The European Medicines Agency (EMA) said Wednesday it aims to approve the Pfizer/BioNTech COVID-19 vaccine early in the fall targeting two subtypes of the rapidly spreading Omicron strain.
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Omicron sublines BA.4 and BA.5 are fueling a rise in COVID-19 cases in Europe and the United States, leading the World Health Organization to declare last month that the pandemic is “not over.”
The European regulator said it began a review on Monday of a modified version of Pfizer’s anti-COVID serum that targets these two sub-variables, which are more easily transmissible and evade the immune system more easily than previous strains.
“EMA expects to receive an application for a modified BA.4/5 vaccine developed by Pfizer/BioNTech, which will be evaluated for possible expedited approval in the fall,” an EMA spokesperson said in an email.
The gatekeeper said it should come “soon after” the expected approval of two more customized vaccines by Pfizer and competitor Moderna, which target the original Covid-19 strain and the previous Omicron variant BA.1.
The spokesperson said Pfizer and Moderna filed separate approval requests for those vaccines on July 22.
The EMA previously said that the first serum targeting Omicron could be approved as early as September.
While vaccines have helped reduce hospitalizations and deaths from the coronavirus, which first emerged in China in late 2019, current injections mainly target earlier strains of the disease.
The World Health Organization (WHO) warned in July that the pandemic was “not over,” due to the prevalence of Omicron subvariants, lifting of health restrictions and declining screenings.
Cases of the Covid virus rose globally in late spring and early summer, driven by the latest variables, but have since begun to stabilize in Europe.
European countries are now beginning to look to fall and winter, when cases are expected to rise again.
Sub variants BA.4 and BA.5 were first identified in South Africa in April and spread rapidly despite high population immunity conferred by previous waves and vaccinations.
Like other Omicron variants, these sublines tend to cause milder cases of 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.
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