Input material shortages may hit COVID-19 vaccine manufacturing, says report

Image: Reuters

Image: Reuters

Many COVID-19 vaccine manufacturers may struggle to meet their targets due to a possible shortage of raw and packaging materials, consumables, and equipment needed to make vaccines, according to a report by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

The shortages may emerge despite several suppliers expanding their capacity by 50 percent in 2020 and are planning to increase capacities by another 50 percent in 2021.

“Signs of input supply challenges are being observed across all vaccine manufacturing steps, e.g. bioreactor bags, single-use systems, cell culture media, filters, gamma sterilization, vials. These individual challenges are amplified as the absence of any single input can disturb the entire manufacturing process,” according to the report titled Landscape of Current COVID-19 Supply Chain and Manufacturing Capacity, Potential Challenges.

Bioreactors are used for cell culture and fermentation, while single-use assemblies consist of plastic components that are used in diverse bioprocessing steps.

“These single-use inputs show signals of potential supply challenges, which is relevant for all four technology platforms, and are likely influenced by four drivers,” the report released by the industry body said.

COVID-19 vaccines are made using four platforms – inoculations based on genetic material like mRNA, viral vector, protein subunit and whole virion.

The COVID-19 demand represents a massive capacity surge for suppliers and sub-suppliers, which comes on top of pre-COVID-19 capacity challenges with single-use bioreactor bags’ backorders for four months.

The report said more data would be needed to holistically assess if these expansions are sufficient.

Reasons for shortages

The report expressed concern that given a lack of supply visibility and signs of shortage, safety stocks are increased, driving further imbalances, as described.

Also major manufacturing sites are located in regions with export restrictions such as the US. The US has invoked the use of the Defense Production Act to block exports of key ingredients and boost supplies needed to make Pfizer-BioNTech COVID-19 vaccines.

Adar Poonawalla, CEO of Serum Institute of India, who is manufacturing Novavax COVID-19 vaccine said the US export ban is leading to a shortage of bioreactor bags, filters and other critical items that manufacturers need.

The report adds that a high degree of specificity and the lack of standardisation of these items represent a hurdle to short-term supplier switches and flexibility. The flexibility of switching supplies is further impeded by complex regulatory process requirements.

In general, bioreactor bags can be substituted by stainless steel; this, however, takes 6-12 months taking into consideration order lead times and validation.

Moneycontrol reported here that the world may see an 18 percent shortfall in the supply of COVID-19 vaccines in 2021, based on a report by science data analytics company Airfinity.

Airfinity pegs the global demand for COVID-19 vaccines in 2021 at 11.5 billion doses, while the forecasted production is estimated to be 9.5 billion doses. Two vaccine doses are required to fully vaccinate people.

Airfinity calculated the vaccine demand on the basis of 75 percent vaccination coverage assuming vaccine efficacy is 90 percent.