Pfizer vaccine for children under 5 may be available in U.S. by end-Feb
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© Reuters. FILE PHOTO : Pfizer BioNTech’s COVID-19 vaccine is being shipped from the Pfizer Global Supply Kalamazoo, Michigan manufacturing facility, U.S.A, on the 13th of December 2020. REUTERS Morry Gash/Pool(Reuters) -Pfizer Inc and Germany’s BioNTech SE (NASDAQ:) are expected to submit an emergency use authorization request as early as Tuesday to the U.S. Food and Drug Administration (FDA) for vaccines for children aged six months to 5 years, the Washington Post reported https://wapo.st/3rfjDrC on Monday.
Coronavirus vaccines could soon be made available to children under 5 years old, according to a plan, which would allow for the authorization of two shots in the next few weeks.
According to this report, FDA asked companies for their permission to file the application in order that regulators can begin to examine the two-shot data.
According to the report, one person familiar with the situation stated that “The idea was, let’s start the review for two doses.” If the submitted data is valid, it’s possible to start children on the primary baseline months sooner than if the third dose data hasn’t been received.
Pfizer (NYSE:), BioNTech was not available for comment immediately.
Pfizer stated in January that it expects the most recent results of a clinical trial with children under 5 years old by April. It amended the study to provide a third dose for anyone who is less than five and at least eight weeks following their last vaccine.
Because children aged 2 to 4 years old received two doses of vaccine at 3 micrograms each, they did not respond the same way as older children who received a higher dose.
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