BioNTech expects to expand manufacturing capacity for the BioNTech/Pfizer vaccine to up to 2.5bn doses by the end of 2021.
The anticipated increase is driven by several factors including optimised production processes; initiation of production at BioNTech’s Marburg facility in Germany; regulatory approval for six-dose vials of their vaccine; and expansion of the manufacturing and supplier network.
BioNTech acquired the Marburg facility in September 2020 to accelerate manufacture of its vaccine. On 26 March, the company announced that manufacture at the site had been approved, making the Marburg site one of the largest mRNA vaccine manufacturing sites in the world. The vaccine is based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer.
The Marburg facility will have an annual production capacity of up to 1bn doses, once fully operational. The first batches of vaccine from the site are expected to be delivered in the first half of April.
Additional measures and talks with potential partners are underway, aimed at further expanding the manufacturing capacity and network.
Ugur Sahin, CEO of BioNTech, said: “We will continue to focus on innovating in the Covid-19 field by advancing new formulations and addressing vaccine variants, as well as initiating new trials in additional sub-populations … We see a tremendous opportunity to reinvest the proceeds from our Covid-19 vaccine into extending and accelerating the research and development of new vaccines and therapeutics to improve the health of people worldwide by harnessing the full potential of the immune system.”
BioNTech and Pfizer are currently investigating the safety and immunogenicity of a third vaccine dose to prolonging immunity and addressing potential newly-emerging variants. In March, the US Food and Drug Administration approved a change in study protocol of the global trial to include an additional dose of the vaccine, or a dose of its modified version which carries a protein specific for a South African variant of the disease. Additionally, phase 3 trials of a lyophilised single-dose vaccine and of a frozen liquid, multidose vaccine will begin in the US this month.
According to financial results published at the end of March, BioNTech and Pfizer had signed orders to deliver 1.4bn vaccine doses in 2021. As of 23 March, BioNTech and its partners had delivered 200m doses of the Covid-19 vaccine to more than 65 countries.
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