According to a federal official and a source familiar with the process, the United States FDA (Food and Drug Administration) is anticipated to approve Pfizer’s coronavirus vaccine for youngsters of ages 12-to-15 by next week, setting up shots for many before the commencement of the next school year.
The statement is set to come a month after the drug company found that its jab, which is already approved for age 16 and older, also protected the younger group.
BREAKING: The FDA is now expected to expand the emergency authorization for Pfizer’s COVID-19 vaccine to include children as young as 12 years old.
— CBS Evening News (@CBSEveningNews) May 3, 2021
To preview the FDA’s action, the federal official stated the agency was expected to expand its emergency use authorization (EUA) for Pfizer’s two-dose COVID-19 vaccine by early next week and perhaps even sooner.
The source familiar with the process, who spoke on to handle internal circumstances, confirmed the timeline and added that it is expected that the Food and Drug Administration would approve Pfizer’s use by even younger children sometime this fall.
The FDA action would be followed by a national COVID-19 vaccine advisory committee meeting to discuss whether to recommend the jab for 12 to15-year-olds. Doses could begin after the CDC adopts the committee’s recommendation. Those measures could be completed in a matter of days.
The New York Times (NYT) first reported on the expected timing for the approval.
In late March, Pfizer released preliminary results from a COVID-19 vaccine study of 2260 United States volunteers 12 to 15 years age, showing there were no COVID-19 cases among fully immunized adolescents compared with 18 among those given dummy vaccine shots.
FDA allowed Pfizer, Moderna to begin American studies in children 11 and younger
The company said that kids had side effects similar to young adults. The main side effects are pain, chills, fatigue, and fever, mainly after the second dose. The study would continue to track participants for two years for more information about long-term safety and protection.
Moreover, Pfizer is not the only pharmaceutical company seeking to lower the age limit for its coronavirus vaccine. The results also are expected by the middle of 2021 from a United States study of Moderna’s COVID vaccine in 12 to 17-year-old youngsters.
However, in a sign that the observations were promising, the US FDA already allowed both drug makers to begin American studies in children 11 and younger, working their way to as young as six months old.
Over 131M Pfizer’s vaccine doses have already been administered in America, where demand for jabs among adults has dramatically slowed in past weeks.
Though younger people are at dramatically lower risk of severe side-effects from coronavirus, they have made up a larger share of new cases as a majority of American adults have been at least partially immunized and as higher-risk activities like indoor dining and contact sports have resumed in most of the country.
The officials hope that extending immunizations to teens would further accelerate the country’s reduced coronavirus caseload and permit schools to reopen with minimal disruptions this Autumn.
The United States has ordered at least 0.3 billion of the Pfizer doses by the end of July 2021, enough to protect 0.15 billion people.