The memo, dated Jan. 15, 2021, stated that incoming reports "significantly exceeded the estimated maximum of 1,000 reports per day." One month later, on Feb. 19, 2021, the CDC's Morbidity and Mortality Weekly Report (MMWR) published an early safety review of the first COVID-19 vaccines authorized for emergency use in the United States.
The report concluded that monitoring "indicates reassuring safety profiles for COVID-19 vaccines." The review examined 6,994 VAERS reports received from Dec. 14, 2020, through Jan. 13, 2021, and stated that 90.8% of reviewed reports were not serious.
Critics have since alleged that the February 2021 MMWR report understated both the volume of reports then being received by VAERS and the proportion of serious injuries. They point to the contractor memo and to later VAERS figures as evidence that safety signals were not promptly disclosed.
VAERS Intake and Contractor Processing Backlog
VAERS is a passive surveillance system that relies on reports from health care providers and the public, according to federal officials. It was created in 1990 under the National Childhood Vaccine Injury Act of 1986 and is jointly operated by the CDC and the Food and Drug Administration (FDA). Reports are not required to meet a threshold of medical certainty, and anyone can submit one.
The Jan. 15, 2021 memo from GDIT to the CDC stated that the contractor was "unable to meet processing and other timeframes" and had sought guidance from the program office and the FDA's Office of Acquisitions and Grants Services (OAS), according to the document. The memo described a backlog that had built up as COVID-19 vaccination campaigns began across the country in mid-December 2020.
Processing delays can affect the analyzed VAERS dataset because reports must be coded, reviewed for seriousness, and made available for follow-up, according to the memo. Serious reports are defined by federal regulations as those involving death, life-threatening illness, hospitalization, disability, or congenital anomaly. Until a report is processed and classified, it may not appear in the cleaned dataset that researchers and the public use for analysis.
Details of the February 19 MMWR Report
The Feb. 19, 2021, MMWR report was authored primarily by Julianne M. Gee, an epidemiologist in the CDC's Immunization Safety Office, with Tom Shimabukuro as senior author, according to the publication. The report stated that 90.8% of reviewed reports were not serious, which by its own data left 9.2% classified as serious.
It mentioned 113 deaths and said available information "did not suggest a causal relationship between COVID-19 vaccination and death." The report also noted that the median age of those who died was 78 years and that most had underlying conditions.
Critics say the report examined only about 6% of the 107,000 reports that had been submitted by that date, an allegation attributed to review of the figures. They note that the MMWR's stated count of 6,994 reports conflicted with contractor communications indicating that tens of thousands of reports had already been received. The CDC has not publicly addressed that discrepancy in detail, according to critics.
Discrepancies and Later VAERS Figures
Critics allege that the MMWR's stated count of 6,994 reports conflicted with contractor communications indicating that tens of thousands of reports had already been received, according to the memo and subsequent analyses. By mid-February 2021, approximately 966 death reports had been recorded in VAERS, according to data cited by critics of the CDC's reporting. VAERS eventually contained about 2.74 million reports, including roughly 39,000 death reports, according to figures cited in later reviews.
Federal officials have said VAERS reports are unverified and do not by themselves establish that a vaccine caused an injury or death. The agency has also said that the system is intended to detect early warning signals that require further investigation.
The CDC did not correct the February 2021 report, according to critics, and the authors remained employed at the agency. The agency has not issued a public retraction or correction notice for the MMWR article. The report remains part of the published scientific record and continues to be cited in discussions of COVID-19 vaccine safety monitoring.
Accountability Questions Remain
The COVID-19 vaccines remain on the market and are required by some schools and institutions, officials said. The CDC's immunization schedule includes COVID-19 vaccination for children and adults, and some state and local health departments and private institutions have used that schedule as a basis for requirements [1]. The vaccines are available under emergency use authorization and, for some age groups, under full approval from the FDA.
Critics continue to call for accountability, citing the contractor memo and the early MMWR report as evidence that safety signals were not promptly disclosed. They have raised questions about the handling of VAERS data, the completeness of the February 2021 review, and the absence of a correction. The CDC has not announced an inquiry into the matter, and no official body has publicly concluded that the report was inaccurate.
References
- Tragic CDC Adds Original COVID mRNA Vaccine ... ChildrensHealthDefense.org.
- How the CDC Lied about Shot Injury. https://brownstone.org/articles/how-the-cdc-lied-about-shot-injury/
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