The U.S. Food and Drug Administration (FDA) has officially granted full approval to Moderna’s controversial mRNA COVID-19 vaccine, Spikevax, for children as young as 6 months old through 11 years of age who are deemed “at increased risk” of COVID-19.
The vaccine was previously available to kids under Emergency Use Authorization (EUA), but the FDA has now handed over full approval, greenlighting the use of the experimental shot despite growing evidence of adverse events, including myocarditis, pericarditis, allergic reactions, and even seizures in young recipients.
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”
While the media parrots talking points about “protecting vulnerable children,” the fine print tells a different story:
- Myocarditis and pericarditis risks are highest in males ages 12 to 24—and Moderna wants to jab children as young as 6 months.
- Adverse reactions include: seizures, chest pain, shortness of breath, vomiting, and even fainting.
- Parents are told to “stay nearby for up to an hour” after their child’s injection—just in case their toddler has a severe allergic reaction or passes out.
- The vaccine may not protect all recipients, yet Moderna continues pushing forward with mass vaccination.
So why is the FDA pushing full approval for a shot that hasn’t even existed long enough to study long-term side effects in children?
More from the press release:
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine to protect you against COVID-19. SPIKEVAX is for people who are:
- 65 years of age and older, or
- 6 months through 64 years of age at high risk for severe COVID-19.
Vaccination with SPIKEVAX may not protect all people who receive the vaccine.
IMPORTANT SAFETY INFORMATION
You or your child should not get SPIKEVAX if you had a severe allergic reaction after a previous dose of SPIKEVAX or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.
What are the risks of SPIKEVAX?
There is a very small chance that SPIKEVAX could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of SPIKEVAX. For this reason, the healthcare provider may ask you or your child to stay for a short time at the place where you or your child received your vaccine. Signs of a severe allergic reaction can include:
- Trouble breathing
- Swelling of your face and throat
- A fast heartbeat
- A rash all over your body
- Dizziness and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving Spikevax, particularly during the 2 weeks after receiving a dose of the vaccine: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart. Additional symptoms in children may include fainting, irritability, poor feeding, lack of energy, vomiting, pain in the abdomen, or cool, pale skin.
Other side effects that have been reported include:
- Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection or in the groin, swelling (hardness), and redness
- General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite.
- Fainting and febrile seizures (convulsions during a fever) were also reported
Tell the healthcare provider about all of your or your child’s medical conditions, including if you or your child:
- have any allergies
- had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or on a medicine that affects your immune system
- are pregnant or plan to become pregnant
- are breastfeeding
- have received any other COVID-19 vaccine
- have ever fainted in association with an injection
These may not be all the possible side effects of SPIKEVAX. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.
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