The companies announce their intention to wait to submit a more complete dossier to the agency
The vaccine ok for the under 5s. The American Pfizer and its German partner BioNTech have in fact announced their intention to expand the data to be submitted to the US drug agency FDA on the anti-Covid vaccine in children aged 6 months to 4 years. For this reason, the US regulatory body has postponed the meeting previously scheduled for February 15. The two companies expect the new information to be available “in early April”.
“The Food and Drug Administration has been informed by Pfizer that new data has recently emerged regarding the request for authorization for the emergency use of its vaccine” in children under 5, explain the interim commissioner of the FDA, Janet Woodcock, and Peter. Marks, director of the regulatory body’s Center for Biologics Evaluation and Research. The FDA will then await the new data. The timing of the panel’s reconvocation has not yet been decided.
On children under 5 “the experimentation is underway – Pfizer and BioNTech explain in a note – and the data on the first two doses of 3 micrograms in this age group are shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more and more information is being generated because infection and disease rates remain high in children of this age, especially due to the recent increase in the Omicron variant. ” As “in December 2021 Pfizer and BioNTech announced that the ongoing trial will evaluate a third 3 µg dose to be administered at least 2 months after the second”, and considering that “the study is progressing at a rapid pace, the companies believe it is important to wait the data of the three doses, continuing to believe that “this scheme” can provide a higher level of protection in this age group “.
“This – Pfizer and BioNTech specify – is also supported by recent observations from the real world according to which, in other age groups, three doses seem to significantly increase the levels of neutralizing antibodies and the protection conferred by the vaccine against Omicron, compared to two-dose regimen. Companies “just” expect to have three-dose protection data in early April. ” However, the two companies highlight that “the independent data monitoring committee (Dmc) of the trial” in progress “supports the continuation of the trial according to the protocol” in place, “and believes that the data collected so far indicate that the vaccine is well tolerated. and support a potential three-dose regimen. “