FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for "Emergency Use" in Adolescents

Pfizer says the vaccine is "generally safe" for children

On May 10, the Food and Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 Vaccine for children ages 12 to 15.

“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. in a press release.

Woodcock also said that “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.”

The authorization follows a clinical trial of 2,260 children spanning the ages 12 through 15 years old. FDA’s press release indicated that “1,131 adolescent participants received the vaccine and 1,129 received a saline placebo.”

There were side effects of the vaccine, which the FDA said were similar to that reported so far with the older population receiving them":

According to the FDA’s press statement, “among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19.”

Some of the Pfizer vaccine testings on children is being done right here in North Carolina at Duke Health in Durham.

The FDA also admitted that currently there is “limited data” on whether the vaccine prevents transmission of the virus from person to person.

Pfizer and Moderna both have started COVID-19 vaccine clinical trials on children, including infants starting at 6 months. Johnson & Johnson is also conducting a study involving its “one-dose” vaccine in kids ages 12 to 17. The results of these studies likely won’t be available until September or October.

At least one school district in the state is planning to have all students vaccinated before the start of the 2021-22 school year. Winston-Salem/Forsyth schools is working with Novant Health, Inc. and local health officials to turn schools into mass vaccination centers.

Novant has claimed state law allows for children ages 12 to 17 to get the shot without a guardian present or verbal or written parental consent.

Parents in North Carolina who reached out this Substack publication are highly concerned that other districts will expand on Winston-Salem/Forsyth’s efforts in an attempt to force public school children to be vaccinated prior to the next school year.

One parent pointed out that districts and state officials can’t require anyone to get a COVID-19 shot as the vaccines are still experimental.

Children contracting severe cases of COVID-19 requiring hospitalization are rare and deaths are uncommon. Most deaths in children are tied to complications from the virus or present as Multisystem Inflammatory Syndrome in Children (MIS-C).

MIS-C is very rare and not contagious. MIS-C typically involves a fever (temperature of 100.4 degrees F or 38.0 degrees C or greater) lasting several days, along with a variety of symptoms like Abdominal pain without another explanation, Diarrhea, vomiting, rash, and red, cracked lips or red, bumpy tongue that looks like a strawberry. Hands and feet may also be swollen and red.

The Centers for Disease Control (CDC) has repeatedly said children are typically asymptomatic and have mild, non-specific symptoms. Additionally, the CDC has stated that children 10 years old and under may be less likely to be infected than adolescents.

Related news: NC House Passes Bill to Bar Cooper From Mandating COVID Shot

Read House Bill 572

Useful Resources

Science Brief: Transmission of SARS-CoV-2 in K-12 schools

Screening K-12 Students for Symptoms of COVID-19: Limitations and Considerations