KUALA LUMPUR: Some 6.4 million Malaysians are expected to be the initial recipients of the Covid-19 vaccine developed by multinational pharmaceutical corporation, Pfizer.
In this regard, 12.8 million doses of the BNT162 mRNA-based vaccine are expected to be made available, with those selected in the initial batch expected to receive two immunisation shots in 2021.
The BNT162 mRNA-based vaccine would be subjected to clinical tests and regulatory approval before it is disbursed for use, said Pfizer Malaysia and immunotherapy company BioNTech SE, in a joint statement, here, today.
Both companies also stated that they have entered into an agreement on the matter with the Health as well as Science, Technology and Innovation ministries today.
Pfizer country manager Luksanawan Thangpaibool said they were honoured to work with the Malaysian government and to marshal their scientific and manufacturing resources towards their shared goal of bringing a potential Covid-19 vaccine to Malaysians soonest possible.
"In the face of this global health crisis, Pfizer's purpose, which is breakthroughs that change patients' lives, has taken on an even greater urgency. Our hope is that, subject to clinical and regulatory success, our vaccine will help make this happen," he said.
BioNTech chief business and chief commercial officer Sean Marett thanked the Malaysian government for its support and trust placed in their ability to develop a vaccine.
"We believe (this vaccine) 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 many people around the world, as quickly as we can," he said.
Apart from the engagements with governments, Pfizer and BioNTech have also expressed interest for possible supply to the Covax Facility, a mechanism established by Gavi; the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organisation (WHO).
The Covax Facility aims to provide governments, including emerging markets, with early access to a large portfolio of Covid-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.
Assuming positive data and availability of the necessary manufacturing and safety data and based on current projections, Pfizer and BioNTech are expected to produce globally up to 50 million doses of vaccines this year and up to 1.3 billion doses in 2021.
"By 2021, to meet those anticipated quantities and milestones, the companies have produced sufficient supply for their phase 2/3 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 pre-clinical and clinical data at the forefront of all their decision making," it said.
The statement said phase 3 clinical trial of BNT162b2 began on July 27 and to date, has enrolled 43,661 participants. As of Nov 13 this year, 41,135 participants had received a second dose of the candidate vaccine.
About 42 per cent of global participants and 30 per cent of United States participants are racially and ethnically diverse, while 41 per cent of global participants and 45 per cent of Americans are between the ages of 56 and 85.
The clinical trial participants are from about 150 sites in the United States, Germany, Turkey, South Africa, Brazil and Argentina.
The trial will continue to collect efficacy and safety data on participants for the next two years, the statement said.