Vaccines: The Week in Review 23 February 2013

Editor’s Notes:

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MMWR Weekly: Interim Adjusted Estimates of Seasonal Influenza Vaccine Effectiveness — United States, February 2013

   The MMWR Weekly for February 22, 2013 / Vol. 62 / No. 7, includes:
Interim Adjusted Estimates of Seasonal Influenza Vaccine Effectiveness — United States, February 2013
February 22, 2013 / 62(07);119-123

Editor’s Excerpt and Bolding
Early influenza activity during the 2012–13 season (1) enabled estimation of the unadjusted effectiveness of the seasonal influenza vaccine (2). This report presents updated adjusted estimates based on 2,697 children and adults enrolled in the U.S. Influenza Vaccine Effectiveness (Flu VE) Network during December 3, 2012–January 19, 2013. During this period, overall vaccine effectiveness (VE) (adjusted for age, site, race/ethnicity, self-rated health, and days from illness onset to enrollment) against influenza A and B virus infections associated with medically attended acute respiratory illness was 56%, similar to the earlier interim estimate (62%) (2). VE was estimated as 47% against influenza A (H3N2) virus infections and 67% against B virus infections. When stratified by age group, the point estimates for VE against influenza A (H3N2) and B infections were largely consistent across age groups, with the exception that lower VE against influenza A (H3N2) was observed among adults aged ≥65 years. These adjusted VE estimates indicate that vaccination with the 2012–13 influenza season vaccine reduced the risk for outpatient medical visits resulting from influenza by approximately one half to two thirds for most persons, although VE was lower and not statistically significant among older adults. Antiviral medications should be used as recommended for treatment of suspected influenza in certain patients, including those aged ≥65 years, regardless of their influenza vaccination status…

…Among the patients with influenza, 32% had been administered the 2012–13 seasonal influenza vaccine, compared with 50% of the influenza-negative controls (Table 2). For all persons with medically attended acute respiratory illness, the overall VE (adjusted for age group, study site, race/ethnicity, self-rated health status, and days from illness onset to enrollment) against influenza A and B virus infections was 56% (95% confidence interval [CI] = 47%–63%) (Table 2). Significant VE against influenza A and B viruses was observed among persons in all age groups, except for adults aged ≥65 years.

Editorial Note

These updated and age-adjusted VE estimates for the 2012–13 influenza vaccine confirm moderate effectiveness in preventing outpatient medical visits caused by circulating influenza viruses, similar to earlier unadjusted estimates in the United States (2) and to recent interim estimates from Canada and Europe (4,5). Overall, influenza vaccination reduced the risk for medical visits resulting from influenza A and B by 56%, from influenza A (H3N2) by 47%, and from influenza B by 67%. The preventive benefits against influenza B were consistent across age groups. The adjusted VE estimates against influenza A (H3N2) viruses also were largely consistent (46%–58%) for persons aged 6 months–64 years, but the estimate was not significant among persons aged ≥65 years. These VE estimates are not final; an increased sample size and adjustment for additional potential confounders (such as chronic medical conditions and functional status) at the end of the season could change these estimates.

Confirmation of the protective benefits of the 2012–13 influenza vaccine among persons aged 6 months–64 years offers further support for the public health benefit of annual seasonal influenza vaccination and supports the expansion of vaccination, particularly among younger age groups. The nonsignificant adjusted VE of 9% against A (H3N2) among persons aged ≥65 years is similar to the estimate in a recent interim report from Europe (6) and reinforces the need for continued advances in influenza vaccines, especially to increase protective benefits for older adults.

One possible explanation for these findings is that some older adults did not mount an effective immune response to the influenza A (H3N2) component of this season’s vaccine. Nonetheless, this finding should not discourage future vaccination by persons aged ≥65 years, who are at greater risk for more severe cases and complications from influenza. Influenza vaccines remain the best preventive tool available, and VE is known to vary by virus type/subtype, age group, season, host immunity, and the outcome measured (7). This study observed a VE point estimate against influenza B (67%) that was much higher than the 9% VE estimate against A (H3N2) among older adults, although the precision of estimates was limited by the small sample. Although some previous studies have shown influenza vaccine benefits for older adults, others have failed to demonstrate statistically significant benefits against specific influenza types or subtypes (7). Variability among studies and across seasons and age groups is to be expected and should not change recommendations for annual vaccination. It is also important to note that the VE estimates in this report are limited to the prevention of outpatient medical visits, rather than more severe illness outcomes, such as hospitalization or death. A previous multiseason study found that the influenza vaccine reduced the risk for influenza-associated hospitalizations among older adults by 61% (CI = 18%–82%) (8). A full evaluation of the VE for older adults this season must await consideration of additional data and outcomes…

Update: Influenza Activity — United States, September 30, 2012–February 9, 2013

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012

GPEI – Update: Polio this week – As of 20 February 2013

Update: Polio this week – As of 20 February 2013
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s Extract and bolded text]
– In Somalia, a new circulating vaccine-derived poliovirus type 2 (cVDPV2) from January 2013 was reported.
– This latest case is confirmation that the cVDPV2 outbreak from 2011 in south-central Somalia is ongoing. In 2012, this outbreak had also spread across the border into neighbouring Kenya. Outbreak response continues to be implemented. See ‘Horn of Africa’ section below for more.

Afghanistan
– No new WPV cases were reported in the past week…
– Two new cases of cVDPV2 were reported in the past week, bringing the total number of cVDPV2 cases for 2012 to nine, and one for 2013. The most recent cVDPV2 case had onset of paralysis on 22 January 2013 (from Hilmand). This is the first case reported in Afghanistan in 2013.

Nigeria
– One new WPV case was reported in the past week (WPV1 from Kano), bringing the total number of WPV cases for 2012 to 122. It is the most recent case in the country and had onset of paralysis on 22 December.

Horn of Africa
– One new cVDPV2 case was reported in the past week, from Somalia, with onset of paralysis on 9 January 2013.
– This latest case is linked to a cVDPV2 outbreak ongoing in south-central Somalia since 2011 – nine cases were reported in 2011 and one case in 2012 (July). Additionally, in 2012 this outbreak spread across the border to Kenya, with three cases reported from Dadaab, in North Eastern Province between April and June 2012.
– In late 2012 and January 2013, access to populations is being achieved for the first time in three years in key areas of south-central Somalia, as a result of concerted local-access negotiations. An emergency action plan for south-central Somalia has been developed and is being implemented. At the same time, efforts are on-going to further boost population immunity levels in accessible, polio-free areas of Somalia, as well as in border areas of Kenya.
– However, confirmation of this most recent case underscores that the outbreak is ongoing and more outbreak response must be implemented.

West Africa
– In Niger, outbreak response immunization activities were conducted 15-18 January, in close coordination with Nigeria, and were followed by NIDs with trivalent OPV on 2-5 February, again synchronized with Nigeria. Vaccinations also focused on reaching mobile populations associated with population movements from Mali, including in refugee camps. OPV continues to be added to broader humanitarian assistance efforts in the region, including in Mali, Mauritania, Burkina Faso and Niger.

WHO: Prequalification of Poliomyelitis Vaccine (Oral) Bivalent Types 1 and 3 in 20-dose

WHO: Prequalification of Poliomyelitis Vaccine (Oral) Bivalent Types 1 and 3 in 20-dose
22 February 2013

Vaccine Trade Name: Poliomyelitis Vaccine (oral) Bivalent types 1 and 3

Vaccine Type: OPV (Oral Polio vaccine) bivalent types 1 and 3

Manufacturer: Serum Institute of India Ltd.

Country of Manufacture: India

Date of prequalification: 04 February 2013

Package insert
pdf, 331kb

http://www.who.int/immunization_standards/vaccine_quality/pq_262_bopv13_20dose_sii/en/index.html

WHO: – Novel coronavirus infection – update 21 February 2013

WHO – Global Alert and Response (GAR)
Disease Outbreak News – Most recent news items

– Novel coronavirus infection – update
21 February 2013 – The Ministry of Health in Saudi Arabia has informed WHO of another confirmed case of infection with the novel coronavirus (NCoV).

The patient was hospitalized on 29 January 2013 and died on 10 February 2013. The case was laboratory-confirmed on 18 February 2013. Further investigation into this case is ongoing.

In the United Kingdom, the Health Protection Agency continues to investigate the family cluster where three members of the family tested positive for NCoV infection. One member of this family, who had an underlying health condition, has died.

To date, WHO has been informed of a total of 13 confirmed cases of human infection with NCoV, including seven deaths.

Based on the current situation and available information, WHO encourages all Member States (MS) to continue their surveillance for severe acute respiratory infections (SARI) and to carefully review any unusual patterns. Testing for the NCoV should be considered in patients with unexplained pneumonias, or in patients with unexplained, severe, progressive or complicated respiratory illness not responding to treatment, particularly in persons traveling from or resident in areas of the world known to be affected.

Any clusters of SARI or SARI in healthcare workers should be thoroughly investigated, regardless of where in the world they occur.

All MS are reminded to promptly assess and notify WHO of any new case or clusters of cases with NCoV infection.

WHO does not advise special screening at points of entry with regard to this event nor does it recommend that any travel or trade restrictions be applied.

WHO continues to closely monitor the situation.

http://www.who.int/csr/don/2013_02_21/en/index.html

NIH: Researchers begin trial of Shigella vaccine candidates

NIH: Researchers begin trial of Shigella vaccine candidates
Aim to thwart a principal cause of diarrheal disease worldwide

NIH-funded researchers have launched an early-stage human clinical trial of two related candidate vaccines to prevent infection with Shigella, bacteria that are a significant cause of diarrheal illness, particularly among children. The Phase I clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccines for safety and their ability to induce immune responses among 90 healthy adults ages 18 to 45 years. The trial is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the eight NIAID-funded Vaccine and Treatment Evaluation Units in the United States.

Shigella infection, called shigellosis, is an intestinal disease spread via contact with infected feces, by consumption of contaminated food or water or by contact with a contaminated surface. Symptoms include diarrhea, abdominal pain, fever, nausea and vomiting. In healthy adults, the infection generally clears on its own in five to seven days, but if left untreated, can lead to hospitalization or death, especially among young children and adults with weakened immune systems.

According to the World Health Organization, shigellosis causes roughly 90 million cases of severe disease each year and 108,000 deaths, most of which occur in the developing world and affect children under 5 years of age. In the United States, 14,000 shigellosis cases are reported annually, with most cases occurring among children ages 1 to 4 years….

http://www.nih.gov/news/health/feb2013/niaid-20.htm

European Medicines Agency: Positive Recommendations 18-21 February 2013

European Medicines Agency: Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013
Meeting highlights

Positive recommendations on new medicines
Hexacima
– Sanofi Pasteur S.A.
– diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed)
– Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib).
Summary of opinion for Hexacima

Hexyon
– Sanofi Pasteur MSD, SNC
-diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed)
– Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib).
Summary of opinion for Hexyon

Positive recommendations on extensions of therapeutic indications
Cervarix
– GlaxoSmithKline Biologicals
– human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, absored)
– Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic human papillomavirus (HPV) types. See section 5.1 for important information on the data that support this indication.
Summary of opinion for Cervarix