Vaccine manufacturers need innovative technology and a supportive regulatory environment, according to industry group Vaccines Europe, which says COVID-19 showed what the sector can do when a flexible, collaborative approach is taken.

The first vaccines against SARS-CoV-2—the virus that causes COVID-19—were made available in the United States in December 2020, less than a year after the pandemic was declared. This accelerated production timeline—on average takes 12 to 36 months to manufacture a vaccine—is testament to the sector’s innovation and the flexibility afforded to manufacturers, says Sibilia Quilici, executive director at Vaccines Europe.

“Vaccines are highly technical biological products with complex and lengthy manufacturing, control, and release processes, making the unprecedented speed at which COVID-19 vaccines were developed that much more impressive,” she explains. “Under pandemic-emergency conditions, production lead times were estimated to be 3.5–6 months for viral vector and 2.5–5.5 months for mRNA-based COVID-19 vaccines.”

The shorter lead times were achieved by industry’s repurposing of pre-existing technology platforms and its willingness to make at-risk investments in research, development, and manufacturing scale-up. Quilici also cites collaboration and partnerships among vaccine manufacturers, regulators, and control laboratories as well as regulatory support for at-risk and or in-parallel processes as important factors.

“Companies’ freedom to select suppliers and other collaborators was critical during the COVID-19 crisis for accelerated delivery of medicines and vaccines,” she continues. “Some of the factors accelerating production lead time during the pandemic could be adopted and applied in a non-pandemic situation, such as further international harmonization of regulatory processes, simplification of package requirements, and early dialogue between key stakeholders.”

Vaccine platforms

Messenger RNA-based vaccines came of age during the pandemic, in part because they are quick to modify and mass produce. But, mRNA is not the only vaccine platform in which the sector is investing, Quilici says.

“The success of mRNA-based COVID-19 vaccines has driven a lot of companies to invest in nucleic-based vaccines but has also highlighted the need for established platform technologies that can be quickly customized to answer to emerging challenges,” she points out.

And having a range of vaccine technologies makes sense for other reasons, notes Quilici, citing genetic diversity as an example.

“It also ensures patients are provided with a choice of vaccines to meet their needs, considering the diverse immune responses of the populations based on factors such as age, genetics, and health status, as well as their individual preferences,” she says. “Additionally, a wide portfolio of vaccine technologies supports better access to vaccination at the global level, having in mind that infrastructures, resources, and healthcare systems vary between regions. Finally, in case of a global health threat, such as a pandemic, having multiple platforms available can accelerate the development of vaccines and support faster protection of populations.”

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