Availability and Accessibility of Live Nonreplicating Smallpox/Mpox Vaccine.

This cross-sectional study compares the availability and accessibility of mpox vaccine sites with the number of reported cases and allocated vaccines.

The livestock vaccine supply chain: Why it matters and how it can help eradicate peste des petits Ruminants, based on findings in Karamoja, Uganda.

Understanding factors that hinder vaccination, including logistical and social constraints, is critical to finding the most effective approach for the global eradication of peste des petits ruminants (PPR). Vaccination projects should analyze the supply chain and take it into consideration when planning and creating a vaccination strategy. Adequate supply chain management of the PPR vaccine could lead to reduced cost, increased availability, and the construction of a data platform for other livestock vaccines. Integrating the supply chain of PPR vaccine with other veterinary or health commodities could reduce cost, as well as increase uptake. The use of a thermostable vaccine could potentially have a positive impact on the eradication of PPR in remote areas, such as the Karamoja subregion in Uganda, as it did with rinderpest across Sub Saharan Africa. In terms of vaccine delivery, the use of community animal health workers (CAHWs) could be beneficial in certain areas, such as the Karamoja subregion of Uganda, by alleviating supply chain constraints in the last-mile delivery, as well as increasing coverage and uptake. A gendered approach to livestock vaccines should also be considered, as decision-making power regarding livestock vaccination is gendered in many various contexts. The PPR eradication strategy-as well as other livestock vaccination programs-would be more effective and efficient if the supply chain management were considered as a key component in the process and efforts tailored, accordingly.

PATH Influenza Vaccine Project: accelerating the development of new influenza vaccines for low-resource countries.

The 2009 influenza A/H1N1 pandemic demonstrated that a pandemic influenza virus has the potential to spread more rapidly in today's highly interconnected world than in the past. While pandemic morbidity and mortality are likely to be greatest in low-resource countries, manufacturing capacity and access to influenza vaccines predominantly exist in countries with greater resources and infrastructure. Even with recently expanded manufacturing capacity, the number of doses available within a 6-month timeframe would be inadequate to fully immunize the global population if the decision to implement a global vaccination program were made today. Improved, affordable vaccines are needed to limit the consequences of a global influenza outbreak and protect low-resource populations. PATH's Influenza Vaccine Project is supporting a range of activities in collaboration with private- and public-sector partners to advance the development of promising influenza vaccines that can be accessible and affordable for people in low-resource countries.

Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully.

A pandemic influenza vaccine in India: from strain to sale within 12 months.

In the event of a highly pathogenic influenza pandemic, the Indian subcontinent would need 1.2 billion doses of vaccine to immunize its entire population, double if two doses were required to assure immunity. Serum Institute of India Limited (SII) thus became one of six initial grantees of the World Health Organization (WHO) technology transfer initiative to create capacity in developing countries to manufacture H5N1 pandemic influenza vaccine. At the outbreak of the A(H1N1) 2009 influenza pandemic, experience gained from the H5N1 project was used to develop a live attenuated influenza vaccine (LAIV), since this was the only option for the level of surge capacity required for a large-scale immunization campaign in India. SII took <12 months to develop and market its LAIV intranasal vaccine from receipt of the seed strain from WHO. As of November 2010, over 2.5 million persons have been vaccinated with Nasovac(®) with no serious adverse reactions or vaccine failure after 3 months' post-marketing surveillance. The product has been submitted for prequalification by WHO for purchase by United Nations agencies. In parallel, SII also developed an inactivated influenza vaccine, and is currently looking to ensure the sustainability of its influenza vaccine manufacturing capacity.

United States of America Department of Health and Human Services support for advancing influenza vaccine manufacturing in the developing world.

Since 2005, the Government of the United States of America has provided more than US$ 50 million to advance influenza vaccine development in low-resourced countries. This programme has provided a unique opportunity for the US Government to develop a comprehensive view of, and to understand better the challenges and future needs for influenza vaccines in the developing world. The funding for this programme has been primarily through a cooperative agreement with the World Health Organization (WHO) to support directly its capacity-building grants to government-owned or -supported vaccine manufacturers in developing countries. A second cooperative agreement with the Program for Appropriate Technologies in Health (PATH) was initiated to accelerate the completion of a current Good Manufacturing Practice cGMP production facility, along with supporting facilities to obtain a reliable source of eggs, and to conduct clinical trials of influenza vaccine manufactured in Vietnam. This mechanism of utilizing cooperative agreements to support capacity-building for vaccine development in low-resourced settings has been novel and unique and has yielded fruitful returns on minimal investment. The information derived from this programme helps to clarify not only the development challenges for influenza vaccines and how the United States may assist in meeting those challenges, but also other vaccine development issues common to manufacturers in developing countries. While building the initial capacity to produce influenza vaccines can be a straightforward exercise, the sustainability of the enterprise and expansion of subsequent markets will be the key to future usefulness. There is hope for expansion of the global influenza vaccine market. Ongoing burden of disease studies are elucidating the impact of influenza infections, particularly in children, and more countries will take note and respond accordingly, since respiratory diseases are now the number one killer of children under five years of age. In addition to achievements described in this issue of Vaccine, the programme has been successful from the US perspective because the working relationships established between the US Department of Health and Human Services' (HHS) Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority (BARDA) and its partners have assisted in advancing influenza vaccine development at many different levels. A few examples of BARDA's support include: establishment of egg-based influenza vaccine production from "scratch", enhancement of live attenuated influenza vaccine (LAIV) production techniques and infrastructure, completion of fill/finish operations for imported bulk vaccine, and training in advanced bio-manufacturing techniques. These HHS-supported programmes have been well-received internationally, and we and our partners hope the successes will stimulate even more interest within the international community in maximizing global production levels for influenza vaccines.

[Analysis and evaluation on quality of live attenuated measles vaccine from market surveillance sampling].

OBJECTIVE: To ensure the quality of live attenuated measles vaccine on the market, viral titers were determined as the market surveillance test. METHODS: The measles vaccine was sampled from sites located in 24 provinces (cities, autonomous regions) of China, including provincial CDC, municipal CDC, county CDC, and primary users. The virus titer of samples was tested to evaluate the quality status of measles vaccine on the market. RESULTS: For all the 54 lots of measles vaccine sampled in this study, the virus titers were in compliance with the requirements of the China Pharmacopeia Vol. III (2005 edition). In comparison with the original test results provided by the manufacturers, the mean virus titer was decreased 0.2 lg +/- 0.3. CONCLUSION: Viral titers of measles vaccine batches sampled from the market were all in compliance with the requirements of the China Pharmacopeia Vol. III (2005 edition). It showed that the measles vaccine in China market has good stability, and the cold chain system for measles vaccine conveyance and storage could ensure the vaccine efficacy.

Decision analysis in planning for a polio outbreak in the United States.

OBJECTIVE: Global eradication of poliomyelitis may soon be achieved, but circulating polioviruses could reemerge years after eradication by reversion of live attenuated oral vaccine virus to a virulent form, laboratory stock mishandling, or bioterrorism. If a poliomyelitis outbreak occurs in the United States, access to a vaccine stockpile to interrupt viral spread will be necessary. Options for the stockpile include the inactivated polio vaccine and the live-attenuated trivalent and monovalent oral poliovirus vaccines. With differences in immunogenicity, adverse effects, availability, and other issues, the optimal vaccine choice for the stockpile is not clear. We sought to compare vaccine interventions for poliomyelitis outbreak control. DESIGN: We applied decision analysis to 8 strategies for outbreak control: no intervention, 1 or 2 inactivated polio vaccine doses, 1 or 2 trivalent oral poliovirus vaccine doses, 1 or 2 monovalent oral poliovirus vaccine doses, and sequential inactivated polio vaccine-monovalent oral poliovirus vaccine. Historical data from outbreaks in developed countries were used to estimate the risk of paralytic disease after a hypothetical reintroduction of circulating polioviruses. The outcome measure was cases of paralytic poliomyelitis. RESULTS: Monovalent oral poliovirus vaccine provided optimal outbreak control in most scenarios because of high seroconversion rates with 1 dose. Control provided by trivalent oral poliovirus vaccine and inactivated polio vaccine was equivalent at high vaccine coverage rates. At low intervention rates, trivalent oral poliovirus vaccine produced fewer paralytic cases than inactivated polio vaccine in highly immune populations but more cases than inactivated polio vaccine in poorly immunized groups because of secondary transmission of oral poliovirus vaccine virus and vaccine-derived viruses. CONCLUSIONS: This model suggests that monovalent oral poliovirus vaccine would be the most advantageous vaccine for outbreak control. If a monovalent oral poliovirus vaccine stockpile is impractical, the optimal vaccine choice depends on the previous immunity and the anticipated intervention rates.

Adecuación de pautas vacunales en viajes internacionales. Vacunas en desarrollo / Adecuation of vaccination to the international traveller. Vaccines under development

Los importantes movimientos poblacionales y los viajes a países exóticos tan frecuentes en los tiempos modernos hacen que cada vez más a menudo el médico sea consultado sobre vacunaciones o medidas preventivas que un viajero debería recibir antes de emprender su viaje. Actualmente la Organización Mundial de la Salud (OMS) sólo exige la vacunación de la Fiebre Amarilla cuando se viaje a zonas endémicas así como la vacuna antimeningocócica para entrar en Arabia Saudí, el resto de las vacunas disponibles serán recomendadas según el tipo de viaje y la situación del viajero (AU)

[Promising experiments with DNA vaccine against HIV. A complete eradication of the virus is a formidable task]. / Lovande försök med DNA-vaccin mot HIV. Fullständig virusutrotning är en formidabel uppgift.

The past few years have witnessed encouraging progress in experimental HIV vaccination. Several new vaccine candidates have been shown to elicit immune response and provide protection in animals, and the first immunotherapy trials in humans have been reported. Difficulties remain to be overcome, however. No consensus exists regarding trials in humans. Some researchers and clinicians believe that we must await a vaccine demonstrably and reproducibly effective in animals. Immunogenicity alone is considered insufficient to ensure clinical protection. Others consider animal experiments valuable, but believe that actual trials should be made in humans in the target population. Trials are urgently needed in countries with high transmission rates, even if optimal efficacy cannot be guaranteed.