Feb 28, 2024 ACIP Meeting - Polio Vaccines
TLDRThe transcript discusses the Polio Vaccine Work Group's considerations for using novel type 2 Oral Poliovirus (nOPV2) as an outbreak control measure in the United States. It also addresses the implications of fractional IPV doses administered in other countries and their validity towards the US vaccination schedule. The presentation highlights the importance of vaccination, the challenges of maintaining high immunization coverage, and the ongoing efforts to monitor and improve vaccine effectiveness and safety.
Takeaways
- π The meeting focused on discussions about the polio vaccine session, specifically the potential use of novel type 2 Oral Poliovirus (nOPV2) in the United States and fractional IPV doses administered in other countries.
- 𧬠Poliovirus infection can lead to poliomyelitis and lifelong paralysis, but most infections are asymptomatic, and the three serotypes have different epidemiological and clinical qualities.
- π The inactivated polio vaccine (IPV) is the only polio vaccine used in the US since 2000, providing protection against paralysis but not substantial intestinal immunity.
- π Oral polio vaccine (OPV) is a live-attenuated vaccine that is no longer used in the US but is still used in other countries. It provides both humoral and mucosal immunity, preventing paralysis and transmission.
- π nOPV2 is a next-generation version of the Sabin monovalent type 2 oral polio vaccine, designed to be more genetically stable and less likely to revert to a neurovirulent form.
- π₯ The work group discussed the potential benefits and harms of using nOPV2 in the US, including the risk of vaccine-associated paralytic polio (VAPP) and the potential for decreased transmission of the virus.
- π§Ύ Modeling studies were presented to estimate the number of paralytic cases under different mixing scenarios for a cVDPV2 outbreak, suggesting that the use of any type of OPV2 would likely end transmission slightly earlier than with IPV alone.
- π The work group's interpretation was that the undesirable consequences of using nOPV2 probably outweigh or are closely balanced with the desirable consequences, mainly due to the availability of IPV in the US.
- π The discussion on fractional IPV doses administered outside the US addressed whether these should be counted as valid towards the US vaccination schedule, concluding that two fractional doses should be considered as one full IPV dose.
- π€ Collaboration and updates from various Health and Human Services (HHS) agencies were highlighted, emphasizing the collective efforts to protect and enhance public health through vaccination.
- π The importance of ongoing research and surveillance for vaccine safety and effectiveness was emphasized, including the work of the FDA and CDC in monitoring vaccines for respiratory illnesses.
Q & A
What is the primary purpose of the polio vaccine session discussed in the transcript?
-The primary purpose of the polio vaccine session is to discuss the potential use of novel type 2 Oral Poliovirus (nOPV2) as an outbreak control measure in the United States and to determine the vaccine status of children who receive fractional-dose inactivated polio vaccine (fIPV) in other countries.
What are the three poliovirus serotypes and how do they differ in terms of paralytic cases to infections ratio?
-The three poliovirus serotypes are types 1, 2, and 3. The serotype ratio of paralytic cases to infections varies significantly, with type 1 having a ratio of approximately 1 in 190 infections, and type 2 having a ratio of approximately 1 in 1,900 infections.
What is the primary transmission route for poliovirus and why is it significant?
-The primary transmission route for poliovirus is the faeco-oral or oro-oral routes, with faeco-oral transmission being the most significant pathway. This is particularly important in settings with suboptimal hygiene and sanitation, as the virus may be present in the stool of infected persons for up to six weeks or longer.
What is the difference between IPV and OPV vaccines?
-Inactivated Polio Vaccine (IPV) contains inactivated polioviruses types 1, 2, and 3 and cannot replicate, infect, or cause disease. It induces humoral immunity and some nasopharyngeal mucosal immunity but does not provide substantial intestinal immunity. Oral Polio Vaccine (OPV) is a live-attenuated vaccine that replicates in the gut, induces both humoral and mucosal immunity, and prevents paralysis and transmission of poliovirus.
What is nOPV2 and how does it compare to the Sabin monovalent type 2 oral polio vaccine?
-Novel type 2 oral polio vaccine (nOPV2) is a next-generation version of the Sabin monovalent type 2 oral polio vaccine. It is designed to be more genetically stable and less likely to revert to a neurovirulent form. Between March 2021 and December 2023, almost a billion doses were administered as part of outbreak responses in 35 countries under WHO Emergency Use Listing approval.
What was the incidence of paralytic polio in the US after the introduction of the Salk inactivated polio vaccine in 1955?
-The incidence of paralytic polio in the US decreased rapidly after the introduction of the Salk inactivated polio vaccine in 1955. The Sabin oral polio vaccine was used for routine childhood immunization for decades, and in 2000, the US moved to an IPV-only schedule.
What was the outcome of the case of paralytic polio caused by vaccine-derived poliovirus type 2 in Rockland County, New York?
-The case of paralytic polio caused by vaccine-derived poliovirus type 2 in Rockland County, New York, was linked to polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. However, no additional paralytic cases were identified, and poliovirus related to the case was no longer detected in wastewater samples collected in the last year.
What is the main benefit of nOPV2 in comparison to IPV?
-The main benefit of nOPV2 would be to confer gastrointestinal immunity, which is not provided by IPV. Sabin OPV2 has been shown to reduce the odds of fecal shedding following a subsequent oral challenge dose by more than 90% compared to no vaccination.
What is the estimated risk of vaccine-associated paralytic polio (VAPP) for nOPV2?
-The estimated risk of VAPP for nOPV2 is estimated to be 0.07 cases per million recipients, or one case per 14.3 million recipients. This is lower than the estimated case rate for Sabin OPV, which is 0.25 to four cases per million recipients, or one per 0.25 million to 4 million recipients.
How does the work group assess the desirable and undesirable anticipated effects of using nOPV2 in addition to IPV?
-The work group assessed the desirable and undesirable anticipated effects of using nOPV2 based on the prevention of paralytic polio, the extent and duration of poliovirus circulation in the community, and serious adverse effects including VAPP and the possible introduction of a new vaccine-derived poliovirus type 2. They used the ACIP Evidence to Recommendations framework and domains to frame their discussions.
What are the potential harms at the population level if nOPV2 is administered?
-Potential harms at the population level include passive vaccination of the unvaccinated, a risk of VAPP among the unvaccinated, possible ongoing transmission of the nOPV2 virus leading to a new cVDPV2 virus, and possible chronic infection in immunocompromised persons.
What is the main challenge for the FDA in allowing the use of nOPV2 in the US?
-The main challenge for the FDA in allowing the use of nOPV2 in the US would involve going through the Expanded Access Investigational New Drug Application (EAIND) process, which requires application, FDA authorization, signed informed consent by vaccinees and/or their guardians, an enhanced system for monitoring vaccine safety, enhanced surveillance for possible vaccine-associated paralytic polio cases, and environmental surveillance for new VDPVs.
Outlines
π Introduction and Polio Vaccine Session
The session begins with an introduction by Dr. Wharton, highlighting the reconvening of the polio vaccine session. Dr. Oliver Brooks, the chair of the Polio Vaccines Work Group, is acknowledged. The discussion focuses on the potential use of novel type 2 Oral Poliovirus (nOPV2) as an outbreak control measure in the United States, the fractional dose inactivated polio vaccine (fIPV), and determining the vaccine status of children who received it in other countries. Dr. Kidd, the CDC Work Group leader, presents on behalf of the group, acknowledging their work and chair Dr. Brooks. The background of poliovirus infection, its transmission, and the different types of polio vaccines (IPV and OPV) are discussed, emphasizing the need for substantial intestinal immunity to prevent gastrointestinal shedding, which IPV does not provide.
π Global Polio Vaccine Strategies and IPV-Only Schedule
The paragraph discusses the global strategies for polio vaccination, particularly the shift to an IPV-only schedule in the United States since 2000. The continued circulation of wild poliovirus and vaccine-derived polioviruses in certain parts of the world is highlighted, along with the distribution of paralytic polio cases. The case of paralytic polio caused by a vaccine-derived poliovirus type 2 in Rockland County, New York, is discussed, emphasizing the link between this case and polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. The importance of timely outbreak response with IPV is noted, along with the WHO recommendations for considering an OPV response if transmission persists.
π‘ Benefits and Risks of nOPV2
The discussion focuses on the benefits and risks of using nOPV2, including its high seroconversion rates when administered to infants, particularly those who have already received IPV. The main benefit of nOPV2 is the conferral of gastrointestinal immunity, reducing fecal shedding following a subsequent oral challenge dose. The paper also addresses the risks associated with nOPV2, such as the low but non-zero risk of vaccine-associated paralytic polio (VAPP) and the potential for ongoing transmission of the nOPV2 virus, leading to a new vaccine-derived poliovirus type 2 (cVDPV2). The work group's considerations for the potential use of nOPV2 in the US, including the balance of risks and benefits, are discussed.
π¬ Modeling and Resource Use for nOPV2
The paragraph presents modeling data from Kim Thompson and colleagues, which compares the expected number of paralytic cases under different mixing scenarios for a cVDPV2 outbreak. The results suggest that the use of any type of OPV2 would likely end transmission slightly earlier than with IPV alone, but the predicted reduction in paralytic cases is minimal. The work group's opinions on the reasonableness and feasibility of using nOPV2, including the need for FDA authorization and the challenges of tracking and containing every dose, are discussed. The potential impact of nOPV2 on health equity is also considered, with the work group acknowledging that the balance of undesirable consequences compared to desirable consequences might shift in the future depending on the size and scope of the outbreak.
π€ Acceptability and Equity Considerations for nOPV2
The discussion revolves around the acceptability of nOPV2, considering public and stakeholder acceptance, especially in light of the previous removal of tOPV from the US vaccination schedule due to the unacceptable risk of VAPP. The work group's divided opinions on whether nOPV2 would be acceptable to key stakeholders and the impact on health equity are explored. The presentation concludes with the work group's consensus that the undesirable consequences of using nOPV2 during an outbreak in the US probably outweigh or are closely balanced with the desirable consequences, and that IPV is readily available in the US to protect against paralytic disease.
π¬ Questions and Comments on nOPV2
The paragraph includes a Q&A session where various concerns and questions about nOPV2 are raised. Dr. Kaslow from the FDA comments on the regulatory challenges of using nOPV2 in the US. Dr. Kotton raises concerns about the risk to immunocompromised individuals from community exposure to live viral vaccines. The discussion also touches on the potential impact of nOPV2 on undervaccinated communities and the overall acceptability of oral vaccines versus injectable ones. Dr. Chen emphasizes the need to address vaccine hesitancy in these communities and the precedent set in 2000 that any VAPP event is unacceptable.
π Global Switch from Wild Poliovirus Type 2 and Fractional IPV Doses
The paragraph discusses the global switch from wild poliovirus type 2 and the introduction of fractional doses of IPV in routine immunization schedules in several countries due to limited IPV availability. The WHO's support for the use of two fractional doses of IPV as an IPV conservation strategy is highlighted. Clinical trial data suggests that two fractional doses are more immunogenic than one full dose of IPV but slightly less effective than two full doses, especially when administered at younger ages. The work group's recommendation on counting two fractional IPV doses as one full dose towards the US vaccination schedule is presented.
π Updates from HHS Colleagues
The final paragraph provides updates from various Health and Human Services (HHS) colleagues, including the Indian Health Service's efforts to prioritize vaccination and improve vaccine coverage rates, the passing of Dr. Jeff Kelman from CMS, updates on the COVID-19 and influenza vaccines from the FDA, and the ongoing work of the National Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP). The NIH's update on vaccine-related research, including the value of maternal vaccine, ancillary benefits of COVID-19 vaccines, and studies on influenza and other diseases, concludes the meeting.
Mindmap
Keywords
π‘Polio Vaccine
π‘Outbreak Control
π‘Immunization Schedule
π‘Vaccine-derived Poliovirus (VDPV)
π‘Seroconversion
π‘Vaccine Shedding
π‘Vaccine-associated Paralytic Polio (VAPP)
π‘Genetic Stability
π‘Work Group
π‘Public Health Importance
π‘Viral Circulation
Highlights
Dr. Oliver Brooks chaired the Polio Vaccines Work Group discussing the potential use of novel type 2 Oral Poliovirus (nOPV2) as an outbreak control measure in the United States.
Dr. Kidd presented on behalf of the Polio Vaccine Work Group, acknowledging the efforts of all members, especially the chair, Dr. Brooks.
Poliovirus infection can lead to lifelong paralysis, with less than 1% of infections resulting in paralytic disease.
The inactivated polio vaccine (IPV) is the only polio vaccine used in the United States since 2000, providing protection against paralysis but not substantial intestinal immunity.
The oral polio vaccine (OPV) is no longer used in the US but is still used in other countries to prevent transmission of poliovirus.
nOPV2 is a next-generation version of the Sabin monovalent type 2 oral polio vaccine, designed to be more genetically stable and less likely to revert to a neurovirulent form.
Between March 2021 and December 2023, almost a billion doses of nOPV2 were administered globally as part of outbreak responses.
Wild poliovirus type 1 and vaccine-derived polioviruses are still circulating in certain parts of the world.
In July 2022, a case of paralytic polio caused by vaccine-derived poliovirus type 2 was confirmed in Rockland County, New York, highlighting the importance of vaccination coverage.
The work group discussed the theoretical use of nOPV2 in combination with a catch-up IPV campaign during a future type 2 poliovirus outbreak in the US.
The work group used the ACIP Evidence to Recommendations framework and domains to frame their discussions on the potential use of nOPV2.
nOPV2 has shown high rates of seroconversion when administered to infants, especially those who had already received one dose of IPV.
There is a risk of vaccine-associated paralytic polio (VAPP) in recipients of nOPV2, estimated to be 0.07 cases per million recipients.
The work group discussed the potential harms and benefits of using nOPV2, including the risk of VAPP and the possible introduction of a new vaccine-derived poliovirus type 2.
The work group was divided on whether the desirable effects of nOPV2 outweigh the undesirable effects, with half feeling the desirable effects did not outweigh the undesirable effects.
The work group discussed the feasibility of using nOPV2 in the US, including the need for FDA authorization and the challenges of implementing an nOPV2 campaign.
The work group acknowledged that the balance of undesirable consequences compared to desirable consequences might shift in the future depending on the size and scope of the outbreak.
Dr. Kidd presented on the clinical considerations for children who receive fractional-dose inactivated polio vaccine (fIPV) in other countries and their vaccine status in the United States.
Two fractional doses of IPV are more immunogenic than one full dose of IPV, but slightly less immunogenic than two full doses, especially when administered at younger ages.
The work group proposed that two fractional IPV doses administered outside the US should be considered valid and counted as one full intramuscular dose of IPV towards the US vaccination schedule.
Current US guidance recommends a total of either three or four doses of IPV, depending on the age of the last vaccination.
Six countries, representing about 20% of the global birth cohort, use fractional IPV in their routine immunization schedules.
The World Health Organization (WHO) recommends countries include at least one dose of IPV as part of their routine immunization schedule, along with bivalent OPV.
Transcripts
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