The FDA announced it will delay its decision on whether children ages 12 to 17 should receive the Moderna Covid vaccine to determine if the shot increases the risk of a rare side effect that impacts kids' hearts.
The announcement comes just three days after the FDA authorized Pfizer'sCOVID-19 vaccine for children between ages five and 11. The Pfizer vaccinations for children are likely to begin this week pending CDC approval on Tuesday or Wednesday. The Pfizer dosing for children is 10 micrograms, 21 days apart. The dose for 12 and above is 30 micrograms, which is the adult dose.
"The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10-µg(microgram) dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age."
Moderna was advised that the FDA would need until at least January 2022 before the FDA can finish its review.
Moderna will delay its request for FDA authorization of its COVID vaccine for children 6 to 11 years old.
The agency informed Moderna on Friday night that it would require the extra time to further examine ongoing and emerging data - from international sources - on the risks of myocarditis, which is an inflammation of the heart muscle that in rare cases occurs after vaccination.
Investigators in one study found 2.13 myocarditis cases per 100,000 people, about a 0.002% incidence—with the highest incidence in men 16 to 29 years old, where it was 10.69 cases per 100,000 people, or a 0.011% incidence.
In Sweden and Finland, health officials there have recommended against the use of the Moderna vaccine for men younger than 30.
In June, Moderna requested the FDA to authorize its vaccine for adolescents, with the shot having been approved previously for people 18 and older.
The proposed vaccine treatment protocol for teens would be the same as that for adults, with two 100-microgram shots received 28-days apart.
Moderna's proposed vaccination for children 6 to 11 years old that is now on hold would have been for them to receive two half-dose shots of 50 micrograms,
Pfizer vaccine is now available for children under 12. The short-term safety profile is very good. Healthy, normal weight children are at very low risk from the Covid-19 virus. Moderna for children will be delayed until at least January. With Moderna, there is a very low risk of myocarditis in young men. If you are a male under thirty, Pfizer might be a better choice if you want a Covid vaccine.
However, in a staggering conflict of interest...
The FDA meeting roster shows that numerous members of the committee which voted to approve Pfizer for Kids have worked for Pfizer or have major connections to Pfizer.
Members include a former vice president of Pfizer Vaccines, a recent Pfizer consultant, a recent Pfizer research grant recipient, a man who mentored a current top Pfizer vaccine executive, a man who runs a center that gives out Pfizer vaccines, the chair of a Pfizer data group, a guy who was proudly photographed taking a Pfizer vaccine, and numerous people who are already on the record supporting Coronavirus vaccines for children. Meanwhile, recent FDA Commissioner Scott Gottlieb is on Pfizer's Board of Directors.
Of 27 voting members- Eight have direct financial connections to Pfizer either presently or in the recent past!
(Arnold Monto, acting Chair worked as a paid consultant for Pfizer as recently as 2018. Archana Chatterjee worked on a research project related to vaccines for infants between 2018-2020, and the research project was sponsored by Pfizer. Myron Levine has mentored some U.S. post-doctoral fellows, and one of his proteges happens to be Raphael Simon, the senior director of vaccine research and development at Pfizer. James Hildreth, temporary voting member, made a financial interest disclosure of $1.5 Million dollars in relevant financial interests. Geeta K. Swamy is listed as the chair of the “Independent Data Monitoring Committee for the Pfizer Group B Streptococcus Vaccine Program,” a committee sponsored by Pfizer, Duke University states that “Dr. Swamy serves as a co-investigator for the Pfizer COVID-19 vaccine trial.” Gregg Sylvester previously served as a vice president for Pfizer Vaccines, where he launched other non-Covid Pfizer vaccines including one for children.)I wouldn't go into detail on this part.
This cronyism and the appearance of undue influence by Pfizer undermines the FDA and the message of protecting the public and impartial decision making that should be the message to the parents of America's children.
THREE (Studies attached)
CDC officials on Friday offered evidence that vaccinations offer better protection against COVID-19 than immunity from a prior infection. Unvaccinated people who had been infected months earlier were 1.7 times as likely to get COVID-19 than fully vaccinated people who didn't have a prior infection, the Centers for Disease Control and Prevention concluded in a new study. These data show that the vaccines are more protective against symptomatic COVID. The study looked at data from nearly 190 hospitals in nine states. The researchers counted about 7,000 adult patients. 5.1% of the vaccinated had breakthrough infections. 8.7% of the previously infected had re-infections.
There is also a study from Kentucky which shows that among people previously infected with Covid (both groups), those who were unvaccinated were 2.34 times as likely to be re-infected as those people who had Covid and were vaccinated.
This data reaches the opposite conclusion of an earlier much larger Israeli study which concluded that native immunity was superior and more long lasting then immunity from vaccination.
More data is needed to prove conclusively that native vs. vaccine immunity is superior. Both groups have very low breakthrough or re-infection rates in the range of 1-10% depending on length of time since vaccine or infection.
FOUR (Study attached)
An inexpensive antidepressant drug has been found to reduce the risk of hospitalization in high-risk adults recently diagnosed with Covid by over 30 percent, according to a study published in The Lancet. The study, titled, “Effect of early treatment with fluvoxamine on risk of emergency care and hospitalization among patients with COVID-19: the TOGETHER randomized, platform clinical trial,” was published on Oct. 27.Fluvoxamine is an FDA-approved drug that belongs to a group of medicines known as serotonin reuptake inhibitors (SSRIs).It works by increasing the activity of serotonin—a key hormone that stabilizes an individual’s mood and feelings of well-being—in the brain and is typically used to treat obsessive-compulsive disorder (OCD) and depression, according to the National Institutes of Health.The drug is also thought to have the ability to reduce inflammation, although further studies are required to determine this. Researchers in Brazil analyzed 1,497 high-risk symptomatic Brazilian adults confirmed positive for Covid-19 including patients from 11 clinical sites across the country with a known risk factor for progression to severe disease. Of the nearly 1,500 patients, 741 patients were prescribed 100 mg of fluvoxamine twice daily for 10 days and 756 were given a placebo. Of those participants given the drug, 79 (11 percent) needed to be hospitalized for medical care compared to 119 (16 percent) in the placebo group. Researchers said their analysis showed the drug cut the risk of hospitalization by 32 percent overall. Only one patient died while taking fluvoxamine, compared with 12 who died while on the placebo. A 10-day course of fluvoxamine costs approximately $4, researchers said. “Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalization defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital,” researchers wrote.
Fluvoxamine is a very safe, widely used, and inexpensive drug which is basically as effective as the new Merck Covid pill, which is unproven and projected to cost $700. We discussed it (FLUVOX) on this show more than a year ago. Its success will likely be unsupported and unreported in this country. Obviously, listeners should discuss any medication before use, especially off-label use which this would be.