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

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

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Omicron’s BA.4 and BA.5 sublines are leading to a surge in COVID-19 cases in Europe and the United States, prompting the WHO to declare last month that the pandemic was “far from over”.

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

“The EMA expects to receive an application for the adapted BA.4/5 vaccine developed by Pfizer/BioNTech, which will be reviewed for possible rapid approval in the autumn,” 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 mostly 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.

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