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Update: Pfizer-BioNTech Vaccine Fully Approved

Update: As of August 23, 2021, the Pfizer-BioNTech vaccine has been fully approved by the FDA for the prevention of COVID-19 disease in individuals age 16 and older. The FDA-licensed vaccine will be marketed under the name Comirnaty, but nothing about its ingredients have changed, and is available under emergency use authorization (EUA) for individuals 12 through 15 years of age.

Overview

Eligible school-aged children should receive their COVID-19 vaccine as soon as possible so they are fully vaccinated for the school year. The New York State Department of Health urges all eligible New Yorkers, including school-aged adolescents 12 years and older, to get their free COVID-19 vaccine as soon as possible to protect themselves, their loved ones, and their communities. Find a vaccine provider.

Get a COVID-19 vaccine for your child as soon as you can

  • COVID-19 vaccines are safe, effective, and free.
  • COVID-19 vaccines have been used under the most intensive safety monitoring in U.S. history, which includes studies in adolescents.
  • Your child will need a second shot of the Pfizer-BioNTech COVID-19 Vaccine 3 weeks after their first shot.
  • Your child can’t get COVID-19 from any COVID-19 vaccine, including the Pfizer-BioNTech vaccine.
  • Your child may get a COVID-19 vaccine and other vaccines at the same visit.

Prepare for your child’s vaccination visit

  • Get tips for how to support your child before, during, and after the visit. • Talk to your child before the visit about what to expect.
  • Tell the doctor or nurse about any allergies your child may have.
  • Comfort your child during the appointment.
  • To prevent fainting and injuries related to fainting, your child should be seated or lying down during vaccination and for 15 minutes after the vaccine is given.
  • After your child’s COVID-19 vaccination, you will be asked to stay for 15–30 minutes so your child can be observed in case they have a severe allergic reaction and need immediate treatment.

COVID-19: A Serious Risk to All Ages

COVID-19 is a serious risk to people of all ages. While children have been significantly less affected by COVID-19 than adults, that does not mean they are “invincible.”

As of September 22, 2021 the State Department of Health is currently investigating 540 reported cases and 3 deaths in New York of and inflammatory condition called "MIS-C" predominantly in school-aged children who experience symptoms similar to Kawasaki disease and toxic shock-like symptoms, possibly due to COVID-19. Of children displaying these symptoms, 98 percent tested positive for COVID-19 either by diagnostic testing, antibody testing or both.

According to CDC data, the number of children being hospitalized for COVID-19 has increased since early July 2021, which may be due to the more contagious Delta variant. Delta is currently the predominant strain of the virus in New York State and the U.S. as a whole and presents the greatest risk to unvaccinated people. Learn more about the Delta variant.

There is currently not enough evidence for scientists to conclude that the Delta variant causes more severe disease in children than other forms of COVID-19, but it is by far the most contagious variant of the virus to date.

When Your Child Is Fully Vaccinated

Once your child is fully vaccinated, your child and family can resume activities that you did before the pandemic.

To reduce the risk of the Delta variant and prevent possibly spreading it to others, the CDC recommends that people continue to wear a mask indoors in public if you are in an area of substantial or high transmission.

If you’ve been fully vaccinated:

  • You can resume activities that you did prior to the pandemic.
  • According to the CDC's Guidance for COVID-19 Prevention in K-12 Schools, fully vaccinated students, teachers, and staff with no COVID-19 symptoms do not need to quarantine at home following an exposure to someone with COVID-19, but should get tested 3-5 days after exposure.
  • If you travel in the United States, you do not need to get tested before or after travel or self-quarantine after travel.
  • You do NOT need to get tested before leaving the United States unless your destination requires it.
  • You still need to show a negative test result or documentation of recovery from COVID-19 before boarding an international flight to the United States.
  • You do NOT need to self-quarantine after arriving in the United States.
  • If you’ve had close contact with someone who has COVID-19, the CDC recommends that you get tested 3-5 days after your exposure, even if you don’t have symptoms. You should also wear a mask indoors in public for 14 days following exposure or until your test result is negative. You should isolate for 10 days if your test result is positive.

In general, people are considered fully vaccinated:

  • 2 weeks after their second dose in a 2-dose series, such as the Pfizer (currently authorized for adolescents age 12 - 17) or Moderna vaccines, or
  • 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine

For now, if your child is fully vaccinated, they may still need to follow guidance at local businesses and other public areas. For example, wearing a mask is still required on public transit in New York State, even if you are vaccinated.

Additional precautions are recommended by the CDC if your child has a weakened immune system or an underlying medical condition that increases the risk for severe disease.

Development & Safety

Safety is a top priority in the development of any vaccine and COVID-19 vaccines are no exception. The U.S. has a robust vaccine safety system in place to ensure that all vaccines are as safe as possible. Safety is always closely monitored during clinical trials of vaccine candidates. After a vaccine is authorized or approved for use by the FDA, vaccine safety monitoring systems watch for adverse events (possible side effects). This ongoing monitoring can pick up on adverse events that may not have been seen in clinical trials. If an unexpected adverse event is seen, experts quickly study it further to see if it is a true safety concern. Experts then decide whether changes are needed in U.S. vaccine recommendations.

Only one COVID-19 vaccine is available for children age 12-17: The Pfizer-BioNTech vaccine. The FDA expanded its Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine to include 12- to 15-year-olds on May 10, 2021. On May 12, New York's COVID-19 Clinical Advisory Task Force unanimously recommended to immediately implement expanded use of the Pfizer COVID-19 vaccine for 12- to 15-year-olds.

On August 23, 2021, the FDA announced that the Pfizer-BioNTech vaccine has been fully approved for the prevention of COVID-19 disease in individuals age 16 and older. The FDA-licensed vaccine will be marketed under the name Comirnaty, but nothing about its ingredients have changed. The Pfizer-BioNTEch COVID-19 vaccine remains available under emergency use authorization (EUA) for individuals 12 through 15 years of age.Before the FDA expanded its EUA, it studied available safety data from an ongoing randomized, placebo-controlled clinical trial in the United States that included 2,260 participants ages 12 through 15. More than half of the participants were followed for safety for at least two months following the second dose.  Millions of Americans have already been vaccinated, including millions of adolescents ages 12-17.

Side Effects & Reporting Adverse Events

Possible Side Effects

Your child may not notice any changes in how they feel after getting the vaccine. But it’s also possible to feel a little “under the weather.” This can happen after any vaccine.  After the COVID-19 vaccine, your child may have:

  • A sore arm where they got the shot
  • A headache
  • Chills
  • Fever
  • Tiredness
  • Nausea and vomiting

These side effects are not dangerous and are just a sign of your child’s immune system doing its job. They are easily treatable with over-the-counter pain medicine and fever reducers, and usually only last for a short period of time. If your child still doesn’t feel well after two or three days, you can reach out to their health care provider.


Myocarditis and Pericarditis

Cases of myocarditis and pericarditis in adolescents and young adults have been reported more often after getting the second dose than after the first dose of one of these two mRNA COVID-19 vaccines. These reports are rare and the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis.


Adverse Event Reporting

The CDC tracks adverse event using their Vaccine Adverse Event Reporting System (VAERS). VAERS is an early warning system used to monitor adverse events that happen after any vaccination, including COVID-19 vaccinations. It is the frontline system of the nation's comprehensive and robust vaccine safety monitoring program. The CDC and the FDA use VAERS to help ensure all vaccines are safe.

VAERS collects reports of possible adverse events that happen after vaccination. As a condition of a vaccine’s use under Emergency Use Authorization, the FDA requires healthcare professionals to report to VAERS certain adverse events that occur after COVID-19 vaccination. However, anyone can submit a report to VAERS, including patients, family members, healthcare providers, and vaccine manufacturers, even if it isn’t clear if the vaccine caused the health problem. Learn more about VAERS

The CDC has also created v-safe, a free, smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after your child receives a COVID-19 vaccination. Through v-safe, you can report any side effects your child may have after vaccination. V-safe also reminds you to get your child's second dose. Learn more about v-safe.