Covid 19: EMA could approve Pfizer vaccine in autumn targeting subvariants of Omicron

AFP, published Wednesday, August 10, 2022 at 3:24 p.m

The European Medicines Agency (EMA) said on Wednesday it is seeking approval for a Pfizer/BioNTech Covid vaccine targeting two subvariants of the rapidly spreading Omicron strain.

The milder but more easily transmissible sublines of Omicron BA.4 and BA.5 have played a role in increasing Covid-19 cases in Europe and the United States.

The European regulator announced on Monday that it had launched a review of an adapted version of Pfizer’s anti-Covid serum that targets those two subvariants, which evade the immune system more easily than previous strains.

“The EMA is expecting to receive an application for the customized BA.4/5 vaccine developed by Pfizer/BioNTech, which will be reviewed in the autumn for possible rapid approval,” an EMA spokesman said in an email.

It should come “shortly after” the expected approval by Pfizer and rival Moderna of two more bespoke vaccines targeting the original Covid-19 strain and the earlier BA.1 subvariant of Omicron, the gatekeeper said.

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

EMA has previously said the first sera targeting Omicron could be approved as early as September.

– “Not over yet” –

While vaccinations have helped reduce hospitalizations and deaths from Covid-19, which first emerged in China in late 2019, current injections are mainly targeting earlier strains of the disease.

The World Health Organization (WHO) warned in July that the pandemic was “far from over” due to the spread of Omicron subvariants, the lifting of health restrictions and the drop in screening.

Covid cases rose globally in late spring and early summer, fueled by newer variants, but have since leveled off in Europe.

European countries are now beginning to look to 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 have spread rapidly despite the high level of population immunity conferred by previous waves and vaccination.

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