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The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age. 

EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children 

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

FDA Authorizes COVID-19 Boosters for All Adults

Novo Nordisk’s 3.3 billion acquisition of Dicerna gives them access to their RNAi technology.

Novo Nordisk Acquires Dicerna for $3.3 Billion

Pfizer’s PAXLOVID oral solid-dosage treatment is designed to combat SARS-CoV-2 in high-risk patients at the first sign of infection.


Pfizer Submits COVID-19 Oral Antiviral Candidate to FDA for Emergency Use Authorization 

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency. 

Califf Named to Head FDA

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children

Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.

Moderna Announces Positive Results in Study On COVID-19 Vaccine in Children 

Pfizer and BioNTech’s Phase III trial demonstrated 95.6% booster efficacy relative to participants who received placebo.

Pfizer and BioNTech Release Phase III Trial Data Supporting Efficacy of Booster Doses

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

FDA Amends EUA to Allow Booster Shots for Moderna, J&J COVID-19 Vaccines

The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.

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