Pfizer CEO says chances are ‘very high’ FDA will approve low-dose Covid shots for kids under 5
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Albert Bourla (Pfizer CEO) speaks during a conference with President European Commission after visiting the Puurs factory of US pharmaceutical giant Pfizer to supervise the production of Pfizer BioNtech Covid-19. This was on April 23, 20,21.
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PfizerOn Tuesday, Albert Bourla, CEO of the company, stated that he believed the Food and Drug Administration would approve the Covid vaccine for children below 5 years. This fast-track procedure allows the agency review the data immediately after it is compiled by researchers.
Bourla said that he believes FDA will approve the project, but added that regulatory processes still need to be completed. He said that he believes the FDA will approve it if they are satisfied with the data.
Pfizer data and BionTechThe FDA vaccine advisory committee will publish briefing documents on Friday to discuss the ‘vaccine for children younger than 5’. A meeting of the committee is scheduled for February 15th to talk about shots for children under 5 years old.
Pfizer BioNTechAsk the FDA last week to expand the authorizationFor their vaccine to all children below 5. FDA requested that the vaccine be approved for two doses in the initial three-dose vaccination for infants aged 6 months to 4 years.
Pfizer, BioNTech and others expect that children under five will need to be given three doses in order to provide the best protection against future strains and the omicron Covid variant. In the next few months, the companies will submit data about the third dose to FDA.
Pfizer changed its clinical trial to test a third shot in its December study for young children. The second dose did not provide adequate immune responses in the 2-year-old to 4-year-olds. Three micrograms will be given to younger children, compared to the adult 30-microgram shot.
Under 5-year-olds are considered the most vulnerable age group in the United States and they can be vaccinated. Parents and doctors are pressing for faster approval of the vaccine. The omicron-based variant of Covid has seen an increase in hospitalizations.
BioNTech and Pfizer said that they applied for an emergency approval last week in an effort to address an “urgent health need” for children younger than five years old, as the outbreak of omicrons has created an unimaginable wave of infections across the nation.
White House Chief Medical Advisor Dr. Anthony Fauci stated last month that the vaccine is in his plans. receive FDA authorization in February.
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