EMA backs active substance scale-up at Janssen’s COVID-19 vaccine site in the Netherlands

By Jane Byrne contact

- Last updated on GMT

© GettyImages/MarsBars
© GettyImages/MarsBars

Related tags: Janssen, COVID-19, active substance, fill/finish, Delta variant

The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.

The plant, which is located in Leiden, produces the active substance for the manufacture of the EU supply of Johnson & Johnson’s COVID-19 Vaccine, developed by its subsidiary, Janssen.

The approved modifications to the Janssen Biologics facility include a newly constructed building, new equipment, and the introduction of additional process optimizations.

The EMA said those amendments will enable an increase of the active substance manufacturing capacity and frequency at the site, supporting the continued supply of Janssen’s vaccine in the EU.

This recommendation does not require a EU Commission decision and the new building can become operational immediately, added the regulatory body.

Italian fill finish site approval 

Last week, the same EMA committee gave its backing for an additional manufacturing site to take on production of Johnson & Johnson’s COVID-19 vaccine, allowing for the fill and finish of vaccines to take place at Catalent’s Anagni, Italy, site immediately.

A spokesperson for Catalent confirmed to BioPharma-Reporter then that production at the site had started the same day as the EMA’s statement.

In addition, they confirmed that the previously announced additional vial filling line, to expand the production capacity at the site for Janssen’s vaccine, was on track and “should be operational as originally announced”.

The original statement on the high-speed vial-filling line noted an expected operational date of the fourth quarter of 2021.

Janssen’s vaccine was approved in the EU back in March of this year, with the EU subsequently ordering 200 million doses. 

Positive data on effectiveness of shot against variants

Separately, Johnson & Johnson reported last week that its one-shot Covid-19 vaccine works well against the delta variant and the immune response lasts at least eight months.

The data has not been peer reviewed yet; two preprint study summaries have been  submitted to bioRxiv.

“Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane,"​ Dr Mathai Mammen, global head of Janssen Research & Development, Johnson & Johnson, said. "Rather, we observe an improvement over time. In addition, we observe a persistent and particularly robust, durable cellular immune response.”

The company said that analysis from blood samples obtained from a subset of participants in its Phase 3 ENSEMBLE study showed that the vaccine elicited neutralizing antibody activity against the Delta variant at an even higher level than what was recently observed for the Beta (B.1.351) variant in South Africa where high efficacy against severe/critical disease was demonstrated.

In the ENSEMBLE trial, the shot was 85% effective against severe/critical disease and demonstrated protection against hospitalization and death, it reported.

The vaccine was consistently effective across all regions studied globally, including in South Africa and Brazil, where there was a high prevalence of rapidly emerging Beta and Zeta (P.2) variants during the study period, said the developer.

Data submitted to bioRxiv from a sub-study of the Johnson & Johnson Phase 1/2a COVID-19 vaccine study showed that humoral and cellular immune responses generated by the single-shot COVID-19 vaccine lasted through at least eight months, the latest timepoint recorded in the study thus far, noted the company,

Data showed that T-cell responses – including CD8+ T-cells that seek out and destroy infected cells – persisted over the eight-month timeframe examined, it added.

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