The pharmaceutical companies Pfizer and BioNTech asked the United States Food and Drug Administration (FDA) to authorize the new vaccine against covid-19 that they have developed against the new variants of the virus.
In a statement, the two companies reported that they have already delivered all the relevant documents to the FDA to study the efficacy of the new dose, which seeks to counteract the effects of the subvariants of omicron BA.4 and BA.5, guilty of the majority of infections in that country.
If the FDA authorizes the use of the vaccine, the doses could be distributed in the United States in September. The new version of the biological, aimed at people over 12 years of age, has not yet been tested on volunteers, although a clinical trial is scheduled to begin this month.
For now, the only studies have been carried out in animals, the results of which have shown a strong immune response against the new variants.
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.
For its part, the American pharmaceutical company Moderna is also developing an updated dose against covid-19 and is expected to request authorization from the FDA soon.
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