News Scan for Oct 08, 2018

FDA approves expanded Gardasil use
Cholera cases rise in Zimbabwe and Niger

FDA approves expanded Gardasil 9 use in women and men aged 27 through 45

The US Food and Drug Administration (FDA) on Oct 5 announced that it approved expanded use of Gardasil 9 human papillomavirus (HPV) vaccine for women and men 27 through 45 years old. The vaccine prevents certain cancers and diseases caused by the nine HPV types contained in the vaccine.

Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research said in an FDA statement that the approval is an important opportunity to help prevent HPV-related diseases in a broader range of ages. "The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing," he added.

In June the FDA granted priority review for Merck's supplemental biologics license application for Gardasil with a target action date of Oct 6. Previously, the vaccine had been approved for use in females and males ages 9 though 26.

The FDA said its approval is based on a study of about 3,200 women 27 though 45 years of age who were followed for an average of 3.5 years. The vaccine was 88% effective in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer. The new data also included long-term follow-up. It added that the effectiveness in 27- through 45-year-old men was inferred from the data from women, efficacy data in younger males, and immunogenicity findings in a clinical trial of 150 men aged 27 through 45 who received 3 doses over a 6-month period.

In safety studies that included 13,000 males and females, the most common adverse reactions were injection-site pain, swelling, and redness and headaches.
Oct 5 FDA press release


WHO: Cases rise in Zimbabwe and Niger cholera outbreaks

Cholera activity in Zimbabwe's capital city, Harare, that began in early September is rapidly increasing, and in Niger, a cholera outbreak that began in July near the Nigerian border threatens the county's capital and some of Niger's neighbors, the World Health Organization (WHO) said Oct 5 in separate updates.

In Zimbabwe, 4,971 more cases have been reported since the WHO's last update on Sep 20. As of Oct 3, the overall total had reached 8,535 cases, 163 of them confirmed and 50 of them fatal. Most are from the densely populated capital, especially the suburbs Glen View and Burdiriro. Last week, a mass oral cholera vaccine campaign was launched in the outbreak area targeting 1.4 million people.

The WHO said the source of the outbreak is suspected to be contaminated boreholes and wells, from which nearly 70% of the urban population relies on as a water source. High demand for water in Harare, complicated by increasing rural-urban migration that is straining the infrastructure, isn't being met by the city's water supply, which is a focus of response efforts. The country is also battling a large typhoid outbreak that began in August.

Meanwhile, Niger's cholera outbreak has grown to 3,692 cases (14% have been in Nigerian residents seeking care in Niger), 68 of them fatal, from 12 health districts in 4 regions, the WHO said. The outbreak began at a known hot spot near the border with Nigeria and has spread to three geographically distinct areas. The ongoing rainy season and the rise in cases along the Nigerian border poses a high risk of spread within Niger and to other countries. Cases were recently confirmed in Niger's Dosso region, a major trading hub with links to Niger's capital city, Niamey, and to Benin. The collapse of a bridge across the Niger River at the Niger-Benin border may slow population movements in the area but could also increase travel through Burkina Faso and Nigeria.

In other African cholera developments, the pace of disease activity in Somalia over the past 10 weeks has slowed, according to an Oct 4 statement from the WHO's Regional Office for the Eastern Mediterranean (WHO EMRO). The outbreak began in December 2017 and has now sickened 6,394 people, 42 of them fatally.
Oct 5 WHO statement on cholera in Zimbabwe
Oct 5 WHO statement on cholera in Niger
Oct 4 WHO EMRO statement on cholera in Somalia

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