The monkeypox (Jynneos) vaccine study CDC conducted in the Congo (DRC) but pretends never existed.

CDC hid the fact this vaccine study existed from its own ACIP members today. Now why would they do that if Jynneos was safe and effective? Did it protect or sicken the Congolese HCWs?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6438175/

Antiviral Res. 2019 Feb; 162: 171–177.

Vaccinating against monkeypox in the Democratic Republic of the Congo

Brett W. Petersen,^a,∗,1 Joelle Kabamba,^b,1 Andrea M. McCollum,^a Robert Shongo Lushima,^c Emile Okitolonda Wemakoy,^d Jean-Jacques Muyembe Tamfum,^e Beatrice Nguete,^d Christine M. Hughes,^a Benjamin P. Monroe,^a and Mary G. Reynolds^a

Abstract

Healthcare-associated transmission of monkeypox has been observed on multiple occasions in areas where the disease is endemic. Data collected by the US Centers for Disease Control and Prevention (CDC) from an ongoing CDC-supported program of enhanced surveillance in the Tshuapa Province of the Democratic Republic of the Congo, where the annual incidence of human monkeypox is estimated to be 3.5–5/10,000, suggests that there is approximately one healthcare worker infection for every 100 confirmed monkeypox cases. Herein, we describe a study that commenced in February 2017, the intent of which is to evaluate the effectiveness, immunogenicity, and safety of a third-generation smallpox vaccine, IMVAMUNE^®, in healthcare personnel at risk of monkeypox virus (MPXV) infection. We describe procedures for documenting exposures to monkeypox virus infection in study participants, and outline lessons learned that may be of relevance for studies of other investigational medical countermeasures in hard to reach, under-resourced populations….

3.1. IMVAMUNE vaccine study

To determine whether the concept of vaccinating HCWs to prevent MPX is feasible and acceptable, the authors of this paper approached two key groups of stakeholders in the DRC to gauge their opinions. First, we approached HCWs in Tshuapa, a sample of whom were systematically surveyed to assess their perceptions of personal risk for MPX and willingness to be vaccinated. The second group queried was a broad group of stakeholders, including representatives of the Congolese Ministry of Health, WHO, Kinshasa School of Public Health, National Institute for Biomedical Research, the Directorate of Pharmacy and Medicines, and the Directorate of Disease Control Immunization Program. For the stakeholder group, we convened a two-day workshop with presentations addressing monkeypox epidemiology in DRC, risks to health workers, vaccine considerations, etc. The workshop concluded with an open discussion about the risk and potential benefits of vaccination as a means to prevent occupationally-acquired MPX infections. Based on feedback received, it was decided to study the ability of vaccination with IMVAMUNE to prevent MPX in DRC HCWs. The study commenced February 2017, and is currently ongoing while study participants undergo immunologic monitoring and follow-up for exposure to MPXV.

The study is a prospective cohort of HCWs, including laboratory workers, aged 18 years and older. Participants receive two doses of IMVAMUNE on days 0 and 28 (Fig. 3 ). Target enrollment for the study is 1000 persons, representing ∼80% of registered HCWs combined in the Boende, Wema, Bokungu and Mondombe health zones within Tshuapa. Study participation is open to male and non-pregnant female HCWs over the age of 18 (some additional exclusion criteria are noted). The primary objectives are to determine the number of suspected and confirmed cases of MPX and the number of MPXV exposures among vaccinated HCWS over a period of observation of two years. The development of MPX disease among participants will be monitored using existing surveillance infrastructure plus health interview and serologic monitoring during follow up visits. Exposures to MPXV will be solicited during follow-up visits and via exposure diaries.

This data and comparisons to retrospective surveillance data from the same locales will provide the basis for evaluating the effectiveness of the vaccine to prevent MPX. The study is powered to detect a statistically significant reduction in HCW cases based on the historical incidence and case ascertainment rates from the enhanced surveillance data. In addition, serum samples for immunogenicity evaluations will be collected prior to each vaccination (days 0 and 28) and on days 14, 42, 180, 365, 545, and 730 after the receipt of the first dose of vaccine. Antibody titers may serve as a surrogate for effectiveness and provide additional confidence in the vaccine. The time points distant from vaccination may also provide some evidence for the duration of immunity.

The safety of the vaccine is also monitored. Participants maintain an adverse event diary to record systemic and local adverse events (AEs) for 7 days after each immunization. Monitoring safety in this context is important, given that IMVAMUNE has never been studied in Africa and the population in Tshuapa differs in many respects from the population that have received IMVAMUNE in clinical trials to date. All previous clinical trials took place in Europe or the United States and involved populations that typically have different background health concerns than those in Africa where MPX occurs (i.e., populations in the United States and Western Europe generally experience a lower burden of infectious and chronic conditions) (Norheim et al., 2015)…..

The MPX surveillance program and IMVAMUNE vaccine study in Tshuapa highlight the unique opportunity to put smallpox medical countermeasures to good use in populations who need them, while at the same time gathering valuable information to ensure their appropriate and efficient use. Lessons learned pertaining to maintenance of a cold chain, the need to mitigate staff fatigue and ways to streamline and strengthen the informed consent process may be of value to others embarking upon investigational vaccine trials in rural DRC, and in other regions affected by MPX.

Funding

Funding for this project comes from the US Centers for Disease Control and Prevention.

Acknowledgements

The authors of this paper would like to thank colleagues from the US Centers for Disease Control and Prevention, the Kinshasa School of Public Health, the Congolese Ministry of Health and the University of Kinshasa for their contributions to this study.