Pfizer could have Covid vaccine for kids 5 to 11 by winter [Video]

• U.S. drug regulators could soon clear Pfizer’s Covid vaccine for emergency use in children ages 5 to 11, according to board member Dr. Scott Gottlieb.
• Gottlieb said he’s optimistic the approval could arrive in late fall or early winter of this year.
• He added that the current spread of the delta variant could pressure regulators to fast-track the approval.

Pfizer board member Dr. Scott Gottlieb expressed his hopes that the Pfizer-BioNTech Covid-19 vaccine could receive approval for emergency use in children ages 5 to 11 by late fall or early winter this year.

Gottlieb told CNBC on Monday that the vaccine trials for the children in that age group could have results by September.

He said that the data will then be submitted to the Food and Drug Administration (FDA) that month, but the application might not be submitted until October.

Gottlieb, who led the FDA from 2017 to 2019 during the Trump administration, explained in a “Squawk Box” interview that the “normal timeline” involves “a four-to-six week review for a potentially emergency use authorization.”

White House chief medical advisor Dr. Anthony Fauci made similar remarks recently on NBC‘s “Today” show.

The FDA has given full approval to the Pfizer-BioNTech two-shot vaccine on Aug. 23 but only for people ages 16 and up. Pfizer vaccination for kids ages 12 to 15 is only on an emergency use basis.

The two-dose Moderna vaccine and the single-shot Johnson & Johnson are still under emergency use in the U.S. for those 18 and up. J&J has not sought a full FDA approval yet. Moderna, meanwhile, has applied for that age range, only to eventually expand its application in June to include kids ages 12 to 17.

Officials have pushed for the vaccination of young adults and kids of school age in time for the start of the school year. It doesn’t help that pediatric Covid hospitalizations reached their highest level on record last week. While children are at a much lower risk of severe illness, they can still pass it on to more vulnerable people.

Gottlieb said that the timeline could still change. Drug regulators could still ask for follow-up trials, which would delay the timeline. On the other hand, the spread of the delta variant, particularly among kids, could pressure the agencies to fast-track the process.

For kids under the age of 5, Pfizer’s vaccine trial data may not arrive until November. Gottlieb added that the dose for much younger children is lower than that used in children aged 5 to 11.

Source: CNBC