A Shot in the Dark? Critical Considerations for Everyone Thinking About Getting the New COVID Vaccine

Are you taking steps to protect your health as the 2023/2024 flu season gets underway? Your doctor may recommend one of the two new COVID shots recently approved by the US Food and Drug Administration and Health Canada, courtesy of Pfizer and Moderna.

Designed to reduce the severity of COVID symptoms and the risk of complications, a component targeting Omicron variant XBB.1.5 is the new mRNA booster vaccine’s main novelty.

North American health authorities advise everyone six months and older to get the shot — but do you need it? Consider these critical points to make an informed decision.

Omicron Variant XBB.1.5 Is Already Past Its Peak

The new, single-dose COVID shot was specifically formulated to protect against Omicron variant XBB.1.5, but how much of a risk does this strain pose?

XBB.1.5 was mildly concerning when the World Health Organization first added the COVID strain to its “variants of interest” list in January 2023. It continued to spread into March when it made up 55 percent of all new cases, but the threat XBB.1.5 posed was short-lived.

By June, only 23 percent of COVID cases were caused by XBB.1.5 — and in September, that number has come down to a vanishingly small three percent. If protecting yourself against XBB.1.5 is your main reason for getting a booster, consider that you’re highly unlikely to encounter it in the wild.

XBB.1.5 isn’t particularly severe, either. The World Health Organization classifies it as a low-risk variant, noting that all available evidence suggests the risks associated with XBB.1.5 are comparable to those of other Omicron variants.

Moderna and Pfizer assure the public that the updated mRNA vaccines also guard against the more recent EG.5 and FL1.5 variants, but it is essential to remember that these strains didn’t descend from XBB.1.5.

Omicron Strains Have Reduced the Risks COVID Poses

COVID-19 lost much of its power since Omicron strains became dominant. Not only are hospitalizations and deaths down by 50 to 80 percent since Delta receded, but the symptoms Omicron strains cause are often so mild that patients don’t even know they have COVID.

In many cases, it takes going into the hospital for unrelated reasons to discover that someone has an Omicron infection. People put the associated symptoms down without the test for seasonal allergies or a common cold.

Other Countries Don’t Recommend the New COVID Vaccine for Everyone

The new COVID shot has been approved and made available in the UK and the European Union, while it remains under evaluation in Australia.

However, other countries’ healthcare authorities aren’t universally recommending a booster for everyone over six months.

Only those most vulnerable to COVID complications in the UK, such as frontline healthcare workers, people with chronic illnesses, and those aged 65 or over, are eligible for a booster. The World Health Organization takes a similar approach in its COVID vaccination guidance, advising immunocompromised or at-risk people to get boosters.

This isn’t the first time North American health authorities universally recommend COVID vaccines approved for “emergency use.” Still, it is the first time since the COVID emergency officially ended in May 2023. Is that necessary?

With other countries taking a more cautious approach to adopting the new single-dose mRNA shot, US and Canadian citizens will have to make their own decisions about their approach to healthcare.

COVID Shots Don’t Prevent Transmission (and May Even Increase It)

You may conclude you don’t need the new COVID shot to protect yourself, given XBB.1.5’s low-risk profile — but you may still want to do your bit to protect others. If you’re considering getting a booster to prevent transmitting COVID to the vulnerable people in your life and community, realize that COVID vaccines don’t appear to do that.

Not only have health officials admitted that COVID shots prevent neither infections nor transmission, but research shows little difference in viral loads between vaccinated and vaccinated people with COVID.

In other words, getting the new COVID booster appears unlikely to protect anyone from becoming infected with XBB.1.5 or any additional strain — but it gets worse.

A Cleveland Clinic study showed that COVID vaccination increases the risk of infection. The study found that “a protective effect of bivalent vaccination could not be demonstrated while the XBB strains were dominant” and that receiving more vaccine doses consistently led to a higher risk of contracting COVID.

Another study conducted in California in 2023 backed this discovery by showing that people who received bivalent COVID vaccines had slightly (but statistically relevant) higher infection rates than those who weren’t vaccinated.

The Safety of the New COVID Vaccine Remains Unclear

Conducting a personal cost-benefit analysis helps you make important decisions about any topic, but that requires data. Do the benefits of the new COVID mRNA shot outweigh the risks? As you ask this question, you’ll discover the data you need to decide doesn’t exist — which means the FDA and Health Canada approved the new shot without it.

The new COVID vaccine's safety, efficacy, and side effects

are currently being evaluated in an “ongoing Phase 2/3 open-label study in participants 18 years of age and older.” At the same time, current data is based on a tiny sample group.

Health Canada’s decision summary, explaining the reasons for moving forward with the new COVID shot, noted that “50 participants received a 50 mcg dose of Spikevax XBB.1.5, and 51 participants received a dose of an investigational bivalent vaccine.”

In summary, the new shot’s current safety record is based on:

·       Trials that remain ongoing after the vaccine’s approval

·       Shockingly small study samples

·       Limited data gathered from adult participants

Before you get the shot, remember that the health authorities currently recommending the updated COVID vaccine don’t know much more about it than you do.

A Final Word

The healthcare authorities recommending the brand-new COVID booster shot to everyone under six months expect members of the public to jump on board and trust their word that the vaccine is safe and beneficial.

At times like these, it helps to remember that COVID vaccination programs have been problematic from the beginning — a fact that was easy to lose sight of amid the panic of a global pandemic. Rushed through using emergency protocols, nobody had the data to prove these revolutionary new vaccines were safe.

We still don’t, but we know more about COVID shots than we did:

·       One in 800 vaccine recipients experience severe side effects.

·       COVID vaccines don’t prevent infection or transmission.

·       Receiving repeated COVID vaccine boosters actively increases the risk of infection.

We also know that XBB.1.5, the COVID strain the new COVID shot specifically targets, is low-risk — like all Omicron variants — and in decline. While developed countries worldwide have either approved the new shot or are evaluating its safety, only the US and Canada universally recommend it for everyone over six months old. Other nations only recommend the booster for the most vulnerable groups.

Can you confidently say that the benefits outweigh the risks in your situation? If not, are you sure you want to line up for (yet another) COVID vaccine?