July 21, 2021 | Access to Medicines, COVID-19


Pfizer-BioNTech Fill and Finish Deal with Biovac in South Africa Is the Latest Step in Pharma’s Campaign to Convince the World the Status Quo is Good Enough

Jessica Bassett (Health GAP): 1 518 593 7628| jessica@healthgap.org

Statement from Brook Baker, Senior Policy Analyst, Health GAP, regarding the COVID-19 vaccine agreement announced today between Pfizer, BioNTech, and Biovac: 

“This is a far cry from actual technology transfer to allow independent manufacture of mRNA vaccines and therapeutics in African countries. This agreement is nothing more or less than a contract manufacturing agreement for sterile formulation, fill, and finish. The final vaccine produced will be a BioNTech/Pfizer vaccine with marketing approval or emergency use authorization/listing under BioNTech/Pfizer’s regulatory dossiers. Biovac will not be an ‘independent producer’ – it will instead be a contract ‘subsidiary’ facility, subject to rigid control by Pfizer. In addition to the vaccine having a BioNTech/Pfizer ‘brand,’ it will have a price set by them.  

“A somewhat more favorable aspect of the agreement is that the Biovac-produced BioNTech/Pfizer vaccine will be distributed only to 55 countries in Africa, but that doesn’t mean that Biovac is really in charge of distribution. But, at least vaccines manufactured in Africa will stay in Africa, unlike the initial Johnson & Johnson agreement with Aspen Pharmacare. 

“BioNTech/Pfizer is still refusing to transfer technology that would enable Biovac to produce the mRNA active ingredient. Thus, the underlying mRNA technology platform continues to be exclusively controlled by BioNTech/Pfizer, and Biovac will not be given the ability to further develop its own internal technical capacity and expertise that might allow it to manufacture other mRNA vaccines and therapeutics in the future. Not only are one hundred million doses by 2022 wildly insufficient to meet the need across the continent of Africa, where 17% of the world’s people live, these doses also don’t come with expanded capacity extending across the spectrum of product development and manufacture. BioNTech and Pfizer thereby signal their enduring intention to maintain monopoly rights over their basic mRNA technology, and to artificially restrict supply during a wave of preventable suffering and death that they could abate, if they chose. 

“This is part of Pharma’s ongoing effort to derail the TRIPS waiver and to convince the U.S. and European Union that 3rd Way approaches are sufficient – ‘let us continue to control our intellectual property and expand contract manufacturing and we’ll eventually have enough supply to vaccinate the world.’

“Like the announcement today of a $200 million investment by the U.S. in Aspen Pharmacare to expand capacity to fill and finish J&J doses, subsidies for pharma-controlled fill and finish contract manufacturing don’t go nearly far enough to address the deadly shortages in COVID-19 vaccines in the short run, let alone build independent capacity in South Africa or elsewhere to manufacture future vaccines and biologics. The Biden administration must invest in expanding and repurposing pharmaceutical capacity in LMICs, rather than propping up continued Big Pharma control over brand, price, distribution, and the underlying technology platforms.”

More: Read Prof. Baker’s analysis of a similar deal between Johnson & Johnson and Merck in March.