FDA authorizes Pfizer-BioNTech COVID-19 vaccine for Emergency Use in children 5 - 11 years of age
by Pinedale Online!
October 29, 2021
On Friday, October 29, 2021, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The vaccine will be one-third of the adult dose, with two injections three weeks apart. The move still needs to be approved by the Centers for Disease Control and Prevention, which is expected.
The FDA states that studies indicate the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11. The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
Most children with COVID-19 have mild symptoms or they may have no symptoms at all. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group. Deaths mostly occurred in children who had other underlying medical conditions that put them more at risk for serious illness due to COVID-19. Similar to adults, children with obesity, diabetes, asthma or chronic lung disease, sickle cell disease, or immunosuppression can also be at increased risk for severe illness from COVID-19.
The FDA stated commonly reported side effects in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days.
"The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age. Therefore, the FDA conducted its own benefit-risk assessment using modelling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children 5 through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause. The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age." (Source: FDA media release)
https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
In Wyoming, over the past two years of the pandemic, there have been no reported deaths of anyone age 18 or under from COVID-19, according to the Wyoming Department of Health. As of October 19, 2021, WDH reports there have been 13,750 confirmed COVID-19 cases among children age 18 and under in Wyoming since the pandemic began nearly two years ago.
As of October 25, 2021, Wyoming Department of Health reports that 70.5% of people age 65 and older in Wyoming were fully vaccinated. This group is considered to be the most vulnerable population at risk for serious illness or death from the virus. This age group accounts for around 80% of the deaths related to COVID-19 in Wyoming since the pandemic began. Of that group, those with underlying health conditions are considered even more at risk.
There have been nearly 103,000 lab confirmed and probable cases of COVID-19 over the past since the pandemic began in Wyoming nearly two years ago. Deaths for people between the age of 19 and 29 account for .77% of all COVID-19 deaths in Wyoming. There have been no reported deaths of children in Wyoming due to COVID-19.
Below are links to more information and articles with additional perspectives related to giving the COVID-19 vaccine to young children.
Wyoming Department of Health – Coronavirus Disease 2019 (COVID-19)
Wyoming Department of Health
Links to case data by county and age, testing information, death data, vaccine information, hospital data, breakthrough data, and more.
CDC: Help Protect Your Child from getting COVID-19 and giving it to others
Centers for Disease Control and Prevention
Getting a COVID-19 vaccination can help protect your child from getting COVID-19. Early information shows that the vaccines may help keep people from spreading COVID-19 to others. They can also help keep your child from getting seriously sick even if they do get COVID-19.
COVID-19 vaccines help protect the community
Johns Hopkins Medicine
Another reason to strongly consider a COVID-19 vaccine for your child is to protect the health of those living and working in your area.
CDC: Risk of inflammation of the heart from the vaccine
Centers for Disease Control and Prevention
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 the two mRNA COVID-19 vaccines, Pfizer-BioNTech or Moderna.
Can COVID-19 vaccines affect the heart?
Mayo Clinic
In the U.S., there has been an increase in reported cases of myocarditis and pericarditis after mRNA COVID-19 vaccination, particularly in male adolescents and young adults age 16 and older. Myocarditis is the inflammation of the heart muscle, while pericarditis is the inflammation of the lining outside the heart. These reports are rare. The Centers for Disease Control and Prevention (CDC) is investigating to see if there is any relationship to COVID-19 vaccination.
Why vaccinate healthy kids?
(Opinion) Martin Makary MD, MPH, Editor-in-Chief, MedPage Today, June 10, 2021
"In reviewing the medical literature and news reports, and in talking to pediatricians across the country, I am not aware of a single healthy child in the U.S. who has died of COVID-19 to date. To investigate further, my research team at Johns Hopkins partnered with FAIR health to study pediatric COVID-19 deaths using approximately half of the nation's health insurance data. We found that 100% of pediatric COVID-19 deaths were in children with a pre-existing condition, solidifying the case to vaccinate any child with a comorbidity. Given that the risk of a healthy child dying is between zero and infinitesimally rare, it's understandable that many parents are appropriately asking, why vaccinate healthy kids at all?"
Should children get COVID vaccines? What the science says
nature.com, July 20, 2021
Vaccine advisers in the United Kingdom have recommended that only adolescents who are clinically vulnerable, or who live with vulnerable adults, be vaccinated for the time being. Severe illness, deaths and even long COVID are rare among healthy adolescents and children, and soon, nearly all vulnerable adults will have received two vaccine doses.
In-Depth: Why some FDA advisers voiced reluctance during vaccine vote for kids 5-11
By Derek Staahl, 10news.com, October 26,2021
Some members of the FDA’s Vaccines and Related Biological Products Advisory Committee expressed a note of reluctance during Tuesday’s vote because of the rare risk of vaccinated-related heart inflammation seen in older children. "It just seems to me, in some ways, we’re vaccinating children to protect the adults. And it should be the other way around," said VRBPAC member Dr. James Hildreth.
Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States
European Journal of Epidemiology, September 30, 2021
We investigated the relationship between the percentage of population fully vaccinated and new COVID-19 cases across 68 countries and across 2947 counties in the US. At the country-level, there appears to be no discernable relationship between percentage of population fully vaccinated and new COVID-19 cases in the last 7 days. In fact, the trend line suggests a marginally positive association such that countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people. Notably, Israel with over 60% of their population fully vaccinated had the highest COVID-19 cases per 1 million people in the last 7 days. The above findings of no discernable association between COVID-19 cases and levels of fully vaccinated was also observed when we considered a 1-month lag on the levels of fully vaccinated. The sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences needs to be re-examined, especially considering the Delta (B.1.617.2) variant and the likelihood of future variants. Other pharmacological and non-pharmacological interventions may need to be put in place alongside increasing vaccination rates. Such course correction, especially with regards to the policy narrative, becomes paramount with emerging scientific evidence on real world effectiveness of the vaccines.
In children, the virus causing the first infection sets the stage for their antibody response for the rest of their lifetime
Thomas Francis Jr, M.D., On The Doctrine of Original Antigenic Sin, Proceedings of the American Philosophical Society, April 21, 1960
An important consequence of this childhood conditioning is that different age groups within a population have a diversity of immunity to strains of influenza. This helps provide for future herd immunity in the population to mutated strains of the virus. The imprint established by the original virus infection governs the antibody response thereafter. This has been called the doctrine of original antigenic sin. When large masses of the childhood population are treated with the same narrow-focused vaccine that doesn’t completely stop the spread of the virus, it impedes the population’s ability to provide broad herd immunity to uprising variants of the virus over the course of that generation’s lifetime. The danger of immunity to one strain alone may lead to permanently impaired immune response to other serotypes, causing worse and longer illness.
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