COVID-19 vaccine : MoH receives conditional registration application from Pfizer

Putrajaya – International pharmaceutical company Pfizer has applied for a conditional registration from Ministry of Health’s National Pharmaceutical Regulatory Agency (NPRA) on Dec 15 for the use of its COVID-19 vaccine.

Health director-general Tan Sri Dr Noor Hisham Abdullah said the ministry is currently evaluating the vaccine in terms of its quality, safety and effectiveness based on documents given.

“We expect that correspondence and engagement with the company will begin at the end of this month and NPRA has already identified 11 physicians who will view the documents which have been submitted to the MoH,” he told a press conference on COVID-19 development.

He said the evaluation process would take 90 to 120 days with priority given to the safety and effectiveness of the vaccine.

Meanwhile, asked on the donation of 500,000 doses of COVID-19 vaccine from the UAE government to Malaysia for the purpose of the third phase of the clinical test, Dr Noor Hisham said, no document on the vaccine has been submitted to NPRA yet.

He said, in order to allow the vaccine to be used in the country it has to go through the same process as Pfizer’s vaccine.

“At the moment, none of the third phase clinical trial of the vaccine has been published. We are waiting for the article and documents to be submitted as how Pfizer had done.

“The vaccine is probably from China. That’s why we are waiting for the full documentation before we can reveal anything about it. For now it is just hearsay rather than confirmation. Nothing has been submitted to NPRA yet,” he pointed out.

It was reported that the Yang di-Pertuan Agong Al-Sultan Abdullah Ri’ayatuddin Al-Mustafa Billah Shah left for Abu Dhabi, UAE, for a five-day special visit starting Dec 18, with the main agenda to discuss UAE government’s intention to donate the vaccine to Malaysia.

In another development, Dr Noor Hisham said two clusters – the Yayasan and Batu Sembilan clusters have been identified at the Tengku Ampuan Rahimah Hospital (HTAR) in Klang.

He said the Yayasan Cluster involved 60 health workers while 10 others contracted the virus from the Batu Sembilan Cluster.

The Yayasan Cluster started from a haemodialysis patient who infected a health care worker, and from there it had spread to others, while the Batu Sembilan Cluster, a community-linked cluster, was detected in HTAR food unit.

“When there’s infection, those with symptoms should not go to the hospital  but there are those who have the infection, have symptoms, and still go to the hospital,” Dr Noor Hisham said.

“There are some who don’t wear masks for example, so the infection occurs in the hospital.”

He  reminded all health care workers to comply with the SOP, especially on the use of personal protective equipment (PPE). – Bernama

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