Vaccine Resources: HPV Vaccine Safety Reviews, Updated VISs, Influenza Vaccine Strains, and Anti-vaccine Lawsuit Claims Explained

HPV vaccine safety reviews

The Centers for Disease Control and Prevention (CDC) recently published two large HPV vaccine safety reviews:

• Shimabukuro TT, Su JR, Marquez PL, et al. Safety of the 9-valent human papillomavirus vaccine. Pediatrics. 2019 Dec;144(6). pii: e20191791. — Vaccine Adverse Events Reporting System (VAERS) reports related to receipt of HPV-9 were reviewed. The authors identified 7,244 reports submitted during the period between December 2014 and December 2017. The review concluded, “No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected.”
• Donahue JG, Kieke BA, Lewis EM, et al. Near real-time surveillance to assess the safety of the 9-valent human papillomavirus vaccine. Pediatrics. 2019 Dec;144(6). pii: e20191808. — This study included participating Vaccine Safety Datalink (VSD) sites. Records from 9- to 26-year-old individuals vaccinated with HPV-9 between October 2015 and October 2017 were identified and evaluated weekly for reports of adverse events following receipt of the vaccine. During the study period, 838,991 doses of HPV-9 were administered. The authors concluded, “After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.”

In reviewing these two studies, it is useful to review the differences between VAERS and VSD programs:

• VAERS reports can be submitted by anyone, so while this program serves as a useful way to detect possible safety events, it is not designed to address causality.
• VSD reports are medical records from several large clinical sites, so studies can be designed to rather quickly compare experimental and control groups, such as those who did or did not receive a particular vaccine, in order to answer questions related to causation.
• For more information about VAERS and VSD, see the “Phase IV Studies” section of the VEC webpage, “Making Vaccines: Process of Vaccine Development.”

Updated VISs

The CDC recently updated some Vaccine Information Statements (VISs), including:

• Multiple vaccines (DTaP, Hib, Hepatitis B, Polio, and PCV13), 4/1/2020, interim
• DTaP (Diphtheria, Tetanus, Pertussis), 4/1/2020, interim
• Tdap (Tetanus, Diphtheria, Pertussis), 4/1/2020, interim
• Td (Tetanus, Diphtheria), 4/1/2020, interim
• Yellow Fever, 4/1/2020

Newer editions should be used immediately, but providers can offer previous editions until their current supply is gone. To check that your practice is offering the most recent versions of each VIS, go to the CDC’s “Current VISs” webpage. Also, remember to check the Immunization Action Coalition’s “Vaccine Information Statements” webpage for VISs in other languages.

Influenza vaccine strains for 2020-2021

The World Health Organization (WHO) published their recommendations for the 2020-2021 influenza vaccine in the northern hemisphere. Only one strain remains the same:

Egg-based vaccine strain recommendations

• A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like virus
• A/Hong Kong/2671/2019 (H3N2)-like virus
• B/Washington/02/2019 (B/Victoria lineage)-like virus
• B/Phuket/3073/2013 (B/Yamagata lineage)-like virus (Strain that remains the same as previous year and not present in trivalent versions.)

Cell- or recombinant-based vaccine strain recommendations

• A/Hawaii/70/2019 (H1N1)pdm09-like virus
• A/Hong Kong/45/2019 (H3N2)-like virus
• B/Washington/02/2019 (B/Victoria lineage)-like virus
• B/Phuket/3073/2013 (B/Yamagata lineage)-like virus (Strain that remains the same as previous year and not present in trivalent versions.)

Read the WHO’s article about why these strains were chosen, including a map with frequency of subtypes in different parts of the world.

Anti-vaccine lawsuit claims explained

In early March 2020, a group known as Informed Consent Action Network, or ICAN, was sharing information indicating that they won a lawsuit against the CDC related to vaccines and autism. This claim was misleading, as described in the following by Dorit Rubenstein Reiss, a Professor of Law at UC Hastings:

• ICAN Lawsuit vaccines and autism, video on YouTube
• ICAN FOIA lawsuit – misrepresenting another non-win from anti-vaccine group, column on the science blog, Skeptical Raptor