The EMA could approve a Pfizer vaccine targeting Omicron’s subvariants in the fall

The European Medicines Agency (EMA) said on Wednesday that it aims to approve a Pfizer/BionTech COVID-19 vaccine as early as fall targeting two subvariants of the fast-spreading Omicron strain.

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Omicron BA.4 and BA.5 sublines are fueling a surge in COVID-19 cases in Europe and the United States, with the WHO declaring last month that the pandemic is “far from over.”

The European regulator said Monday it had launched a review of an adapted version of Pfizer’s anti-Covid serum targeting these two sub-variants, which are more easily transmitted and escape the immune system more easily than earlier strains.

“The EMA expects to receive an application for the adapted vaccine BA.4/5 developed by Pfizer /BioNTech, which will be evaluated for potential accelerated approval in the fall,” an EMA spokesperson said in an email.

The gatekeeper said the expected approval of two more tailored vaccines by Pfizer and rival Moderna, targeting the original Covid-19 strain and Omicron’s earlier BA.1 subvariant, would come ‘some time later’.

Pfizer and Moderna filed separate approval applications for those vaccines on July 22, the spokesman said.

The EMA previously said the first sera targeting Omicron could be approved by September.

“too far”

While vaccines have helped reduce hospitalizations and deaths from COVID-19, which first emerged in China in late 2019, current injections mainly target earlier strains of the disease.

Due to the spread of Omicron subvariants, the lifting of health restrictions and a decline in screenings, the World Health Organization (WHO) warned in July that the pandemic was “far from over”.

Covid cases spiked globally in late spring and early summer, driven by new strains, but have since started to level off in Europe.

European countries are now starting to look towards autumn and winter, when cases are expected to rise again.

The BA.4 and BA.5 subvariants were first identified in South Africa in April and spread rapidly despite previous waves and high population immunity through vaccination.

Like other omicron variants, these sublines cause milder cases of the disease because they settle less in the lungs and more in the upper nasal passages, causing symptoms such as fever, fatigue, and loss of smell.