Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5. The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6…
Moderna says Pfizer-BioNTech COVID vaccine infringed its patents
Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer (NYSE:PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq:BNTX) over patent infringement in U.S. and German courts. Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany. The suits could…
FDA advisors unanimously back Moderna and Pfizer COVID-19 vaccines in young children
An FDA panel voted 21 to 0 to authorize the Pfizer/BioNTech and Moderna COVID-19 vaccines in children between the ages of 6 months and 4 years of age. Children under the age of 5 constitute the only age group that has not been eligible to be vaccinated against COVID-19. “I know there are a lot…
NIH to study allergic reactions to COVID-19 mRNA vaccine
Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…
Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA
COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg. The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine. Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose…
Pfizer and BioNTech set their sights on developing mRNA-based shingles vaccine
Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles). Roughly one million people in the U.S. get shingles each year, according to the CDC. Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market.…
FDA authorizes expanded use of Pfizer-BioNTech vaccine boosters
With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between…