acquiring Covid-19 were prioritised with 2,750 participants above 60 years of age and 5,724 participants who reported at least one pre-existing medical condition, such as cardiovascular disease, diabetes, or obesity, across ages.
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