Green light in the US from the Food and Drug Administration to Pfizer-BioNTech’s anti-Covid vaccine booster also for children between 12 and 15 years old. The regulator announced that it has changed the Emergency Use Authorization (Eua) for the shield product to expand the use of the third booster dose to this age group.
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Two other points have been changed: the time interval between the primary vaccination cycle and the booster has been reduced to “at least 5 months”. Green light also to the third additional dose (third dose as part of a primary course) for some immunocompromised children between the ages of 5 and 11 years.
“With the current wave of the Omicron variant, it is essential to continue to adopt effective and life-saving preventive measures such as primary vaccination and anti-Covid boosters, the use of masks and social distancing to effectively fight the virus”, stressed the commissioner. interim of the FDA, Janet Woodcock.
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In the US, according to the CDC, about 13.5 million children aged 12 to 17, just over half of the total, have received two doses of Pfizer.
The FDA reviewed real-world data from Israel, including safety data from more than 6,300 people aged 12 to 15 who received a booster dose of the vaccine at least 5 months after completing their vaccination series. two-dose primaries.
These additional data allowed the FDA to reassess the benefits and risks of using a booster in the younger teen population in the context of the current increase in Covid-19 cases.
There are currently no reported cases of myocarditis or pericarditis in people who received the vaccine.
Before the authorization is formalized, the decision of the Centers for Disease Control and Prevention (CDC) is now awaited, which should arrive by the end of the week.
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