PUTRAJAYA: Pharmaceutical giants Pfizer and BioNTech say they will take all effort to ensure their Covid-19 vaccine for Malaysians will be safe and fully tested.
“We are deeply honoured to work with the Malaysian government and to marshal our scientific and manufacturing resources toward our shared goal of bringing a potential Covid-19 vaccine to Malaysians as quickly as possible, ” said Pfizer country manager Luksanawan Thangpaibool.
BioNTec chief business and chief commercial officer Sean Marett said the company understands that the vaccine is urgently needed as Covid-19 is a global health crisis.
“I would like to thank the Malaysian government for its support and putting trust in our ability to develop a vaccine that, we believe, has the potential to help address this global pandemic threat.
“Our goal remains to create a global supply of a safe and effective Covid-19 vaccine for as many people around the world as quickly as we can, ” said Marett.
In a joint statement on Friday (Nov 27), Pfizer and BioNTech said that they are committed to supplying 12.8 million doses of the BNT162 mRNA-based vaccine candidate over the course of 2021.
“The supply will be subject to Malaysia’s approval and this agreement with the Malaysian government is part of our global commitment to help address the Covid-19 pandemic, ” they said.
They added that all clinical studies and efforts to get regulatory approval began early this month and the two companies are expected to manufacture up to 1.3 billion doses globally by the end of next year.
“Assuming positive data and availability of the necessary manufacturing and safety data, and based on current projections, Pfizer and BioNTech expect to produce globally up to 50 million doses of the vaccine in 2020 and up to 1.3 billion doses in 2021.
To meet those anticipated quantities and milestones, the companies have produced sufficient supply for their phase two and three clinical trials and have begun producing and stocking their pandemic supply.
“The BNT162b2 candidate vaccine is not currently approved for distribution anywhere in the world.
“Both partners are committed to developing these novel vaccines with preclinical and clinical data at the forefront of all their decision making, ” they said.
According to Pfizer and BioNTech, the phase three clinical trial of BNT162b2 began on July 27 and to date, has enrolled 43,661 participants.
“As of Nov 13,41,135 have received a second dose of the candidate vaccine. About 42% of global participants and 30% of US participants are racially and ethnically diverse, and 41% of global participants and 45% of Americans are between 56 and 85 years old.
"The trial will continue to collect efficacy and safety data on participants for a further two years, ” said Pfizer and BioNTech.
Pfizer also said that the companies will use specially designed temperature controlled thermal conveyors as part of the cold chain infrastructure to distribute the vaccine around the world.
“They can be used as temporary storage units for 15 days by filling with dry ice. Each sender contains a thermal sensor with GPS to track the location and temperature of each vaccine shipment through its pre-established routes taking advantage of Pfizer's extensive distribution network.
“Pfizer and BioNTech plan to submit the study's safety and efficacy data for peer review to a scientific journal once the data analysis is complete, ” said the companies.
The statement follows the announcement by Prime Minister Tan Sri Muhyiddin Yassin that Malaysia had signed a deal with Pfizer to get an early purchase deal of 12.8 million doses of the Covid-19 vaccine for 6.4 million Malaysians, as soon as the vaccine is deemed safe enough to be used.