Moderator: Let's jump right into the Q&A portion of our talk. To start, what's the difference between emergency use authorization and FDA approval?
Dr. Shulman: The COVID-19 vaccine for 5- to 11-year-olds now has, by the Food and Drug Administration (FDA), an Emergency Use Authorization (EUA). During a public health emergency like this pandemic, the FDA can issue an EUA to allow use of a vaccine before they're officially licensed so that they can be used sooner. With the EUA, certain criteria must be met. There needs to be data to show that the vaccine is safe and effective and that the benefits of taking the vaccine outweigh any risks. Vaccines with an EUA continue to go through clinical trials and can only get FDA approval after six months of follow up for serious adverse effects.
Moderator: Are the COVID-19 vaccines safe to take since they were developed so quickly?
Dr. Shulman: Experience developing prior vaccines allowed things to happen quickly when it came to COVID-19 vaccines. Programs pushed aside their other work to focus on COVID-19 vaccines. There were multiple clinical trials being run in parallel, and safety was monitored extremely closely during every phase of development. In fact, this is one of the most highly scrutinized vaccines in history. Shortcuts weren't taken.
Moderator: Will I get COVID from the COVID-19 vaccine?
Dr. Shulman: No. The COVID-19 vaccines are not live vaccines. They don't carry any risk of causing COVID-19.
Moderator: Do COVID-19 vaccines alter a person's DNA?
Dr. Shulman: No. COVID-19 vaccines never go into the nucleus of the cells and never contact DNA
Moderator: Can the COVID-19 vaccine be administered with other vaccines?
Dr. Shulman: Yes. Initially, scientists were saying wait 14 days between vaccines, but now that's not the case. Even in pediatric offices children may be offered the COVID-19 vaccine soon, along
with their other vaccines.
Moderator: After getting a COVID-19 vaccine will I test positive for COVID-19 on a viral test?
Dr. Shulman: No.
Moderator: If I already had COVID-19 should I still get the COVID-19 vaccine?
Dr. Shulman: Yes, even people who had COVID-19 naturally should still get the vaccine. The vaccine creates an immunity that's more robust than natural immunity.
Moderator: Does the vaccine affect future fertility or having a healthy baby one day?
Dr. Shulman: No. What's interesting about this question is that it has appeared regarding vaccines across history, like the smallpox vaccine. People were saying it was not safe and would affect fertility. It's a very scary allegation. Understandably, it would leave parents feeling very concerned about getting their child vaccinated. But there is literally no evidence, across billions of vaccinations, that COVID-19 vaccinations would affect future fertility. The American College of Obstetricians and Gynecologists recommends vaccination for all eligible people who may consider future pregnancy.
Moderator: Do we know how long the vaccine offers protection against COVID-19?
Dr. Shulman: We are now needing boosters and there's a very good chance that COVID-19 vaccination will follow the pattern of flu vaccines and require future boosters.
Moderator: Will my child get myocarditis from the COVID-19 vaccine?
Dr. Shulman: So, this is the most significant side effect from the COVID-19 vaccine to date. It is very rare. There have been 877 cases confirmed, all in people under 30 years of age, out of 86 million doses of vaccines (Boehmer et al. 2021). That would mean the prevalence rate is 1 out of 100,000. It has never been fatal. Signs
FINDING ANSWERS : COVID-19 AND VACCINATION RESOURCES
ROSE F. KENNEDY CENTER
Children's Evaluation and Rehabilitation Center at the Children's Hospital at Montefiore: COVID-19 Vaccines and Children with Developmental Disabilities: Let's Talk with Dr. Lisa H. Shulman. English slide deck, English recording, and Spanish audio einsteinmed.edu/centers/children-evaluation-rehabilitation/vaxfactsddny
ASSOCIATION OF UNIVERSITY CENTERS ON DISABILITIES' (AUCD) N
ational Center on Disability in Public Health nationalcenterdph.org/vaccine-resources
NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE youtube.com/watch?v=xCjhDgM0fOE
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) COVID-19 Vaccines for Children and Teens www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html
Children with Developmental Disabilities www.cdc.gov/vaccines/covid-19/planning/children.html#information-children-developmentaldisabilities
COVID-19 Myocarditis and Pericarditis: What you Need to Know. www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html
Pfizer-BioNTech COVID-19 Vaccine Overview and Safety www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html
CDC Videos on COVID-19 Vaccines and Fertility Dr. Walters: www.youtube.com/watch?v=KjR1HtUz0so Dr. Castillo: www.youtube.com/watch?v=awkDkrhpK-8
SESAME STREET
NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE youtube.com/watch?v=xCjhDgM0fOE The ABCs of COVID Vaccines youtube.com/watch?v=yPlhRUF2aXA