This pandemic has hit us all hard, and particularly those with a larger proportion of the elderly population But what about children? As for today’s news? The Food and Drug Administration (FDA) approved the use in an emergency of Pfizer BioNTech COVID-19 Vaccine, a COVID-19 vaccine for kids to guard against COVID-19 among children between 5 to 11 years. age. The approval was based upon the FDA’s thorough and clear review of the evidence. This included the contributions of an advisory panel of experts from outside who unanimously approved the use of the vaccine to children of the same age bracket. This vaccine is available with us at Utah Family Pharmacy.
The most important thing parents and caregivers look out for is:
- Efficiency Extent:
Immune responses of children aged five to eleven years were similar to those who were between 16 and 25 years. It was also determined that it was 90.7 % effective in preventing COVID-19 among children aged between 5 and 11 years.
- Level of Safety:
The vaccination’s safety was studied in a group of approximately 3100 children aged between 5 and 11 who received the vaccine. There were no negative side effects discovered during the ongoing research.
The COVID-19 vaccine for kids aged between 5 and 11 years old. It is administered as two doses in a sequence that is separated by three weeks. It has a lower dose (10 mcg) than the dose that is used for children aged 12 years and older and more (30 mcg).
In the U.S., COVID-19 cases for children aged between 5 and 11 years old account for 39% of cases of those older than 18. Reports from CDC showed that about 8300 instances of the COVID-19 vaccine for kids aged between 5 and 11 years old resulted in hospitalization. In October. 17th, 691 deaths related to COVID-19 were reported across the U.S. in individuals less than 18 years old, and 146 deaths in the 5 to 11 year age bracket.
It is known that the FDA is confirming that the Pfizer vaccine is compliant with the criteria for an emergency authorization for usage. Based on the most comprehensive amount of scientific evidence, the benefits currently and in the future that could be derived from the Pfizer BioNTech COVID-19 vaccines for kids to those aged between five outweigh the known risks and potential.
Evaluation of the Existing Effectiveness Data
The evidence of efficacy that supports the efficacy of EUA even for infants as young as 5 years old comes from an ongoing study that has been placebo-controlled and randomized that included more than 4,700 children between the ages of 5 to eleven years of age. The participants in the vaccination study received two doses of Pfizer BioNTech COVID-19 vaccine, which contained 10 mcg messenger RNA in each dose. The FDA examined the data to compare the immune reactions of 264 people in the study with those of individuals who were between 16 and 25 years of age who received two more levels of vaccination in a previous study that showed the efficacy of the vaccine for the treatment of COVID-19 vaccine for kids. In this study, the immune responses of young participants were comparable to those experienced by older individuals.
The FDA also conducted a preliminary study of COVID-19 cases that happened within 7 days of receiving the second dose. In this study, in absence of any evidence of previous SARS-CoV-2 infections, three cases of COVID-19 were observed in 1305 vaccine recipients. In addition, 16 cases of COVID-19 were discovered in 663 patients who received placebo. The vaccine was 90.7 percent effective in treatment of COVD-19.
Safety Data Evaluation and Verdict
The data supporting the EUA include more than 4,500 people that includes both vaccinated and placebo cases between 5 to 11 years old who are enrolled in the current study. In this study participants were followed to make sure they were safe for at least 2 months after receiving their second dose.
The most commonly reported side effects in the clinical trial were discomfort at the injection locations (sore arm) as well as redness and swelling and headaches, fatigue, joint or muscles discomfort, chills swelling of lymph nodes, fever nausea and a decreased appetite. The majority of children experienced adverse reactions after two doses than they did following their initial dose. The side effects varied in severity from moderate to serious and began to manifest within two days after the vaccination. But, the majority of them disappeared within about one to two days.
It is well-known that the FDA and the CDC Safety surveillance mechanisms have identified increased risk of myocarditis (inflammation of the heart muscle) and the condition referred to as the pericarditis (inflammation of the heart’s tissue) following vaccination with BioNTech COVID-19 Vaccine for kids particularly after the second dose and the highest risk being observed in males aged between 12 and 17 years old. So, the FDA conducted its own benefit-risk analysis using a mathematical model in order to identify the amount of COVID-19-related cases that result in symptomatic hospitalizations, ICU units (ICU) admissions and deaths due to COVID-19. This vaccine for children between five and eleven years of age prevents as compared to the possible myocarditis-related illnesses, hospitalizations, ICU admissions and deaths that the vaccine could cause. The FDA’s study predicts that in the future the advantages of the vaccine will far outweigh the risks to children ranging from between 5 and 11 years old.
Current Situation of Safety Vigilance
Pfizer Inc. has updated its safety monitoring program to include an examination of myocarditis, pericarditis and other related events relevant to children five to eleven years old. Furthermore, the FDA and the CDC have several ways in place to constantly examine the effectiveness of COVID-19 and permit the quick evaluation and detection of safety concerns.
It is mandatory for Pfizer Inc. and vaccination providers to notify of any adverse events that are severe for instance, instances with multisystem inflammatory Symptoms and COVID-19 cases that can lead to hospitalization or death among those who have been treated with vaccines. It is also mandatory that vaccine providers submit all mistakes in the administration of vaccines to VAERS if they are aware of and to Pfizer Inc. to include an analysis and a summary of all errors reported in vaccination administration in the monthly Safety reports to FDA.
Data Supports New Vaccine Formulation to Improve Stability and Storage Conditions
It is also important to note that the FDA has also today approved a change to the process of manufacturing the vaccine. It includes an ingredient that makes use of another buffer. Buffers help to keep the pH of the vaccine (a test to determine the amount of acidity or alkalinity that the solution might have) in addition to ensuring stability. The variant is more stable when refrigerated for a long period of time. This permits greater flexibility for the providers of vaccination.
The most recent variant of the vaccine that was developed by Pfizer Inc. contains Tris buffer that is a commonly utilized buffer in a variety of FDA-approved biologics and vaccines including those intended for use for children. The FDA evaluated the data of production to confirm the usage of the COVID-19 vaccine manufactured by Pfizer BioNTech with Tris buffer. They concluded that it does not pose safety or security concerns.
Now the question arises: Should I Get my Child Vaccinated ?
The vaccine is a way to keep children from contracting COVID-19.
While the COVID-19 virus in kids is often milder than that of adults, children affected by the coronavirus could develop severe lung infections and become very sick and require hospitalization. It is particularly crucial to be aware of considering the delta variant that is more infectious than other coronavirus types. “The current vaccines are still effective in preventing severe illness from the delta variant of the virus,” Sick-Samuels writes. Children may also experience issues such as multisystem inflammatory syndrome (MIS) in children which may require a long-term care plan or signs that impact their health and wellbeing. The virus is a cause of death in children, though this is rarer than for adults.
The Vaccine is able to Prevent or Reduce the Spread of COVID-19
Like adulthood, kids are able to transmit the coronavirus virus to others when they’re affected, even if they don’t show any symptoms. The COVID-19 vaccination can safeguard the child as well as others by reducing the risk of transmitting the virus to other people like relatives and friends who could be more prone to serious consequences from the virus.
The Vaccination for COVID-19 is a Good Way to Prevent New Variants from Forming:
Cases of COVID-19 are growing among children with the Delta variant seems to play a part. Reduced viral transmission when vaccination also decreases the chance of the virus to develop new variants which could be more harmful. The virus is able to spread easily between unvaccinated children and adults, which gives new variants the opportunity to appear.
A COVID-19 Vaccine for Kids Could Help Them Return to the Normality of Life
“Getting vaccinations will help keep kids in school and taking part in activities they love,” Sick-Samuels says. “Children exposed to the coronavirus who are vaccinated are less likely to get infected, and so are more likely to be able to continue participating with less disruptions to school attendance and other activities.”
COVID-19 Vaccinations can Help to Protect the Community
Another reason to seriously look into a COVID-19 vaccine for kids is to safeguard the health of the people working and living within your region. Every adult or child who is infected by the coronavirus virus can spread the virus to other people in the local community.
If this happens, some of those affected may develop a severe illness or transmit the virus to other people who are very sick, and possibly end up dying — all because of an infection that is preventable.
The transmission also offers an opportunity for the virus to evolve further and develop an entirely new type that could be more infected or resistant to treatments and vaccines. A lower incidence of infections across the population reduces the risk of death or serious infection within the community, as well as risky coronavirus variants that are emerging.
We at Utah Family Pharmacy offer medicines from different verticals at very reasonable prices. And as the pandemic situation continues we understand your personal and your family wellness is important. So every week bring special discounts and offers on our products so that you can get what you want within your budget.
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