The National Academies of Sciences, Engineering and Medicine (NASEM) announced late yesterday that a public comment session will be held next week relating to the committee charge of reviewing relevant literature regarding adverse events associated with COVID-19 vaccines and shoulder injury related to vaccine administration (SIRVA). The meeting will be live-streamed, and there is an opportunity for public comment.
The review of epidemiological, clinical, and biological evidence has been requested by the U.S. Department of Health and Human Services (DHHS) and appears to be in preparation for the addition of vaccine injuries to the federal vaccine injury table. According to the NASEM presentation given to the Advisory Commission for Childhood Vaccines (ACCV) in December 2022, the report and its findings are expected in March 2024.1
Injuries Under Review
DHHS has asked the NASEM committee to review the medical literature for the following vaccine adverse events to determine if the evidence indicates that COVID-19 vaccines are causally associated:
- Guillain-Barrè Syndrome (GBS)
- chronic inflammatory demyelinating
- polyneuropathy (CIDP)
- transverse myelitis (TM)
- Bell’s palsy
- hearing loss
- chronic headaches
- sudden death
- thrombosis with thrombocytopenia syndrome (TTS)
- immune thrombocytopenic purpura (ITP)
- thromboembolic events (e.g., cerebrovascular accident (CVA), myocardial infarction (MI), pulmonary embolism, deep vein thrombosis (DVT)
- capillary leak syndrome
The review of literature for SIRVA will be the second review by the NASEM, with the first review published in their last report in 2012.2
Completing the Liability-Free Pathway for COVID-19 Vaccines to the VICP
As noted in a previous NVIC article about our 2021 correspondence with the U.S. Department of Health Resources & Services Administration (HRSA) on COVID-19 vaccine inclusion in the federal vaccine injury compensation program (VICP),3 DHHS is getting closer to completing a liability-free pathway to include COVID-19 vaccines into the VICP. Once the NASEM report is completed, the ACCV is likely to consider the report findings and potentially make recommendations to add any associated injuries to the vaccine injury table. The only step remaining after COVID-19 vaccines are added to the vaccine injury table will be for Congress to enact the excise tax that is used to fund compensation awards from the VICP.4
View the Meeting and Register to Make a Comment
The NASEM virtual public comment session on the committee’s charge will be held on Thursday, March 30, 2023, from 12-1:15 p.m. ET. The deadline for registration is Monday, March 27, 2023, with email verifications of obtaining a public comment slot going out Tuesday, March 28, 2023. Space is limited; however, public comment is also welcomed via email at [email protected].
The livestream event will be aired publicly on the NASEM event page and published after the event for additional viewing by the public.
To register for public comment, click here.
1 Stratton K. Review of Relevant Literature Regarding Adverse Events Associated with Vaccines. U.S. Health Resources and Services Administration Dec. 2, 2022.
2 Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012.
3 Wrangham T. Injury Compensation Implications of Adding COVID-19 Vaccines to CDC Vaccination Schedule. National Vaccine Information Center Dec 14, 2022.
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