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The pharmaceutical companies Pfizer and BioNTech asked the U.S. Food and Drug Administration (FDA) on Monday to authorize the vaccine they developed against the new variants of the virus that causes Covid-19.
The two companies announced Monday in a statement that they have already submitted all the relevant documents to the FDA to study the efficacy of the new version of the vaccine, directed against the BA.4 and BA.5 omicron sub-variants.
The vaccine could be distributed in the United States in September if FDA approves it, the companies said.
This new version of the vaccine, aimed at those 12 and older, has not yet been tested on volunteers, although a clinical trial is scheduled to begin this month.
So far, the only studies have been conducted on animals.
In June, Pfizer and BioNTech applied to the European Medicines Agency (EMA) for authorization for this new version of the vaccine, but have not yet received a response.
The U.S. pharmaceutical company Moderna is also developing an updated Covid-19 vaccine and is expected to apply for FDA approval soon.
