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NEWS SCAN: H5N1 death in Egypt, CSL flu-vaccine probe called 'inadequate,' H1N1 vaccine and pregnancy, measles spread
Jun 22, 2011
Egyptian man dies of H5N1 avian flu
Egypt's Ministry of Health has confirmed that a 27-year-old man has died of H5N1 avian flu, according to the World Health Organization (WHO) today. The man, from the Deshna district of Qena governorate, first developed symptoms Jun 5, was hospitalized and given oseltamivir (Tamiflu) Jun 13, and died Jun 14. Officials said he had been exposed to poultry that were suspected to have avian flu. The case was confirmed by a lab in Cairo, a National Influenza Center of the WHO's Global Influenza Surveillance Network. His case brings Egypt's 2011 total to 31, including 12 deaths. Since 2006 the country has confirmed 150 H5N1 cases and 52 deaths. The global count for WHO-confirmed H5N1 cases now stands at 562, with 329 deaths, for a case-fatality rate of 58.5%.
Jun 22 WHO update
FDA finds CSL probe into flu-vaccine side effects 'inadequate'
The US Food and Drug Administration (FDA), in a warning letter released to the public this week, called the investigation into flu-vaccine side effects in children by vaccine maker CSL Biotherapies of Australia "inadequate." The agency cited "a number of significant objectionable conditions" that contravened good manufacturing practice (GMP) at CSL's plant in Parkville, Victoria. Last April Australian officials pulled CSL's seasonal flu vaccine Fluvax from use in children younger than 5 years old after 23 children from Western Australia were hospitalized with post-vaccination convulsions and high fever, according to a report in the Melbourne-based Herald Sun today. The company's investigation found that adverse events were reported in 1 in 10 children from one Fluvax batch, which is about 10 times higher than expected. By the time the vaccine was taken off the market, 67 cases of convulsions, high fever, and vomiting were reported. The FDA letter cited a lack of documentation of the investigation, limited analysis of the manufacturing process, no assessment of the testing of raw material, and other problems. In a response to the letter yesterday, CSL Biotherapies Executive Vice President Dr. Jeff Davies said, "Our technical team is in the process of preparing more substantive detail about our corrective actions to meet the FDA's requirements. We will work diligently with the FDA to resolve these GMP issues as quickly as possible."
Jun 15 FDA warning letter
Jun 22 Herald Sun article
Jun 21 CSL response
H1N1 vaccine did not raise maternal or fetal risk
Reports of adverse events after pregnant women received the 2009 H1N1 pandemic flu vaccine showed no unexpected problems with the vaccine, according to federal officials writing in the American Journal of Obstetrics and Gynecology (AJOG) yesterday. Scientists from the Centers for Disease Control and Prevention (CDC) and the FDA analyzed data from the US Vaccine Adverse Event Reporting System (VAERS), which is maintained by the CDC and FDA. VAERS received 294 reports of adverse effects, including 2 maternal deaths, 59 hospitalizations, and 131 pregnancy-related events. These included 95 spontaneous abortions (less than 20 weeks gestational age), 18 stillbirths (20 weeks or more), 7 preterm deliveries, 3 threatened abortions, and 2 cases of preterm labor, 2 of preeclampsia, and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip. Given the number of pregnant women who received the vaccine, none of these occurrences was out of the ordinary. The scientists conclude, "H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes."
Jun 21 AJOG abstract
Measles spreads in New Zealand, Utah
The number of cases in a measles outbreak in West Auckland, New Zealand, has risen to 26, Radio New Zealand reported today. Most of the cases are linked to an unvaccinated student from Oratia Primary School who developed the disease after traveling to Britain through Singapore. The student then exposed others to measles. Health official Richard Hoskins urged people to get up to date on their immunizations.
Jun 22 Radio New Zealand story
Elsewhere, measles has spread from northern to central Utah, where the infection in a plant worker has required about 100 employees to stay home from their jobs, according to an article in The Salt Lake Tribune today. Central Utah Public Health officials said a Millard County resident tested positive after apparently contracting the disease while traveling to Logan to get married. The person works at a 500-person power plant, which has asked about 100 employees born after 1957 not to come to work until they can prove they have been fully vaccinated against measles.
Jun 22 Salt Lake Tribune article
NEWS SCAN: H5N1 death in Egypt, CSL flu-vaccine probe called 'inadequate,' H1N1 vaccine and pregnancy, measles spread
Jun 22, 2011
Egyptian man dies of H5N1 avian flu
Egypt's Ministry of Health has confirmed that a 27-year-old man has died of H5N1 avian flu, according to the World Health Organization (WHO) today. The man, from the Deshna district of Qena governorate, first developed symptoms Jun 5, was hospitalized and given oseltamivir (Tamiflu) Jun 13, and died Jun 14. Officials said he had been exposed to poultry that were suspected to have avian flu. The case was confirmed by a lab in Cairo, a National Influenza Center of the WHO's Global Influenza Surveillance Network. His case brings Egypt's 2011 total to 31, including 12 deaths. Since 2006 the country has confirmed 150 H5N1 cases and 52 deaths. The global count for WHO-confirmed H5N1 cases now stands at 562, with 329 deaths, for a case-fatality rate of 58.5%.
Jun 22 WHO update
FDA finds CSL probe into flu-vaccine side effects 'inadequate'
The US Food and Drug Administration (FDA), in a warning letter released to the public this week, called the investigation into flu-vaccine side effects in children by vaccine maker CSL Biotherapies of Australia "inadequate." The agency cited "a number of significant objectionable conditions" that contravened good manufacturing practice (GMP) at CSL's plant in Parkville, Victoria. Last April Australian officials pulled CSL's seasonal flu vaccine Fluvax from use in children younger than 5 years old after 23 children from Western Australia were hospitalized with post-vaccination convulsions and high fever, according to a report in the Melbourne-based Herald Sun today. The company's investigation found that adverse events were reported in 1 in 10 children from one Fluvax batch, which is about 10 times higher than expected. By the time the vaccine was taken off the market, 67 cases of convulsions, high fever, and vomiting were reported. The FDA letter cited a lack of documentation of the investigation, limited analysis of the manufacturing process, no assessment of the testing of raw material, and other problems. In a response to the letter yesterday, CSL Biotherapies Executive Vice President Dr. Jeff Davies said, "Our technical team is in the process of preparing more substantive detail about our corrective actions to meet the FDA's requirements. We will work diligently with the FDA to resolve these GMP issues as quickly as possible."
Jun 15 FDA warning letter
Jun 22 Herald Sun article
Jun 21 CSL response
H1N1 vaccine did not raise maternal or fetal risk
Reports of adverse events after pregnant women received the 2009 H1N1 pandemic flu vaccine showed no unexpected problems with the vaccine, according to federal officials writing in the American Journal of Obstetrics and Gynecology (AJOG) yesterday. Scientists from the Centers for Disease Control and Prevention (CDC) and the FDA analyzed data from the US Vaccine Adverse Event Reporting System (VAERS), which is maintained by the CDC and FDA. VAERS received 294 reports of adverse effects, including 2 maternal deaths, 59 hospitalizations, and 131 pregnancy-related events. These included 95 spontaneous abortions (less than 20 weeks gestational age), 18 stillbirths (20 weeks or more), 7 preterm deliveries, 3 threatened abortions, and 2 cases of preterm labor, 2 of preeclampsia, and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip. Given the number of pregnant women who received the vaccine, none of these occurrences was out of the ordinary. The scientists conclude, "H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes."
Jun 21 AJOG abstract
Measles spreads in New Zealand, Utah
The number of cases in a measles outbreak in West Auckland, New Zealand, has risen to 26, Radio New Zealand reported today. Most of the cases are linked to an unvaccinated student from Oratia Primary School who developed the disease after traveling to Britain through Singapore. The student then exposed others to measles. Health official Richard Hoskins urged people to get up to date on their immunizations.
Jun 22 Radio New Zealand story
Elsewhere, measles has spread from northern to central Utah, where the infection in a plant worker has required about 100 employees to stay home from their jobs, according to an article in The Salt Lake Tribune today. Central Utah Public Health officials said a Millard County resident tested positive after apparently contracting the disease while traveling to Logan to get married. The person works at a 500-person power plant, which has asked about 100 employees born after 1957 not to come to work until they can prove they have been fully vaccinated against measles.
Jun 22 Salt Lake Tribune article