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U.S. Government Will Focus on Marketing HPV Vaccine in 2019

Report on Vaccine Related Federal Advisory Committee Activities

By Theresa Wrangham
National Vaccine Information Center

After the U.S. Food and Drug Administration’s (FDA) approved Merck’s HPV-9 Gardasil vaccine for use in adults age 27 to 45 in 2018, the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) of the Department of Health and Human Services (HHS) is evaluating whether to expand their current HPV vaccine recommendation to include this new age group.

ACIP’s current recommendation is that boys and girls ages 9 through 15 should get two-doses of HPV-9. The “catch-up” vaccine schedule is a three- dose series for females above age 15 through age 27 and males above 15 years of age to 21 years of age, if not previously vaccinated with HPV vaccine. [1]

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CDC to Step Up HPV Vaccine Marketing Strategies

Should ACIP expand their recommendations for use of HPV-9 vaccine in the newly approved age group, the CDC won’t be alone in the push to increase the use of the HPV vaccine by children and adults in the U.S.

During the September meeting of the National Vaccine Advisory Committee (NVAC), a federal advisory committee that makes recommendations to the National Vaccine Program Office (NVPO), the HHS Assistant Secretary ADM Brett Giroir M.D. emphasized that HHS supported the NVAC’s HPV vaccine recommendations [2] published in June 2018.

Dr. Giroir stated that increasing HPV vaccination in America would be a focus for HHS in 2019.

The federal government’s focus on increasing the use recommendations for the HPV vaccine may result in a renewed effort by state legislators to introduce legislation in many states to mandate HPV vaccine for school entry.

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HPV-9 Use in Older Adults Considered by ACIP

During the October 2018 ACIP meeting, the HPV workgroup presented preliminary information for discussion purposes.

Cost data, though incomplete, showed that increasing use recommendations of the HPV-9 vaccine is not likely to be cost effective.

In addition, preliminary data showed that receiving the vaccine would not likely have a significant positive impact on those who may have chronic HPV infections that go on to become HPV associated cancers. [3]

As this discussion unfolds and finalized data is presented to ACIP during 2019, reportedly a permissive use recommendation is more likely than a routine use recommendation. [4]

A permissive use recommendation would mean that consumers would be advised of the vaccine’s approval for use in 27 to 45 year olds, while a routine use recommendation would mean that vaccine providers would more strongly recommend use of the vaccine in this older age group.

Any recommendation by ACIP to expand the use recommendation of the HPV vaccine in this age group will result in providing a liability shield to vaccine providers and require anyone in this age group who is injured by this vaccine to petition the federal vaccine injury compensation program (VICP) for injury compensation.

ACIP may vote on this issue as early as their next meeting in February 2019. However, ACIP’s February agenda has not yet been published. Notably, during  the February 2018 ACIP meeting, the CDC presented data indicating that it may be decades before it is known whether HPV vaccine has impact on HPV associated cancers. [5]

ACIP Recommends Routine Hepatitis A Vaccination for the Homeless

Votes carried out during October’s ACIP meeting included the passage of a routine recommendation of Hepatitis A vaccine for the homeless to prevent outbreaks in this at risk group; [6] and formatting and language clean up of the CDC recommended childhood [7] and adult [8] vaccine schedules (routine, catch-up and medical indication tables).

The CDC’s website will be updated with these vaccine schedules with the goal of making the new schedules clearer to vaccine administrators and the public.

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Vaccine Access A Key Factor in Rise in Unvaccinated Children

At the October ACIP meeting, the CDC set forth the latest MMWR reports on childhood vaccine coverage.

Dr. Nancy Messonnier, Director of the National Center for Immunization and Respiratory Diseases (NCIRD) commented on the slight increase in the number of unvaccinated children. Dr. Messonnier stated,

“Parental choice may play some role, but CDC’s data really suggests that many of these parents do want to vaccinate their children, but they may not be able to get vaccines for them.

They may face hurdles like not having a health care professional near by, not having time to get their children to a doctor, and thinking that they cannot afford vaccines.”9

New Anthrax Vaccine Likely to be Stockpiled

A presentation was made on the new anthrax vaccine AV7909, which is manufactured by Emergent Biosolutions, and uses the novel CpG 7909 adjuvant.

The new adjuvant CpG oligodeoxynucleotide (CpG ODN) is a synthetic oligodeoxynucleotide derived from bacterial DNA that accelerates the pro-inflammatory response of the immune system to stimulate immunity. [10] [11]

This vaccine, once approved, will be stockpiled in the Strategic National Stockpile, to be used in the event of a bioterrorism attack. [12] [13]

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Pneumococcal Vaccine May Provide Little Benefit To Seniors

ACIP is also conducting a routine review of their use recommendation for PVC 13 pneumococcal vaccine in adults.

Data was presented suggesting that the vaccine has little direct benefit to seniors.

Additional data will be presented during February’s ACIP meeting with a possible vote in February or June that may result in a change to the routine use recommendation of the PCV 13 vaccine in 65+ adults. [14]

Change in Tetanus Revaccination Considered

Data was presented on the use of Tdap in place of Td vaccine for the 10-year booster vaccination recommended by the CDC. [15]

It appears a key reason behind this possible substitution has to do with vaccine providers opting to keep little to no Td vaccine supplies on hand.

ACIP has formed a workgroup to evaluate a possible change in this policy and will present data and recommendations to ACIP for additional consideration.

Infant Dose of Influenza Vaccine May Change

Sanofi Pasteur presented data on the initial use of a full dose (.5-ml) of the Fluzone Quadrivalent vaccine in infants six months of age compared to the current half dose recommended for this age group. [16]

Additional information will be presented at future ACIP meetings as the committee considers a possible change in recommendations.

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CDC Removes Many Pertussis Vaccine Contraindications

The CDC removed four DTaP precautions to receipt of pertussis containing vaccines, including

  • Fever over 105 F within 48 hours following DTaP;
  • Persistent, inconsolable crying lasting more than 3 hours within 48 hours following a dose of DTaP;
  • Collapse or shock-like state within 48 hours following a dose of DTaP;
  • Seizure within 72 hours following a dose of DTaP.

from their Best Practice Guidelines webpage. [17] [18]

The reason provided for this change was that these precautions were associated with the DTP vaccine, which is no longer licensed for use in the U.S. due to its higher reactivity and risk for vaccine injury, and not the DTaP vaccine.

Parents Describe Vaccine Injury and Death During ACIP Public Comment Period

During ACIP’s public comment session, the majority of comments were made by individuals reporting vaccine injuries and deaths and those concerned about lack of informed consent protections in vaccine policies and laws.

Health care professionals provided public comments that were critical of data presented to ACIP and of current ACIP vaccine recommendations.

Many parents echoed these concerns and shared their heart breaking stories of vaccine injury and death. [19] [20]

Destiny Maynard tearfully shared with the committee the story of her son, Christopher, who died in the summer of 2018 following complications from Acute Disseminated Encephalomyelitis (ADEM) shortly after receiving an HPV vaccination.

She read a statement from her son’s neurologist explaining that cases of ADEM can be triggered by vaccines and that the HPV vaccine, specifically, has been implicated in cases of ADEM within one month of vaccination.

The statement concluded that strong consideration must be given to the HPV vaccine causing ADEM, which resulted in the death of Christopher. [21]

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ACCV Requests Funding for More  Special Masters But Ignores Vaccine Safety Gaps

On December 6, 2018, The Advisory Committee on Childhood Vaccines (ACCV) met and passed a resolution to request that the Secretary of Health provide additional funding to hire more special masters for the U.S. Court of Federal Claims to adjudicate vaccine injury claims in the federal vaccine injury compensation program (VICP).

When the Secretary of HHS opposes awarding compensation, the special masters make determinations about whether plaintiffs will or will not receive an award from the federal vaccine injury compensation program (VICP).

Noting a serious backlog in pending compensation claims, ACCV expressed hope that providing funding for hiring more special masters will accelerate to processing of claims.

The Government Accountability Office published a report in 2014 critical of the length of time it takes to process VICP claims, [22] one of many criticisms of the implementation of the VICP created by Congress in the 1986 National Childhood Vaccine Injury Act. [23]

The Secretary of Health still has not fulfilled NVIC’s long-standing request for funding of research to address acknowledged vaccine safety science gaps identified in over 25 years of reports issued by the National Academy of Medicine (NAM), formerly the Institute of Medicine (IOM).

Vaccine Administrators Get Liability Shield for Causing Shoulder Injuries

According to reports by federal officials during ACCV’s meeting, the leading injury claim in the VICP by adults is shoulder injury (SIRVA) from improperly administered vaccines, followed by Guillian-Barre Syndrome (GBS) caused by from influenza vaccine.

Notably, during the June 4, 2015 meeting of ACCV, HRSA noted that SIRVA was not an adverse reaction to the vaccine itself, rather it was an injury resulting from incorrect administration of the vaccine too high in the shoulder muscle causing shoulder injury.

NVIC provided public comment opposing the addition of SIRVA to the Vaccine Injury Table (VIT) due to the fact that this injury is not a vaccine adverse event, rather it is the result of a lack of professional training and/or misadministration by the vaccine provider. [24]

Despite these comments, ACCV recommended adding SIRVA to the VIT to provide healthcare professionals with a liability shield if they incorrectly administer any routinely recommended childhood vaccine in the shoulder and cause a shoulder injury.

SIRVA injuries can range from mild to severe, can cause temporary or permanent injury that limits movement and results in pain from bursitis and tendinitis. [25] [26]

ACCV Considers Survey to Assess VICP Experience and Awareness

ACCV’s process workgroup presented initial discussion results on their review of a survey of petitioners rating their experience with VICP, the outcome of their claim, and how they found out about the VICP.

This survey is, in part, the result of the acknowledged lack of public awareness of the VICP and how it might be improved.

NVIC has requested that ACCV amend the survey to include questions relating to the satisfaction and adequacy of awards from VICP based on recommendations from federally commissioned reports on VICP.

Upcoming Federal Advisory Committee Meetings.

For more than three decades, NVIC has monitored and reported on federal vaccine advisory committee meetings that shape federal vaccine policy and influence state vaccine laws.

These meetings are open to the public and most are streamed live. All meetings allow for public comment and have different requirements on registering to make a public comment.

A selection of NVIC’s previous public comments can be read here.

We encourage our supporters to make their voice heard and to voice their concerns to these federal committees.

Upcoming committee meetings in 2019 are:

ACIP – February 27-28, 2019, learn more and register here.

ACCV – March 7-8, 2019, learn more and register here.

NVAC – March 25, 2019, learn more and register here.

Read the full article at NVIC.org.

References

1 CDC. Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR. Dec. 16, 2016. Vol 65. No. 49.

2 NVAC. Strengthening the Effectiveness of National, State, and Local Efforts to Improve HPV Vaccination Coverage in the United States. ASPPH Public Health Reports. Aug. 9, 2018.

3 CDC . ACIP Meeting Presentation – Impact and economic analysis – Summary of three models of 9-valent HPV vaccination among adults up to age 45 years in the United States. Chesson, H., CDC. Oct. 25, 2018.

4 CDC. ACIP Meeting Presentation – Expanded age range for 9-valent HPV vaccine: Work Group plans and policy considerations. Markowitz, L. Oct.  25, 2018.

5 CDC. ACIP Meeting Presentation – Trends in HPV-associated cancers in the United States. Dr. Elizabeth VanDyne, CDC/NCIRD. Feb. 12, 2018.

6 CDC. ACIP Presentations – Hepatitis A Vaccines. Oct. 24, 2018.

7 CDC. ACIP Presentations – 2019 Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger. Bernstein, H. Robinson, C. Oct. 24, 2018.

8 CDC. ACIP Presentation – Recommended Adult Immunization Schedule, 2018. Hunter, P. Kim, D. Oct. 24, 2018.

9 CDC. ACIP Video Recording – October 2018 ACIP Meeting – Agency Updates & HPV. Nov. 14, 2018.

10  Hopkins RJ, Daczkowski NF et al. Randomized, Double Blind, Placebo Controlled, Safety and Immunogenicity Study of 4 Formulations of Anthrax Vaccine Adsorbed Plus CPG7909 (AV7909) in Health Adult Volunteers. Vaccine 2013; 31(30): 3051-3058.

11 Coherent Market Insights. CpG Oliogodeoxynucleotide Market. January 2019.

12 CDC. ACIP Meeting Presentations – Anthrax. Oct. 24, 2018.

13  Hackett DW. Anthrax Vaccine Stockpile is Reloading. Precision Vaccines Dec. 28, 2017.

14 CDC. ACIP Meeting Presentation – Preliminary Evidence to Recommendations for the ongoing review of the PCV 13 recommendation for adults >65 years old. Matanock, A. Oct 24, 2018.

15 CDC. ACIP Meeting Presentation – Background: Repeat Tdap vaccination. Havers, F. Oct. 25, 2018.

16 Sanofi Pasteur. ACIP Meeting Presentation – Study GRC88, Safety and Immunogenicity of Fluzone Quadrivalent Vaccine 0.5-mL Dose for Children 6 through 35 Months of Age. Mercer, M. Oct. 25, 2018.

17 CDC. Recommendations and Guidelines of the ACIP – General Best Practice Guidelines. Table 4.2. Sep. 14, 2018.

18 CDC. ACIP Video Recording – October 2018 ACIP Meeting – General Recommendations; Influenza; Rabies; Meningococcal; Pertussis. Nov. 14, 2018.

19 CDC. ACIP Video Recording – Japanese Encephalitis. Nov. 14, 2018.

20 CDC. ACIP Video Recording –Pertussis. Nov. 14, 2018.

21 CDC. ACIP Video Recording –Pertussis. Nov. 14, 2018.

22  Government Accountability Office (GAO). Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled Through Negotiation. U.S. Government Accountability Office Nov. 21, 2014.

23 Fisher BL, Williams K, Wrangham TK. NVIC response to an inquiry from the Government Accountability Office (GAO) on the implementation of the federal vaccine injury compensation program (VICP) after passage of the 1986 National Childhood Vaccine Injury Act. National Vaccine Information Center July 11, 2014.

24 HRSA. ACCV Certified Minutes. Pg 5. Jun. 4, 2015.

25 CDC. Intramuscular Influenza (Flu) Vaccination Infographic. Jun. 4, 2018.

26 Llamas, M. Shoulder Injury Related to Vaccine Administration: SIRVA. Drugwatch.

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