The EU medicines watchdog said Wednesday it intends to approve a Pfizer/BioNTech Covid vaccine adapted for two fast-spreading subvariants of the Omicron strain this fall.
Types BA.4 and BA.5 are milder but more contagious than previous types of the Covid virus and have helped unleash a wave of new cases in Europe and the United States.
The European Medicines Agency (EMA) said it launched a review on Monday of an adapted version of the Pfizer syringe targeting those two types, which are more transmissible and immune-avoidable than previous variants.
“The EMA expects to receive an application for the BA.4/5 adapted vaccine developed by Pfizer/BioNTech, which will be reviewed for possible rapid approval in the autumn,” an EMA spokesman told AFP in an e-mail. Mail sent statement.
This would come “shortly after” the expected approval by Pfizer and its rival Moderna of two more customized vaccines targeting both the original Covid virus and Omicron’s earlier BA.1 subvariant, the spokesman said.
Both Pfizer and Moderna filed separate applications for approval of these vaccines on July 22, the spokesman added.
The EMA, which oversees medicines for the 27-nation European Union, has previously said the first Omicron-adapted vaccines could be approved as early as September.
– ‘Not over yet’ –
While vaccines have helped reduce hospital admissions and deaths from Covid, which first emerged in China in late 2019, current vaccinations are mainly targeting the earlier strains of the disease.
The World Health Organization warned in July that the pandemic was “far from over” due to the spread of Omicron subvariants and the lifting of control measures.
Covid cases spiked globally in late spring and early summer, fueled by the new variants, but have since started to stabilize in Europe.
European nations are now beginning to look forward to the fall and winter seasons when a renewed peak in cases is expected.
The EU said on Tuesday it had reached an agreement with Moderna to delay vaccine shipments scheduled for the summer to await vaccinations matched for new Omicron variants.
The WHO and EU health and medical authorities have now all recently recommended a second booster vaccination for older people.
The BA.4 and BA.5 variants were first discovered in South Africa and spread rapidly despite a high level of population immunity conferred by previous waves and vaccination.
Like other Omicron variants, they tend to have a milder disease course, 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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