The Bahrain National Health Regulatory Authority (NHRA) has approved the registration of the Covid-19 vaccine by Chinese company Sinopharm.
The latest development comes after the company’s distributor in the Middle East and North Africa, G42 Healthcare, submitted necessary documentation.
The NHRA approval for the vaccine is based on data from the trials carried out in several countries.
Results from Phase III trials on 42,299 participants showed a vaccine efficacy rate of 86%, a 99% seroconversion rate of neutralising antibody and 100% effectiveness in preventing moderate to severe Covid-19.
In addition, the authority reviewed the scientific data behind the manufacturing process and the stability of the product to verify vaccine quality.
Based on preliminary results, the NHRA had previously authorised the emergency use of Sinopharm’s vaccine in treating frontline workers who have come into contact with Covid-19 patients.
As reported by the Bahrain News Agency, more than 7,700 participants have signed up to take part in a trial of the Sinopharm vaccine in the kingdom.
Meanwhile, in a separate development, the ongoing trials of Sinopharm’s Covid-19 vaccine were suspended in Peru after a participant was detected with neurological problems, AFP reported.
The news agency quoted Cayetano Heredia University chief researcher German Malaga as saying: “Several days ago, we signalled, as we are required, to the regulatory authorities that one of our participants (in trials) presented neurological symptoms which could correspond to a condition called Guillain-Barre syndrome.”
Guillain-Barre syndrome is a rare and non-contagious disorder affecting arm and leg movement.
Sinopharm is carrying out trials in Peru on around 12,000 participants and nearing completion of the first stage of the trials.