International stakeholders debate COVID-19 vaccine manufacturing bottlenecks to be tackled urgently

Pharma News: Key international stakeholders convened a Global COVID-19 Vaccine Supply Chain & Manufacturing Summit on 8^th and 9^th March.

The unprecedented scaling up of vaccine manufacturing, from zero to billions of doses in record time, has led to shortages that are impacting the entire vaccine supply chain. Open dialogue among manufacturers, suppliers, international organisations and governments is urgently needed to address these shortages so that they do not interrupt vaccine manufacturing. The meeting aimed to kick start the dialogue to identify, understand, and discuss potential solutions for these supply chain challenges.

Richard Hatchett, CEO, Coalition for Epidemic Preparedness Innovations (CEPI) “Over the last two days, stakeholders from across the spectrum, from upstream suppliers to vaccine manufacturers, multilateral organisations, governments, and representatives of nongovernmental organisations and civil society, have had a frank and vigorous discussion about the challenges we face. What is clear is that our industry partners have risen to the occasion in developing safe and effective vaccines but now are struggling to ensure they have all the materials they need to deliver them. We must urgently work together to prevent these shortages from slowing the delivery of the vaccines we need in order to end the pandemic”.

Dr Seth Berkley, CEO, Gavi, the Vaccine Alliance “Through unprecedented partnership, COVAX is now rolling out vaccines to many countries that otherwise would not have had access to doses. Manufacturing has played a key role in helping us begin to close the vaccination divide and continued collaboration will be vital if we are to achieve the global capacity needed to end the pandemic. Today’s Summit represents an important step in building the global consensus needed to solve the bottlenecks and supply constraints that stand in our way”.

Thomas Cueni, DG, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said “Let’s put the current challenge in perspective: pre-Covid-19 global vaccine manufacturing capacity was 3.5 bn doses per year, 5bn if you include seasonal flu shots. This year for Covid-19 vaccines alone, manufacturers have scaled up new capacity from zero to 10bn. Doubling world vaccine capacity of what is a very complex process in a matter of months; thanks to unprecedented industry commitment and collaboration. We should not be surprised if there are bumps along the road, in the manufacturing process itself as well as strains on the whole supply chain; starting with hundreds of raw materials needed to make vaccines. It will inevitably lead to bottlenecks that will urgently need to be addressed. We are deeply aware that we are not only in a war against the virus, but also in a war against time, because we know that no one is safe until everyone is safe. During the Summit discussions there was a clear desire to to leave no stone untouched to address inefficiencies and increase manufacturing capacities. I’m confident we will see new players coming in with their manufacturing know-how and capacities”.

Dr Michelle McMurry-Heath, President and CEO, Biotechnology Innovation Organization (BIO) added “The technical and logistical complexities of the task before us will require vaccine manufacturers, suppliers, governments, multilateral organizations and non-governmental organizations to work together in new and creative ways to find solutions to our shared challenges. We must invest across all of the ecosystem to ensure that there is not only manufacturing capacity but also increasing amounts of the vital production supplies needed for that capacity”.

Mr Sai D.Prasad, President, Developing Countries Vaccine Manufacturers’ Network (DCVMN) noted “COVID-19 can be conquered only through equal participation of innovators and manufacturers. Developing country vaccine manufacturers and industry at large have lead through innovation and large scale manufacturing. With rapid capacity expansion and new manufacturing partnerships, global access of COVID-19 vaccines will become a global reality in the months to come, in all countries. Global products, local manufacturing, and leave no one behind”.

Vaccine manufacturers and upstream suppliers are increasingly reporting shortages of raw and packaging materials, critical consumables, and equipment. Over time such shortages, if left unaddressed, will lead to shortages of vaccines and impact delivery commitments. Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics. Preventing bottlenecks in the system requires among others: addressing export restrictions, immediate easing and facilitation of access to raw materials and upstream supplies; regulatory prioritisation of validation of supply, batch release and achieving greater visibility on vaccines demand forecasts to enable upstream suppliers to do better supply planning. All stakeholders agreed there is a need to expand capacity and in a way that promotes equitable access and leaves no one behind.