The U.S. Food and Drug Administration (FDA) has approved the updated vaccines from Moderna and Pfizer/BioNTech COVID-19 to deal with omicron variant sublineages such as XBB.1.5.

By declaration, the decision was based on the evidence presented and on the contribution of the entity’s expert advisors, and the update was made to include a monovalent component corresponding to the variant. They also indicated that the benefits of vaccines have been shown to outweigh their risks.

It was explained that people over the age of five and regardless of their previous vaccination are eligible for the single dose that will be updated at least two months after the last dose of a COVID-19 vaccine.

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For people between six months and four years of age who have been previously vaccinated, they can receive an updated mRNA vaccine. “The timing and number of doses to be administered will depend on the COVID-19 vaccine previously received,” it said.

In the case of unvaccinated children between six months and four years old, they can receive three doses of the updated approved Pfizer COVID-19 vaccine or two doses of the updated Moderna vaccine.

“People who receive an updated COVID-19 mRNA vaccine may experience side effects similar to those reported by people who have previously received COVID-19 mRNA vaccines, as described in the respective prescribing information or fact sheets,” so it was explained.

As part of the FDA update, the original bivalent Moderna and Pfizer-BioNTech vaccines are no longer authorized for use in the United States, the FDA said.

Through a statement, Pfizer/BioNTech explained that “this season’s vaccine” is indicated as a single dose for most people aged 5 years and older.

Additionally, children under age 5 may be eligible for additional doses of this season’s vaccine if they have not already completed a three-dose series of previous formulations.

“This decision comes at a time when cases of Covid-19 are once again increasing,” said Albert Bourla, president and CEO of Pfizer.

The pharmaceutical company reported that they hope the vaccine “will be available in the coming days” as they “await the recommendation of public health authorities.”

Once approved by the FDA, the Advisory Committee on Immunization Practices, a group of independent experts that advises the U.S. Centers for Disease Control and Prevention (CDC), will weigh the safety and effectiveness of the updated vaccines and make recommendations for their use. .

The FDA has indicated that the advisory group will meet tomorrow, Tuesday, so that the vaccines could be available in just a few days in select pharmacies and doctor’s offices.

“Vaccination remains essential for public health and continued protection against the serious consequences of Covid-19, including hospitalization and death,” Peter Marks, director of the Center for Biologicals Evaluation and Research in the US, said in the FDA statement. (JO)