FDA response to BMJ on reports of death after covid-19 vaccination
Dear Editor
As the rollout of covid-19 vaccines continues, trustworthy and reliable pharmacovigilance systems are vital. In the 2009-2010 “swine flu” epidemic, initial concerns over febrile convulsions in young children[1] and narcolepsy in adolescents[2] following pandemic influenza vaccine receipt emerged from pharmacovigilance systems. And in the current covid-19 pandemic, reports of anaphylaxis,[3] blood clots,[4] and deaths[5] have all triggered regulatory investigations.
In the United States, the CDC and FDA jointly administer the Vaccine Adverse Event Reporting System (VAERS),[6] similar to the UK Yellow Card system. Unlike Yellow Card releases reports, the VAERS database is directly query-able, and allows access to the user-submitted adverse event narratives.[7]
The CDC webpage on "Selected Adverse Events Reported after COVID-19 Vaccination” currently discusses two types of adverse events: anaphylaxis and reports of death. Regarding deaths, the website states "CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.”[8]
I requested further details from FDA and CDC to better understand the process by which pharmacovigilance staff review VAERS reports, specifically of deaths post covid-19 vaccines. In the interest of readers, I share my questions - and FDA’s responses, sent March 23 - in full below.
Question 1. How many full-time equivalents (and what kind of e.g. physicians and pharmacists or physicians only?) CDC/FDA staff are assigned to reviewing case reports of deaths following covid-19 vaccines, that are submitted to VAERS?
FDA RESPONSE: Because both agencies draw upon available physicians depending on the number of reports received, we cannot provide a firm number as the number varies greatly based on workload. Both agencies assign an appropriate number of staff to ensure these reports are reviewed thoroughly.
Question 2. In what proportion of cases have CDC/FDA staff contacted families of the deceased for further details about VAERS reports?
FDA RESPONSE: A letter expressing condolences for the death of a family member and an explanation of what VAERS does is sent to all who report on the death of a family member. According to the reporter’s selected Communication Preference an electronic note may be sent. If no preference is specified by the time the letter is generated, a paper letter is sent. Condolence letters are only sent if the reporter is identified by visual review to be a relative.
Because the VAERS system is not designed to determine causality of adverse events, there is not a mechanism to follow-up with families for additional details. The determination of the cause of death is done by the certifying official who completes the death certificate or the pathologist who conducts the autopsy. While some reported adverse events may be caused by vaccination, others are not and may have occurred coincidentally..
Question 3. Are there standards for the proportion of families contacted? If so, what are they, and also how soon after the report is received or the event in question should a family be contacted?
FDA RESPONSE: [[see above]]
The letter/email is sent within a few weeks after receipt of the VAERS report.
Rapid Response:
FDA response to BMJ on reports of death after covid-19 vaccination
Dear Editor
As the rollout of covid-19 vaccines continues, trustworthy and reliable pharmacovigilance systems are vital. In the 2009-2010 “swine flu” epidemic, initial concerns over febrile convulsions in young children[1] and narcolepsy in adolescents[2] following pandemic influenza vaccine receipt emerged from pharmacovigilance systems. And in the current covid-19 pandemic, reports of anaphylaxis,[3] blood clots,[4] and deaths[5] have all triggered regulatory investigations.
In the United States, the CDC and FDA jointly administer the Vaccine Adverse Event Reporting System (VAERS),[6] similar to the UK Yellow Card system. Unlike Yellow Card releases reports, the VAERS database is directly query-able, and allows access to the user-submitted adverse event narratives.[7]
The CDC webpage on "Selected Adverse Events Reported after COVID-19 Vaccination” currently discusses two types of adverse events: anaphylaxis and reports of death. Regarding deaths, the website states "CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.”[8]
I requested further details from FDA and CDC to better understand the process by which pharmacovigilance staff review VAERS reports, specifically of deaths post covid-19 vaccines. In the interest of readers, I share my questions - and FDA’s responses, sent March 23 - in full below.
Question 1. How many full-time equivalents (and what kind of e.g. physicians and pharmacists or physicians only?) CDC/FDA staff are assigned to reviewing case reports of deaths following covid-19 vaccines, that are submitted to VAERS?
FDA RESPONSE: Because both agencies draw upon available physicians depending on the number of reports received, we cannot provide a firm number as the number varies greatly based on workload. Both agencies assign an appropriate number of staff to ensure these reports are reviewed thoroughly.
Question 2. In what proportion of cases have CDC/FDA staff contacted families of the deceased for further details about VAERS reports?
FDA RESPONSE: A letter expressing condolences for the death of a family member and an explanation of what VAERS does is sent to all who report on the death of a family member. According to the reporter’s selected Communication Preference an electronic note may be sent. If no preference is specified by the time the letter is generated, a paper letter is sent. Condolence letters are only sent if the reporter is identified by visual review to be a relative.
Because the VAERS system is not designed to determine causality of adverse events, there is not a mechanism to follow-up with families for additional details. The determination of the cause of death is done by the certifying official who completes the death certificate or the pathologist who conducts the autopsy. While some reported adverse events may be caused by vaccination, others are not and may have occurred coincidentally..
Question 3. Are there standards for the proportion of families contacted? If so, what are they, and also how soon after the report is received or the event in question should a family be contacted?
FDA RESPONSE: [[see above]]
The letter/email is sent within a few weeks after receipt of the VAERS report.
Peter Doshi
References
[1] https://www.bmj.com/content/340/bmj.c2991
[2] https://www.bmj.com/content/362/bmj.k3948.full
[3] https://www.bmj.com/content/371/bmj.m4780
[4] https://www.bmj.com/content/373/bmj.n931
[5] https://www.bmj.com/content/372/bmj.n149
[6] https://vaers.hhs.gov/
[7] https://wonder.cdc.gov/vaers.html
[8] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events...
Competing interests: None specifically related to this letter. For a general list, see https://www.bmj.com/about-bmj/editorial-staff/peter-doshi