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ACCV Meeting on Proposed Removal of SIRVA and Syncope from Vaccine Injury Table

Advocacy groups and business industry leaders from across the country gathered on Monday during a governmental meeting to say they are all opposed to removing SIRVA and syncope from the National Vaccine Injury Compensation Program (NVICP).

On Monday, May 18th, the Advisory Committee on Childhood Vaccines (ACCV) met to discuss proposed changes to the Vaccine Injury Table. The Secretary of Health and Human Services proposed removing SIRVA and syncope from the Vaccine Injury Table because these injuries are “depleting the pool of funds available to those injured by vaccine antigens,” which is false.

After hearing from medical doctors, the pharmaceutical industry, vaccine administrators, and vaccine injury attorneys, the ACCV unanimously rejected removal of SIRVA and syncope from the program. The ACCV is a committee within HHS that advises the Secretary of Health and Human Services (HHS) on issues relating to the NVICP.  No one from HHS showed up to the meeting to support its suggestion that these injuries should be removed from the Vaccine Injury Table. 

Below find relevant excerpts from the many letters presented during the ACCV meeting showing strong support for keeping SIRVA and syncope within the Vaccine Program:

Vaccine Injured Petitioners Bar Association (VIPBar)

The NPRM creates more problems than it attempts to solve, and even a forthright and comprehensive deliberation of the NPRM with individuals regularly involved in the NVICP would highlight the NPRM will only irreversibly damage the NVICP.

National Association of Chain Drug Stores (NACDS)

NACDS urges ACCV to recommend that HRSA not proceed with the NPRM, as the HRSA proposal would likely result in dramatically negative public health consequences by significantly reducing Americans’ access to vaccinations. Especially in this time of nationwide pandemic and associated health care crises, we believe it would be unwise to adopt such a health policy change.Ironically, the HRSA proposal would limit access to vaccinations, which are the only potential preventative treatment that could halt the spread of the coronavirus.

American Pharmacists Association (APhA)

“By seeking to remove vasovagal syncope and SIRVA from the Vaccine Injury Table, HRSA’s NPRM threatens patient access to COVID-19 and other critical vaccinations. Rather than encouraging vaccination, this proposal could severely impact our nation’s ability to research, develop, and widely administer life-saving vaccines due to concerns about potential liability.”

Biotechnology Innovation Organization (BIO)

“The Biotechnology Innovation Organization (“BIO”) is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.”

“We also question whether SIRVA and syncope claims pose a risk of “reducing the funding available for children and others who are injured by vaccine antigens. The fund balance as of January 31, 2020 is greater than $4 billion. It has continued to grow even after SIRVA and syncope were added to the Table. It therefore does not appear that inclusion of SIRVA on the Table, to say nothing of syncope, is putting the fund at risk.”

Dr. Uma Srikumaran MD, MBA, MPH Associate Professor of Orthopaedic Surgery Johns Hopkins School of Medicine

1. The scientific evidence does support a causal relationship between injection of vaccine antigen and SIRVA. SIRVA should remain a table injury and the evidence is summarized above.
2. The policy reasons to remove SIRVA are weak and the policy reasons to keep SIRVA are much stronger, summarized above, and maximize the net benefits related to economic, public health, safety, and equity issues.

Anne Toale, Vaccine Injury Attorney with Maglio Christopher & Toale, P.A.

Our firm also strongly disagrees with the proposal to remove SIRVA and syncope from the NVICP. You can read our complete statement below: 

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