The EU’s medicines watchdog said on Wednesday it intends to approve this fall a Pfizer/BioNTech Covid vaccine tailored for two subvariants of the fast-spreading Omicron strain.
Milder but more infectious than earlier types of the Covid virus, types BA.4 and BA.5 have helped trigger a wave of new cases in Europe and the United States.
The European Medicines Agency (EMA) said Monday it began testing an adapted version of Pfizer’s shot, which targets the two types, which are more transmissible and immune-evading than earlier versions.
“The EMA expects to receive an application for the adapted BA.4/5 vaccine developed by Pfizer/BioNTech, which will be evaluated for potential early approval in the fall,” an EMA spokesperson told AFP in an emailed statement.
This will come “shortly after” the expected approval of the other two adaptations vaccines Pfizer and its competitor Moderna, which are targeting both the original Covid virus and the earlier BA.1 subvariant Omicron, said the spokesperson.
Both Pfizer and Moderna filed separate applications for approval of these vaccines on July 22, the spokesperson added.
The EMA, which oversees medicines for the 27 countries of the European Union, previously said that the first injections adapted to Omicron could be approved as early as September.
– “It’s never over” –
While vaccines have helped reduce hospitalizations and deaths from Covid, which first appeared in China in late 2019, current shots mostly target earlier strains of the disease.
In July, the World Health Organization warned that the pandemic was “not over” due to the spread of Omicron subvariants and the lifting of control measures.
Cases of Covid increased worldwide in late spring and early summer, driven by new variants, but have since started to decline in Europe.
European countries are now starting to look ahead to the fall and winter season, when cases are expected to peak again.
On Tuesday, the EU said it had agreed with Moderna to delay vaccine shipments planned for the summer to wait for shots adapted for the new Omicron variants.
Meanwhile, the WHO and EU health and medicine agencies recently recommended a second shot for the elderly.
Variants BA.4 and BA.5 were first identified in South Africa and spread rapidly despite high population immunity created by previous waves and vaccinations.
Like other Omicron variants, these tend to have a milder course of 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.