Authors: im Hoft Published June 14, 2022 Gateway Pundit
Moderna’s COVID-19 vaccine may have a higher risk of heart inflammation than the Pfizer shot based on recent data, the U.S. Centers for Disease Control and Prevention said on Tuesday.
On Tuesday, the U.S. Food and Drug Administration met with its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss Moderna’s EUA request for a COVID-19 vaccine for children 6 through 17 years of age.
The same expert panel will meet again on Wednesday to discuss shots from Moderna and Pfizer for the kids under 5.
According to the CDC data, the incidence of heart inflammation was 4.41 excess per 100,000 who received the Pfizer/BioNTech for males aged 18-39 versus 6.27 excess cases per 100,000 for Moderna, Reuters reported.
The overall incidence is relatively rare and the vast majority who suffer the side effect fully recover, but a comparison showed the risk of myocarditis and pericarditis in young males aged 18-39 was 1.1 to 1.5 times higher after the Moderna shot, the FDA said in its presentation, citing data from three U.S. vaccine safety databases.
Some countries in Europe have limited use of Moderna’s vaccine for younger age groups after surveillance suggested it was tied to a higher risk of heart inflammation, and the FDA delayed its review of the Moderna shot to assess the myocarditis risk.
The FDA said data from European and Canadian regulators showed that the risk was 1.7 to 7.3 times higher for Moderna’s vaccine than Pfizer’s in adolescents and young men.
Outside experts are considering the data before deciding whether to recommend Moderna’s vaccine for children and teens aged 6-17 years of age. The Pfizer vaccine is already authorized for children 5 and older.
An FDA official claimed that the findings on myocarditis and pericarditis linked to both the mRNA shots “were not consistent across all of the U.S. vaccine safety monitoring systems.”
The CDC also claimed that recent data suggests that most people with myocarditis after mRNA COVID-19 vaccination recover over time.
Daniel Horowitz, the senior editor at The Blaze, tweeted on Monday regarding the side effects of the Moderna vaccine.
“Holy Moly! one-quarter of the kids in Moderna’s trial reported Grade 3 side effects, meaning they couldn’t go to school https://fda.gov/media/159189/download… So many had flu-like symptoms! Even the original strain of covid mainly did this to kids. Yet, we are giving them these symptoms upfront,” Horowitz tweeted.
Robert F. Kennedy also weighed in and said, “FDA’s risk-benefit document in connection with the Moderna mRNA shot in kids is dishonest, and evidence that the public health establishment has abandoned science, logic, reason, rationality, empathy, health and medicine.”
Moderna’s vaccine efficacy was 36.8% at ages 2-5 years during for omicron
The headline : “Briefing data… also support Moderna’s vaccine for kids up to age 17” is challenging, as an understatement.
The Food and Drug Administration previously said on Friday night that Moderna’s coronavirus vaccine for children under 6 is effective in preventing symptomatic infection without causing worrisome side effects.
Despite all the evidence and data showing the risks of myocarditis and pericarditis, FDA advisers consider Moderna’s COVID shots for children 6 through 17 years of age.
The FDA held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. Moderna got extra scrutiny because its shots are a far higher dose..
In their review, FDA scientists said there were no confirmed cases of the heart inflammation in Moderna’s kid studies. But experts say the studies may have had too few participants for a rare side effect like that to appear.
“It’s just not enough people in the clinical trials to detect” the problem if it’s occurring, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, in a call with reporters earlier this week.
The FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 illness in teens and younger kids, with the levels of virus-fighting antibodies comparable to those developed in young adults.
Vaccine effectiveness was estimated at 93% for the 12-17 group, and 77% for the younger group. However, the research was done when earlier versions of the coronavirus were causing most U.S. infections, and it’s not clear how well they work against more recent variants.
The FDA review said it was likely a booster shot would be needed, as is now recommended for children vaccinated with Pfizer’s shots, as well as for all adults.
If the FDA authorizes Moderna shots for teens and schoolchildren, the matter moves next to the CDC, which makes recommendations about vaccinations to doctors and the public. A CDC spokesperson said the agency is not expected to take up the question until later this month.