Infectious Disease
Pfizer expects to file for approval for the COVID-19 vaccine for younger children in September
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Bourla works for Pfizer. Biden does not report any relevant financial information.
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Pfizer expects to file its COVID-19 vaccine with the FDA for emergency approval in children under 2 years old in September, Chairman and CEO Albert Bourla, DVM, PhDsaid Tuesday.
By then, the company will have results from ongoing studies in young children and be able to submit an emergency authorization (EUA) to the FDA in children ages 2 to 5 years and 5 to 11 years old, Bourla said prepared remarks a quarterly earnings call.
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Currently, the Pfizer BioNTech vaccine is approved for people aged 16 and over – the only COVID-19 vaccine that can be used in a pediatric age group. The FDA is expected to decide soon – perhaps this week – to extend the EEA to children ages 12-15, based on phase 3 data showing that they were highly effective in that age group.
“I want American parents to know that if this announcement comes, we will be ready to move immediately,” said the president Joe Biden said in a speech on Tuesday that the White House will provide around 20,000 pharmacy locations for vaccinating adolescents and ship doses up to the EUA directly to pediatricians.
“We know that young people are at risk from COVID-19. Although serious illnesses are rare in this age group, they can still get sick and spread the virus to others, ”Biden said. “So I hope that once the vaccine is approved, parents will benefit from it and have their children vaccinated.”
In other countries, Canada has already announced that the vaccine will be made available to children between the ages of 12 and 15.
“We hope the Pfizer BioNTech vaccine will continue to have a global impact by helping to bring the devastating pandemic under control and not only opening up economies around the world, but also staying open, creating a scenario , in which Pfizer can continue to exist, is both a leader and a beneficiary, ”Bourla said in his remarks.
According to the AAP, more than 3.7 million American children have tested positive for COVID-19, which is 13.8% of all cases in the United States. In the week ending April 29, 71,649 new pediatric COVID-19 cases were reported, representing 22.4% of all cases, according to the AAP.
More than 148 million Americans have received at least one dose of COVID-19 vaccine in the United States, including more than 107 million who are fully vaccinated, according to the CDC. Biden on Tuesday announced several steps to at least partially vaccinate 160 million Americans by July 4th, including vaccinating teenagers, people who have had trouble finding a vaccine, and people who are reluctant to use vaccines.
In his remarks, Bourla said the vaccine had worldwide sales of $ 3.5 billion in the first quarter and that Pfizer and BioNTech had shipped approximately 430 million doses to 91 countries.
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