Topline
Pfizer will soon submit data on Covid-19 vaccinations to the government, CEO Albert Bourla stated Sunday. This means that the shots could be made available to children later in the fall, after initial data showed the vaccine stimulates strong immunity.
Pfizer will submit data on Covid-19 vaccines for 5- to 11-year olds to the government for approval [+] "within days." getty
The Key Facts
Bourla stated on ABCs This Week, that the company plans to submit its trial data to the FDA for approval for children aged five to eleven years old. Bourla added that it will take only days for the FDA to approve the vaccine, but Pfizer will have the manufacturing capability to supply the new vaccine. Pfizer has released preliminary trial data, which have not been peer reviewed yet, to show that the child Covid-19 vaccine, which is one-third of the dose given to adults, was safe and well tolerated by five- to eleven-year-olds. Data suggests that the vaccine triggers an immune reaction in children similar to fully vaccinated 16 to 25-year olds. This is despite the smaller dose and mild side effects such as pain at the injection site, fever, fatigue, chills, and other minor side effects. Scott Gottleib, former FDA chief, stated on CBS Sunday that he expected the agency's review of Pfizer data will take between four and six weeks. This would put the timeframe for approval at approximately Halloween to mid-November. U.S. U.S.
Big Number
5.5 million. This is the estimated number of Covid-19-related cases in children as of September 16, according the American Academy of Pediatrics. The most recent data available. Children account for 15.7% of all U.S. Covid-19 patients, and cases are particularly high among children in the last few months due to the spread of highly infectious delta variants. According to the AAP, child cases accounted for 25.7% of all cases reported between September 9-16. The total number of Covid-19 children's cases since the outbreak of the pandemic has increased by 9% in just two weeks.
What to Watch
Moderna is currently testing Covid-19 vaccines for children, but has not released its findings. Pfizer is also conducting trials of the shot in children below five years of age. Pfizer stated earlier this week that the trial data will be available by the end of 2011. Johnson & Johnson has so far tested its vaccine only among adolescents. AstraZeneca, however, began trials for its vaccine in children as early as six years old. However, it was halted in April due to safety concerns over blood clots.
Important Background
Bourla's comments Sunday were in line with prior estimates regarding the FDA approval process. Gottleib had predicted earlier in September that the shots would be approved by Halloween in a best-case scenario. He reiterated this Sunday. BioNTech leaders, who developed the vaccine along with Pfizer, said Sunday that they would seek FDA approval for the vaccine within the next few weeks. Gottleib had predicted earlier in September that the shots could be approved by Halloween under a best-case scenario. However, Gottleib reiterated Sunday that he still believes the shots will be approved by Halloween. Although studies have shown that children are less likely to suffer severe illness or death from Covid-19 than adults, pediatric hospitalizations are on the rise. Children are also at greater risk of suffering from long Covid, which can cause debilitating symptoms for many months. Recent research has suggested that the incidence of long Covid may actually be lower than originally thought. However, the data is still inconclusive. Parents are asking for more information about the FDA approval process, and that the vaccine be made available to children as soon as possible. More than 100 legislators wrote a letter to FDA in August seeking clarifications on the timeline.
Tangent
Bourla also stated Sunday that he believes people will be able return to normal within one year despite Covid-19. This echos comments made earlier in the week by Moderna CEO Stphane Bangcel. However, he believes there will always be new coronavirus variants. Bourla admitted that we don't know what the future pandemic looks like. However, he suggested that future Covid-19 vaccines to combat new variants of the virus could last at most a year. He also predicted that people will receive annual Covid-19 vaccinations.
Continue reading
Pfizer to Apply for U.S. and EU Approval after Study shows Vaccine Safe for Five-to-11-Year-Olds (Forbes).
Gottlieb suggests that Covid Vaccines for Kids could be approved by Halloween under the Best Case Scenario.
Pfizer-BioNTech To Seek Approval For First Covid Vaccine For Young Children In Next Few Weeks (Forbes)
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