eriodically during the Covid-19 pandemic, CDC scientific staff have

employed their available studies’ data to estimate the efficacy of current or

recent versions of Covid-19 vaccines to reduce risk of testing positive for
Covid-19. While the fact of “testing positive” has been somewhat
controversial because of the secret PCR Ct threshold numbers involved
that have allowed for uninfectious people with unrecognized Covid-19
from some weeks in the past to remain test-positive, my goal here is to
illustrate CDC’s problematic epidemiologic methods that have
substantially inflated the vaccine efficacy percents that they have reported.

Controlled epidemiologic studies fall into three and only three basic study
designs. Either a total sample of subjects is sampled, and each subject is
evaluated both for case status and previous exposure status—this is a
cross-sectional study—or a sample of exposed people and a sample of
unexposed people are followed to see who becomes a case and who a
control—a cohort study—or a sample of cases and a sample of controls is
obtained, and each subject evaluated for past exposure status—this is a
case-control study. If a cohort study involves randomizing the subjects into
those exposed and unexposed, this is a randomized controlled trial (RCT),
but the study design is still cohort.

In a cross-sectional study and a cohort study, the risk of getting the

outcome of interest (i.e., of being a case subject, here, testing positive) can
be estimated for the exposed people by the number of cases among the
exposed divided by the total number exposed. Similarly for the unexposed.
What is of interest, the comparison of these two risks, the relative risk
(RR), is the risk in the exposed divided by the risk in the unexposed. The
RR estimates how much worse the risk is among the exposed compared to
the unexposed. For a vaccine or other exposure that lowers risk, the RR
will be less than 1.0.

Cross-sectional and cohort studies, by their sampling designs, allow the

RR to be estimated from their data. However, case-control studies do not
allow the outcome risks to be estimated, because changing the relative
numbers of sampled cases vs controls affects what would be the risk
estimates. Instead, case-control studies allow for the estimation of
the odds of the outcome, not the risk. For example, 2:1 odds of an event
happening. This value is unaffected by the sampling design. In case-
control studies, the relative odds (or odds ratio, OR) of the outcome is
estimated by the odds of the outcome among the exposed, divided by the
odds among the unexposed.

For a vaccine, its efficacy is estimated as 1.0 – RR. For case-control study
data which only estimate OR not RR, when does the OR approximate the
RR accurately enough to be substituted in this formula? This question has
a detailed epidemiologic history beyond the current scope, but in the
simplest sense, the OR approximates the RR when in the population, cases
are infrequent compared to controls.

Now to the CDC and its systematic epidemiologic errors. In a recent

analysis, Link-Gelles and colleagues sampled a total of 9,222 eligible
Covid-19-like symptomatic individuals seeking Covid-19 testing at CVS
and Walgreen Co. pharmacies during September 21, 2023 through January
14, 2024. They assessed the previous vaccination status of each individual,
as well as positivity of test result. By definition, this is a cross-sectional
study, because individual numbers of cases and controls, or individual
numbers of exposed (vaccinated) and unexposed (unvaccinated) were not
sampled. Only the total number of subjects was sampled.

However, the investigators estimated the OR not the RR from these data,
by using a statistical analysis method called logistic regression that allows
the OR to be adjusted for various possible confounding factors. There is
nothing wrong with using logistic regression and obtaining estimated ORs
in any study design; the problem is using the OR value instead of the RR
in the vaccine efficacy formula 1.0 – RR. Because the study design was
cross-sectional, the investigators could have examined relative case
occurrence in the population from their sampled numbers, but they did not
appear to do this. In fact, cases comprised 3,295 of the total 9,222
sampled, 36%, which is not nearly small enough to use the OR as a
substitute for the RR. This is true both among the exposed subjects (25%)
and the unexposed (37%).

Nevertheless, it is possible to get a rough idea of how much this bad

assumption affected the authors’ claimed overall 54% vaccine efficacy.
The relevant numbers of subjects, shown in the table below, are stated in
Tables 1 and 3 of the Link-Gelles paper. The RR calculation from these
raw data is simple. The risk in the vaccinated is 281/1,125 = 25%; in the
unvaccinated, it is 3,014/8,097 = 37%. The RR is the ratio of these two,
25%/37% = 0.67, thus the vaccine efficacy based on these raw data would
be 1.0 – 0.67 = 0.33 or 33%.

eriodically during the Covid-19 pandemic, CDC scientific staff have

employed their available studies’ data to estimate the efficacy of current or
recent versions of Covid-19 vaccines to reduce risk of testing positive for
Covid-19. While the fact of “testing positive” has been somewhat
controversial because of the secret PCR Ct threshold numbers involved
that have allowed for uninfectious people with unrecognized Covid-19
from some weeks in the past to remain test-positive, my goal here is to
illustrate CDC’s problematic epidemiologic methods that have
substantially inflated the vaccine efficacy percents that they have reported.

Controlled epidemiologic studies fall into three and only three basic study
designs. Either a total sample of subjects is sampled, and each subject is
evaluated both for case status and previous exposure status—this is a
cross-sectional study—or a sample of exposed people and a sample of
unexposed people are followed to see who becomes a case and who a
control—a cohort study—or a sample of cases and a sample of controls is
obtained, and each subject evaluated for past exposure status—this is a
case-control study. If a cohort study involves randomizing the subjects into
those exposed and unexposed, this is a randomized controlled trial (RCT),
but the study design is still cohort.

In a cross-sectional study and a cohort study, the risk of getting the

outcome of interest (i.e., of being a case subject, here, testing positive) can
be estimated for the exposed people by the number of cases among the
exposed divided by the total number exposed. Similarly for the unexposed.
What is of interest, the comparison of these two risks, the relative risk
(RR), is the risk in the exposed divided by the risk in the unexposed. The
RR estimates how much worse the risk is among the exposed compared to
the unexposed. For a vaccine or other exposure that lowers risk, the RR
will be less than 1.0.

Cross-sectional and cohort studies, by their sampling designs, allow the

RR to be estimated from their data. However, case-control studies do not
allow the outcome risks to be estimated, because changing the relative
numbers of sampled cases vs controls affects what would be the risk
estimates. Instead, case-control studies allow for the estimation of
the odds of the outcome, not the risk. For example, 2:1 odds of an event
happening. This value is unaffected by the sampling design. In case-
control studies, the relative odds (or odds ratio, OR) of the outcome is
estimated by the odds of the outcome among the exposed, divided by the
odds among the unexposed.

For a vaccine, its efficacy is estimated as 1.0 – RR. For case-control study
data which only estimate OR not RR, when does the OR approximate the
RR accurately enough to be substituted in this formula? This question has
a detailed epidemiologic history beyond the current scope, but in the
simplest sense, the OR approximates the RR when in the population, cases
are infrequent compared to controls.

Now to the CDC and its systematic epidemiologic errors. In a recent

analysis, Link-Gelles and colleagues sampled a total of 9,222 eligible
Covid-19-like symptomatic individuals seeking Covid-19 testing at CVS
and Walgreen Co. pharmacies during September 21, 2023 through January
14, 2024. They assessed the previous vaccination status of each individual,
as well as positivity of test result. By definition, this is a cross-sectional
study, because individual numbers of cases and controls, or individual
numbers of exposed (vaccinated) and unexposed (unvaccinated) were not
sampled. Only the total number of subjects was sampled.

However, the investigators estimated the OR not the RR from these data,
by using a statistical analysis method called logistic regression that allows
the OR to be adjusted for various possible confounding factors. There is
nothing wrong with using logistic regression and obtaining estimated ORs
in any study design; the problem is using the OR value instead of the RR
in the vaccine efficacy formula 1.0 – RR. Because the study design was
cross-sectional, the investigators could have examined relative case
occurrence in the population from their sampled numbers, but they did not
appear to do this. In fact, cases comprised 3,295 of the total 9,222
sampled, 36%, which is not nearly small enough to use the OR as a
substitute for the RR. This is true both among the exposed subjects (25%)
and the unexposed (37%).

Nevertheless, it is possible to get a rough idea of how much this bad

assumption affected the authors’ claimed overall 54% vaccine efficacy.
The relevant numbers of subjects, shown in the table below, are stated in
Tables 1 and 3 of the Link-Gelles paper. The RR calculation from these
raw data is simple. The risk in the vaccinated is 281/1,125 = 25%; in the
unvaccinated, it is 3,014/8,097 = 37%. The RR is the ratio of these two,
25%/37% = 0.67, thus the vaccine efficacy based on these raw data would
be 1.0 – 0.67 = 0.33 or 33%.