Oluwatobiloba Jaiyeola
The United States’ two biggest vaccine makers, Pfizer/BioNTech and Moderna have sought approval from the United States Food and Drug Administration requesting emergency use authorisation of their updated COVID-19 booster vaccine.
The companies, on Monday, said the Omicron BA.4/BA.5-adapted bivalent vaccine will be used for kids ages five through 11 years of age.
“The request for Emergency Use Authorisation of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision.
“An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorisation to include children ages five through 11 years will be submitted to the European Medicines Agency in the coming days,” the companies disclosed.
Pfizer added that a trial has been initiated to evaluate the safety, tolerability, and effectiveness of the doses, in children six months through 11 years of age.
“This paediatric study is consistent with regulatory guidance and follows a previous Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 Vaccine is well-tolerated and offers a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent,” Pfizer said.
The FDA had previously issued an emergency use authorisation for the updated versions of the Moderna and Pfizer-BioNTech COVID-19 Vaccine booster shots.
The FDA said the updated Pfizer COVID-19 Vaccine is authorised for those who are 12 years and up, while the Moderna COVID-19 Vaccine is approved for use as a single booster dose in individuals who are 18 years of age and older.
Pfizer advised, “Seek medical attention right away if you have any of the following symptoms: difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness.”
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