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Pfizer COVID-19 vaccines are seen kept on the table at the Christine E. Lynn Rehabilitation Center in Miami, Fla., on April 15, 2021. (Chandan Khanna/AFP via Getty Images) Pfizer and its German partner on Tuesday said they submitted data concerning results of a COVID-19 vaccine trial in children as young as 5.
Pfizer and BioNTech sent the data to the U.S. Food and Drug Administration (FDA).
The data is from a Phase 2/3 trial examining the companies’ COVID-19 shot in children 5 to 11, an age group that cannot currently get a COVID-19 vaccine in the United States.
The companies say the data showed a favorable safety profile and that the vaccine triggered antibody responses in the children. The kids were given a two-dose regimen of 10 micrograms each.
The companies have not released full results from the trial. Results for children 6 months old to 4 years of age, another group being studied in the trial, are expected to be released in the fourth quarter of this year. The companies are planning to submit the trial data to a peer-reviewed publication at some point.
While the data was submitted to the FDA, Pfizer and BioNTech have not yet formally asked for emergency use authorization for the vaccine. The companies expect to send a formal submission “in the coming weeks,” with similar submissions planned for the European medical authority and other regulatory bodies, according to a press release.
Pfizer’s vaccine is the only one authorized for use in kids 12 to 15. It’s also approved for children ages 16 and 17.
The other two vaccines authorized in the United States are only cleared for adults 18 and older.
The FDA granted an expansion of the original emergency use authorization for children 12 to 15 about a month after Pfizer’s submission for that age group.The companies are continuing to push for vaccinations for children despite kids being at low risk of contracting severe cases of COVID-19, the disease caused by the CCP (Chinese Communist Party) virus . Federal health officials have also said they believe children should get vaccinated. They say kids can pass on the virus to […]
One Sick Day Proves We Need More Voices in Truthful Media
On October 19, I was sick. It crossed my mind that I had finally gotten the ‘rona, but my wife’s cream of chicken soup and a few extra hours of sleep into mid-afternoon had be back up and running after a sleepless night before.
When I finally stumbled over to my computer in the evening, I was met with a deluge of concern from readers. They asked what had happened as only one article had been posted that day. Generally, we post between 10-20 daily between all of the sites, not included curated and aggregated content. Seeing that we’d only posted my super-early morning article before taking the rest of the day off had readers assuming the worst.
We have a wonderful and talented group of writers who volunteer their time for the sites and their readers. Sharing their amazing perspectives has always been a blessing to us because we cannot afford to hire anyone at this time. But having great writers is meaningless if we don’t have great editors, or at least one additional. My wife helps me read and edit stories from time to time, but I’m a one-man show when it comes to getting the stories posted.
Whenever I highlight our desperate need for donations, I note that we do not receive money from Google ads even though most in conservative media are beholden. I often ambiguously note that the money donated will help us grow. Today, I’m highlighting a specific need. We must get an editor to help take some of the load and to expand on our mission of spreading the truth to the world. One sick day proved that.
The great news is that there is no shortage of people who CAN help. I am emailed variations of resumes every week by people who are much smarter than I am. As much as I’d love to hire some of them, we simply cannot. That takes money and as blessed as we’ve been to receive donations and collect ad money (though not from Google or Facebook), we have still fallen short.
Those who have the means, PLEASE consider donating. We have the standard Giving Fuel option and people can donate through PayPal. We are also diving into what we believe is extremely disruptive technology at LetsGo.finance, the world’s first major donation portal for crypto. I’ll be talking a lot more about them in the near future. Those who prefer Bitcoin can send to my address here: 3A1ELVhGgrwrypwTJhPwnaTVGmuqyQrMB8
We can get the voices out there and we’re willing to shine a spotlight on new talent. We just need the resources to make it happen. If you can help, we would be extremely grateful.
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