January 28, 2021 VIA EMAIL AND FEDEX Dr. Rochelle P. Walensky Director, Centers for Disease Control and Prevention 1600 Clifton Road Atlanta, GA 30329 [email protected] Dear Dr. Walensky: We write on behalf of Informed Consent Action Network to bring to your attention a letter previously sent to Secretary Azar on December 29, 2020 (enclosed) and Dr. Redfield’s response dated January 19, 2021 (enclosed). ICAN has requested that federal health authorities require health providers to report all COVID-19 vaccine adverse reactions, apart from mild ones, to the CDC’s Vaccine Adverse Events Reporting System (“VAERS”). While Dr. Redfield’s letter is appreciated, it did not respond to whether this request will be implemented. Can you please advise whether this requirement will be put in place? Without this rule, as detailed in our opening letter, only certain narrow categories of adverse reactions are required to be reported. For example, “serious” adverse reactions is a very limited category of events. This limitation would exclude many chronic diseases and reactions that the public would find concerning. The CDC’s V-Safe program provides a further hurdle since it directs adverse reaction reports to be submitted through this application and not to VAERS. These reports are therefore less likely to end up on VAERS further reducing the utility of the already handicapped VAERS system, as detailed in our letter of December 29, 2020. Further, Dr. Redfield did not address ICAN’s concern with regard to long-term safety tracking of all adverse events following COVID-19 vaccines. As you are aware, these are novel vaccine platforms. Pfizer’s and Moderna’s clinical trial protocols are deficient in tracking serious adverse events for an adequate period of time. The need for longer-term multi-year safety surveillance cannot be overstated. Compounding this concern is the fact that both manufacturers have already begun the unblinding process and are vaccinating their placebo groups. Placebo comparator groups will no longer exist beyond 6 months post-second dose. At ICAN’s request, we include with this follow-up letter a copy of a letter exchange ICAN had with HHS regarding vaccine safety. We note that the response from HHS was approved by the CDC. It includes an exchange with regard to VAERS and vaccine safety, in general, that ICAN sincerely hopes you, as the new CDC Director, will take the opportunity to review. As with most things, there is room for improvement and ICAN merely asks that you review these letters and consider whether there is any room for improvement in the area of vaccine safety. The children injured by vaccines are as worthy of your attention as those that could suffer from an infectious disease. Kind Regards, Aaron Siri, Esq. Elizabeth A. Brehm, Esq. Enc: December 29, 2020 ICAN letter to Secretary Azar; January 19, 2021 Dr. Redfield response letter; ICAN and HHS letter exchange December 29, 2020 VIA EMAIL AND FEDEX Mr. Alex Azar Secretary, HHS U.S. Department of Health & Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 [email protected] Re: Mandated Reportable Events for COVID-19 Vaccines Authorized or Licensed in the United States Pursuant to 42 U.S.C. § 300aa-25 Dear Secretary Azar: We write on behalf of our client, Informed Consent Action Network (“ICAN”), to make an important request regarding safety surveillance of any COVID-19 vaccine which is, or will be, authorized or licensed for use in the United States. Pursuant to 42 U.S.C. § 300aa-25, as Secretary of Health and Human Services, you have the authority to require health care providers and vaccine manufacturers to report adverse reactions, events, and contraindications following the receipt of a vaccine to the Vaccine Adverse Events Reporting System (“VAERS”) – a system co-administered by the Centers for Disease Control & Prevention (“CDC”) and the Food and Drug Administration (“FDA”).1 ICAN therefore requests that you immediately make it mandatory that all adverse events following a COVID-19 vaccination, with the exception of mild events, be reported by vaccine manufacturers and all health care providers to VAERS. Currently, only a very limited number of adverse events must be reported pursuant to 42 U.S.C. § 300aa-25, namely shoulder injuries or fainting within seven days of receiving the vaccine or any serious issue resulting from such shoulder injury or fainting.2 The Pfizer emergency use authorization does require that health care providers report a limited list of serious adverse events, however this list is not exhaustive and would not capture all adverse events including, for example, 1 See 42 U.S.C. § 300aa-25(b). 2 See 42 U.S.C. § 300aa-25(b) and https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_ Vaccination.pdf. Bell’s Palsy, nor is there any indication the requirement to report such events will apply once licensure is granted for this vaccine.3 Both the CDC and the FDA have acknowledged the need for comprehensive safety surveillance as the nation implements the widespread administration of COVID-19 vaccinations. Tom Shimabukuro (Captain, U.S. Public Health Service Vaccine Safety, Team Lead of COVID- 19 Response for the Centers for Disease Control and Prevention) recently presented at the Clinician Outreach and Communication Activity Webinar, held on December 14, 2020, about the importance of safety surveillance: “Clinical trials used to authorize or license vaccines for use - may not detect all types of adverse events, especially ones that are rare or take longer to occur (delayed onset) and - don’t always look at special populations (e.g., pregnant women and people with certain pre-existing medical conditions).”4 The FDA has also acknowledged that “[f]ollowing authorization of the vaccine, use in large numbers of individuals may reveal additional, potentially less frequent and/or more serious adverse events not detected in the trial safety population of approximately 30,000 participants over the period of follow-up at this time.”5 The FDA has stated, then, that “[a]ctive and passive safety surveillance will continue during the post-authorization period to detect new safety signals.”6 Safety surveillance must therefore be undertaken as thoroughly as possible. The need for long-term safety tracking of all adverse events (other than mild local or systemic reactions) is also critical. The Moderna vaccine trial protocol calls for monitoring of certain adverse events through the duration of the study (759 days) and the Pfizer vaccine trial protocol calls for monitoring for only 6 months post-second dose. Neither of these is an appropriate time-period to capture potential serious long-term adverse events including cancer or any neurological, cardiovascular, or autoimmune diseases. Additionally, the unblinding and/or cross-over (either blinded or open label) which both Pfizer and Moderna are currently planning obviate the comparator placebo group, creating yet another concern. Compounding this problem is the well and long-known fact that VAERS suffers from significant inadequacies. This passive system collects a drastically low percentage of actual adverse events that occur, with one study funded by the Federal government finding that only 1% of vaccine adverse events are reported to VAERS.7 Many health care professionals do not report to VAERS because they are not mandated to do so, they do not know what adverse events to look for or to connect to a vaccination, or because there is no routine follow-up with doctor or patient after an adverse event is reported. Until these very serious issues are corrected, reporting of any and all adverse events (with the exception of mild local and systemic reactions) must be required in an attempt to identify any signals or causal relationships missed in the limited clinical trials for COVID-19 vaccines. 3 https://www.fda.gov/media/144413/download. 4 https://emergency.cdc.gov/coca/calls/2020/callinfo_121420.asp. 5 https://www.fda.gov/media/144434/download at 50. 6 Id. 7 https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf. Page 2 of 3 In the absence of any liability on the part of the manufacturers and vaccine administrators, the American public must be confident that safety surveillance is the highest priority with these vaccines. For this and the other reasons above, detailed and thorough mandates regarding adverse event reporting must be put into place. Requiring that health care providers and vaccine manufacturers report all adverse events, other than mild reactions, following receipt of a COVID-19 vaccine is critical to assuring that any safety issues with these products are captured and addressed. This minimal level of safety surveillance of these innovative and novel vaccines is critical to increase confidence with the American public that decisions pertaining to any coronavirus vaccine are made with a sound, independent scientific basis, with people’s safety at the forefront. We ask that you respond to ICAN’s request and address the serious issue identified above forthwith in order to avoid erosion of confidence in the HHS, Operation Warp Speed, and vaccine programs generally. Very truly yours, Aaron Siri, Esq. Elizabeth Brehm, Esq. Page 3 of 3 January 19, 2021 Ms. Elizabeth Brehm, Esq. Siri & Glimstad 200 Park Avenue 17th Floor New York, New York 10166 Dear Ms. Brehm: Thank you for your letter to Secretary of Health and Human Services Alex M. Azar II requesting that all adverse events following a Coronavirus Disease 2019 (COVID-19) vaccine, with the exception of mild events, be reported by vaccine manufacturers and all health care providers to the Vaccine Adverse Events Reporting System (VAERS). I am responding on behalf of Secretary Azar. use, is an important part of a successful national vaccination effort.