EU regulator begins review of Pfizer-BioNTech's vaccine adapted to Covid variants

Shot targets new strains of the virus which are driving a surge in cases across Europe

An elderly woman receives a dose of the Pfizer-BioNtech Covid-19 vaccine at a vaccination centre in Garlan, western France. AFP
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The European Medicines Agency has started a rolling review of a Pfizer-BioNTech Covid-19 vaccine adapted to new variants.

The bivalent shot is adapted to target two strains of the virus — the original strain first identified in China at the beginning of the pandemic and the Omicron offshoots BA.4/5 that are driving a rise in cases across Europe.

The EMA on Tuesday announced the beginning of its review, a process which means it will assess the data on the vaccine as it becomes available. The examination will continue until there is enough data for a formal marketing application.

The authority last month said it had started a rolling review of another version of the Pfizer-BioNTech’s shot which targets the original Covid strain and the Omicron subvariant BA.1.

While existing coronavirus vaccines continue to provide good protection against being taken to hospital and death, their effectiveness has taken a hit as the virus has evolved.

EU officials plan to use bivalent shots in their autumn vaccination campaign, with most cases across the 27-member states now linked to the BA.5 variant.

The EMA expects new Covid variant-adapted vaccines to be approved by September. However, it has signalled it is open to using shots aimed at the older BA.1 variant for that campaign, given the shots aimed at the newer BA.4 and BA.5 strains are further behind in clinical development.

Pfizer on Monday sealed a $5.4 billion (£4.46bn) deal to buy drugmaker Global Blood Therapeutics, as it seeks to capitalise on a rise in revenue from its Covid vaccine and treatment.

Global Blood specialises in the development and delivery of therapies for people living with sickle cell disease.

With the acquisition of the firm, Pfizer adds sickle cell disease treatment Oxbryta, which was approved in 2019 and is expected to top $260m in sales this year. It will also pick up two pipeline assets — GBT601 and inclacumab — aimed at the same disease.

Pfizer has been on the lookout for acquisitions that could bring in billions in annual sales by the end of the decade.

Aamir Malik, Pfizer's top dealmaker, said the company was focused on improving growth for the second half of the decade, rather than large deals that generate value through cost-cutting.

In May, Pfizer struck an $11.6bn deal for migraine drug manufacturer Biohaven Pharmaceutical Holding and recently also completed a $6.7bn pact to buy Arena Pharmaceuticals.

Pfizer said if they are all approved, it believes GBT's drugs could generate more than $3bn in sales annually at their peak.

Updated: August 09, 2022, 2:00 PM