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From babies to adolescents, individuals will need vaccines through childhood to offer them with immunity from likely hazardous infectious disorders. If persons opt for not to vaccinate by themselves or their little ones, some disorders that are now uncommon or nonexistent in the United States could resurface. The Food and drug administration has licensed the Pfizer-BioNTech COVID-19 Vaccine for emergency use to stop COVID-19 in individuals twelve and older. The Centers for Illness Manage and Prevention (CDC) recommends COVID-19 vaccination for everyone twelve and older.
one. Is the Pfizer-BioNTech COVID-19 Vaccine for adolescents twelve via 15 the similar vaccine licensed for emergency use in individuals sixteen and older?
Sure. Pfizer, Inc. examined its COVID-19 vaccine in a scientific demo in adolescents twelve via 15. Based mostly on this facts, the Food and drug administration determined that the identified and potential added benefits of Pfizer-BioNTech COVID‑19 Vaccine outweigh the identified and potential risks of the vaccine for the prevention of COVID-19 in adolescents twelve via 15.
“Parents and guardians can relaxation certain that the company undertook a demanding and thorough overview of all offered facts, as we have with all of our COVID-19 vaccine emergency use authorizations.”
– Performing Food and drug administration Commissioner Janet Woodcock, M.D.
2. Were being the facet outcomes reported throughout the scientific demo in adolescents twelve via 15 constant with facet outcomes reported by individuals sixteen and older?
Sure. The most normally reported facet outcomes were:
- pain at the injection site
- muscle mass pain
- joint pain
Like individuals sixteen and older, adolescents twelve via 15 are extra most likely to practical experience facet outcomes immediately after the 2nd dose of the vaccine.
Though some individuals practical experience facet outcomes subsequent any vaccination, not everyone’s practical experience will be the similar and some individuals could not practical experience facet outcomes.
3. Is the Food and drug administration continuing to keep track of the security of COVID-19 vaccines? What about reports of heart swelling subsequent vaccination with Pfizer-BioNTech and Moderna COVID-19 Vaccines?
Sure, the Food and drug administration is checking the security of all vaccines, which includes COVID-19 vaccines, which has and usually will be a major precedence for the Food and drug administration. COVID-19 vaccines are going through intense security checking in the U.S.
The Food and drug administration and the CDC have various techniques in put to continually keep track of COVID-19 vaccine security. These techniques, termed “passive surveillance” and “active surveillance” techniques, rapidly detect and examine potential security troubles. Programs these types of as the Vaccine Adverse Occasion Reporting Technique (VAERS) and CDC’s textual content-primarily based v-protected program, which obtain reports of adverse activities subsequent vaccination, are examples of passive surveillance techniques. The FDA‘s Most effective Initiative is an example of an lively surveillance program, which can evaluate facts developing in thousands and thousands of persons recorded in big facts techniques to examine any security signals that are discovered by VAERS or v-protected. Given the risk of COVID-19 sickness and associated, likely significant, complications, the facts continue on to present that the identified and potential added benefits of just about every of the three licensed COVID-19 vaccines outweigh their identified and potential risks.
Reports to VAERS counsel an amplified risk of myocarditis (swelling of the heart muscle mass) and pericarditis (swelling of tissue encompassing the heart) subsequent vaccination with both of those Pfizer-BioNTech and Moderna COVID-19 vaccines, notably subsequent the 2nd dose. (Moderna COVID-19 Vaccine is licensed for emergency use in persons eighteen and older). Commonly, onset of signs and symptoms has been various times to a 7 days subsequent vaccination.
The Food and drug administration expected both of those makers to revise the Actuality Sheet for Healthcare Vendors Administering Vaccine (Vaccination Vendors) to include a Warning pertaining to the risk of myocarditis and pericarditis, as perfectly as the Actuality Sheet for Recipients and Caregivers to include facts about myocarditis and pericarditis. The Food and drug administration will offer updates to the general public as more details grow to be offered.
four. Can my adolescent get other vaccines with the Pfizer-BioNTech COVID-19 vaccine?
Sure. In accordance to the CDC, if an adolescent twelve via 17 is getting the Pfizer-BioNTech COVID-19 Vaccine, they can obtain routinely advisable vaccines at the similar time as the COVID-19 vaccine.
five. Why need to I get my adolescent vaccinated to stop COVID-19?
Vaccination is one particular of the most effective methods to guard individuals twelve and older from COVID-19.
The most modern experiments present that presently licensed COVID-19 vaccines stop COVID-19, which includes potential severe wellness penalties of hospitalization and dying. The U.S. is presently suffering from a surge of COVID-19 scenarios and extra adolescents are starting to be ill and becoming hospitalized with COVID-19 throughout this surge.