Young children using Pfizer-BioNTech Vaccines against covid-19 There are usually mild side effects, but serious reactions are rare, according to a recent government analysis on vaccine safety in children 5 to 11. The data comes from the Vaccine Adverse Event Reporting System (VAERS), a large vaccine safety monitoring system maintained by the Centers for Disease Control and Prevention. and the United States Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration. (FDA), and v-safe, the CDC’s smartphone-based reporting system specifically for COVID-19 vaccine reactions.
“After more than 8 million COVID-19 vaccinations in this age group, we found that side effects reported with v-safe were generally mild and included things like injection site pain, fatigue and pain. early, and mostly reported the day after vaccination, said Anne Hause, lead author of the CDC study. Report, released on December 31, 2021, includes data collected between November 3 and December 19.
Of the reactions reported to VAERS, 97.6% were non-serious adverse events and 2.4% were serious reactions. Only 11 verified cases of Myocarditis, or myocarditis, has been reported, and all children have recovered or are recovering. Two deaths have been reported to VAERS; both children were in “pre-vaccination poor health” and had multiple chronic illnesses, and the data did not show a causal link between mortality and vaccination, the report said. V-safe data reveals that although reactions to injections are common, most are mild. Only 1% of parents go to the doctor in the week after vaccination.
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Because the latest report includes information from two different monitoring systems — VAERS and v-safe — the results are exceptionally comprehensive. Two different data collection systems. Any patient (or in the case of children, their parents) can report an adverse reaction to VAERS vaccination. Ease of reporting means that even a very rare adverse event or unusual pattern can be picked up by the system, but it can be difficult to determine what is really causing the adverse event or frequency. it actually happens, especially because the system has a negative bias; According to the FDA, adverse reactions are more likely to be reported to VAERS if they are more severe. News reports of side effects or controversy about vaccines can also skew the number of people who report a particular adverse reaction. “Everybody can put anything in that database, and people in the past have not for medical reasons,” said Saad Omer, director of the Yale Institute of Global Health. For example, in search published in Journal of Pediatric Infectious Diseases in 2020, Hause, Omer, and other researchers found that after California eliminated the nonmedical vaccine exemption in 2015, reports of adverse reactions to VAERS increased. The researchers suspect that this increase is due to parents seeking medical exemptions for their children and think reporting to VAERS would make it easier. Researchers had to sort out how many of the reactions reported to VAERS were caused by the vaccine itself and not just random symptoms that occurred after they got the vaccine; They do this by thoroughly investigating the cases involved, interviewing healthcare professionals, and reviewing electronic health records.
Other database participants, v-safe, are encouraged to report their child’s reactions as they occur. Simple questions will be sent via text over the next few days, such as how their child is feeling and whether they will be able to go to school after that. V-safe participants are also required to contribute to other tracking services; for example, if they approach a health care provider to get care for their child, they are encouraged to report what is happening to VAERS.
The Pfizer-BioNTech COVID-19 vaccine for children has been under particularly close supervision since it was authorized for emergency use; it was approved for children 5-11 years old in October 2021. (It was authorized for children 12-15 years old in May 2021 and fully approved by FDA for those 16 age or older.) That authorization status means that providers must report certain Dr. Tom Shimabukuro of the CDC’s COVID-19 Vaccine Task Force. “The COVID-19 vaccines have been monitored under the most rigorous surveillance procedures in the history of vaccination,” said Shimabukuro.
No database can tell scientists everything they need to know about the safety of COVID-19 vaccine in children. But they can show how vaccines are affecting children in real life — and what we know now is encouraging.
https://time.com/6133317/covid-vaccine-kids-safe/ COVID-19 Vaccine Safe for Children 5-11 Years, CDC Data Show