Pfizer said Tuesday it is advancing late-stage clinical trials of its COVID vaccine, in lower doses, on children ages 5 to 11 years old and expects to apply for approval early this fall.
Article by Megan Redshaw.
Pfizer’s vaccine is already being administered to children 12 and up, who receive the same 30 microgram dose as adults.
Moderna said it also expects its COVID vaccine will be available for kids as young as 5 by early fall. CEO Stéphane Bancel said Monday he thinks the data will become available sometime in September, CBS Boston reported.
Earlier this month, Moderna applied to the U.S. Food and Drug Administration (FDA) for full approval of its COVID vaccine for adults 18 and older, which is being administered now under Emergency Use Authorization. The company said it plans to seek expanded emergency use approval in the U.S. for the vaccine for ages 12 and up early this month.
Pfizer plans trials on children as young as 6 months
The Pfizer study on children 5 to 11 will enroll up to 4,500 children at more than 90 clinical sites in the U.S., Finland, Poland and Spain, the company said.
Based on safety, efficacy and tolerability data from the 144 children included in Pfizer’s phase 1 trial, the company will use 10 micrograms of each vaccine dose for kids between the ages of 5 and 11 in phase 2/3 trials, and 3 micrograms of each dose for those 5 and younger.
In the coming weeks, late-stage trials will start for 2- to 4-year-olds, as well as those as young as 6 months, Gruber said.
“We take a deliberate and careful approach to help us understand the safety and how well the vaccine can be tolerated in younger children,” Dr. Bill Gruber, senior vice president of clinical research and development at Pfizer, said in a statement.
Another Pfizer spokesperson said the company expects data from 5- to 11-year-olds in September and would likely ask regulators for Emergency Use Authorization (EUA) later that month. Data for children 2 to 5 years old could arrive soon after that, Reuters reported.
Pfizer expects to have data from the 6-month to 2-year-old age group in October or November.
On May 10, the U.S. Food and Drug Administration (FDA) expanded the EUA for Pfizer’s COVID vaccine to include children aged 12–15 years, and Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices recommended it for this age group on May 12.
Kids at low risk for COVID, raising questions about need for vaccine
As The Defender reported earlier this month, some physicians and scientists oppose vaccinating children against COVID — including a group of 40 doctors who told UK drug regulators vaccinating kids is “irresponsible, unethical and unnecessary.”
In an open letter addressed to the Medicines and Healthcare Products Regulatory Agency, the group said no one under 18 should be vaccinated for COVID because evidence shows the virus poses almost no risk to healthy children.
The authors of the letter said the risk of death from COVID in healthy children is 1 in 1.25 million. COVID vaccines, however, are linked to strokes due to cerebral venous thromboses in people under 40 — a finding that “led to the suspension of the Oxford-AstraZeneca children’s trial,” the authors said.
According to the CDC, COVID adolescent hospitalization rates in the 12-17 age group was 2.1 per 100,000 in early January 2021, and 1.3 per 100,000 in April. Of 204 hospitalizations assessed by the CDC from March 1, 2020 to April 24, 2021, no deaths occurred.
According to CDC data, the death rate among adolescents ages 0 to 17 who get COVID and are subsequently hospitalized is 0.7%, with many experiencing either mild or no symptoms at all. The COVID death rate in all adolescent age categories is less than 0.1%, according to the CDC.
As The Defender reported, two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.
Big Pharma’s Five Major Minions that Everyone, Vaxxed or Unvaxxed, Must Oppose
This is not an “anti-vaxxer” article, per se. It’s a call for everyone to wake up to the nefarious motives behind vaccine mandates, booster shots, and condemnation of freedom.
The worst kept secret in world history SHOULD be that the unquenchable push for universal vaccinations against Covid-19 has little if anything to do with healthcare and everything to do with Big Pharma’s influence over the narrative. Unfortunately, that secret has stayed firmly hidden from the vast majority of people because of the five major minions working on behalf of Big Pharma.
What’s even worse is the fact that Big Pharma’s greed is merely a smokescreen to hide an even darker secret. We’ll tackle that later. First, let’s look at the public-facing ringleaders behind the vaccine push, namely Big Pharma. But before we get into their five major minions, it’s important to understand one thing. This is NOT just an article that speaks to the unvaccinated. Even those who believe in the safety and effectiveness of the vaccines must be made aware of agenda that’s at play.
Let’s start with some facts. The unvaccinated do NOT spread Covid-19 more rampantly than the vaccinated. Even Anthony Fauci acknowledged the viral load present in vaccinated people is just as high as in the unvaccinated. This fact alone should demolish the vaccine mandates as it demonstrates they have absolutely no effect on the spread of the disease. But wait! There’s definitely more.
This unhinged push to vaccinate everyone defies science. Those with natural immunity may actually have their stronger defenses against Covid-19 hampered by the introduction of the injections which fool the body into creating less-effective antibodies. Moreover, the push to vaccinate young people is completely bonkers. The recovery rate for those under the age of 20 is astronomical. Children neither contract, spread, nor succumb to Covid-19 in a statistically meaningful way. What they DO succumb to more often than Covid-19 are the adverse reactions to the vaccines, particularly boys.
All of this is known and accepted by the medical community, yet most Americans are still following the vaccinate-everybody script. It requires pure cognitive dissonance and an overabundant need for confirmation bias to make doctors and scientists willingly go along with the program. Yet, here we are and that should tell you something.
Before I get to the five major minions of of Big Pharma, I must make the plea for help. Between cancel culture, lockdowns, and diminishing ad revenue, we need financial assistance in order to continue to spread the truth. We ask all who have the means, please donate through our GivingFuel page or via PayPal. Your generosity is what keeps these sites running and allows us to expand our reach so the truth can get to the masses. We’ve had great success in growing but we know we can do more with your assistance.
Who does Big Pharma control? It starts with the obvious people, the ones who most Americans believe are actually behind this push. Our governments at all levels as well as governments around the world are not working with Big Pharma. They are working for Big Pharma. Some are proactive as direct recipients of cash. Others may oppose Big Pharma in spirit but would never speak out because they know anyone who does has no future in DC.
This may come as a shock to some, but it’s Big Pharma that drives the narrative and sets the agenda for the “experts” at the CDC, FDA, WHO, NIH, NIAID, and even non-medical government organizations.
Most believe it’s the other way around. They think that Big Pharma is beholden to the FDA for approval, but that’s not exactly the case. They need approval for a majority of their projects, but when it comes to the important ones such as the Covid injections, Big Pharma is calling the shots. They have the right people in the right places to push their machinations forward.
That’s not to say that everyone at the FDA is in on it. Big Pharma only needs a handful of friendlies planted in leadership in order to have their big wishes met. We have seen people quitting the FDA in recent weeks for this very reason. The same can be said about the other three- and five-letter agencies. Too many people in leadership have been bribed, bullied, or blackmailed into becoming occasional shills for the various Big Pharma corporations. Some have even been directly planted by Big Pharma. That’s the politics of healthcare and science that drives such things as Covid-19 “vaccines.”