(The Defender)—The World Health Organization (WHO) today approved the first mpox vaccine for use in adults — and also said it can be used for babies, children, teens and pregnant women if they are in “outbreak settings where the benefits of vaccination outweigh the potential risks.”
WHO’s approval of Bavarian Nordic’s vaccine will help governments and international agencies such as the Gavi, the Vaccine Alliance, and UNICEF, buy it, MedicalXpress reported.
The MVA-BN vaccine — short for “Modified Vaccinia Ankara-Bavarian Nordic” — is a smallpox/mpox vaccine. It is sold in the U.S. under the name Jynneos.
WHO Assistant Director-General Yukiko Nakatani said, “The decision can also help national regulatory authorities to fast-track approvals, ultimately increasing access to quality-assured mpox vaccine products.”
Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker called the WHO’s approval of the shot for infants and children in Africa “a train wreck in the making.”
Hooker told The Defender:
“The safety profile is abysmal in adults (up to 2.1% serious cardiac events in clinical trials) and the vaccine has not been adequately tested for efficacy or safety in pediatric populations.
“In other words, the WHO has no idea whether it will work nor do they know how much damage it will do. The WHO has again abandoned good public health principles and waved their magic vaccine wand on the mpox outbreak.”
Dr. David Bell, a public health physician and biotech consultant, also criticized the WHO for overly focusing on mpox vaccines and neglecting to address broader public health issues in Africa.
“So far this year, about 40,000 children have died from malaria in the DRC [Democratic Republic of Congo] alone, and similar numbers of people from malnutrition, tuberculosis and HIV/AIDs,” Bell said.
Although these numbers “obviously dwarf” the number of mpox deaths, the WHO is allocating fewer resources to addressing them.
Bell — who formerly served as a medical officer and scientist at the WHO — explained what he sees occurring:
“We have become much better at detecting much rarer diseases such as mpox, and addressing these is certainly more lucrative for the growing industry feeding off the WHO’s misinformation regarding rapidly rising pandemic risk.
“However, it is clear that the people of DRC and Africa in general would benefit far more if WHO returned to impactful public health. There has been a move over recent years to a concentration on addressing the symptoms of diseases of poverty (which mpox is) with Western-developed commodities, rather than dealing with underlying causes.
“This signals a return to colonialist-era approaches rather than evidence-based public health. It presumably reflects the way WHO is now funded, with increasing control from the private sector and a few large Western nations with large Pharma industries.”
No clinical trials on kids
In its press release, the WHO said the MVA-BN vaccine can be administered to adults over 18 as a two-dose injection four weeks apart but can also be given as a single dose “in supply-constrained outbreak situations.”
“While MVA-BN is currently not licensed for persons under 18 years of age,” it said, “this vaccine may be used ‘off-label’ in infants, children and adolescents, and in pregnant and immunocompromised people.”
The WHO called for more data on the vaccine’s safety and efficacy in these situations.
The WHO Strategic Advisory Group of Experts on Immunization — which reviewed all available evidence and recommended the use of MVA-BN vaccine — noted in its Weekly Epidemiological Record report that “MVA-BN has not been specifically studied in clinical trials in children.”
However, they said:
“The same non-replicating MVA viral vector is used as a platform for other vaccines that include MVA-filo (Mvabea™) against Ebola virus disease (EVD).
“The EVD vaccine is approved by the EU for adults and children aged 1 year and older. Data from 5 published studies on MVA-BN as a viral vector platform for the prevention of EVD, with a total population of 52 229 children, support the favourable safety profile of the product.”
The authors of a new study — published Sept. 11 in The BMJ — presented results on MVA-BN’s effectiveness in adult males but said nothing about children or pregnant women.
In 2023, researchers funded by the UK Health Security Agency looked at the health outcomes of 87 children who received a single dose of MVA-BN.
They reported that the vaccine was “well tolerated” but that larger studies needed to be done to fully assess the shot’s safety and efficacy in kids.
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The Defender asked Bavarian Nordic for information about its mpox vaccine in pediatric populations but did not receive a response by the deadline.
The WHO’s process for granting a drug “prequalification” approval for “emergency use listing” requires drugmakers to “commit to continue generating missing information to fulfill prequalification requirements.”
“Once this information becomes available,” the WHO said, “a PQ [prequalification] application should be submitted to complete the full process to achieve recommendation for international procurement in both emergency and non-emergency settings.”
It is unclear how much pediatric safety and efficacy data Bavarian Nordic has collected so far and what it showed.
Mpox vaccine approved for U.S. kids and teens since 2022
The U.S. Food and Drug Administration (FDA) in 2022 granted emergency use authorization for the vaccine for “in individuals less than 18 years of age determined to be at high risk for monkeypox infection.”
Jynneos has been licensed for use in U.S. adults since 2019.
The Centers for Disease Prevention and Control (CDC)’s mpox vaccination website states that while teens and children at risk for mpox can receive Jynneos, it is not recommended for babies under 6 months.
The CDC also says Jynneos can be given to pregnant or breastfeeding women.
Although it remains unknown if Jynneos may pose risks to a developing fetus if taken during pregnancy, animal studies haven’t shown any harm to developing fetuses when the vaccine was given to pregnant animals, the agency said.
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.
