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WHO Approves Third Cholera Vaccine Producer

8 January 2016 (Reuters [Stephanie Nebehay])—A third producer of oral cholera vaccine has been approved that is expected to provide 3 million doses in 2016, the World Health Organization (WHO) said, doubling the world's stockpile against cholera.

EuBiologics, a South Korea–based producer, joins Shantha Biotechnics of Sanofi Pasteur as a pre-qualified supplier, WHO expert Stephen Martin told a news briefing. The third producer, which currently does not have doses in the stockpile, is Sweden's Crucell, he said.

“It has future potential in the next 3–4 years for a much greater increase in vaccine production,” he said. A vaccine campaign will begin in Haiti this month, targeting some 240 000 people, he added.

Copyright © 2016 Reuters Limited. All rights reserved.

Editorial comment. The 2 oral vaccines available are WC-rBS (marketed as Dukoral) and BivWC (marketed as Shanchol and mORCVAX). These vaccines give 85% protection for 6 months with decreasing effectiveness thereafter. There is no approved vaccine for cholera in the United States.

Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux: Class I Recall—Potential for Test Result Error

29 December 2015 (FDA Safety Alert)—BioMérieux recalled the Etest PIP/TAZO/CON-4 PTC 256 [on 24 November 2015] because the test results from the affected product may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria when it may not actually be effective in treating those bacteria. This recall includes all affected products with manufacturing dates 20 December 2012 to 23 October 2015 and distribution dates 24 January 2013 to 9 November 2015. The Etest PIP/TAZO/CON-4 PTC 256 is used to help predict if the antibiotic piperacillin/tazobactam (PIP/TAZO) will be effective in treating serious infections.

Hong Kong on Holiday Health Alert After China Bird Flu Death

6 January 2016 (Reuters [Rain Liang and Donny Kwok])—A woman in the southern Chinese city of Shenzhen has died after being infected with the highly contagious H5N6 bird flu virus, days after she was admitted to hospital, Hong Kong's Health Department said.

The 26-year-old woman's death in late December comes ahead of the Chinese New Year holiday in early February when millions of Chinese travel to their home towns to celebrate with their families, with chicken a popular festive meal.

All border check points between Shenzhen and Hong Kong, and the airport, had already introduced disease prevention measures with thermal imaging systems in place, a department spokesman said.

The department was also notified by the Guangdong health authority on 1 January that a 40-year-old woman from Zhaoqing city in the same province was infected with H5N6 and was in a critical condition.

The government has not banned poultry imports from the mainland so far, according to a spokesman from the city's Food and Environmental Hygiene Department.

Hong Kong culled thousands of chickens and suspended imports of live poultry from mainland China in December 2014 after an H7 bird flu strain was discovered in live chickens.

Copyright © 2016 Reuters Limited. All rights reserved.

Editorial comment. Avian influenza A(H5N6) was first detected in China in April 2014 and has since been detected in Laos and Vietnam. It is a recombinant virus, with the hemagglutinin gene closely related to that of H5N1 and the neuraminidase gene closely related to that of H6N6. It is highly pathogenic in poultry. It also seems to cause severe disease in the relatively few humans who have been infected. The low number of human cases (probably <10 over the past 20 months) suggests that the virus does not jump species easily.

Gilead's Hepatitis B Drug as Effective as Viread but Safer

5 January 2016 (Reuters [Amrutha Penumudi])—Gilead Sciences Inc said its experimental hepatitis B drug proved as effective as but safer than its approved treatment, Viread, in 2 late-stage studies.

The once-daily drug, tenofovir alafenamide (TAF), showed improved renal and bone safety compared with Viread (tenofovir disoproxil fumarate), Gilead said. The company plans to seek regulatory approval for TAF in the United States and Europe in the first quarter of 2016.

The drugmaker said in September that TAF was found safer than but as effective as its popular HIV drug, Truvada (tenofovir disoproxil/emtricitabine), in a late-stage study.

Patients given TAF experienced significantly lower loss of bone mineral density and kidney function than those on Truvada.

Gilead is developing TAF as a safer replacement for Viread and Truvada.

Copyright © 2016 Reuters Limited. All rights reserved.

Dynavax Reports Top Line Results of Phase 3 HEPLISAV-B Study

7 January 2016 (Marketwired)—Dynavax Technologies Corporation reported preliminary top-line results from HBV-23, a phase 3 trial of the safety and immunogenicity of its investigational hepatitis B vaccine, HEPLISAV-B, compared with a currently marketed vaccine, Engerix-B, in adults 18 to 70 years of age. HEPLISAV-B participants received 2 doses, at zero and one month, and Engerix-B participants received 3 doses, at zero, one, and 6 months. Both co-primary endpoints were met. The rates of clinically significant adverse events were consistent with randomization and similar to rates in prior trials, and HEPLISAV-B provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants as a group.

HEPLISAV-B participants were followed for 52 weeks after the last dose, and Engerix-B participants were followed for 28 weeks after the last dose. The total safety database for HEPLISAV-B now comprises 10 038 participants.

The peak seroprotection rate (SPR) in participants with type 2 diabetes mellitus who received HEPLISAV-B was 90.0% compared to 65.1% for Engerix-B, demonstrating non-inferiority and a statistically significant higher percentage of seroprotection provided by HEPLISAV-B compared to Engerix-B.

The peak SPR in the entire HBV-23 HEPLISAV-B group (95.4%) was statistically significantly higher than the peak SPR in the Engerix-B group (81.3%).

The peak SPR in the HEPLISAV-B group was statistically significantly higher than the peak SPR in the Engerix-B group in each age decile.

The peak SPR in the HEPLISAV-B group was statistically significantly higher than the peak SPR in the Engerix-B group in each prespecified subpopulation analyzed, including by sex, body mass index, and smoking status.

HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response.

Editorial comment. There were (are?) concerns that this vaccine could trigger autoimmune diseases. A key question for me is what percentage of nondiabetic nonresponders to currently available vaccines will respond to HEPLISAV-B. Knowing the response rate of individuals without diabetes in each arm of the trial should help answer the question.

Puerto Rico Reports First Case of Zika Virus, Spread by Mosquitoes

1 January 2016 (Reuters [Nick Brown and Victoria Cavaliere])—Puerto Rico has reported its first case of [locally acquired] Zika, a mosquito-borne virus that has been spreading across South America and the Caribbean and has been linked by Brazilian authorities to a serious birth defect, a US Congressman said.

Pedro Pierluisi, Puerto Rico's representative in Congress, said in a statement that his office had been in touch with the US Centers for Disease Control and Prevention, which had confirmed the single case of Zika on the island.

Zika was first detected in Africa in the 1940s but was unknown in the Americas until 2015.

The mosquito-transmitted disease has been confirmed in countries including Brazil, Panama, Venezuela, El Salvador, Mexico, Suriname, the Dominican Republic, Colombia, Guatemala, and Paraguay, according to public health officials.

Brazilian authorities in November linked Zika to a surge in babies born with microcephaly, a birth defect that seriously limits a child's mental and physical abilities.

Brazil has reported nearly 2000 cases of babies born with microcephaly, or unusually small brains, the World Health Organization (WHO) said.

The WHO said the cause of the outbreak [of microcephaly] in Brazil had yet to be determined.

Between 3 and 12 days after being bitten by a mosquito carrying the virus, 3 out of 4 people come down with symptoms including mild fever, rash, conjunctivitis, headaches, and joint pain.

Copyright © 2016 Reuters Limited. All rights reserved.

Editorial comment. Zika virus infection in its early stages is indistinguishable clinically from uncomplicated dengue fever and chikungunya infection. All 3 are transmitted by Aedes mosquitoes. The great majority of cases of Zika in the Western hemisphere have occurred in Brazil and Colombia, with much lower numbers reported from other Latin American countries and only sporadic cases from the Caribbean islands.

Since the onset of the outbreak, as of 26 December 2015, >3000 cases of microcephaly have been reported from Brazil. This compares with annual case numbers of microcephaly in Brazil, previous to arrival of Zika virus (2010–2014), of 139–167 cases. The relationship between Zika infection and microcephaly is not clear cut. About 80% of cases of Zika (not 25% as in the article) are said to be asymptomatic, and relatively few clinical cases have been proven serologically or by virus isolation in Brazil. Furthermore, despite thousands of suspected cases of Zika virus infection in Colombia, there has been no mention of microcephaly from that country.