New Study: Bivalent Booster Demonstrated No Efficacy Against Infection from the XBB Lineages. *Important Booster Considerations*

Should you get a COVID-19 bivalent booster or 2nd booster if eligible?

The CDC says, “The updated boosters are called “updated” because they protect against both the original virus that causes COVID-19 and the Omicron variant BA.4 and BA.5. Two COVID-19 vaccine manufacturers, Pfizer and Moderna, have developed updated COVID-19 boosters.” Are they updated enough? We will see below that the latest study is showing that it isn’t enough to limit infections.

According to the CDC website, they recommend everyone stay up to date with COVID-19 vaccines for their age group¹.

“One updated booster dose: If you have completed your updated (bivalent) booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose.”

Updated Pfizer-BioNTech vaccine:

• “Children aged 6 months–4 years who completed their primary series with 3 doses of the original Pfizer-BioNTech COVID-19 vaccine are recommended to receive an updated Pfizer-BioNTech booster.”

• “Children aged 6 months-4 years who completed their primary series with 2 doses of the original Pfizer-BioNTech vaccine and a 3^rd dose of the updated Pfizer-BioNTech vaccine are not currently recommended to get an updated Pfizer-BioNTech booster.”

If you are considering a booster for your children aged 6 months - 4 years, you should read this review of the study they used to authorize it.

A False Promise? Review of Pfizer Booster for Children Under 5

The CDC says everyone should get at least one booster dose of the bivalent vaccines. They say if you are immunocompromised or over 65 years old then you might consider getting a second bivalent booster.

Should you get a COVID-19 bivalent booster or 2nd booster if eligible?

This is a question that many people are asking themselves. There are a lot of factors to consider, such as age, health status, vaccination history and the efficacy of the vaccine against the XBB variants. We must consider the potential risks associated with getting a booster shot.

First, it's important to understand the impact that each booster shot has on our immune system. Each shot induces the body to use a large number of the finite amount of naive T-cells or existing cells, which are older, to build an army to fight off the infection that the body thinks is present. To maintain that army for 6 to 10 months uses up more of these cells. The thymus starts shrinking after puberty and becomes nothing but fatty tissue by the time people are about 65 years old. The thymus is like the heart of the immune system. As it shrinks with age, it becomes harder to fight infections with each passing year because the body is recycling older memory T-cells. These cells cannot divide forever. There is a limit which is measured by looking at the length of telomeres. By 45 years old, the thymus has withered quite a bit compared to when someone is 25 years old. That is why the older people get, the more likely they are to suffer more severe issues.

At 65 years old, without a thymus, each time the T-cell army is boosted, it pulls resources away from fighting future infections, containing persistent infections, healing injuries, and maintaining cognitive function. Additionally, every booster increases the odds of autoimmune disorders, weakens the immune system temporarily for a week or two, and may give a false sense of security. The booster does not stop infections or long-term persistence in organs.

If you have been infected with a mild or asymptomatic case of COVID-19 within the past 6 to 10 months and never confirmed it, getting a booster shot could be pointless and potentially harmful. It wouldn’t benefit because the antibodies don’t prevent infections and because the T-cells aren’t boosted until at least 6 to 10 months after the last vaccine dose or infection. It could harm by causing an autoimmune response when taken to soon after an infection.

The CDC updated the guidance to say “If you recently had COVID-19, you still need to stay up to date with your vaccines, but you may consider delaying your next vaccine dose (whether a primary dose or booster) by 3 months from:”

• “when your symptoms started.”

• “Or, if you had no symptoms, when you first received a positive test.”

It’s good that they say wait at least 3 months to help lower the odds of an autoimmune response, but there is a very short period helping to reduce infection, even with older variants. The benefit to prevent severe diseases doesn’t happen until at least 6 to 10 months from the last shot or prior infection. That benefit against infection goes negative after a couple months when infection risk actually increases and therefore so do the chances of a persistent infection or Long COVID symptoms. The CDC should update their guidance on the timing. The Walgreens data has been showing this situation for many months. We can see that the positivity rate increases above unvaccinated after just 3 months from the last dose.

COVID Infections and Severity Have Been Mitigated by the Strong T-cell Response Induced by Prior Infections and Vaccines

COVID-19 infections that occur after T-cells wane, outside of the 6 to 10 months, can be much worse, especially if infected with a high viral load so that must be taken very seriously. Getting the booster has been effective at boosting the T-cell army, thus it can quickly eliminate infections. COVID infections come with an unknown dose upon exposure, as opposed to the known dose without infectious virus from the vaccine. Being exposed to a high viral load can have much larger and devastating impact on the immune system and every organ system so the faster the T-cell response, the less likely someone would have severe symptoms and die. The latest variants might have some new tactics to evade the T-cells making it harder to fight and more likely to persist.

N-95 masks significantly reduce that risk. If you are very careful, following all the mitigation protocols, there is an argument to hold on getting a booster. This argument is strengthened as we discuss the efficacy of the bivalent booster against the XBB variants a little further down.

Consideration of the Temporarily Weakened Immune System After Booster

Important to note if you are outside of the 6 to 10 months, haven’t been infected in that time and are getting a booster prior to a larger event, then getting the booster at least 4 weeks before the event is a good idea because during the first one to two weeks after a booster people should take extra care to avoid being exposed to any airborne pathogens while the body is preparing the T-cell army to fight COVID. That process can pull resources that would have been available to fight off another infection, whether it is COVID, Flu, RSV or something else. Allowing for the time to recover and bring the immune system back to full strength before the event is a wise decision. The older you are, the longer it might take, but by the third or fourth week, you should be good to go.

It's important to remember that the booster shot doesn't stop infections or long term persistence from new variants.

The Bivalent Booster Demonstrated No Efficacy Against Infection from the XBB Lineages

A large study by the Cleveland Clinic published in March 2023, found that the bivalent vaccine effectiveness during the XBB dominant phase was only 4%. The study also found that the more recent the last COVID-19 infection was, the lower the risk of a new infection. The study is a pre-print so not peer reviewed yet but with that said, it confirms what we have already been seeing.

They found that the greater the number of vaccine doses previously received, the higher the risk of a new infection. That is very unsettling but as noted above with the Walgreens data, we have known that after the first few months, the risk of infection increases compared to unvaccinated. There are some theories as to why this is occurring such as immune imprinting. In summary, they wrote, “Among 51,017 working-aged Cleveland Clinic employees, the bivalent COVID-19 vaccine was 29% effective in preventing infection while the BA.4/5 lineages were dominant, and 20% effective while the BQ lineages were. Effectiveness was not demonstrated when the XBB lineages were dominant.” No demonstrated efficacy against XBB lineages.

We need new vaccines that prevent infections and Long COVID but that isn’t going to happen in the near future. Boosting with the bivalent booster that was only half geared to the BA.5 variant, and is so far removed from the latest variants that it is much less effective. If the latest variants evolve to evade the memory T-cells induced by a previous infection or the vaccine, then people could be worse off taking the booster than if the body were to develop new memory T-cells geared toward the latest variants. We do not know if this is happening yet so as of now getting the booster to prevent severe disease is still recommended.

The best bet for most people is to take the extra precautions and wear an N-95 mask when out, require anyone coming into the house to wear one, add air purifiers to the home, open windows when someone comes over, etc. If exposed to a very low viral load, then risks are reduced, and hopefully, the immune system can adapt to the new variant. This is a terribly dangerous situation to be in, especially for those at greatest risk.

Strategies to Avoid COVID and Other Respiratory Viruses

The decision to get a COVID-19 booster shot should be made after careful consideration of all the risks and benefits. You should always discuss these variables with your doctor to better understand your particular situation. It's important to understand that each booster shot has potential risks associated with it. We need new vaccines that are better suited to the latest variants and actually prevent transmission. The most important thing we can do is to invest in new ventilation and filtration or update the existing ventilation and filtration systems in schools and other places of large gatherings to significantly limit the prevalence of COVID and other airborne pathogens in any one space. In the meantime, we should continue to take personal precautions such as wearing N-95 masks and using air purifiers to reduce our risk of infection.

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Universal Use of N-95 Masks in Hospitals is Necessary

The CDC posts a long list of studies that show the efficacy of masks and universal mask use. Even in hospital settings. The CDC shows that “at least ten studies have confirmed the benefit of universal masking in community level analyses: in a unified hospital system,⁴⁷ a German city,⁴⁸ two U.S. states,^{49, 50} a panel of 15 U.S. states and Washington, D.C.,^{51, 52} as well as both Canada⁵³ and the U.S.^54-56 nationally. Each analysis demonstrated that, following directives from organizational and political leadership for universal masking, new infections fell significantly. Two of these studies^{51, 52} and an additional analysis of data from 200 countries that included the U.S.⁵⁶ also demonstrated reductions in mortality. Another 10-site study showed reductions in hospitalization growth rates following mask mandate implementation.^54”

The page quoted hasn’t been updated since Dec 6, 2021. There have been more studies since and many studies before COVID that show using masks work to prevent transmission of respiratory viruses. If everyone wore N-95 masks then that reduction would be much greater. The universal use of N-95 masks in hospitals is the ethically responsible thing to do. Anything less is negligent and open to liability for failing to provide a safe environment.

To protect patients, hospitals must use high-quality N-95 masks. We know from all of the data that anything less than an N-95 or similar type mask is negligent. A hospital may be held liable for any resulting harm if it fails to take reasonable steps to prevent the spread of infectious diseases, such as failing to implement proper infection control measures or failing to adequately screen patients. COVID is the most contagious airborne virus in modern human history, and it necessitates the use of an N-95 or similar type mask to limit transmission. Second, hospitals are responsible for providing a safe and sanitary environment for both patients and staff. If a hospital fails to implement appropriate infection control measures, they may be held liable for any harm that results.

This is not a time to let our guard down. We should be especially concerned about the children who do not have adequate protection. Without adequate monitoring, this could wreak havoc on schools and homes long before we intervene.

This study, published in January 2023, looked at mild and asymptomatic cases of COVID in children and adult family members and how this impacted the immune systems of children. All consented samples used in these analyses were collected between July 23 and October 24, 2020, so before the vaccines were used.

They found that "adults but not children develop robust memory T cell responses to SARS-CoV-2." Children do not have the same memory T-cell protection that adults develop, so that would leave them more exposed to reinfections, or it means they are using more naïve T-cells and damaging the development of the naïve T-cells that accumulate until puberty. In other words, children may have permanent damage to the immune system, making them more susceptible to infections, cancers, autoimmune disorders and other health problems at a much earlier age than otherwise would have happened.

"This failure of infection-induced immunity places children at the risk of recurrent infection and progressive restriction of their T cell repertoire and responses as they grow older."

This is not an acceptable situation. We should have learned from our mistakes, applied what we knew, and become better prepared. Instead, there is less surveillance and almost no treatment for either the initial infection or Long COVID. The HVAC systems have not been upgraded. We do not have any new vaccines. We are not prepared.

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