Reuters reported last month that up to 4,500 children under the age of 12 would be enrolled in the study at more than 90 clinical sites in the U.S., Finland, Poland and Spain.
Based on safety, tolerability and the immune response generated by 144 children in a phase I study of the two-dose vaccine, Pfizer said it would test a dose of 10 micrograms in children between 5 and 11 years of age and 3 micrograms for the age group of 6 months to 5 years.
Pfizer's COVID-19 vaccine has been authorized for use in children as young as 12 in Europe, the U.S. and Canada. They receive the same dose as adults: 30 micrograms.
As of July 1, over 4.04 million children have tested positive for COVID-19 since the onset of the pandemic, according to data from the American Academy of Pediatrics. Available data indicated that hospitalization and death associated with COVID-19 were uncommon in children.
Yeadon, former vice president and chief scientist for allergy and respiratory at Pfizer, stressed that the vaccines used against COVID-19 have not been sufficiently tested and that they shouldn't have received emergency use authorization when there are safe and effective medicines available for COVID-19. (Related: Pfizer cut corners, slashed quality standards to produce covid vaccine at "warp speed.")
Yeadon explained that the mRNA gene technology used in Pfizer's COVID-19 vaccine to trigger the body to create viral spike proteins is a "fundamental problem" that scientists and researchers have known about for years. According to Yeadon, those spike proteins can lead to blood clots and other health problems.
This could help explain the large number of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Yeadon said roughly 5,000 deaths related to COVID-19 vaccine have been reported in the first half of 2021.
"Normally, there are only about 200 a year for all vaccines combined," he said.
Reports of potential link between mRNA vaccines and cases of myocarditis and pericarditis also began to emerge in recent weeks.
In fact, the Centers for Disease Control and Prevention (CDC) announced on June 23 that the Food and Drug Administration (FDA) would add a warning to the Pfizer and Moderna COVID-19 vaccines about possible link to myocarditis and pericarditis in teenagers and young adults. (Related: FDA admits covid injections from Pfizer, Moderna cause heart inflammation.)
Myocarditis is a condition that involves inflammation of the heart muscle. Symptoms can include fever and fatigue, as well as shortness of breath and a very specific type of chest pain. Patients tend to say their chest hurts more when they lean forward. The pain tends to subside when they lean back. Pericarditis, on the other hand, is the swelling and irritation of the thin, sac-like tissue surrounding the heart.
There have been 484 combined preliminary reports of myocarditis and pericarditis in young people under age 30 as of June 11, mostly in people between ages of 12 and 24.
Dr. Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said in a presentation that data from the Vaccine Safety Datalink (VSD) suggests a rate of 12.6 cases per million in the three weeks after the second shot in people between the ages of 12 and 30.
The higher-than-expected rate of the myocarditis and pericarditis cases among Americans below 30 is consistent with the data from Israel.
Israel's Ministry of Health identified over 200 cases in men between 16 and 30 years old, a vast majority of those happening at the younger end of that range. That equates to a risk of between 1 in 3,000 and 1 in 6,000 of suffering from heart inflammation.
Pfizer previously said it had not observed a higher rate of heart inflammation than would normally be expected in the general population while Moderna said it could not identify a causal association with the heart inflammation cases and its vaccine.
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