‘Informed Consent Is Back’: New COVID Vaccine Recommendations Give Families More Say
The CDC updated its childhood immunization schedule yesterday to emphasize individual-based decision-making for COVID-19 vaccination.
The Centers for Disease Control and Prevention (CDC) announced its updated childhood immunization schedule today, calling for individual-based decision-making regarding COVID-19 vaccination for children 6 months and older.
The CDC also recommends that children ages 3 and younger receive the varicella (chickenpox) vaccine as a standalone shot rather than as part of the combined measles, mumps, rubella and varicella (MMRV) vaccine.
“Informed consent is back,” U.S. Department of Health and Human Services (HHS) Deputy Secretary Jim O’Neill said in an HHS statement about the new childhood vaccination schedule.
The changes will take effect on Oct. 7.
O’Neill said the CDC’s previous “blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. “That changes today.”
The CDC’s new recommendations align with those recently adopted by the agency’s Advisory Committee on Immunization Practices (ACIP).
During its meeting last month, ACIP members unanimously voted to recommend “individual-based decision-making” for COVID-19 vaccination for people ages 6 months to 64 years, emphasizing that the risk-benefit of vaccination is most favorable for those at increased risk for severe disease.
According to HHS, individual-based decision-making refers to “vaccination based on shared clinical decision-making,” in consultation with providers, including physicians, nurses and pharmacists.
“The clinical decision to vaccinate should be based on patient characteristics that unlike age are difficult to incorporate in recommendations, including risk factors for the underlying disease as well as the characteristics of the vaccine itself and the best available evidence of who may benefit from vaccination,” HHS stated.
ACIP also voted last month to recommend that the childhood vaccine schedule be updated to say that the MMRV vaccine is not recommended for children under age 4. The vote followed a presentation containing evidence of an increased risk of febrile seizures following the MMRV vaccine.
Febrile seizures are convulsions most often caused by fevers brought on by infections related to common childhood illnesses.
The CDC’s updated schedule recommends that children 3 and younger still get the MMR (measles, mumps, rubella) and varicella (chickenpox) vaccines, but separately — not in one combined shot.
“I commend the doctors and public health experts of ACIP for educating Americans about important vaccine safety signals,” O’Neill stated. “I also thank President Trump for his leadership in making sure we protect children from unintended side effects during routine immunization.”
Individual decision-making ‘best course for all medical interventions’
HHS said the uptake of COVID-19 shots has declined, as COVID-19 boosters “prompted widespread risk-benefit concerns about their safety and efficacy as the COVID-19 virus became endemic” after much of the population developed immunity to the virus.
HHS noted that the U.S. Food and Drug Administration has limited its approval of COVID-19 vaccines to people at higher risk for severe illness. This policy, in effect since August, ended the population-wide authorization of COVID-19 vaccines.
However, U.S. Health Secretary Robert F. Kennedy Jr. has said the shots will be available to anyone who wants them, after consulting with their doctors.
COVID-19 vaccines will continue to be covered under the CDC’s Vaccines for Children Program and the Children’s Health Insurance Program, HHS stated.
Medical and scientific experts who spoke with The Defender welcomed the changes to the CDC’s childhood immunization schedule.
“Individual-based decision-making is the best course for all medical interventions,” said Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD). “Mandates and edicts for children’s vaccines are inappropriate given that every child is different and each child may react differently to each vaccination.”
Dr. Michelle Perro, a pediatrician, said the new recommendation “makes COVID-19 vaccination a conversation rather than a default.”
Perro said the changes will allow families to “weigh risk and benefit with their own clinician, assuming that clinician is willing to give an unbiased view.”
Karl Jablonowski, Ph.D., senior research scientist at CHD, said the individual-based recommendations counter the financial interests of Big Pharma.
“Population-wide medical decision-making optimizes profits. Individual-based medical decision-making optimizes health. With the mounting mountains of evidence of harm, COVID-19 vaccinations are not, and have never been, defensible for most healthy people,” Jablonowski said.
‘A victory for common sense and precautionary medicine’
HHS said the CDC’s new recommendation for the standalone chickenpox vaccination for children ages 3 and younger is a direct outcome of the evidence presented at last month’s ACIP meeting. HHS stated:
“Healthy 12-23 months old toddlers have increased risk of febrile seizure seven to 10 days after vaccination for the combined measles, mumps, rubella, and varicella vaccine compared to those given immunization for chickenpox separately.
“The combination vaccine doubles the risk of febrile seizures without conferring additional protection from varicella compared to standalone vaccination.”
Biologist Christina Parks said it is “refreshing to see decisions being made by the ACIP committee based on the data.” The evidence presented during the meeting “is critical information for parents to have when making a decision on vaccinating their child,” she said.
Parks added:
“Clear data was presented … demonstrating that vaccination with MMR increases risk of seizures 3.7 times while vaccination for chickenpox does not increase risk of seizures.
“If a child gets an MMR vaccine and a vaccine for chickenpox (varicella) at the same well-child visit, their risk of seizure increases a tiny bit. However, children vaccinated with the combined MMRV vaccine were 7.6 times more likely to have a seizure 7-10 days following vaccination than if they had just received the vaccine for chickenpox alone.”
Jablonowski called the new recommendation “a victory for common sense and precautionary medicine.”
He referenced the package insert for Merck’s ProQuad MMRV vaccine — the only such vaccine approved for use in the U.S. — which acknowledges that the shot poses a greater risk to children than the separate MMR and varicella vaccines.
Jablonowski said:
“Merck’s ProQuad MMRV vaccine has a statistically significant 120% greater risk of febrile seizures between days 5 and 12 post-injection than Merck’s MMR II and Merck’s VARIVAX [varicella vaccine] taken on the same day.
“Merck’s ProQuad contains a 60% larger dose of the mumps component than its MMR II vaccine and a 624% larger dose of varicella than its VARIVAX vaccine.”
New recommendations ‘a step in the right direction’ — but questions remain
Perro said new recommendations regarding the varicella vaccine align the CDC’s childhood immunization schedule “with long-standing safety guidance that already favored separate shots unless parents specifically preferred MMRV.”
However, Perro said the new recommendation “still misses the mark regarding providing a real in-depth analysis of the overall safety of the MMR” and may convey the message to parents that “the vaccines are safe and we just needed to separate out the varicella portion.”
“That is not the reality,” Perro said.
She said individual-based decision-making for COVID-19 vaccination “is a step in the right direction,” but may also lead to similar challenges. “Will parents be aware of the data showing significant morbidity and mortality from the COVID-19 shots? And if not, will pediatricians provide that data?” Perro asked.
Perro said some physicians may advise parents based on a new “evidence-based immunization schedule” the American Academy of Pediatrics (AAP) issued in August. The AAP is recommending COVID-19 vaccination for all children between 6 and 23 months of age, “to help protect against serious illness.”
The AAP also recommends a single dose of the COVID-19 vaccine for all children and adolescents 2-18 years old who are in a high-risk group and recommends the vaccine “be available” for children ages 2-18 who are not at high risk but whose parent or guardian wants “the protection of the vaccine.”
Perro said:
“Shared decision-making should mean real discussions regarding clear risks, benefits, and alternatives without pressure. Parents deserve transparent, individualized guidance. However, will pediatricians deliver what is being presented by the CDC or choose to go with the AAP policy that adheres to the previous schedule and disregards the recommended changes?”
Parks suggested the CDC’s changes to the COVID-19 vaccine recommendations will increase the likelihood that vaccine injuries will be noticed and diagnosed correctly.
“Adverse events are more likely to get observed, tracked and treated, and better information on the cost and benefits of COVID-19 vaccination will be able to be gathered,” she said.
This “will increase parent confidence that their concerns are being heard and that they will feel empowered with information that will help them raise healthy children,” Parks added.
Related articles in The Defender
Key Takeaways From Last Week’s Meeting of New CDC Vaccine Advisers
ACIP Votes to Recommend Kids Don’t Get MMRV Vaccine Until Age 4, Delays Vote on Hep B for Newborns
FDA Restricts Some COVID Vaccines to High-Risk Groups, But HHS Says Everyone Will Have Access
Leading Pediatrician Group Defies CDC, Tells Parents to Get COVID Shots for Infants, Kids
Only for the weapon of the cvd 19 vx? What about informed consent for all the others? End the grift!
I'd be willing to bet that the reality is NOT that the Covid injections are safe for the immunocompromised but rather that multiple variables prevent the severe adverse events from reaching statistical significance in these groups.