UK grants full marketing authorisation to COVID-19 vaccine Janssen

THE UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has granted the one-dose Janssen COVID-19 vaccine full marketing authorisation (MA).

On Wednesday, February 22, the UK’s MHRA converted the COVID-19 Vaccine Janssen to a full GB Marketing Authorisation (MA).

The update made to the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) was to reflect the COVID-19 Janssen vaccine being converted to a full marketing authorisation as of 20 February 2023, the UK government announced.

The original Conditional Marketing Authorisation (CMA) granted by the MHRA was approved via the European Commission (EC) Decision Reliance Route.

The Johnson & Johnson Covid vaccine from Janssen Pharmaceuticals is authorised in Northern Ireland under the MA issued by the European Medicines Agency.

The MHRA, the UK’s stand-alone medicines and medical devices regulator, “take decisions and carries out any functions which were taken or carried out at EU level except for decisions on Marketing Authorisation (MA) applications made through the European procedures to market products in Northern Ireland.”

On May 28, 2021, the one-dose Janssen COVID-19 vaccine was approved by the MHRA “after meeting the required safety, quality and effectiveness standards.”

An announcement at the time read: “The COVID-19 Vaccine Janssen has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA).

“This is the fourth COVID-19 vaccine to be authorised by the UK’s independent regulator and is the first to be approved for protection against COVID-19 with a single dose.”

Dr June Raine, MHRA Chief Executive, said at the time: “We have reviewed the conditional marketing authorisation application submitted by Janssen, including the information on quality, safety and effectiveness. I am pleased to confirm today that this authorisation has been granted.

“This is encouraging news for the public and the healthcare sector. We now have four safe and effective vaccines approved to help protect us from COVID-19.

“Our work does not end here. We are continually monitoring all COVID-19 vaccines in use once they have been approved to ensure that the benefits in protecting people against the disease continue to outweigh any risks.

“The safety of the public will always come first – you can be absolutely sure of our commitment to this.”

Back in February last year, Johnson & Johnson reportedly halted the production of its Covid vaccine.

According to the New York Times at the time, the company shut down the only plant making usable vaccine batches in Leiden, Netherlands.

J&J had reportedly been using the facility to develop an experimental vaccine and potentially more profitable drug unrelated to the Covid-19 pandemic.

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