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An advisory committee to the U.S. Food and Drug Administration (FDA) held a virtual meeting Thursday to discuss what data would be needed to vaccinate children under 12 against COVID.
While some advisors said it’s too soon to rush the use of vaccines in the pediatric population because kids are at such low risk from the virus, most argued that it’s important to have authorizations on hand should there be a resurgence of the virus in the fall and winter.
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The members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) were not asked to provide specific advice or to vote during the meeting.
The role of the FDA is to advise companies on what kind of clinical trials and data the agency wants to see before extending Emergency Use Authorization (EUA) or full approval of drugs, including vaccines, for use in new age groups.
The following issues were discussed during the meeting:
- What’s needed in terms of data — including safety data, database size and duration follow-up — to support EUA and licensure for COVID vaccines for pediatric age groups 6 to 12 years, 2 to 6 years and 6 months to 2 years of age.
- Provided there is sufficient evidence of effectiveness to support the benefit of a COVID preventive vaccine for adolescents 12 to 18 years old, safety data, including database size and duration of follow-up, would be needed to support licensure of the vaccine.
- Studies following licensure and/or issuance of an EUA needed to further evaluate safety and effectiveness of COVID vaccines in different pediatric age groups.
Pfizer’s COVID vaccine is currently authorized for emergency use in people as young as age 12. Moderna is authorized for people 18 and older, although the company has asked the FDA to authorize its use in children as young as 12. Johnson & Johnson’s vaccine is authorized in people 18 and older.
Both VRBPAC members and public health experts and scientists expressed concerns about using COVID vaccines in the pediatric population.
Peter Doshi, Ph,D, associate professor University of Maryland School of Pharmacy and senior editor of The BMJ, said during the open public hearing session, there is no emergency that would warrant using EUA to authorize COVID vaccines for children.
Pointing to Pfizer’s trial of 12- to15-year-olds which supported the recent EUA, Doshi said the harms outweighed the benefits and those who had the placebo were “better off” than those who received the vaccine.
In terms of the benefits, Doshi said “the reported 100% efficacy in Pfizer’s trial was based on 16 COVID cases in the placebo group versus none in the fully vaccinated group. But there were about 1,000 placebo recipients so just 2% got COVID. Put another way, 2% of the fully vaccinated avoided COVID, whereas 98% of the vaccinated wouldn’t have gotten COVID anyway. “
On the other side of the ledger, Doshi said, side effects were common:
“Three in 4 kids had fatigue and headaches, around half had chills and muscle pain, around 1 in 4 to 5 had fever and joint pain. The list goes on. In sum, all the fully vaccinated 12- to 15-year-olds avoided symptomatic COVID but most wouldn’t have gotten COVID even without the vaccine. So, the benefit is small but it came at the price of side effects that were mild to moderate in severity and lasted a few days.”
Doshi said few children in Pfizer’s trial benefited because they didn’t get COVID, already had COVID or were asymptomatic. Doshi pointed to data from the Centers for Disease Control and Prevention (CDC) showing 23% of 0- to 4-year-olds and 42% of 5- to17-year-olds have already had COVID and have robust natural immunity.
As for long-term side-effects, Doshi said many severe side effects occur beyond six weeks after dosing, specifically referencing a quote by top FDA advisor Dr. Paul Offit who stated otherwise.
Vaccinating children for the benefit of adults is an “unproven hypothetical benefit,” Doshi said. He reminded the FDA they cannot authorize or approve a medical product in a population unless the benefits outweigh the risks in that same population.
“If the FDA does not have a high bar for EUAs and licensing, the point of regulation is lost,” Doshi said.
Kim Witczak, an FDA consumer representative, expressed great concerns over the premature approval of COVID vaccines for children. Witczak said data shows children are neither in danger or dangerous and questioned the timing of last Friday’s CDC announcement of the rise in children being hospitalized with COVID.
“The media ran with it and more fear was stirred — perfectly timed in advance of this meeting,” Witczak said.
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“The truth is we don’t really know that much about these vaccines,” Witczak said. “The ‘safe and effective’ messaging is being thrown around by everyone from government officials to media, community, religious leaders, to Hollywood celebrities. Then you add in all the promotions like multimillion dollar lotteries, free donuts, free shots at the local bar and so on. This subconsciously creates the illusion that there are no downsides whatsoever, nothing to weigh or consider.”
Witczak added: ”We simply cannot ignore the growing evidence of harm and just accept the narrative that adverse reactions are a good thing — and that means the shot is working.”
Witczak and Doshi were two of 27 researchers and clinicians around the world who launched a citizen’s petition demanding the FDA withhold full approval of COVID vaccines until efficacy and safety measures are met.
Some VRBPAC members expressed concern about reports of heart inflammation potentially linked to COVID vaccines.
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Dr. Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, said children are at low risk of severe disease from the virus and more study is needed about safety in younger age groups.
“Before we start vaccinating millions of adolescents and children, it’s important to find out what the consequences are,” Meissner said, noting a low COVID hospitalization rate among children.
“As more people are immunized and become immune from infection, I think it’s likely that we are going to get this pandemic under pretty good control,” he said. “I do not feel we can justify an EUA. The burden of disease is so small and the risks are just not clear.”
But other members of the committee sharply disagreed.
“I think we need these vaccines sooner rather than later in children,” said Dr. Mark Sawyer, a pediatrics professor at the University of California San Diego School of Medicine.
“It just seems silly to think that we’re not going to have to include children as part of that,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, co-inventor of Merck’s lucrative rotavirus vaccine and advisor to the FDA. “They can suffer and be hospitalized and occasionally die.”
“The notion that we are not going to have to vaccinate children going forward I think is wrong,” Offit added.
“I think that we need to have EUA ready to go if we start to see an upsurge of cases in the fall,” said Dr. Stanley Perlman, professor of pediatrics at the University of Iowa.
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Risk of heart inflammation
Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said during the meeting “there are ‘very few’ reports of myocarditis or pericarditis in 12- to 15-year-olds who have been given coronavirus vaccines.”
However, the CDC data Shimabukuro presented showed a higher-than-expected number of cases of heart inflammation among young people recently vaccinated with their second doses of mRNA vaccine. The agency identified 226 reports that might meet the agency’s “working case definition” of myocarditis and pericarditis following the shots.
Among 16- to 17-year-olds through May 31, 79 cases of myocarditis and pericarditis were reported. The expected rate among people in this age group is between two and 19 cases, Shimabukuro said during his presentation.
CDC data also showed that among 18- to 24-year-olds, there were 196 reports of myocarditis and pericarditis. The expected rate is between eight and 83 cases.
The CDC’s Advisory Committee on Immunization Practices scheduled an emergency meeting for June 18 to update data and further evaluate myocarditis following vaccination with Pfizer and Moderna vaccines.
The FDA’s meeting ended with remarks by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“I also want to take a moment to remember all the children who have died of COVID-19 in this pandemic, because that should not be forgotten here,” Marks said. “I just want to reiterate something here — this is an illness that takes the lives of children. We know that over 300 children have died in the pandemic so far.”
As Dr. Sidney Wolf, founder and senior advisor of Health Research Group, pointed out during the FDA meeting, CDC data from Jan. 1 to March 31 showed only 204 hospitalizations and 0 deaths in the 12- to17-year-old age group due to COVID.
As The Defender reported May 26, two papers recently published in the journal of Hospital Pediatrics, found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
New Conservative Network Seeks Crowdfunding Help
They say we have to go big or go home. We’re trying to go big and bring the patriotic truth the the nation, but we need help.
Readers may or may not realize that over the past year, we’ve been bringing more conservative news and opinion outlets under our wing. Don’t take our expansion as a sign of riches; all of the “acquisitions” have been through sweat and promises of greater things to come for all involved. As a result, we’ve been able to bring together several independent media sites under a unified vision of preventing America from succumbing to the progressive, “woke,” Neo-Marxist ideologies that are spreading like wildfire across America.
The slow and steady reopening of America is revealing there was a lot more economic hardship brought about from the Covd-19 lockdowns than most realize. While we continue to hope advertising dollars on the sites go up, it’s simply not enough to do things the right way. We are currently experiencing a gap between revenue and expenses that cannot be overcome by click-ads and MyPillow promos alone (promo code “NOQ” by the way).
To overcome our revenue gap and keep these sites running, our needs fluctuate between $3000-$7000 per month. In other words, we’re in the red and hemorrhaging.
The best way you can help us grow and continue to bring the truth to the people is by donating. We appreciate everything, whether a dollar or $10,000. Anything brings us closer to a point of stability when we can hire writers, editors, and support staff to make the America First message louder. Our Giving Fuel page makes it easy to donate one-time or monthly. Alternatively, you can donate through PayPal as well.
As the world spirals towards radical progressivism, the need for truthful journalism has never been greater. But in these times, we need as many conservative media voices as possible. Please help keep NOQ Report and the other sites in the network going.
Thank you and God Bless,
JD Rucker
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Five Things New “Preppers” Forget When Getting Ready for Bad Times Ahead
The preparedness community is growing faster than it has in decades. Even during peak times such as Y2K, the economic downturn of 2008, and Covid, the vast majority of Americans made sure they had plenty of toilet paper but didn’t really stockpile anything else.
Things have changed. There’s a growing anxiety in this presidential election year that has prompted more Americans to get prepared for crazy events in the future. Some of it is being driven by fearmongers, but there are valid concerns with the economy, food supply, pharmaceuticals, the energy grid, and mass rioting that have pushed average Americans into “prepper” mode.
There are degrees of preparedness. One does not have to be a full-blown “doomsday prepper” living off-grid in a secure Montana bunker in order to be ahead of the curve. In many ways, preparedness isn’t about being able to perfectly handle every conceivable situation. It’s about being less dependent on government for as long as possible. Those who have proper “preps” will not be waiting for FEMA to distribute emergency supplies to the desperate masses.
Below are five things people new to preparedness (and sometimes even those with experience) often forget as they get ready. All five are common sense notions that do not rely on doomsday in order to be useful. It may be nice to own a tank during the apocalypse but there’s not much you can do with it until things get really crazy. The recommendations below can have places in the lives of average Americans whether doomsday comes or not.
Note: The information provided by this publication or any related communications is for informational purposes only and should not be considered as financial advice. We do not provide personalized investment, financial, or legal advice.
Secured Wealth
Whether in the bank or held in a retirement account, most Americans feel that their life’s savings is relatively secure. At least they did until the last couple of years when de-banking, geopolitical turmoil, and the threat of Central Bank Digital Currencies reared their ugly heads.
It behooves Americans to diversify their holdings. If there’s a triggering event or series of events that cripple the financial systems or devalue the U.S. Dollar, wealth can evaporate quickly. To hedge against potential turmoil, many Americans are looking in two directions: Crypto and physical precious metals.
There are huge advantages to cryptocurrencies, but there are also inherent risks because “virtual” money can become challenging to spend. Add in the push by central banks and governments to regulate or even replace cryptocurrencies with their own versions they control and the risks amplify. There’s nothing wrong with cryptocurrencies today but things can change rapidly.
As for physical precious metals, many Americans pay cash to keep plenty on hand in their safe. Rolling over or transferring retirement accounts into self-directed IRAs is also a popular option, but there are caveats. It can often take weeks or even months to get the gold and silver shipped if the owner chooses to close their account. This is why Genesis Gold Group stands out. Their relationship with the depositories allows for rapid closure and shipping, often in less than 10 days from the time the account holder makes their move. This can come in handy if things appear to be heading south.
Lots of Potable Water
One of the biggest shocks that hit new preppers is understanding how much potable water they need in order to survive. Experts claim one gallon of water per person per day is necessary. Even the most conservative estimates put it at over half-a-gallon. That means that for a family of four, they’ll need around 120 gallons of water to survive for a month if the taps turn off and the stores empty out.
Being near a fresh water source, whether it’s a river, lake, or well, is a best practice among experienced preppers. It’s necessary to have a water filter as well, even if the taps are still working. Many refuse to drink tap water even when there is no emergency. Berkey was our previous favorite but they’re under attack from regulators so the Alexapure systems are solid replacements.
For those in the city or away from fresh water sources, storage is the best option. This can be challenging because proper water storage containers take up a lot of room and are difficult to move if the need arises. For “bug in” situations, having a larger container that stores hundreds or even thousands of gallons is better than stacking 1-5 gallon containers. Unfortunately, they won’t be easily transportable and they can cost a lot to install.
Water is critical. If chaos erupts and water infrastructure is compromised, having a large backup supply can be lifesaving.
Pharmaceuticals and Medical Supplies
There are multiple threats specific to the medical supply chain. With Chinese and Indian imports accounting for over 90% of pharmaceutical ingredients in the United States, deteriorating relations could make it impossible to get the medicines and antibiotics many of us need.
Stocking up many prescription medications can be hard. Doctors generally do not like to prescribe large batches of drugs even if they are shelf-stable for extended periods of time. It is a best practice to ask your doctor if they can prescribe a larger amount. Today, some are sympathetic to concerns about pharmacies running out or becoming inaccessible. Tell them your concerns. It’s worth a shot. The worst they can do is say no.
If your doctor is unwilling to help you stock up on medicines, then Jase Medical is a good alternative. Through telehealth, they can prescribe daily meds or antibiotics that are shipped to your door. As proponents of medical freedom, they empathize with those who want to have enough medical supplies on hand in case things go wrong.
Energy Sources
The vast majority of Americans are locked into the grid. This has proven to be a massive liability when the grid goes down. Unfortunately, there are no inexpensive remedies.
Those living off-grid had to either spend a lot of money or effort (or both) to get their alternative energy sources like solar set up. For those who do not want to go so far, it’s still a best practice to have backup power sources. Diesel generators and portable solar panels are the two most popular, and while they’re not inexpensive they are not out of reach of most Americans who are concerned about being without power for extended periods of time.
Natural gas is another necessity for many, but that’s far more challenging to replace. Having alternatives for heating and cooking that can be powered if gas and electric grids go down is important. Have a backup for items that require power such as manual can openers. If you’re stuck eating canned foods for a while and all you have is an electric opener, you’ll have problems.
Don’t Forget the Protein
When most think about “prepping,” they think about their food supply. More Americans are turning to gardening and homesteading as ways to produce their own food. Others are working with local farmers and ranchers to purchase directly from the sources. This is a good idea whether doomsday comes or not, but it’s particularly important if the food supply chain is broken.
Most grocery stores have about one to two weeks worth of food, as do most American households. Grocers rely heavily on truckers to receive their ongoing shipments. In a crisis, the current process can fail. It behooves Americans for multiple reasons to localize their food purchases as much as possible.
Long-term storage is another popular option. Canned foods, MREs, and freeze dried meals are selling out quickly even as prices rise. But one component that is conspicuously absent in shelf-stable food is high-quality protein. Most survival food companies offer low quality “protein buckets” or cans of meat, but they are often barely edible.
Prepper All-Naturals offers premium cuts of steak that have been cooked sous vide and freeze dried to give them a 25-year shelf life. They offer Ribeye, NY Strip, and Tenderloin among others.
Having buckets of beans and rice is a good start, but keeping a solid supply of high-quality protein isn’t just healthier. It can help a family maintain normalcy through crises.
Prepare Without Fear
With all the challenges we face as Americans today, it can be emotionally draining. Citizens are scared and there’s nothing irrational about their concerns. Being prepared and making lifestyle changes to secure necessities can go a long way toward overcoming the fears that plague us. We should hope and pray for the best but prepare for the worst. And if the worst does come, then knowing we did what we could to be ready for it will help us face those challenges with confidence.
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This article has nothing to do with the headline. It’s also disjointed and rambling.