AstraZeneca and J&J COVID-19 vaccines face viral vector shortage
pharmafile | March 25, 2021 | News story | | Astrazenaca, COVID-19, Johnson & Johnson, Vaccine
Both AstraZeneca and J&J face major manufacturing deficiencies for their recombinant vector COVID-19 vaccines, forcing competition over limited production capacity for gene and gene-modified cell therapies, according to GlobalData.
The recombinant vector vaccines use an attenuated virus to introduce microbial DNA to cells of the body, a different molecule type from those used in the mRNA-based vaccines from Pfizer/BioNTech and Moderna.
Because recombinant vector vaccines use a virus as a vector for DNA delivery, they must therefore compete for the world’s limited virus production capacity with gene therapies and gene-modified cell therapies, both of which also use viral vectors.
Fiona Barry, Associate Editor, PharmSource at GlobalData said: “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.”
The first approval for this vaccine molecule subtype was in 2020, initially from the EMA for two J&J Ebola vaccines and then from Russia in the approval of a COVID-19 vaccine from the Gamaleya Federal Research Centre of Epidemiology and Microbiology.
However, even before the approval of recombinant vector vaccines, the pharma industry was struggling to manufacture sufficient viral vectors to meet the needs of the few marketed gene therapies and clinical trials.
The biopharma industry is working to address the shortage through expanding facilities and improving processes, but with 14 gene therapies and recombinant vector vaccines approved and marketed worldwide and more than 3,000 gene therapy or recombinant vector vaccine pipeline products in active development – this is a tall order to fill.
Kat Jenkins
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