PUTRAJAYA: The National Pharmaceutical Regulatory Agency (NPRA) has received an application to register the Covid-19 vaccine developed by Pfizer Inc on Dec 15 in the country.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the review on documents involving the clinical trials would take between 90 to 120 days before the conditional registration could be granted for the vaccine developed in cooperation with German company BioNTech.
He said the process would comprise five stages, namely, review of clinical assessments by field experts, distribution and procurement; distribution of vaccines to targeted groups including frontliners; monitoring of side effects and overall vaccine efficacy in protecting the people from Covid-19.
"Engagement session with the company would start at the end of the month while NPRA has identified 11 medical experts in the field to review the documents.
"Emphasis would be placed on the safety and efficacy of the vaccine," he told reporters in a press conference today.
Meanwhile, Dr Noor Hisham said the ministry had yet to receive any documents on the clinical trials of Covid-19 vaccines reported to be donated by the United Arab Emirates (UAE).
"We heard about the matter, but it has to go through the NRPA.
"On our part, once we receive the clinical trial reports from China, we need to study them before making a decision.
"It's just hearsay at the moment. We are waiting for the documentation, but so far nothing has been sent to the NRPA," he said, adding that he was unable to verify whether the UAE vaccine was from China or other countries.
Rumours of the UAE donating 500,000 dosages of Covid-19 vaccine to Malaysia were spread following news of Yang di-Pertuan Agong Al-Sultan Abdullah Ri'ayatuddin Al-Mustafa Billah Shah's five-day visit to Abu Dhabi last week.