Pharmaniaga to supply 12 mil COVID-19 vaccine doses to the Govt

The agreement was signed by Minister of Health, Datuk Seri Dr Adham Baba on behalf of the MOH, and Pharmaniaga was represented by its group managing director, Datuk Zulkarnain Md Eusope.

Zulkarnain said Pharmaniaga expects to receive the first supply of CoronaVac from China's Sinovac Lifesciences Co Ltd (Sinovac) next month, and the vaccines will be available for the Malaysian by end of March or early April.

"Pharmaniaga is honoured by the trust given by the government to supply the vaccine to the government health facilities. We will manufacture fill and finish CoronaVac as well as handle the logistics and distribution of the vaccine to the government designated hospitals, clinics and other facilities.

"Our wholly-owned subsidiary company, Pharmaniaga LifesSience Sdn Bhd (PLS) will manufacture, fill and finish CoronaVac at its EU and GMP-certified Small Volume Injectable plant which has been repurposed for this project," he said in a statement today.

He said the logistics and distribution of CoronaVac will be carried out by Pharmaniaga Logistics Sdn Bhd (PLSB), which has 26 years of experience in managing vaccine distribution and has well-established infrastructure to support the needs.

In view of the unprecedented situation, Pharmaniaga has also beefed up the security aspects in terms of the logistics of the vaccine, said Zulkarnain.

On Jan 12, Pharmaniaga signed a deal with Sinovac to obtain the bulk supply of the vaccine, which will be manufactured fill and finish at its high-tech plant.

The deal also includes the vaccine technology transfer to the company.

Zulkarnain said Pharmaniaga was pleased with Sinovac's preliminary results from the Phase Three clinical trial conducted on the general population in Turkey, which showed CoronaVac's efficacy at 91.25 percent.

"Pharmaniaga, MOH as well as the Ministry of Science, Technology and Innovation have had several discussions with Sinovac on the Phase Three clinical trial results in Indonesia and Brazil which were conducted using different study designs, but in accordance to the strict standards and guidelines of World Health Organisation.

"In Brazil, for instance, the clinical trial was done solely on healthcare professionals' group. Pharmaniaga is satisfied with the outcome especially when CoronoVac is the only vaccine in the market to have taken such a bold step to conduct the study in a highly infectious environment of that group.

"We are very confident that CoronaVac is safe, efficacious and of high quality for the use of Malaysians," he said.

Zulkarnain said the CoronaVac has been registered and approved for emergency use in China, Chile, Brazil, Indonesia and Turkey, with President of Turkey, Recep Tayyip Erdogan and Indonesian President Joko Widodo having taken the vaccine.

"Despite the encouraging development on the use of CoronaVac, we must adhere to the regulations in Malaysia and let the National Pharmaceutical Regulatory Agency (NPRA) review the dossier and relevant documents of the vaccine which have submitted recently.

"Subject to NPRA's approval, In shaa Allah (God willing) we will have the vaccines available for the rakyat as soon as end of March or early April," he said.

He said once CoronaVac gets registered with NPRA, PLS will be the product registration holder and exclusive distributor, authorised by Sinovac for Malaysian market of finished products both locally manufactured or imported from China for the government and private sector.

In a filing with Bursa Malaysia today, Pharmaniaga said PLS had submitted its application for registration with the NPRA on Jan 19, 2021.

It said PLS had signed an agreement with the government for the purchase and distribution of COVID-19 CORONAVAC, SARS-COV-2 Vaccine (Vero Cell) Inactivated to be delivered to hospitals, clinics and any other facilities nationwide as instructed by the MOH.

"The supply of the finished COVID-19 vaccine is subject to getting registered with drug control authority and meeting all regulatory requirements," it said.

It said the agreement shall be effective from Jan 26, 2021, and remain in force for a period of one year, subject to earlier termination by either party for failing to meet the obligations or upon entering into the definitive agreement.

Pharmaniaga said CoronaVac is an inactivated virus type of vaccine which consists of virus particles that have been grown in culture and then lose disease producing capacity.

This type of vaccine is very reliable and the technology has been proven to be dependable since it was established 40 years ago. It is also ready to use without the need for dilution.

The storage and distribution condition of this vaccine are between two and eight degrees Celsius, which is a common vaccine temperature catered by Pharmaniaga's existing facilities as well as storage facilities at government hospitals and clinics.