AstraZeneca’s & J&J’s COVID-19 Vaccines Manufacturing Face Viral Vector Shortages
The latest wave of COVID-19 vaccines – those from AstraZeneca and Johnson & Johnson (J&J) – are recombinant vector vaccines, which are a different molecule type from the first wave of mRNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna. As recombinant vector vaccines use a virus as a vector for DNA delivery, they will be forced to compete for the world’s limited virus production capacity with gene therapies and gene-modified cell therapies, both of which also use viral vectors, says GlobalData, a leading data and analytics company.
Recombinant vector vaccines use an attenuated virus to introduce microbial DNA to cells of the body. This vaccine molecule subtype received its first approvals in 2020. Two J&J Ebola vaccines were approved by the EMA, and one COVID-19 vaccine, Sputnik V, was approved in Russia.
Fiona Barry, Associate Editor, PharmSource at GlobalData, comments “Even before the approval of recombinant vector vaccines, the pharma industry was struggling to manufacture a sufficient viral vector to meet the needs of the handful of marketed gene therapies and growing number of clinical trials. Manufacturing these viruses is a relatively lengthy manufacturing process that is burdensome in terms of equipment and staffing.”
There are 14 gene therapies and recombinant vector vaccines approved and marketed in the EU, Japan, US, or UK. Currently, there are more than 3,000 gene therapy or recombinant vector vaccine pipeline products in active development between the Discovery and Pre-Registration stages. The majority of these are gene therapies, and fewer than 500 are recombinant vector vaccines. Clinical trials for these therapies are further impacting this capacity crunch. The biopharma industry is working to address the shortage through expanding facilities and improving processes.
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