CDC’s Risk-Benefit Assessment for New COVID-19 Vaccines Flawed: Experts

CDC’s Risk-Benefit Assessment for New COVID-19 Vaccines Flawed: Experts
The Centers for Disease Control and Prevention headquarters in Atlanta on April 23, 2020. (Tami Chappell/AFP via Getty Images)
Zachary Stieber

A new U.S. government comparison of COVID-19 vaccine risks and benefits exaggerated benefits and downplayed risks, experts say.

The U.S. Centers for Disease Control and Prevention (CDC) recently provided a risk-benefit assessment for the updated bivalent vaccines. One assessment was for adolescents aged 12 to 17.

The CDC estimated that a million doses in the age group, over a period of six months, would prevent up to 136 hospitalizations and zero or one death. But it relied on effectiveness estimates from an outdated, non-peer-reviewed CDC study that analyzed only data for adults. Hospitalization rates included hospitalizations for which COVID-19 was an incidental reason, not a primary reason, for admission.

“When we look at both the potential benefits and harms for adolescents together, using the hospitalization ranges from the sensitivity analyses, we see that per million doses we would expect to prevent between 31 and 136 hospitalizations, nine to 40 ICU admissions, and one death,” Megan Wallace, a CDC official, said while presenting the assessment.

A second version, which took into account incidental hospitalizations, lowered the estimate of hospitalizations prevented to between 17 and 75.

Both versions noted that, in a single CDC-run surveillance system, there have been zero myocarditis cases among young people who received a bivalent booster. But fewer than 100,000 doses have been given to adolescents in the system, and as many as 62 cases per million doses could occur in young males, a footnote reads.

Myocarditis, or heart inflammation, is one of the side effects of the COVID-19 vaccines, and it’s most prevalent in young males.

Critics took issue with the presentation.

“It’s definitely flawed,” Allison Krug, an epidemiologist, told The Epoch Times.

Among the issues: using hospitalization rates from COVID-NET, which don’t include rates for children, and not including outpatient medical encounters, as some researchers have done, when searching for myocarditis cases.

“The risk-benefit analysis is a marketing strategy to maximize uptake of the vaccine,” Krug said. “It is not an honest effort to estimate risks and benefits because it ignores the most durable protection on the ’market'—immunity from prior infection—which is near universal now.”

She has performed risk-benefit analyses of the Pfizer and Moderna vaccines for adolescent boys and for booster mandates at colleges.
Dr. Tracy Hoeg, another epidemiologist, described the assessment as “top level incompetence” as the CDC, she said, tried “to justify giving bivalent boosters to children.” She pointed out that the CDC study used to estimate hospitalizations prevented didn’t include adjustments for factors such as the likelihood of being tested.
The CDC and Wallace didn’t respond to requests for comment.

No Clinical Data

U.S. authorities have had to rely on observational data for the bivalent boosters from Pfizer and Moderna, which were authorized and recommended in fall 2022, because there are still no clinical effectiveness data available six months later. Mice data were used to justify authorizing the vaccines.

Pfizer and Moderna haven’t responded to requests for comment about when the data from their trials will be available.

Pfizer and its partner, BioNTech, announced on March 1 that it had asked U.S. regulators to authorize a bivalent booster for children younger than 5 years old based on data from its trials, claiming that the data show that the bivalent elicited a higher level of neutralizing antibodies and that the safety profile “remained similar to that of the original vaccine.”

Multiple members of the Advisory Committee on Immunization Practices, to whom the CDC presented the risk-benefit assessment, noted the lack of trial data after they were asked whether authorities should transition to an annual booster moving forward.

“I would like to see a study saying, ‘OK, you’ve just got one bivalent vaccine. What is the benefit? And how long does that last?’ I think that would enhance the confidence in making a change rather than inferring the data,” Dr. Camille Kotton, one of the advisers, said.

Both Kotton and Dr. Matthew Daley said they wanted trials examining the vaccines, although Daley floated one comparing coadministration of influenza and COVID-19 vaccines with administering each of the vaccines separately.

“We would learn a lot about immunogenicity and safety,” Daley said. “That might be valuable for this conversation.”

Inflated Death Toll

Officials have repeatedly pointed to how some children have died from COVID-19 as justification for recommending that children get vaccinated, despite the dearth of effectiveness data for even the original shots in the population.
The CDC has used inflated children’s death data before and has refused requests to make a correction.
Dr. Sara Oliver, a CDC official, presented death data on a slide during the recent meeting. The claim was that 1,489 COVID-19 deaths had occurred in children aged 6 months to 17 years, but the total included children aged 0 to 5 months.

Oliver didn’t respond to a request for comment.

Kelley Krohnert, a Georgia mother who has repeatedly fact-checked false CDC claims, noted that the slide also included deaths of which COVID-19 was a contributing cause, not the underlying cause.

“Yet another example of why I argue CDC acts more as a sales/marketing agency than a health agency,” she wrote on Twitter.

New Myocarditis Study

The presentations happened after researchers in Canada reported a higher incidence of myocarditis or pericarditis, a related condition, after Pfizer or Moderna vaccination, particularly after the second dose of a primary series.

Analyzing health records from Quebec, Canada, the researchers found that there was a 15 times higher incidence than expected within seven days of a second dose among males aged 16 and 17 and a 7.6 times higher incidence among males aged 12 to 15.

Of 77 incidents, 63 occurred among males, and 51 occurred after dose two. All but three of the adolescents were assessed in the emergency department, and 34 were hospitalized.

Myocarditis can lead to long-term problems, including heart failure and death, other research has shown.