EU eyes autumn approval of Pfizer jab for Covid variants
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The BA.4 and BA.5 types of the Covid virus have contributed to a surge in new cases of the disease in Europe and the United States.
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A healthcare worker preparing a Pfizer COVID-19 vaccination in Los Angeles, California, January 7, 2021 (Reuters)
The European Medicines watchdog said Wednesday that it expects to approve a Pfizer/BioNTech Covid vaccine adapted for two fast-spreading subvariants of the Omicron strain this autumn.
The BA.4 and BA.5 types of the Covid virus, which are milder but more infectious than earlier types, have contributed to a surge in new cases of the disease in Europe and the United States.
The European Medicines Agency (EMA) announced, on Monday, that it had begun a review of an adapted version of the Pfizer vaccine targeting those two types, which are more transmissible and immune evasive than previous variants.
"EMA is expecting to receive an application for the BA.4/5 adapted vaccine developed by Pfizer/BioNTech, which will be evaluated for a potential rapid approval in the fall," an EMA spokesperson said as quoted by AFP in an emailed statement.
That would come "shortly after" the expected approval of two other adapted vaccines by Pfizer and its rival Moderna, which target both the original Covid virus and the earlier BA.1 subvariant of Omicron, the spokesperson added.
On July 22, both Pfizer and Moderna submitted separate applications for approval of those vaccines, according to the spokesperson.
The European Medicines Agency (EMA), which regulates medicines for the EU's 27 member states, has previously stated that the first Omicron-adapted vaccines could be approved as early as September.
While vaccines have helped reduce hospitalizations and deaths from Covid, which first appeared in China in late 2019, the current vaccines are primarily aimed at the disease's earlier strains.
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 increased globally in late spring and early summer, owing to the new variants, but have since begun to plateau in Europe.
European countries are now beginning to plan for the autumn and winter seasons when cases are expected to spike once more.
The EU announced on Tuesday that it had reached an agreement with Moderna to postpone vaccine deliveries scheduled for the summer in order to await vaccines adapted for new Omicron variants.
Meanwhile, the WHO and the EU's health and medicine agencies all recently recommended a second booster shot for older people.
The BA.4 and BA.5 variants were discovered in South Africa and spread rapidly despite prior waves and vaccinations conferring high population immunity.
They, like other Omicron variants, have a milder disease course because they settle in the upper nasal passages rather than the lungs, causing symptoms such as fever, tiredness, and loss of smell.
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