Children’s health is an important topic no matter what the age. We want to make sure that our children are safe and healthy, and we often go out of our way to take care of them. Recently, Pfizer has petitioned the Food and Drug Administration FD in order to get approval for their COVID shots. This would allow children ages 5 through 11 years old to be able to receive these shots as well. If you’re interested in reading more about this topic or signing a petition yourself, check out the article below!
The U.S Food and Drug Administration is currently considering a proposal that would allow Pfizer to market its pneumococcal vaccines – Prevnar 13, Prevenar 13, for use in children from the age of 5 up to 11 years old . The vaccine was previously only available for children under the age of 2. Prevnar 13 is used to prevent diseases caused by 13 different types of pneumococcal bacteria.
Prevnar 13 is currently one of the best selling vaccines in the United States, with sales in 2013 totaling over $2 billion . This makes it second only to GSK’s pneumococcal vaccine, Synflorix. The FDA is currently considering the proposal in order to expand its use in children between 5 and 11 years old.
Pfizer has submitted data supporting the efficacy, immunogenicity, and safety of Prevnar 13 in children in that age range. The company’s research concluded that Prevnar 13 was safe for use, with antibody response rising in tandem with age.
While the vaccine has not been approved for children 5-11 years of age yet, Prevnar 13 was found to be effective at protecting against pneumonia and meningitis disease in infants 6 weeks to 11 months old. This will allow healthcare professionals to administer the treatments prior to the time that the children are at risk for these diseases.
The FDA is currently reviewing the available data to determine whether or not the vaccine is effective enough to be able to be administered to children between 5 and 11 years old. They plan on making a decision soon, as Pfizer has requested that it be considered medically necessary.
Pfizer submitted data in support of the vaccines’ safety and efficacy. A randomized clinical trial was conducted on a group of children aged 5-11 years old to assess Prevnar 13’s effectiveness in preventing invasive pneumococcal disease, including meningitis. The data showed that after three doses of the vaccine, more than 70 percent of children were found to have immune protection against the disease.
Pfizer also submitted data on the vaccine’s safety. Researchers found that within 30 days after receiving a vaccination, children in this age group were no more likely to suffer from common adverse effects such as fever and decreased appetite than they were prior to receiving it. This data was submitted alongside new labeling for Prevnar 13, indicating that the vaccine is effective in children between 5 and 11 years of age.
A group of researchers has found that using Prevnar 13 on children ages 5-11 would be cost effective, which could potentially speed up the FDA’s decision on whether or not to approve it for this age range. They looked at data on how many cases of invasive pneumococcal disease early-onset disease would have been prevented if Prevnar 13 had been administered. Using the data, they estimated that for every 1 million doses of Prevnar 13 given to children in this age range, there would be a reduction in cases of meningitis and pneumonia by over 900.