Saudi Food and Drug Authority approves registration of Pfizer coronavirus vaccine

JEDDAH: The Saudi Food and Drug Authority (SFDA) announced on Thursday that it has approved the Pfizer/BioNTech COVID-19 vaccine for use in the Kingdom.
The approval is based on a review of data provided by US pharmaceutical giant Pfizer and German partner BioNTech on November 24 and confirmation that it meets the authority’s requirements in regard to efficacy, safety, stability, and the manufacturer’s commitment to applying the principles of good manufacturing practice in accordance with international pharmaceutical standards.
In a previous comment, Ministry of Health spokesman Dr. Mohammed Al-Abd Al-Aly stated that no vaccine would be approved without going through the proper evaluation, as the health and safety of the Kingdom’s residents is the ministry’s topmost priority.
No date has yet been confirmed for the arrival of the vaccine in the Kingdom. The vaccine will go through a series of tests before it is cleared for use by the public.
Commenting on the government’s approval, BioNTech CEO Ugur Sahin said that registration for local use shows that the region is taking a proactive stance in bringing an end to the pandemic.
“From the beginning, our goal has been to develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages,” Sahin said.
“Based on the data seen so far, we believe we have successfully accomplished this. The virus has no borders, so we are working to bring the vaccine to as many people globally as possible, as quickly as possible.”

He added that the company’s discussions with regulatory and public health authorities across the globe are ongoing, and that the number of orders provided to any one country is determined by the local government’s request, but that orders could be adjusted taking into account the overall population of the country.
Saudi Arabia is the fourth country to approve the vaccine after the UK, Bahrain and Canada.
Meanwhile, the Kingdom continues to see a decline in new COVID-19 cases with 141 new cases recorded on Thursday, raising the total number of cases since the start of the pandemic to 359,415, of which 3,531 are active, with 537 in critical care.
There were 248 new recoveries recorded in the previous 24 hours, raising the total number of recoveries to 349,872. The number of deaths per day is also decreasing — there were 10 new COVID-related deaths reported by the MoH on Thursday, raising the total to 6,012.
An additional 41,775 polymerase chain reaction tests were conducted in the previous 24 hours, raising the total number of tests in the Kingdom to over 10.2 million so far.