The latest news on the COVID-19 Vaccine

With the recent news that the FDA has granted full authorization to the Pfizer COVID-19 vaccine for patients 16 and older, we have been getting many questions about the vaccine.  Here are some answers to help guide parents.

1. Why wasn’t full authorization granted for children 12-15 years?

• The FDA is unable to grant full authorization until 6 months have passed from when the last vaccine dose in the trials were given.  Since Emergency Use Authorization for kids 12-15 came a few months after application for 16 years and up, the FDA needs to wait until 6 months have passed to evaluate all of the data from the studies.  We expect that when this time frame is up, it will be fully approved for kids 12-16

2. When will the FDA approve COVID vaccine for children under age 12?

• These studies are currently wrapping up, and we expect Pfizer to submit the data to the FDA soon.  Most likely the vaccine will be approved near the end of 2021 or early 2022.

3. Is it possible for kids under the age of 12 to receive the Pfizer vaccine “off label”?

• While it may be tempting to ask that your child receive the vaccine early, both the CDC and AAP do not recommend this.   Younger children may require a different dose and these trials have yet to be fully evaluated.  If pediatricians use the vaccine off-label, they could lose their eligibility to provide further COVID vaccine.

4. I keep hearing about vaccinated people getting “breakthrough” infections.  Why is this happening?

• The COVID vaccine was never expected to prevent 100 percent of infections.  The vaccine is extremely effective in preventing the vaccine from entering the lungs, which is where it causes the most damage and often results in hospitalization, ICU admission, and death.  The vaccine is less effective at preventing the virus from entering the nose.  Even though after vaccination the virus can enter the nose and would result in infection (a positive COVID test), these breakthrough infections are either asymptomatic or very mild.  99.9 percent of patients admitted to the hospital for serious COVID infections ARE NOT vaccinated. 

5. I am worried about complications from COVID vaccine such as myocarditis or infertility.

• The most common side effects of the vaccine are mild soreness at the injection site, mild fever, body aches and fatigue.  There have been some reports of older teenagers and young adults developing mild inflammation of the heart (known as myocarditis) after the second dose.  This complication is very rare, and the patients that did develop myocarditis had a very mild case and recovered without issue.  Myocarditis is a known complication from COVID infection.  In fact, the chances of getting COVID if you are not vaccinated, and then developing myocarditis is much greater than any risk post-vaccination.  As far as infertility, there is no data at all that suggests the COVID vaccine affects fertility in either men or women.  The vaccine is safe and recommended if you are pregnant or breastfeeding.

6. I have had COVID infection.  Should I get vaccinated?  Isn’t natural immunity better?

• You should still get vaccinated even if you have had COVID.  A recent study showed that unvaccinated individuals are more than twice as likely to be reinfected with COVID-19 than those who were fully vaccinated after initially contracting the virus. These data further indicate that COVID-19 vaccines offer better protection than natural immunity alone and that vaccines, even after prior infection, help prevent reinfections

7. My child has a chronic medical condition that affects their immune system.  Should they get a third dose.

• Earlier this month the FDA approved a third dose of COVID vaccine for patients who are immunocompromised.  We would recommend that you check with your child’s pediatric specialist to verify that they recommend a third dose.  If so, we can administer in our office.  

Given the rise in COVID infections due to the Delta variant (which is more contagious and causing more serious illness in children), we would recommend that everyone age 12 and up get fully vaccinated against COVID-19.  In addition, we would recommend other mitigation efforts such as masking in schools regardless of vaccine status, masking indoors if you are unvaccinated or if you live in an area that has a high incidence of transmission, social distancing and good hand hygiene.  We are available to vaccinate children as well as parents against COVID.  Please call 513-752-3650 to schedule your appointment.