Have you heard the big news in the anti-vaccine world?

Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.

It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.

Really?

Which ones?

Did the US Government Lose a Landmark Vaccine Lawsuit?

While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.

The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.

It should be clear that the HHS has done plenty to promote vaccine safety though.

Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.

And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.

Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?

And also consider that:

• the National Vaccine Advisory Committee (NVAC), established in 1987, has had regular meetings and published regular reports about vaccine safety
• a number of other vaccine safety oversight advisory committees and government groups were established, including the Advisory Commission on Childhood Vaccines, the Advisory Committee on Immunization Practices (ACIP), the Microbiology and Infectious Diseases Review Advisory Committee (MIDRAC) of NIAID, and the Vaccines and Related Biological Products Advisory Committee, with the Vaccine Interagency Group of the National Vaccine Program Office providing overall coordination. They all report to the Secretary of HHS.
• the Vaccine Adverse Events Reporting System (VAERS) and Vaccine Safety Datalink were established in 1990, but it is important to keep in mind that VAERS was created from a merger of the CDC Monitoring System for Adverse Events Following Immunization (MSAEFI) and the vaccine reports contained in the FDA Spontaneous Reporting System (SRS) programs. It’s not like we just start following adverse events following immunization in 1990.
• a Task Force on Safer Childhood Vaccines was established and completed a report, “identifying key issues and enhancing collaboration on behalf of vaccine safety” in 1996. Did someone forget to send it to Congress?
• the Salk inactivated polio vaccine (IPV) replaced the oral polio vaccine (OPV) in 1996 because of a small risk of vaccine-associated paralytic poliomyelitis (VAPP), beginning with a sequential IPV-OPV vaccine schedule and then going to an all IPV schedule in 2000
• the DTaP vaccine, which is supposed to have fewer side effects than DTP is licensed, and replaces DTP for all required doses by 1997, although DTP is never actually shown to have caused seizures or brain damage
• RotaShield, the first rotavirus vaccine is licensed in 1998 but is soon withdrawn from the market in 1999 after it is associated with an increased risk of intussusception, a form of bowel obstruction
• the Clinical Immunization Safety Assessment (CISA) Project was established in 2001
• a new National Vaccine Plan was established in 2010, with the goal to develop new and improved vaccines, enhance the vaccine safety system, support communications to enhance informed vaccine decision-making, ensure a stable supply of, access to, & better use of recommended vaccines in the U.S., and increase global prevention of death & disease through safe & effective vaccination. Was the plan sent to Congress?
• vaccine recalls have occasionally been issued
• a White Paper on the U.S. Vaccine Safety System was published in 2011
• a report on Safety of Vaccines Used for Routine Immunization
  in the United States was published in 2014
• a report on Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations was published in 2016

Most importantly, new vaccines have been approved that protect our kids against many more now vaccine-preventable diseases.

HHS Settles Lawsuit Over Vaccine Safety Reporting

But wait, did the HHS even lose the lawsuit?

They actually didn’t.

They did settle a lawsuit though, a lawsuit which was then dismissed.

So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.

Vaccines are still safe. And they are still necessary.

What to Know About the HHS Vaccine Lawsuit

Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.

More on the HHS Vaccine Lawsuit

• Anti-vaccine ICAN settles with HHS – what does this mean for vaccines?
• Del Bigtree vaccine safety complaints – HHS Vaccine Program responds
• Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century Report to Congress
• Evaluation of the 2010 National Vaccine Plan Mid-course Review: Recommendations From the National Vaccine Advisory Committee
• National Vaccine Program Office (NVPO)
• National Vaccine Advisory Committee (NVAC)
• NVAC Reports & Recommendations
• Task Force on Safer Childhood Vaccines – Final Report and Recommendation
• Strengthening the U.S. Vaccine and Immunization Enterprise: The Role of the National Vaccine Advisory Committee
• 1994 National Vaccine Plan
• The Standards for Pediatric Immunization Practice
• The Energy and Commerce SubCommittees
• Senate Committee on Health, Education, Labor and Pensions
• Chairman Alexander’s Prepared Remarks for Senate Health Committee’s Hearing – “Zika Virus: Addressing the Growing Public Health Threat”
• S. Hrg. 114-554: The Reemergence of Vaccine-preventable Diseases: Exploring the Public Health Successes and Challenges, Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, First Session, February 10, 2015
• Smallpox Vaccination Plan: Challenges and Next Steps
• Influenza Vaccine Shortages and Implications – CRS Report for Congress
• CDC – Vaccine Safety Publications