Apr 15: A booster dose of Pfizer Inc and BioNTech’s Covid vaccine produced significant protection against the Omicron variant in children aged between 5 and 11 years, the firms said.
Analysis of blood samples of 30 children who received a booster dose showed a 36-fold increase in antibodies against the omicron variant of the coronavirus. In 140 children, a third dose increased antibodies sixfold against the original strain of the virus.
The phase 2/3 clinical trial was testing the safety and immunogenicity of a 10 microgram booster dose in 140 healthy children aged 5 through 11 years.
Pfizer and BioNTech said the data from the clinical trial reinforces the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group.
The firms plan to submit this data to the US Food and Drug administration and apply for Emergency Use Authorization of a booster dose in the 5-11 age group in coming days, with additional submissions to global regulatory agencies including the European Medicines Agency to follow.
The firms stated, “To date, more than 10,000 children under the age of 12 have participated in clinical trials investigating the Pfizer-BioNTech Covid-19 vaccine, and in this most recent booster data readout, the vaccine was well tolerated with no new safety signals observed.”
The Pfizer-BioNTech Covid-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
NB: Content credit from external sources.
