Daily Newsletter

06 September 2023

Daily Newsletter

06 September 2023

MHRA grants approval for Pfizer-BioNTech’s adapted vaccine for Covid-19

The approval obtained through the European Commission Decision Reliance Route is valid only in Great Britain.

Vishnu Priyan September 06 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Pfizer and BioNTech’s adapted Covid-19 vaccine (Comirnaty) targeting the Omicron XBB 1.5 subvariant.

After validating the safety, quality and effectiveness, the UK regulator approved the vaccine.

The vaccine is indicated for usage in individuals aged six months and above.

The regulator said: “The adapted vaccine works in the same way as the original vaccine by causing the immune system to produce antibodies and blood cells that work against the virus, so giving protection against Covid-19.” 

All adapted Covid-19 vaccines that received approvals aid in boosting protection obtained from prior doses and also help offer extended protection from becoming extremely ill.

The latest approval obtained through the European Commission (EC) Decision Reliance Route is valid only in Great Britain. 

This is due to the marketing authorisation application submitted by the companies referencing the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

In such scenarios, the UK regulator takes into consideration the application along with the EC’s approval.

MHRA approval for the vaccine comes after the EC granted clearance for the Comirnaty XBB.1.5-adapted Covid-19 vaccine on 1 September 2023.

This is the third adaptation of the vaccine targeting new variants of the SARS-CoV-2 virus and is indicated for use in adults and children aged over six months.

M&A in the Contract Manufacturing Industry

Despite challenging business conditions in 2021 and 2022, large CMOs were still involved in acquisitions to enhance their capabilities or scale of production. Catalent and Recipharm were particularly active in acquiring companies during this period, and these acquisitions had a focus on advanced biologic capabilities related to cell and gene therapies. CMOs are increasingly targeting companies with sophisticated (biologic and specialized) capabilities to manufacture modern drugs and seek high-value contracts.

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