Failure to reach conclusion on approval for Sinovac NMRA to make inquiries from its expert panel

12 July 2021 08:48 am Views - 185

 By Kelum Bandara   

The National Medicines Regulatory Authority (NMRA) is to make inquiries from its expert panel regarding the reason for the failure to come to conclusion on approval for emergency use of the Sinovac Covid-19 vaccine in Sri Lanka despite clearance even by the World Health Organization (WHO), an official said yesterday.   

The expert panel is divided equally on approval making it difficult for reaching any conclusion on the matter.   
NMRA Chairman Dr. Rasitha Wijewantha who expressed concern in this regard told Daily Mirror yesterday evening that he would inquire into reasons for being unable to reach a conclusion on the emergency use of this vaccine. “I am concerned and inquiring into the exact reasons behind this kind of situation by the expert panel,” he said.  He said a webinar was organized by the Sri Lanka Medical Association (SLMA) last Monday with the experts of the WHO. All the stakeholders of Sri Lanka attended the webinar including the  Chairman of the State Pharmaceutical Corporation (SPC) Dr. Prasanna Gunasena. The SPC is planning to purchase 2.5 million doses of the vaccine.   
Dr. Wijewantha said the questions related to the efficacy of Sinovac were raised at the webinar, and the WHO experts answered convincingly. “According to WHO experts, this vaccine reduces infections, severe disease and deaths,” he said.   


The vaccine is produced by the Beijing-based pharmaceutical company Sinovac. The Lancet, the longest running medical journal, says the Sinovac vaccine, administered in two shots has an efficacy of 83.5 percent.   
The WHO on June 1validated the Sinovac COVID-19 vaccine for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety and efficacy.