FDA Authorizes COVID Vaccine For 5-11 Year Olds: Trials For 6 Month Old Infants Underway


In Brief

  • The Facts:
    • The U.S. Food and Drug Administration has authorized emergency use authorization for the Pfizer-BioNTech's COVID-19 vaccine for children ages 5 to 11.

    • The FDA cleared kid-size doses — just a third of the amount given to teens and adults and up to 28 million more American children could be eligible for vaccinations as early as next week.

  • Reflect On:

    How come all of the science and data calling into question vaccines and vaccine mandates for children is being completely ignored by governments and mainstream media? A proper cost-benefit analysis has not been conducted.

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The United States Food and Drug Administration (FDA) has issued emergency use authorization of the Pfizer vaccine for children ages 5-11. CNN explains,

“Pfizer says a clinical trial showed its vaccine provides more than 90% protection against symptomatic disease among children, even at one-third the dose, and the company hopes the lower dose will reduce the risk of any side effects.”

Clinical trials for children as young as 6 months old are also currently underway.

Although the vaccine has been authorized, they cannot be administered yet. The Centres for Disease Control and Prevention (CDC) will decide when to recommend the use of the vaccine among children. It is not yet known whether these vaccines will be required for children to attend school, participate in sports leagues and more, but given what we’ve seen with adults and children ages 12-18, mandates will most likely follow.

CNN quotes the president of the American Academy of Paediatrics,  Dr. Lee Savio Beers,

“Authorization of the vaccine for younger children is an important step in keeping them healthy and providing their families with peace of mind. The vaccine will make it safe for children to visit friends and family members, celebrate holiday gatherings, and to resume the normal childhood activities that they’ve missed during the pandemic.”

The CNN article does not mention that The American Academy of Pediatrics also confirmed that while the Delta variant is infecting more children, it is not causing increased disease severity. They found that 0.1-1.9% of their child COVID-19 cases resulted in hospitalizations, and 0.00-0.03% of all child covid-19 case resulted in death.

Emergency use authorization in the US requires that an intervention address a serious or life threatening condition, and for known and potential benefits of the intervention to be balanced against the known and potential harms. Has this been done with COVID vaccines and children?

Stanford medical professors have estimated the survival rate for this age group to be approximately 99.997 percent. This is based on seroprevalence data from multiple countries around the globe.

Here in Canada, as of May 28, 2021, there have been 259,308 confirmed cases of SARS-CoV-2 infections in Canadians 19 years and under. Of these, 0.48% were hospitalized, 0.06% were admitted to ICU, and 0.004% died . For children, seasonal influenza is associated with more severe illness than COVID-19 in Canada .

In the United States, 170 5-11 have died of COVID. If these statistics include deaths that are not a result of COVID but children who died with COVID, as we’ve seen throughout this pandemic, these numbers may not be completely accurate. CDC estimates that from the 2010-2011 season to the 2019-2020 season, flu-related hospitalizations among children younger than 5 years old have ranged from 7,000 to 26,000 in the United States. During the 2009 H1N1 pandemic, 358 pediatric flu-related deaths were reported to CDC from April 2009 to September 2010.

There are many reasons why parents are hesitant to vaccinate their children. They include the data regarding COVID vaccine injuries in children as well. A recent study out of the University of California shows that the risk of myocarditis is greater as a result of the vaccine than the risk of being hospitalized for COVID for boys ages 12-15. Sweden, Denmark, Iceland, and Finland have paused the moderna vaccine for people under the age of 30 because of this problem.

Vaccine injuries are also going unacknowledged. For example, Stephanie De Garay has been documenting her daughter’s journey after she became severely ill shortly after taking the second dose of the COVID vaccine from Pfizer during the clinical trial. It’s one of many examples. A 13-year-old Michigan boy died June 16, three days after he received his second dose of Pfizer’s COVID vaccine. More than 100 Ontario, Canada youth have been sent to the hospital for vaccine-related heart problems.

Not only would vaccinating children pose risks on them without any substantial direct benefit. Also, vaccinating children can only offer collective good if this reduces infection levels in the community. However, while COVID-19 vaccines almost certainly will provide long-term protection against severe disease and death, their infection blocking effects are incomplete and very likely to be transient. This means there is actually no collective benefit to trade off against individual harm to children.

Sunetra Gupta, an infectious disease epidemiologist from the University of Oxford. Carl Heneghan, an NHS urgent care doctors and Professor of Evidence Based Medicine at the University of Oxford, and Alberto Giubilini, senior research fellow in infectious diseases at Oxford.

An appropriate cost-benefit analysis has not been done. On October 6th, 2021 I published an article providing three science based reasons why many parents won’t vaccinate their children. The article goes more in-depth than this one and provides more science that’s being ignored by mainstream media, if you’re interested.

With all of this information, should governments simply be recommending and encouraging vaccination? Should they really have the power to mandate such an intervention while simultaneously censoring information on social media that calls their interventions into question?

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