COVID-19 impact on infant and adolescent vaccine supplies.

Vaccine production is quadrupling rapidly, creating supply chain challenges.

Immunogenicity and safety of the combined vaccine for measles, mumps, and rubella isolated or combined with the varicella component administered at 3-month intervals: randomised study

BACKGROUND Field testing required to license the combined measles, mumps, and rubella (MMR) vaccine must take into account the current recommendation of the vaccine in Brazil: first dose at 12 months and second dose at 15 months of age in combination with a varicella vaccine. OBJECTIVES This study aimed to evaluate the clinical consistency, immunogenicity, and reactogenicity of three batches of MMR vaccine prepared with active pharmaceutical ingredients (API) from Bio-Manguinhos, Fiocruz (MMR-Bio), and compare it to a vaccine (MMR produced by GlaxoSmithKline) with different API. METHODS This was a phase III, randomised, double-blind, non-inferiority study of the MMR-Bio administered in infants immunised at health care units in Pará, Brazil, from February 2015 to January 2016. Antibody levels were titrated by immunoenzymatic assays. Adverse events were recorded in diaries. FINDINGS Seropositivity levels after MMR-Bio were 97.6% for measles, 84.7% for mumps, and 98.0% for rubella. After the MMRV vaccine, seroconversion rates and GMT increased substantially for mumps. In contrast, approximately 35% of the children had no detectable antibodies to varicella. Systemic adverse events were more frequent than local events. CONCLUSION The demonstration of batch consistency and non-inferiority of the Bio-MMR vaccine completed the technology transfer. This is a significant technological achievement with implications for immunisation programs.

[THE EPIZOOTIC AND EPIDEMIC ACTIVITY OF NATURAL TULAREMIA FOCI OF DIFFERENT LANDSCAPE EPIDEMIOLOGICAL TYPES IN 2009-2014].

OBJECTIVE: to assess the present state of the natural tularemia foci of different landscape epidemiological types, by using individual focal areas as an example. MATERIALS AND METHODS: Epizootological monitoring and epidemiological analysis were conducted in the areas of natural tularemia foci of tundra (Wrangel Island), meadow-field (Central Federal District of the Russian Federation), flood-swamp (Arkhangelsk Region, Khanty-Mansi Autonomous District), and steppe (Mongolii) types. Small mammals (organs, blood), tularemia patients' sera, and environniental objects were examined. Molecular genetic and immune serological diagnostic assays were used. The incidence of tularemia in the past decade was analyzed using the maps for the epidemiological examinations of tularemia cases and medical reports. RESULTS: The natural foci of tularemia were established to continue to actively operate. There were 2913 cases of tularemia in the Russian Federation in 2001 to 2014. The flood-swamp natural foci, in which there were summer transmissive tularemia outbreaks, the largest of high occurred in Khanti-Mansiysk in 2013 when a total of 1005 people fell ill, are a special epidemic hazard. Analysis of the tularemia outbreaks suggests that there is a need for continuous epizootological monitoring of the areas of natural tularemia foci for the timely prediction and prevention of epidemic complications. It is noted that there is an unfounded reduction in the scope of preventive measures, and immunoprevention in particular, and a weaker control of the antitularemia immune status in the population residing in the area of active natural foci of tularemia.

Notice of CDC's discontinuation of investigational pentavalent (ABCDE) botulinum toxoid vaccine for workers at risk for occupational exposure to botulinum toxins.

Effective November 30, 2011, CDC will no longer provide investigational pentavalent (ABCDE) botulinum toxoid (PBT) for vaccination of workers at risk for occupational exposure to botulinum serotypes A, B, C, D, and E. This change might affect persons working in public health laboratories, research facilities, and manufacturing institutions who work with botulinum toxin or neurotoxin-producing species of Clostridium. CDC's decision is based on an assessment of the available data, which indicate a decline in immunogenicity of some of the toxin serotypes. The occurrence of moderate local reactions related to annual booster doses also has increased, which was noted in the 1990s at the U.S. Army Medical Research Institute for Infectious Diseases and resulted in a change in boosting from an annual requirement to only boosting when antibody titers have declined significantly. Additionally, the PBT was manufactured more than 30 years ago. CDC, therefore, has decided not to continue offering this investigational product.

End of a century-long scourge?

As this year's meningitis season comes to a close, Felicity Thompson reports on how a new vaccine that costs less than a soda pop is making inroads into a dreaded disease in Africa.

Vaccine production, distribution, access, and uptake.

For human vaccines to be available on a global scale, complex production methods, meticulous quality control, and reliable distribution channels are needed to ensure that the products are potent and effective at the point of use. The technologies used to manufacture different types of vaccines can strongly affect vaccine cost, ease of industrial scale-up, stability, and, ultimately, worldwide availability. The complexity of manufacturing is compounded by the need for different formulations in different countries and age-groups. Reliable vaccine production in appropriate quantities and at affordable prices is the cornerstone of developing global vaccination policies. However, to ensure optimum access and uptake, strong partnerships are needed between private manufacturers, regulatory authorities, and national and international public health services. For vaccines whose supply is insufficient to meet demand, prioritisation of target groups can increase the effect of these vaccines. In this report, we draw from our experience of vaccine development and focus on influenza vaccines as an example to consider production, distribution, access, and other factors that affect vaccine uptake and population-level effectiveness.

Product development partnerships hit their stride: lessons from developing a meningitis vaccine for Africa.

The Meningitis Vaccine Project, a so-called product development partnership, developed a new vaccine against bacterial meningitis, an inflammation of brain tissues that causes an estimated 10,000 deaths among African children and young people each year. The vaccine--known as MenAfriVac and specifically targeted for use in low-income countries in Africa--was designed to be made available to governments at a price of fifty cents per dose. The Meningitis Vaccine Project is an example of how product development partnerships have reinvigorated research on vaccines for neglected diseases. These partnerships disperse the multiple tasks of product development across a network of partners that are best suited for each task. The vaccine was rapidly embraced by African health officials, and in its first few weeks on the market, in late 2010, more than nineteen million people in Burkina Faso, Mali, and Niger were vaccinated.

HIV-infected children living in Central Africa have low persistence of antibodies to vaccines used in the Expanded Program on Immunization.

BACKGROUND: The Expanded Program on Immunization (EPI) is the most cost-effective measures to control vaccine-preventable diseases. Currently, the EPI schedule is similar for HIV-infected children; the introduction of antiretroviral therapy (ART) should considerably prolong their life expectancy. METHODS AND PRINCIPAL FINDINGS: To evaluate the persistence of antibodies to the EPI vaccines in HIV-infected and HIV-exposed uninfected children who previously received these vaccines in routine clinical practice, we conducted a cross-sectional study of children, aged 18 to 36 months, born to HIV-infected mothers and living in Central Africa. We tested blood samples for antibodies to the combined diphtheria, tetanus, and whole-cell pertussis (DTwP), the measles and the oral polio (OPV) vaccines. We enrolled 51 HIV-infected children of whom 33 were receiving ART, and 78 HIV-uninfected children born to HIV-infected women. A lower proportion of HIV-infected children than uninfected children had antibodies to the tested antigens with the exception of the OPV types 1 and 2. This difference was substantial for the measles vaccine (20% of the HIV-infected children and 56% of the HIV-exposed uninfected children, p<0.0001). We observed a high risk of low antibody levels for all EPI vaccines, except OPV types 1 and 2, in HIV-infected children with severe immunodeficiency (CD4(+) T cells <25%). CONCLUSIONS AND SIGNIFICANCE: Children were examined at a time when their antibody concentrations to EPI vaccines would have still not undergone significant decay. However, we showed that the antibody concentrations were lowered in HIV-infected children. Moreover, antibody concentration after a single dose of the measles vaccine was substantially lower than expected, particularly low in HIV-infected children with low CD4(+) T cell counts. This study supports the need for a second dose of the measles vaccine and for a booster dose of the DTwP and OPV vaccines to maintain the antibody concentrations in HIV-infected and HIV-exposed uninfected children.

Q fever vaccine uptake in South Australian meat processors prior to the introduction of the National Q Fever Management Program.

Despite the availability of a vaccine, the incidence of Q fever disease among populations at risk continues to be high. Q fever is an important cause of morbidity for workers, particularly in the meat and agricultural industries. Following an increase in 1998 in the number of Q fever notifications among meat processors to the Communicable Disease Control Branch, South Australia, a survey was conducted in the same year to assess the uptake of Q fever immunisation programs in meat processors and to identify barriers to offering these programs. This survey was conducted prior to the introduction of the National Q Fever Management Program in 2001 that provided a targeted vaccination program to specific at-risk occupations. The results of the survey highlighted that very few meat processors in South Australia offered a Q fever immunisation program to their workers. More importantly, this article highlights that there was a wide variety of attitudes and beliefs about Q fever disease and its prevention. These attitudes and beliefs have the potential to impact on whether workers at risk are offered or seek Q fever vaccination. Previous attitudes may return and levels of protection in at-risk occupations will decrease without a concerted effort at a state level. A replication of this study should benchmark the prevailing attitudes about Q fever programs. In response to the 1998 survey a number of strategies and initiatives were developed to address the barriers to Q fever vaccination in South Australian meat processors. The National Q Fever Management Program (2001-2005) further enhanced the ability to address barriers such as vaccine cost.

Impact of vaccine shortages on immunization programs and providers.

BACKGROUND: During 2001 and the first half of 2002, the United States experienced severe shortages of five of the eight universally recommended vaccines for children. OBJECTIVES: To evaluate the impact of shortages of diphtheria-tetanus-acellular pertussis vaccine (DTaP), pneumococcal conjugate vaccine (PCV7), and tetanus and diphtheria vaccine (Td) shortages on state and urban area immunization programs and immunization providers between September 2001 and January 2002. METHODS: (1) Survey of state and urban area immunization program managers. Outcome measures included changes in vaccine distribution and suspension of daycare/Head Start and school entry immunization requirements for Td, DTaP, and PCV7. (2) Interviews with Vaccines for Children Program immunization providers scheduled to receive a routine site visit between January 21 and February 1, 2002. Outcome measures included problems experienced with vaccine orders, implementation of Advisory Committee on Immunization Practices (ACIP) interim recommendations for DTaP and PCV7, and length of time with no DTaP or PCV7 vaccines in stock. RESULTS: Over 85% of immunization programs changed the way they distributed PCV7, DTaP, and Td vaccines to providers, including limiting the amount of vaccine ordered or distributing partial orders. Additionally, 76% of programs experienced problems purchasing or receiving varicella vaccine. Sixty-eight percent of programs suspended school entry requirements for Td. Immunization providers reported problems with orders of Td (56%), PCV7 (45%), DTaP (30%), and varicella (29%). Approximately 16% and 29% of providers implemented the interim ACIP recommendations for DTaP and PCV7, respectively. However, 21% of providers suspended administration of all doses of PCV7 because they ran out of vaccine before learning of the shortage. CONCLUSIONS: From suspension of school entry requirements to delaying administration of vaccine, the recent vaccine shortages affected immunization programs' and providers' ability to administer vaccines in a timely manner.