FDA Approves Pfizer Booster For 12-15 Year Olds, Dismisses Risk Of “Mild” Heart Inflammation
As expected, the FDA has finally approved Pfizer’s COVID booster for children between the ages of 12 and 15, despite the fact that certain dangerous side effects are far more likely to occur in young patients.
These dangerous side effects include myocarditis and pericarditis, two forms of heart inflammation that have been found in thousands of patients and have even contributed to some suspicious vaccine-linked deaths.
But don’t worry kids: Dr. Peter Marks, the FDA’s vaccines chief, said that in the overwhelming majority, the cases of heart inflammation that have afflicted younger patients have been “mild”.
It’s worth noting that Dr. Robert Malone, the inventor of mRNA technology who was recently banned by Twitter (and is now facing a crackdown by Facebook), has said the exact opposite: that these side effects could present a greater risk to young patients than the virus itself especially for younger patients.
Unfortunately for some, those views are being more or less ignored.
Marks said in his statement that the agency made its decision because a booster “may help provide better protection against both the delta and omicron variants” especially as omicron is “slightly more resistant” to the vaccine-induced antibodies that help fend off infection.
The FDA didn’t just approve boosters for younger patients, it also shortened the time in between shots. In a statement released Monday, the FDA said it had amended the emergency use authorization for the Pfizer vaccine to shorten the time between the completion of primary vaccination and the first booster dose to five months, instead of six. The FDA will also allow a third dose for immunocompromised children 5 through 11 years of age, officially allowing the first patients as young as 5 to receive their first booster doses.
The agency said the protective health benefits and the “continued protection against COVID and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age” outweighed any risks from side effects.
All of this was based on “real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.”
Additionally, the FDA said, “peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant. Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.”
The CDC must now review the FDA’s recommendations and its director, Dr. Rochelle Walensky, must sign off – but this is considered largely a formality.
As for the children as young as five who are now eligible to get boosted, these patients include “children 5 through 11 years of age who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise, may not respond adequately to the two-dose primary vaccination series.”
Mon, 01/03/2022 – 12:21
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