Pfizer Seeks Authorization For Under-5 Bivalent Shots — But There’s A Twist
The company wants the green light from the FDA to add the vaccination not as a booster but as part of kids' initial series of shots. In other news, Pfizer has countersued Moderna over vaccine patents.
AP:
Pfizer Asks FDA To Clear Updated COVID Shot For Kids Under 5
Pfizer is asking U.S. regulators to authorize its updated COVID-19 vaccine for children under age 5 — not as a booster but part of their initial shots. Children ages 6 months through 4 years already are supposed to get three extra-small doses of the original Pfizer COVID-19 vaccine — each a tenth of the amount adults receive — as their primary series. If the Food and Drug Administration agrees, a dose of Pfizer’s bivalent omicron-targeting vaccine would be substituted for their third shot. (Neergaard, 12/5)
CNN:
Pfizer/BioNTech Seek FDA Authorization For Updated Covid-19 Vaccine For Youngest Kids
The vaccine makers announced on Monday that if authorized for emergency use, children in that age group will still receive the original version of the Covid-19 vaccine as their first two doses and then the updated Covid-19 vaccine – formulated to target the coronavirus Omicron subvariants BA.4 and BA.5 – as the third dose. (Howard, 12/5)
In related news about covid vaccine development —
NBC News:
Myocarditis After Covid Vaccine Low Among Teens, Young Adults, New Study Finds
The incidence of myocarditis and pericarditis after Covid vaccination is low and most patients make a full recovery, a large international study from Nationwide Children’s Hospital found. (Lovelace Jr., 12/5)
In other news about Pfizer —
Reuters:
Pfizer, BioNTech Countersue Moderna Over COVID-19 Vaccine Patents
Pfizer Inc and its German partner, BioNTech SE, fired back at Moderna Inc on Monday in a patent lawsuit over their rival COVID-19 vaccines, seeking dismissal of the lawsuit in Boston federal court and an order that Moderna's patents are invalid and not infringed. (Brittain, 12/5)
AP:
Pfizer Announces $750M Expansion Of Western Michigan Plant
Pfizer announced a $750 million project Monday toward expanding capacity at the western Michigan pharmaceutical plant where the company first mass produced its COVID-19 vaccine. Company officials said the project will boost the plant’s manufacturing of sterile injectable medications and could lead to 300 new jobs at the Portage plant near Kalamazoo that now has about 3,000 workers. (12/5)
