FDA primed to consider Pfizer COVID-19 vaccine for younger kids

Vaccine syringe
Vaccine syringe

Kentucky National Guard, Sgt. Matt Damon / Flickr cc

Tomorrow the Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee will meet to consider Pfizer-BioNTech's application for emergency use authorization of its COVID-19 vaccine for children 5 to 11 years old.

Late last week the company submitted data to the administration showing its vaccine was 91% effective in preventing COVID-19 illnesses in children. If authorized, the vaccine will become the first approved for use in young children.

If the FDA committee endorsed the authorization, the application moves to the Centers for Disease Control and Prevention (CDC) advisory committee early next week.

Chief White House medical adviser Anthony Fauci, MD, told ABC News yesterday that COVID-19 vaccines for children ages 5 to 11 will very likely be available within the first week or two of November, if approved by both the FDA and CDC. This means many kids could enter the holiday season fully or partially vaccinated against a virus that has dominated two school years.

The Pfizer vaccine dose is a reduced dose compared with the strength used with recipients ages 12 and older. Like the standard dose, the vaccine is administered in a two-shot series 21 days apart.

Moderna shares positive pediatric data

In related news, Moderna today announced promising immunogenicity and safety findings for its mRNA vaccine (two doses given 28 days apart) in children ages 6 to 11.

"We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints," said Stephane Bancel, Chief Executive Officer of Moderna in a press release. "We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages."

The phase 2/3 study enrolled 4,753 kids ages 6 to 11, who were administered the vaccine 28 days apart at a dose of 50 micrograms per shot, half the dose of the Moderna vaccine for adults.

CDC issues new travel orders

Beginning Nov 8, non-US citizens who are not immigrants to the United States will be required to be fully vaccinated and provide proof of their vaccination status to fly to the country, the CDC said today in a media release.

Fully vaccinated air passengers will still be required to show a negative pre-departure COVID-19 test taken no more than 3 days before they board a flight to the United States. For unvaccinated or partially vaccinated passengers, the test must be taken no more than 1 day prior to departure.

The CDC's new travel orders are part of a broader travel order issues today by President Joe Biden, which re-opens travel to the United States by visitors from China, India, and much of Europe on Nov 8, according to Reuters.

The new travel requirements will not require children under 18 to be vaccinated.

Cases continue to decline nationally

The 7-day average of new daily COVID-19 cases is 72,217, with 1,526 deaths, according to the Washington Post tracker. In the past week, new daily cases fell 12.7%, deaths fell 0.4%, and hospitalizations fell 8%.

Yesterday the nation recorded 72,644 COVID-19 cases, according to the New York Times, including 1,509 deaths.

Currently, the CDC COVID Data Tracker shows that 57.4% of Americans are fully vaccinated against COVID-19, 66.4% have at least one dose of vaccine, and 6.8% of fully vaccinated people have received a booster shot.

This week's top reads