EMA Recommends Updated Pfizer-BioNTech COVID-19 Vaccine


The European Medicines Agency (EMA) based its decision on preclinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages, including XBB15, XBB116, XBB23, and EG51.

This week, the Committee for Medicinal Products for Human Use (CHMP) of the EMA decided to recommend marketing authorization for the Pfizer-BioNTech Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

The committee also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.

“This season’s vaccine is ready to ship as soon as the final regulatory decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises,” said Pfizer CEO Albert Bourla. “It's been nearly a year since many citizens in the European Union were vaccinated against COVID-19 and the updated formulation provides the opportunity for them to receive a vaccine more closely matched to current sublineages."

As COVID-19 is now viewed as a seasonal respiratory virus, the vaccines will be updated annually to protect against the dominant variants.

“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are better matched to relevant circulating variants or sublineages to people worldwide, to support vaccinations in the upcoming fall and winter season,” said BioNTech CEO and Cofounder Ugur Sahin, MD. “Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally. The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalization.”

In the United States, federal regulators decided earlier this year to update vaccines annually, and follow the existing influenza vaccine model, where depending on the flu variants circulating, the CDC and FDA recommend vaccines be updated to protect against specific variants.

This past spring, the CDC and FDA recommended that the Moderna and Pfizer-BioNTech mRNA bivalent mRNA vaccines (original and Omicron BA.4/BA.5 strains) be used for all future vaccinations in the US. Both agencies decided to move away from the original, monovalent COVID-19 vaccines.

Specifically, the CDC recommended:

  • Adults 65 years and older receive an additional dose of either the Moderna or Pfizer-BioNTech COVID-19 bivalent mRNA vaccine.
  • Everyone 6 years of age and older receive an updated bivalent mRNA vaccine (unless they have already).
  • Individuals who are unvaccinated against COVID-19 receive a single dose of an authorized bivalent vaccine, rather getting than multiple doses of original monovalent mRNA vaccines to complete a primary series.

Despite the belief that COVID-19 has evolved into a seasonal virus, there has been an increase in COVID-19 reported cases in recent weeks. According to the CDC COVID-19 Data tracker, during the week of August 13 through August 19, there were 15,067 hospital admissions—an increase of 18.8% from the most recent week. During the week of August 20 through August 26, deaths were a reported 2%, which was an increase of 17.6% from the previous week.

Pfizer and BioNTech have also filed an application with the FDA requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older. The companies say a decision is expected in the coming days.

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