Big Pharma’s representatives are warning of upcoming bottlenecks in the COVID-19 vaccine manufacturing supply chain and are asking for a unified approach to address inefficiencies and increase manufacturing capacities. However, recently published reports and news point to inefficiencies within the manufacturing industry itself and not necessarily a lack of raw material.


At a moment when the waiver of IP rights for COVID-19 vaccine continues to gain traction, representatives for Big Pharma and manufacturers are looking to put the focus on shortages that are impacting the entire vaccine supply chain.


During a recent virtual global summit, representatives for COVAXIFPMADVCMN, and BIO, cautioned about incoming “inevitable bottlenecks” and assured that there is a need to expand capacity in a way that promotes equitable access and leaves no one behind.


The solutions proposed range from a free flow of goods and workforce to “support from the highest political level”, including the continuation of tech transfer (as opposed to IP waivers) and regulatory harmonization.


Their arguments, however, do not seem backed by specific data on shortages or particular cases of bottlenecks, besides a recent incident in Brazil. The problem may instead be a lack of accurate forecasting of demand and the inventory management of raw materials caused by inefficiencies within the manufacturing industry.


According to a discussion document published by the Coalition for Epidemic Preparedness Innovations (CEPI), IFPMA, BIO and the DCVMN, it has become apparent that many COVID-19 vaccine input supplies of raw and packaging materials, consumables and equipment are in short supply which “may result” in unfulfilled vaccine commitments.


The document details the complexity of vaccine manufacturing processes (upstream, downstream, fill-and-finish), mentions the supply target of up to 14 billion doses in order to inoculate the global population, but also admits that there is “not yet a complete and aligned view” on the current and to-be-expected input supply challenges, indicating simply that signs of supply challenges are “being observed.”


Moreover, the document concedes that COVID-19 vaccines are likely to need less than 2.8 billion vials capacity (which can contain 5 to 20 vaccines each), juxtaposed to an estimated existing capacity of more than 10 billion vials. In other words, there are enough vials for the 2021 demand.


In another admission, the document says that, according to industry proponents, the built capacity for mRNA vaccines is likely to be sufficient, at least to meet announced supply targets for 2021.


The global vaccine manufacturing networks are built by collaborations between pharma companies and CDMOs; around 55 percent of capacity is located in East Asia, 40 percent in Europe and North America, and less than 5 percent in Africa and South America.


Supporting IFPMA’s warning, the industry saw one of the first announcements of shortages of ingredients in Brazil, although for now it appears to be a single case and no pattern has been established.


It was reported that Brazil’s Fiocruz biomedical institute would stop the production of the AstraZeneca vaccine for a few days next week due to a lack of ingredients.


However, the government-backed Rio de Janeiro organization also said that production based on current supplies would allow it to continue delivering vaccines through the first week of June, putting in question the true impact of the shortage, and more supplies would come around May 22. Today, 90 to 120 days are needed on average for the manufacturing and control of a single batch of COVID-19 vaccine.


The other widely reported example of COVID-19 vaccine manufacturing setback occurred after the production of Johnson & Johnson’s vaccine at a U.S. manufacturing plant was halted by the US FDA while the agency investigated an error that led to millions of doses being ruined last month. In that case, the FDA pointed to a mistake by Emergent BioSolutions, the company running the plant, and not supply issues.