Photo: Marco Gabber/Getty Images
Fizer and Biontech have officially requested that their Covid-19 vaccine be approved for use among young children.
In a tweet on Thursday, Fizer Said The companies presented their request to the US Food and Drug Administration for an Emergency Use Authority (EUA) for their vaccines. They are demanding withdrawal for this to be used among children between 5 and 11 years of age.
The request of EUA will be evaluated on 26 October during the upcoming vaccines and the meeting of the respective Organic Products Advisory Committee (VRBPAC).
“We know from our huge experience with other pediatric vaccines that children are not small adults, and we will make a comprehensive evaluation of diagnostic testing data presented in support of the safety and effectiveness of the vaccine used in a small pediatric population, which may require a separate dose or formulation used in a chronic pediatric population.”
Why does it matter
EUA submission is not surprising, as companies said that they would seek “regulatory approval as soon as possible” when they released vaccine data for children between 5 and 11 years of age.
Statistics showed that a small dose of Physics and Bontech vaccines obtained a similar antibody reaction and had comparative side effects seen in people between the ages of 16 and 25 years.
As mentioned in Fizer’s tweet, Kovid -19 cases are increasing among young children. During the week of September 30, 173,469 Bal Kovid -19 cases were reported, representing 26.7% of all cases recorded that week, according to the American Academy of Pediatrics.
In the two -week period before 30 September, AAP was found that the cumulative number of children Kovid -19 cases had increased by 7% since the onset of epidemic.
“Children in America continue to be high level with new cases in the US,” Fizer said in its tweet, it is an important step in our ongoing attempt against #Covid19. ” “We are committed to working with FDA with the ultimate goal of helping children protect children from this serious public health threat.”
Huge trend
In August, PFIZER and Biontech’s Covid-19 became the first to receive full approval from the Vaccine FDA. The vaccine has now been marketed as Comirnati and has been approved for the prevention of Kovid -19 for people aged 16 years and above.
Companies have also obtained an EUA for a booster shot in Comirnati among some population, such as 65 years of age and older, individuals at high risk of serious Kovid -19 through 64 to 64 and people aged 18 are at high risk of serious complications of Kovid -19.
Modern and Johnson & Johnson have also presented requests from the FDA for the Booster shot EUAS. VRBPAC has held meetings for 14 and 15 October to discuss potential booster shot approval.
Twitter: @Hacketttmallory
Email the author: mHackett@himss.org
