Novavax delays 100 million vaccines to the EU
Published on 26/03/21
The company had planned to supply the EU with 100 million doses of its vaccine, with an option for a further 100 million. This blow comes in a week where the EU has drawn criticism for its vaccination rollout programmes amid a third wave hitting the continent.
The EU has also faced supply issue from other COVID-19 vaccine producers, most notably AstraZeneca, which has led the EU immunisation campaign to lag far behind vaccinations in the UK and US.
The news comes from an anonymous EU official involved in the deal Novavax, who spoke to Reuters on Thursday, saying the company was “working through some pandemic-related raw material supply shortages”, which is causing the delays.
Novavax has eight manufacturing locations, including the Serum Institute of India, the world’s biggest vaccine maker, and has plans to produce key components of its two-dose vaccines for the EU in several of its factories.
One of the company’s main factories is based in the Czech Republic, making antigens, the inactivated organisms that trigger an immune response. However, the EU official said production capacity at the plant, the only one in the EU, was too small the meet the needs of the 27-nation bloc.
Novavax concluded exploratory talks on vaccine supply with the EU in mid-December, a step that has usually been followed by the signature of a contract within two or three months. However, the timeline for the agreement is now unclear.
The European Commission, which coordinates talks with vaccine makers, declined to comment.
Novavax is currently working towards submitting its application for regulatory approval in the EU, its vaccine has been assessed by the EU drugs regulator under a rolling review since early February.
Earlier in March, Novavax announced final efficacy of 96.4% against mild, moderate, and severe disease caused by the original COVID-19 strain in its Phase III trial.
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
No comments:
Post a Comment