On Friday, Pfizer (NYSE:PFE) and BioNTech (BNTX) announced that Health Canada has approved the 3-g dosage of their COVID-19 vaccination as a main 3-dose regimen for children less than five years old.
With this approval from Health Canada, we’ve made significant progress in our mission to safeguard populations against the spread of COVID-19. Pfizer (PFE) Canada’s mRNA Vaccines and Antiviral Portfolio Lead Fabien Paquette made a statement.
More than 4,500 children aged six months to under five participated in a Phase 2/3 randomized, controlled study that informed the conclusion.
When the COVID Omicron variation was predominating, the study participants got a third 3-g dose of the vaccination at least two months after the first two doses.
A recent analysis of the trial’s data showed that the vaccination was 73 percent effective in children between 6 months and 4 years old.
Ritlecitinib, made by Pfizer, is being reviewed in the US and EU to treat alopecia areata.
In a related press release, Pfizer (NYSE:PFE) announced the FDA has agreed to assess its NDA for ritlecitinib to treat patients 12 and older with alopecia areata.
In Q2 2023, we anticipate a decision from the FDA.
The firm said that the MAA for oral medicine was also approved by the European Medicines Agency (EMA) on September 9, the same indication, and a decision is anticipated in the fourth quarter of 2023.
Hair loss due to alopecia areata is caused by an autoimmune disorder. Approximately 147 million individuals across the world are affected by the illness, Pfizer said.
Both the completed ALLEGRO phase 2b/3 trial and the current ALLEGRO-LT phase 3 trial provided the basis for the filings.
Additional regulatory filings for ritlecitinib have been completed by Pfizer in the United Kingdom, China, and Japan, with decisions expected in 2023.
PFE in Premarket was up 0.47%, closing at $47.30.
Featured Image – Megapixl © Mikemareen