CDC Says Kids Can Get BS 19 and Flu Vax at the Same Time — But Where’s the Safety Study?
CDC Says Kids Can Get BS 19 and Flu Vax at the Same Time — But Where’s the Safety Study?
By Children’s Health Defence Team
Story at-a-glance:
- The CDC’s Advisory Committee on Immunization Practices unanimously voted to coadminister the COVID-19 and flu vaccine without any scientific evidence to back the decision.
- CDC staff cite one preprint study funded by Novavax, which the CDC said showed coadministration was safe. However, the study was small, used participants with fewer comorbid conditions and used the Novavax vaccine, which is not an mRNA vaccine.
- The ACIP also warns providers about increased reactogenicity with the combined shot as they expect more adverse reactions. Data suggest that flu vaccines increase your risk of death from COVID-19.
- Parents should be aware of the risks of giving children a COVID-19 vaccine for several reasons: Children usually are asymptomatic or only experience mild symptoms; their ability to transmit the infection is limited; many have natural immunity after recovering from the illness and vaccinating children to protect adult health has not been proven to be an effective disease control strategy.
- Currently, the COVID-19 vaccine is being distributed under an Emergency Use Authorization granted to vaccine manufacturers by the FDA and, as of June 18, there have been reports of nine COVID-19 vaccine-related deaths in children ages 12 to 17. Medical professionals administering vaccines are required to report vaccine reactions to the federal Vaccine Adverse Event Reporting System — if they refuse, you can file a report yourself.
The CDC’s Advisory Committee on Immunization Practices (ACIP) recently unanimously voted 14-0 to coadminister the COVID-19 and flu vaccine to adults and children. The proposed policy for the 2021-2022 influenza season was made to implement changes that coincide with the timing of children returning to school in fall 2021, and to align with the CDC’s guidelines allowing COVID-19 vaccines to be coadministered with other vaccines.
This also will be the first influenza season where nearly all available flu vaccines are quadrivalent, rather than trivalent. This means flu shots will contain four vaccine strain influenza viruses — two influenza A viruses and two influenza B viruses.
The ACIP vaccine policy recommendations also included explicit information about when influenza vaccines should be given to children and adults. For example, the recommendations direct vaccine providers to give non-pregnant adults flu shots after August because of concerns about waning vaccine-acquired artificial immunity.
Vaccine providers are directed to give children flu shots by the end of October, with the dog kidney (MDCK) cell-based Flucelvax quadrivalent vaccine now being recommended for children starting at age 2 and older.
The policy also calls for precautions in giving a vaccine to anyone with a moderate or severe acute illness, history of Guillain-Barré syndrome within six weeks of receiving an influenza vaccine, or a history of severe allergic reactions to any other dose of flu vaccine.
Unanimous vote: CDC approved one flu and COVID vaccine
In addition to approving the coadministration of flu and COVID-19 vaccines, ACIP warns that providers should be aware their patients may exhibit increased reactogenicity. This is a term health authorities use to describe expected adverse reactions to pharmaceutical products, especially hyper-inflammatory immunological responses to vaccination.
The literature calls it a “physical manifestation of the inflammatory response to vaccination” and “symptoms may include pain, redness, swelling or induration for injected vaccines and systemic symptoms, such as fever, myalgia, headache or rash.”
In other words, the CDC expects more people to experience side effects/adverse reactions when influenza and COVID-19 vaccines are administered concurrently. ACIP member Dr. Matthew Daly believes that this year “Most adolescents will be vaccinated [against] COVID-19 in the summer and have their flu vaccination in the fall.”
But coadministration of the two vaccines next year could increase the number of children receiving COVID-19 vaccine together with influenza vaccine and, subsequently, potentially increase reactogenicity. In the same meeting, the committee also voted unanimously to recommend a shorter rabies vaccination series for children traveling to areas where the potential risk is high.
Lastly, ACIP recommended the dengue vaccine for children ages 9 to 16 who live in areas where the virus is endemic. According to the CDC, the dengue virus spreads through the bite of a mosquito, infecting up to 400 million people each year. Each year, nearly 100 million will get sick and 22,000 will die from dengue.
No evidence to suggest concurrent vaccination policy is safe
Despite the unanimous vote by CDC health experts charged with protecting the health of U.S. citizens, there is no evidence to suggest that giving children or adults influenza and COVID-19 vaccines simultaneously on the same day is safe. Some ACIP members noted the lack of data proving that concurrent vaccination policy is safe.
However, Medpage reports that CDC staff countered by citing one preprint study — published just days before the ACIP meeting — that examined the safety issues and efficacy of coadministering flu vaccine with the Novavax COVID-19 vaccine.
With this study, CDC staff noted there were “no changes in antibody titers for influenza vaccine and no safety issues” when given in combination, although participants did have greater tenderness or pain at the injection site, and higher levels of fatigue and muscle pain.
It’s also crucial to note that the information on which they based this decision was gathered from a sub-study of just 217 participants who had fewer comorbid conditions and were younger than those in their vaccine’s main study.
Also important to note is that the experimental Novavax COVID-19 vaccine is a subunit protein, which is different from the mRNA COVID-19 vaccines. This means that information from the Novavax study cannot be extrapolated to the experimental mRNA vaccines now being administered under an EUA.
Unlike the messenger RNA vaccines, which use genetic material to trigger the body to make parts of the SARS-CoV-2 spike protein, the Novavax vaccine’s protein adjuvant contains the spike protein as a nanoparticle. The manufacturer proposes that it stimulates the immune system to recognize the virus and resist infection.
Additionally, none of the mRNA COVID-19 vaccines being distributed under an EUA has been tested for safety and efficacy when coadministered with influenza vaccine. In other words, the CDC made a recommendation that the two vaccines can be given simultaneously to children and adults without providing data conclusively demonstrating safety or efficacy.
Could flu vaccines increase risk of COVID-19?
Over the years, data have demonstrated that the flu vaccine has kept missing the mark when it comes to effectiveness. In the 2004-2005 season, the vaccine’s overall effectiveness was only 10%, which means 90% of the time it failed. During the 2012-2013 flu season it was 49% effective overall and in 2014-2015 it was only 19% effective overall.
The abysmal success rate of the seasonal influenza vaccines is related to how the vaccine is developed each year. Because influenza viruses are constantly mutating, the vaccine must be reviewed and updated to include those the scientists estimate will be circulating in the coming flu season.
Each year, 100 centers in over 100 countries conduct surveillance, which includes testing thousands of influenza virus samples from patients. Twice a year these results are analyzed, and the World Health Organization recommends the specific viruses that should be included in the coming year’s influenza vaccine. In America, the FDA makes the final decision.
In other words, scientists must guess based on past data which influenza viruses will be circulating in the upcoming season. There is also evidence from Canadian studies that with repeated vaccinations, flu vaccine effectiveness wanes. This type of study will not be done in the U.S. for the simple reason that U.S. authorities recommend everyone get vaccinated every year. As noted by STAT news:
“Given that policy, it would be unethical for researchers here to randomly assign some people to forgo vaccinations in some years. But experts elsewhere, including in Hong Kong, where influenza circulates year-round, are trying to put together the funding for what would have to be a large, multiyear study.”
The SARS-CoV-2 virus that causes COVID-19 also mutates and is expected to continue to mutate in the environment, resulting in new strain variants. Additionally, a study published in January 2020 in the journal Vaccine found that people who had received influenza vaccines during the 2017-2018 flu season were more likely to get some form of coronavirus infection.
When compared to unvaccinated individuals, those who had gotten the seasonal flu shot were 36% more likely to contract an unspecified coronavirus infection and 51% more likely to contract human metapneumovirus, which has respiratory symptoms similar to COVID-19.
In October 2020, another positive association was found between COVID-19 deaths and flu vaccination rates in the elderly. This means coadministration of these vaccines may have potentially serious side effects.
An analysis of data from 39 countries with more than one-half million inhabitants showed that those over 65 years old who had gotten a flu shot had an increased risk of death from COVID-19. An analysis published in May 2020 looked at European countries with the highest COVID-19 death rates and found those countries also had the highest rate of influenza vaccinations among the elderly.
Why COVID-19 vaccine for children is very risky
There is no evidence that coadministration of influenza vaccine and COVID vaccine is safe, but there is evidence that giving the COVID-19 vaccine to children is extremely risky. A video titled “Why Children Should Not Receive the COVID Shot,” features comments that Peter Doshi, Ph.D., made during a June 10 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
Doshi is the senior editor of The BMJ and associate professor at the University of Maryland School of Pharmacy. In a paper published in The BMJ, he points out that Pfizer‘s claim the vaccine is 95% effective refers to relative risk reduction. The absolute risk reduction is actually less than 1%.
In addition, the primary endpoint measured is a reduction in severity and not the vaccine’s ability to prevent infection or save lives. The decision to vaccinate should be made on a risk-benefit analysis, where the benefit far outweighs the potential risks involved.
However, as I discussed in the linked article above, the benefits are rare, the side effects are common and the long-term effects are completely unknown. For example, Pfizer boasts a 100% efficacy rate in the 12-to-15 age group. In the video, Doshi explains this was based on less than 2% of the placebo group getting COVID-19, while none in the fully vaccinated group got sick.
As reported in The Defender, many of the side effects have been short-lived but, by June 11, 2021, there were 6,332 total adverse events in 12- to 17-year-olds, seven deaths and 271 events rated “serious.”
According to OpenVAERS one week later, data through June 18, 2021, showed 11,584 adverse events and nine deaths in the same age group. In one week, there were two more deaths and 5,252 more adverse events reported to OpenVAERS.
One of the reasons health experts give for vaccinating children, many of whom Doshi explains have natural immunity from a COVID-19 infection, is to benefit adults. This practice is sometimes called “cocooning” and has never been proven to be effective.
The authors of an editorial in The BMJ stressed that giving children COVID-19 vaccine is “hard to justify right now” since children experience mild disease symptoms and transmission is limited, while the potential for unintended consequences from the vaccine is high. They go on to write:
“Should childhood infection (and re-exposures in adults) continue to be typically mild, childhood vaccination will not be necessary to halt the pandemic. The marginal benefits should therefore be considered in the context of local healthcare resources, equitable distribution of vaccines globally, and a more nuanced understanding of the differences between vaccine and infection induced immunity.
Once most adults are vaccinated, circulation of SARS-CoV-2 may in fact be desirable, as it is likely to lead to primary infection early in life when disease is mild, followed by booster re-exposures throughout adulthood as transmission blocking immunity wanes but disease blocking immunity remains high. This would keep reinfections mild and immunity up to date.”
How to report a vaccine reaction
The number of vaccines recommended by health authorities for children has grown significantly in the past decades. The CDC’s childhood vaccine schedule recommends all children receive 69 doses of 16 vaccines with 50 doses of 14 vaccines given between the day of birth and age 18. The majority of children in the U.S. today receive three times as many vaccinations as children received in 1983.
If you or your child gets a COVID-19 vaccine and your health deteriorates within hours, days or weeks of being vaccinated, the medical professional who gave you the shot is required to file a report with the federal vaccine adverse event reporting system (VAERS).
Despite the VAERS having been established in 1990 and used for over 30 years, Dr. Anne Schuchat from the CDC said in an interview with ABC News that one of the reasons for pausing the Johnson & Johnson COVID-19 vaccine was to teach vaccine providers how to report adverse events to VAERS.
Since the experimental COVID-19 vaccines currently are being distributed under an Emergency Use Authorization (EUA) granted to vaccine manufacturers by the FDA there is a great need to report vaccine reactions, especially injuries and deaths. If your health care provider refuses to file an injury report with VAERS, the system allows you to do it yourself.
As of June 18, the system shows there have been 6,136 deaths, 21,806 people hospitalized and 51,575 people seen in urgent care after receiving a COVID-19 vaccination. Additionally, the system highlights these injuries:
Reported injury numbers:
- Life threatening reactions: 6,450
- Heart attack: 2,483
- Myocarditis or pericarditis: 1,644
- Low platelet count: 1,776
- Miscarriage: 720
- Severe allergic reactions: 17,408
- Disabled: 5,194
- Tinnitus (ringing in the ear): 4,447
You can report an adverse reaction to a COVID-19 vaccine, or to any other vaccine, to the VAERS system. There are two ways to make a report — online or through a writable PDF form that can be uploaded to the system.