🇺🇸@COVID19Up: In an open letter to the directors of the CDC and the FDA written on December 28, U.S. Senator Ron Johnson (R-WI) asked Rochelle Walensky and Janet Woodcock to explain why a low percentage of COVID-19 vaccine lots (as reported here in October 2021) have been associated with most of the serious adverse events and deaths in the CDC’s Vaccine Adverse Event Reporting System (VAERS).
“Dear Drs. Woodcock and Walensky,
“Due to the unprecedented number of adverse events and deaths associated with the COVID-19 vaccines on the Vaccine Adverse Event Reporting System (VAERS), independent researchers have downloaded VAERS data and begun analyzing the apparent variation in the distribution of adverse events between vaccine lots. If the production of vaccines were under control, with quality systems working properly, one would expect to see relatively even distribution of adverse events and deaths across all lots.”
Johnson continues, “According to these researchers, the variation of adverse events among COVID-19 vaccine lots stands in stark contrast to a much lower degree of variation of adverse events associated with seasonal flu vaccine lots reported over a 30-year period. Furthermore, the total number of adverse events reported in COVID-19 vaccine lots appear to be much higher than the total number of adverse events reported in the context of seasonal flu vaccine lots.
“The significant differences between adverse event reports in the contexts of COVID-19 and seasonal flu vaccines, both in terms of absolute numbers and vaccine lot variation, should be raising major alarms with the vaccine manufacturers and federal health agencies.”
“Fortunately, VAERS data is publicly available, and these alarming safety signals have not remained totally hidden,” he added.
The letter goes on to demand answers to many serious questions, including:
- Is the FDA and the CDC aware of VAERS data showing certain COVID-19 vaccine lots with high numbers of adverse events?
- If so, please identify those lots.
- If so, what investigations or corrective action have the FDA and CDC
- If no action has been taken, please explain why.
- If not aware, please describe what action(s) you are taking to ensure you identify such events in the future.
- In the past, has there ever been such a wide variability in the safety
- Please provide a definitive listing of all COVID-19 vaccine lots by manufacturer.
- Identify the COVID-19 vaccine lots that:
- Have been discarded;
- Are no longer administered; and
- Are under investigation.
- Describe what, if any, actions FDA and CDC took to investigate reports of severe allergic reactions or other adverse events linked to the Moderna vaccine lot that the California Department of Public Health reportedly examined in January 2021 (vaccine lot #041L20A).
- How many doses are in each COVID-19 vaccine lot?
- If vaccine lots contain different numbers of doses, what is the range of doses across all vaccine lots?
- How many FDA audits have been conducted at each COVID-19 vaccine manufacturing site since the vaccines received Emergency Use Authorization?
- Please provide the results and findings of those audits.
- Were all COVID-19 vaccine manufacturing sites found to be in full FDA and Current Good Manufacturing Practice compliance?
- If not, have there been any instances where any amounts of drug substance or drug product have not been locatable at the time of the inspection? If so, how often has this occurred?
- What specific quality control checks are performed on each vaccine lot?
- What is the statistical sampling criteria for each quality check?
- What quality control information is provided to your agency by the COVID-19 vaccine manufacturers?
- On a routine basis?
- As part of your ongoing quality surveillance requirements?
- What do the numbers and alpha characters represent in the lot numbering system?
- Can the manufacturing location be identified by the lot number? How?
- Can the manufacturing date be identified by the lot number? How?
- What other manufacturing information is captured in the lot number?
The Senator demanded answers no later than January 12, 2022.