The European Medicines Agency (EMA) has begun this Wednesday a real-time review of a version of the vaccine developed by the pharmaceutical companies Pfizer and BioNTech that plans to provide better protection against specific variants of SARS-CoV-2, the virus that causes COVID-19.
ICUs dodge omicron effects
Details on whether this tailored vaccine will work against one or more variants or sub-variants of SARS-CoV-2 are not yet known, although the EMA review will focus, for now, on the data for the component targeting omicron sub-variants. . The experts will analyze the chemistry, manufacturing and controls related to the manufacturing process of the vaccine, waiting for the company to submit more data to the EMA on the immune response to the preparation or its efficacy against these subvariants that are now circulating in Europe. .
The Minister of Health, Carolina Darias, referred this Wednesday to the BA.4 and BA.5 omicron variants. According to the minister, both have been gaining ground in Spain in recent weeks without this leading to greater severity in registered COVID cases.
The analysis of the EMA experts on Pfizer will continue until enough data is collected to approve an updated version of the vaccine, although it is expected that it can receive the approval of the EMA around the month of September.
"We are considering September as a potential moment for the approval of the first updated vaccines," said Marco Cavaleri, head of Vaccination Strategy, in early June. "The results of the clinical trial are expected to be available between June and August."
By initiating this continuous review process, the EMA is beginning to assess data related to this updated version of the vaccine as it becomes available, rather than waiting until the pharmaceutical company finally brings it all together, which also speeds up its future approval in the European Union, as work has been advanced.
The review of this vaccine coincides with the rise in infections in several European countries, although at the moment there is no worrying increase in hospitalizations and deaths caused by COVID-19.