Tag: Pfizer-BioNTech

Just the News Sues Biden Administration to Force Disclosure of COVID-19 Vaccine Safety Data

Just the News
COVID Vaccines

Just the News on Thursday sued the Biden administration in federal court seeking to force the disclosure of COVID-19 safety data that is being kept outside the government’s normal adverse events reporting system

In the lawsuit filed in partnership with the America First Legal public interest law firm, Just the News asked the U.S. District Court in Washington, D.C., to order the Department of Health and Human Services to comply with two Freedom of Information Act requests to the Food and Drug Administration and the Centers for Disease Control and Prevention seeking COVID-19 reactions data kept in a back-end, nonpublic system to the nation’s Vaccine Adverse Event Reporting System (VAERS).

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FDA Quickly Authorizes COVID Shots for Infants and Young Children

Susan Berry, PhD

The Food and Drug Administration (FDA) quickly authorized the Moderna and Pfizer-BioNTech COVID vaccine shots for infants and young children Friday, paving the way for the Centers for Disease Control and Prevention (CDC) advisory committee to vote on authorization over the weekend to allow the youngest children to get the shots as early as next week.

Per the press announcement by the FDA, the Emergency Use Authorization (EUA) for the Moderna COVID vaccine for older children and adults has been “amended” to “include use of the vaccine in individuals 6 months through 17 years of age,” while the EUA for the Pfizer COVID shot will now include use of the vaccine for babies as young as “6 months through 4 years of age.”

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FDA Announces Postponement of Approval of COVID Vaccine for Babies and Young Children

Susan Berry, PhD
Young girl with a blue shirt on getting a vaccine

Pfizer and the Food and Drug Administration (FDA) said Friday they are delaying their plan for Pfizer’s Emergency Use Authorization (EUA) for its coronavirus vaccine for children under five years old due to insufficient data on the efficacy of a third dose.

Pfizer announced February 1 FDA had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as six months old and young children up until age five.

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Pfizer Plan for COVID Vaccine Series for Babies of 6 Months Draws Fierce Controversy

Susan Berry, PhD
closeup of a baby

Pfizer announced last week the Food and Drug Administration (FDA) had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as 6 months old.

Albert Bourla, chairman and CEO of Pfizer, said in the statement:

As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus. Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.

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