The U.S. Food and Drug Administration (FDA) has approved the vaccine you may know as the Pfizer-BioNTech COVID-19 vaccine for people 16 years and older. The drug for that age group will now be marketed as Comirnaty.

The Food and Drug Administration (FDA) spent the past several months reviewing updated data from clinical trials, which supported the emergency use authorization (EUA) late last year. This data showed the vaccine to be 91% effective in preventing COVID-19 disease. The most common reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. It also proved the vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

A Pfizer vaccine also continues to be available under emergency use authorization (EUA) for children 12 through 15 years of age. The Moderna and Johnson & Johnson vaccines are only for adults because they have not completed their studies in children.

The American Academy of Pediatrics strongly discourages the administration of off-label COVID-19 vaccines for children aged 11 and younger, who currently have no available vaccine.

“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” said AAP President Lee Savio Beers, MD, FAAP. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”

The AAP strongly recommends all eligible adolescents (12 years and up) be vaccinated as soon as possible. The data from clinical trials and experience with the vaccine over the past four months show that the vaccine is safe and very effective for this age group.

However, the dose of the adult vaccine is much higher than the doses currently being tested in children under 12.

The AAP does not want physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients.

“We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials,” said Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases

Doctors, researchers and scientists are all working very hard to make the vaccines ready for children under 12. They have to collect enough information, or data, to show that the vaccine is safe and effective.

Pfizer and Moderna are both working on large trials for children under 12 and the use of a COVID-19 mRNA vaccine. The early research shows very promising results. Both trials are in the placebo stages, meaning they compare a vaccinated group of children with those who do not receive the vaccine. Researchers can then be confident and how effective the vaccine is and how it works.

Thousands of children are participating in the trials to make sure that the vaccines are safe and to avoid any rare, but serious events.

The AAP has called on the FDA to work aggressively to authorize a vaccine for ages 11 and younger. The delta variant is spreading rapidly among unvaccinated people, including children. The delta variant has led to significant increases in the number of children and adults infected with the virus.

Pfizer looks to have its vaccine available to children for ages 5 to 11 years old by the end of September. They hope to have enough data by that time to show how safe and effective their vaccine is for that age group. Parents can be rest assured that that once the vaccine is available it is because ALL the research has been studied and everyone involved feels it is safe for children.

Then Pfizer will look at the data collected for children under 5 to make a decision on when that age group can get the vaccine.

Moderna hopes to have its research done by the end of the year to receive authorization for children 6 and 11 years of age.

While the vaccine became available under EUA for 16 years and older in Dec. 2020, authorization was not expanded for 12-15 year olds until May 2021. Much like the emergency authorization process, the FDA will need more time to review data for this younger population before it can grant full approval.

Yes, Pfizer-BioNTech’s COVID-19 vaccine is recommended for children 12 years and older. Many people mistakenly believe that children cannot become ill from COVID-19 and this is simply not true. Unfortunately, children and teens can become very ill from the virus and need hospitalizations, even intensive and life-saving care. The Pfizer-BioNTech vaccine is safe for children and teens, and protects them from potentially developing severe illness and long-term health issues.

At this time, no COVID-19 vaccine has been authorized for children under the age of 12. This means it’s vitally important for this population to wear a mask around non-family members, stay six feet apart from others and practice frequent handwashing. Families can also protect these children by ensuring those closest to the child (parents, older siblings, grandparents) are all vaccinated. This will help decrease the chances of the child becoming exposed to COVID-19.

With school back in session and the rise of the delta variant, COVID-19 cases among children are surging. Doctors at Cook Children’s are seeing more kids for COVID now than they did in the winter.

While children typically have milder symptoms from COVID-19 infection, they can become very ill and require hospitalization. In rare cases, life-saving measures such as ventilators and extracorporeal membrane oxygenation (ECMO), which oxygenates a patient’s blood outside of the body, have to be used on young COVID-19 patients. Children can also experience long-term symptoms of COVID-19, a diagnosis known as ‘long COVID,’ as well as a disease called Multisystem Inflammatory Syndrome in Children (MIS-C). Both of these syndromes can occur weeks after a COVID-19 infection in which the child may or may not have shown any symptoms.

Children and teens can also spread COVID-19 to more vulnerable populations, such as the elderly and immunocompromised. Getting this population vaccinated is a key step in reaching herd immunity and defeating COVID-19.

• Antibodies: Blood proteins produced in response to and counteracting a specific antigen.
• Antigen: A toxin or other foreign substance which generates an immune response in the body, especially the making of antibodies.
• Appendicitis: An inflammation of the appendix, which is a small tube leading off from the intestine.
• Lymph: A colorless fluid containing white blood cells, which covers the tissues and drains through the lymphatic system into the bloodstream.
• Lymph nodes: A number of small swellings in the lymphatic system where lymph is filtered and lymphocytes are formed.
• Placebo: A harmless pill or injection given during a clinical trial that may affect the mental and emotional state of a person but not the physical body.

Referenced source: Merriam-Webster

Pfizer-BioNTech recientemente publicó información acerca de que su vacuna COVID-19 es segura y efectiva para los niños de 12 a 15 años. Actualmente, la vacuna está disponible para su uso en personas de 16 años o mayores en base a ensayos previos y está aprobada para autorización de uso de emergencia (Autorización de Uso en Emergencia o EUA, por sus siglas en inglés) por la FDA. Se espera que Pfizer solicite una EUA para este grupo de edad más joven en las próximas semanas.

Sabemos que muchos padres tienen preguntas que van desde qué tan segura es la vacuna para su hijo hasta cuándo estará disponible. Mary Suzanne Whitworth, M.D., directora médica de enfermedades infecciosas en Cook Children's Medical Center, y Nicholas Rister, M.D., especialista en enfermedades infecciosas pediátricas están de acuerdo en que es seguro vacunar a los niños una vez que esté aprobado. Puedes leer más sobre la vacuna aquí.

Los estudios sobre la seguridad de la vacuna aún están en curso, incluso para aquellos que se distribuyen bajo la autorización de uso de emergencia de la FDA. Aunque estas vacunas se produjeron más rápido que nunca, la FDA dice que las medidas de seguridad no se han visto comprometidas y los beneficios proporcionados por la vacuna superan los riesgos asociados con ella.

La mayoría de las personas que reportaron una reacción adversa a la vacuna dijeron que experimentaron las mismas reacciones que comúnmente se reportaron con otras vacunas: reacciones en el lugar de la inyección, fatiga, dolor de cabeza, dolor muscular, dolor en las articulaciones y fiebre durante unas horas a unos días después de la inyección. Algunos recipientes de la vacuna experimentaron inflamación de los ganglios linfáticos brevemente después de ser inmunizados, lo que se cree que es el resultado de que la vacuna activa una respuesta del sistema inmunológico.

La FDA ha autorizado la vacuna Pfizer para los niños de 12 a 15 años y para personas de 16 años en adelante y Moderna es para personas de 18 años o más.

Actualmente, la vacuna se está probando en los niños de hasta 6 meses de edad. Los niños no son adultos pequeños, por lo que se necesitan más pruebas antes de que se pueda aprobar su uso en este grupo de niños más pequeños.

Seguiremos siguiendo los estrictos criterios de los CDC sobre quién debe recibir la vacuna COVID-19 y cuándo debe suceder.

Todavía no sabemos si la vacuna COVID-19 se hará una vez o si será necesaria cada año. Se necesitan más estudios para entender si la protección que proporciona es a largo plazo.

El resultado producido tanto a partir de las vacunas tradicionales como de la nueva vacuna COVID-19 es el mismo, una respuesta del sistema inmunitario que produce anticuerpos. Esos anticuerpos protegen a un individuo de la enfermedad si entran en contacto con el virus. Sin embargo, la forma en que la vacuna COVID-19 produce esa respuesta es diferente comparada a otras vacunas.

Las vacunas tradicionales se fabrican utilizando un virus debilitado o muerto que desencadena el sistema inmunitario para producir anticuerpos contra el virus. La vacuna COVID-19 utiliza material genético llamado ARN mensajero (ARNm) para instruir a las células inmunitarias del cuerpo a producir una proteína que también se encuentra en COVID-19 para que el cuerpo pueda reconocer el virus y producir anticuerpos contra él.

Para obtener más información sobre cómo funciona una vacuna de ARNm, visite la página de internet cdc.gov y busque "entender vacunas de ARNm".

Los datos actuales muestran que la vacuna de Pfizer es 95 por ciento eficaz en la protección contra COVID-19, mientras que Moderna reporta una tasa de efectividad del 94.5 por ciento.

Se necesitan más estudios para determinar la seguridad de la vacuna en los niños, en particular aquellos con condiciones de salud subyacentes. Actualmente, no existen riesgos conocidos para las personas con sistemas inmunitarios comprometidos porque la vacuna no contiene un virus vivo. Si su hijo tiene antecedentes de reacción alérgica, debe consultar a su pediatra antes de vacunarlo.

No sabemos cuánto tiempo uno es inmune al COVID-19 después de contraer y recuperarse del virus. Tampoco sabemos si el virus en sí o la vacunación hace un mejor trabajo en la producción de inmunidad. Por lo tanto, por ahora, los adultos que han tenido el virus deben ser vacunados después de haberse recuperado. Esperemos que haya datos que respondan a esta pregunta para los niños en los próximos meses.

• Anticuerpos: Proteínas de la sangre producidas en respuesta y contrarrestando un antígeno específico.
• Antígeno: Una toxina u otra sustancia extraña que genera una respuesta inmune en el cuerpo, especialmente la fabricación de anticuerpos.
• Apendicitis: Una inflamación del apéndice, que es un tubo pequeño que sale del intestino.
• Linfa: Líquido incoloro que contiene glóbulos blancos, que cubre los tejidos y drena a través del sistema linfático hacia el torrente sanguíneo.
• Ganglios linfáticos: Una serie de pequeñas inflamaciones en el sistema linfático donde se filtra la linfa y se forman linfocitos.
• Placebo: Una píldora o inyección inofensiva que se administra durante un estudio clínico que puede afectar el estado mental y emocional de una persona, pero no del cuerpo físico.

Fuente de información: Merriam-Webster