Remove COVID-19 Remove COVID-19 Vaccine Remove FDA
article thumbnail

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

Bill of Health

Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set. The CDC, through its vaccine provider agreements, prevents physicians and parents from pursuing off-label use of COVID-19 vaccinations in young children.

article thumbnail

FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Healthcare Dive

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids

Healthcare Dive

The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5.

article thumbnail

FDA clears Novavax's COVID-19 vaccine as 4th option in US

Healthcare Dive

The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron.

article thumbnail

FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift

Healthcare Dive

The agency pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting scheduled for next week has been postponed as a result.

article thumbnail

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

Bill of Health

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. Advocacy for Vaccine Access. By Fatima Khan. While over 11.5

COVID-19 344
article thumbnail

FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children

Healthcare Dive

The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use. A CDC panel is meeting Friday and Saturday to develop specific recommendations.