6 things to know before taking the latest COVID shot - analysis
U.S. and Canadian regulatory agencies approved a new mRNA vaccine against COVID and are recommending that everyone over 6-months-old get the shot this fall.
With COVID’s reemergence in the headlines and public health officials warning of a dire upcoming flu season, officials are encouraging the public to get vaccinated with the latest mRNA shot against COVID. Before your friends or family roll up their sleeves there are a few things to consider:
1. Only the U.S. and Canada recommend vaccination for everyone over 6 months
The FDA approved the new COVID vaccine for those 12 and over, but for children under 12 the FDA has only authorized it under “emergency use,” even though the U.S. federal government ended the “COVID emergency” back in April.
Emergency use authorization should require an emergency. COVID deaths were always very rare in children, with a 0.0003% infection fatality rate among ages 0–19. There was never any “emergency” for children.
Regulatory agencies in the United Kingdom, Sweden, Germany, Norway, Finland, and the World Health Organization all recommend the shots only for ages 60 or 65 and older or for those with a higher risk of COVID complications. To date, only Canada and the U.S. approved and recommended the shot for low-risk individuals.
FDA vaccine adviser, vaccine developer and pediatrician Dr. Paul Offit disagrees with the CDC recommendation to give the shots to everyone over 6 months. According to Offit, mRNA shots for COVID are different than annual flu shots; only high-risk people should take the new injection.
2. The targeted variant is in decline
The new vaccine is different from previous COVID vaccines in that it targets specifically the XBB1.5 sub-variant of Omicron. What’s so special about this particular sub-variant that a new vaccine was needed? Nothing. The WHO classifies the overall risk as “low” explaining that “available evidence does not suggest that XBB.1.5 has additional public health risks [compared to other Omicron variants].”
XBB1.5 became a variant of interest in January 2023, increased in prevalence worldwide, and made up about 55% of COVID infections during March, then began to decline, dropping to about 23% by June. Now in mid-September, the CDC estimates that less than 3% of infections in the U.S. are XBB1.5.
Pfizer and Moderna argue that the new vaccine is also protective against the newer EG.5 and FL1.5 variants even though they are not a subset of the XBB1.5 variant it was designed to protect against.
If there was a time to release a vaccine targeting XBB1.5 it would have been late last year, but now with the XBB1.5 variant in a steep decline, it’s less relevant.
3. Current COVID variants are far less dangerous
All Omicron variants are far less of a threat than previous variants. Compared to Delta, Omicron hospitalizations and deaths are 50% to 80% less. This has been the case for nearly two years.
Recently doctors are seeing COVID patients coming in with even milder cases. Last week, New York City's Mount Sinai Downtown Vice Chair of Operations for Emergency Medicine Dr. Erick Eiting told NBC News, “Just about everyone who I've seen has had really mild symptoms," adding, "The only way that we knew that it was COVID was because we happened to be testing them."
4. COVID vaccines are associated with increased COVID infections
Many well-intentioned people still believe that taking a COVID vaccine protects others, so even if they are low-risk, they should take an updated shot to prevent transmitting the virus to others. But public health officials concede that COVID vaccines do not prevent infection or transmission past a few weeks.
What has not been made widely known is that the COVID shots are associated with negative effectiveness of infection, meaning a vaccinated person is more likely to become infected and transmit the virus to others compared to an unboosted or unvaccinated person.
Scientists at the Cleveland Clinic studied last year’s bivalent booster to see what effect it had on infection rates. They examined staff medical records over a period of 6 months and concluded that "the higher the number of vaccines previously received, the higher the risk of contracting COVID-19."
Another study looked at the prison population in the state of California between January and July 2023, comparing inmate infection rates to vaccination status. The study found that the “bivalent-vaccinated group had a slightly but statistically significantly higher infection rate than the unvaccinated group [3.24% vs 2.72%] in the statewide category.” The difference was even greater in age cohorts of 50+ and 65+.
The negative effectiveness of the original COVID vaccines has been observed in several other studies, so it’s not surprising that it also occurred with last year’s booster, and will therefore likely occur with this newly approved vaccine.
5. Weak safety data
Understanding the safety and potential risks of the new vaccine is of critical importance when evaluating the risk/reward equation. Especially in a situation of moderate or low risk from COVID where even the WHO does not recommend vaccination due to the “comparatively low public health returns.”
What safety data did public health officials use to base their decision on? For those over the age of 18, Health Canada wrote, in their decision summary for approving the vaccine, that “[t]he safety, reactogenicity, and immunogenicity of Spikevax XBB.1.5 are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and older.”
The decision summary described the study “mRNA-1273-P205 Part J" as follows: "50 participants received a 50 mcg dose of Spikevax XBB.1.5, and 51 participants received a dose of an investigational bivalent vaccine.”
It is not a placebo-controlled comparison. Rather, it’s a comparison between the new vaccine to some other “investigational bivalent vaccine.” Also, the sample group is so small that it wouldn’t detect adverse events that are less frequent than 1 in 50 since only 50 participants received the vaccine.
In addition, this study is still ongoing and is scheduled to be completed in November 2023 - two months after the vaccine has already been approved.
The data supporting safe use for children 6 months to 18 years is even weaker. “[S]afety and effectiveness of Spikevax XBB.1.5 for individuals 6 months of age and older is inferred from studies of a primary series and booster dose of Spikevax.” In other words, there was no study to show the new vaccine is safe. It is merely “inferred.”
The weakness of the safety data led Florida Surgeon General Dr. Joseph Ladapo to advise people not to get the new vaccine: "There’s been no clinical trial showing that it is a safe product for people — and not only that but then there are a lot of red flags."
6. History of past COVID vaccines
Since regulators have cited the safety record of previous COVID vaccines to assure the public that these new vaccines are safe, it is imperative to examine the safety record of the earlier COVID shots.
After examining the data that led to the approval of the first mRNA COVID vaccines, red flags were found. One peer-reviewed study, published in the journal Vaccine did just that and found that serious adverse events occurred at a rate of 1 in 800 — far more than what is considered acceptable, and well surpassing the rate of COVID hospitalizations.
Large numbers of adverse events including deaths were observed at unprecedented levels in vaccine monitoring systems worldwide. Increases in disabilities, excess deaths, and cardiovascular problems were closely associated with previous COVID vaccines.
Approval of the new COVID booster vaccine comes with an abundance of red flags. Its effectiveness is questionable and safety data is weak. Furthermore, there have been numerous adverse events associated with earlier COVID vaccines.
People need to be aware of the risks before making a decision, and not simply take another shot in the dark.
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