FDA Approval for 12 to 15 year olds to take COVID vaccine does not trigger local approval… yet

#TurksandCaicos, May 12, 2021 – Turks and Caicos has not authorized for children under 16 years old to be vaccinated for the coronavirus said Minister of Health E Jay Saunders overnight. 

The US has gone forward with a plan to get 12 to 15 year old vaccinated for the virus which has literally turned the world upside down. 

“From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.” 

The US Food and Drug Administration approved the vaccine for this newest age group and already there is interest in Turks and Caicos for the jabs for teens. 

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” in a statement issued on May 10.

Minister Saunders says allowance for younger teenagers to take Pfizer/BioNtech now that clinical trials have proven successful and results accepted, will be an informed Cabinet decision which has not been taken as yet.

The FDA provided:  The available safety data to support the EUA in adolescents down to 12 years of age, include 2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.

The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older. It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individual’s experience will be the same and some people may not experience side effects.