GSK projects 2-million-dose flu vaccine shortfall for Canada
GSK, Canada's largest flu vaccine supplier, said today it won't be able to fill about 30% of its Canadian order for the upcoming flu season because of problems at its Ste. Foy, Que., plant, the Canadian Press reported today.
It's unclear how the deficit will affect GSK doses in the United States, a GSK spokesman told CIDRAP News.
GSK said the problem in Canada is not related to issues raised in inspections earlier this year by the US Food and Drug Administration (FDA) and Health Canada, according to the Canadian Press story. The company did not specify the current problems, which will result in about a 2-million-dose shortage.
"We are continuing to investigate the cause of this issue," GSK spokewoman Michelle Smolenaars Hunter said in an e-mail.
The shortfall represents almost 17% of Canada's total flu vaccine doses for the 2014-15 season, but the country has been preparing contingency plans since problems at the Ste. Foy plant were highlighted by the FDA in June, the story said. Other vaccine makers have been asked to supply extra doses, and so far the Public Health Agency of Canada has secured 1.2 million additional doses from them.
The difficulties at the Canadian plant will have some effect on delivery dates and amounts of GSK flu vaccines made for the US market this fall, but how much of an impact is not yet clear, GSK spokesman Robert Perry told CIDRAP News today.
He said the company is facing some delays in delivery of FluLaval and FluLaval Quadrivalent doses in the United States, which are related to lot releases by the FDA at the Quebec facility. GSK is keeping the CDC informed of the situation, he noted.
The company previously estimated it would produce 28 million to 33 million doses of flu vaccine for the US market this year, some of which are made at the Canadian plant and some in Dresden, Germany. "I'd say we're still in that range," said Perry, who works in Philadelphia.
Sep 4 Canadian Press story
Study: Flu vaccine about 50% effective in pregnant women, their babies
A randomized trial from South Africa suggests that influenza provides about 50% protection in pregnant women and their infants up to the age of 24 weeks, while a companion study suggests slightly higher protection in HIV-infected pregnant women.
The two studies, covered in one report yesterday in the New England Journal of Medicine, were double-blind, placebo-controlled trials conducted in 2011 and 2012 among HIV-uninfected women and in 2011 among HIV-infected women. The authors assessed immune responses with a hemagglutination inhibition (HAI) assay and used reverse-transcriptase polymerase chain reaction (RT-PCR) assays to diagnose flu.
The researchers recruited 2,116 HIV-uninfected pregnant women. In this group, the flu attack rates for placebo recipients and their babies were both 3.6%, while the attack rates for vaccine recipients and their infants were 1.8% and 1.9%, respectively. This translated into vaccine efficacy (VE) levels of 50.4% (95% confidence interval [CI], 14.5%-71.2%) for the mothers and 48.8% (95% CI, 11.6%-70.4% ) for the infants.
For the study of HIV-infected women, the authors enrolled 194 pregnant volunteers. The attack rate for placebo recipients was 17.0%, and the rate for vaccine recipients was 7.0%, which signaled a VE of 57.7% (95% CI, 0.2%-82.1%). For these women's infants, the attack rates were 5.0% in the vaccine group and 6.8% in the placebo group, indicating a nonsignificant VE of 26.7% (P = .60).
The authors found that the vaccine was immunogenic in both HIV-uninfected and HIV-infected women, as represented by higher rates of seroconversion and HAI titers of at least 1:40 in the vaccine groups than in placebo groups.
Sep 4 NEJM abstract
Study notes airborne transmission of H3N8 flu from seals
The H3N8 flu virus that caused widespread harbor seal deaths in 2011 can spread readily via respiratory droplets among mammals and potentially infect humans, according to a study yesterday in Nature Communications.
Scientists from the US Geological Survey (USGS) and St. Jude Children’s Research Hospital in Memphis, Tenn., tested an H3N8 virus taken from an infected harbor seal in New Hampshire in 2011 and found that it is closely related to inﬂuenza viruses from wild birds.
They also noted that the seal H3N8 virus contained mutations that allowed it to reproduce efficiently in human lung cells, cause disease in mice, and infect ferrets in adjacent cages via respiratory droplets.
The team wrote, "Analysis of a panel of human sera for H3N8 neutralizing antibodies suggests that there is no population-wide immunity to these viruses."
"The ability to transmit through the air is an important step in the path toward any influenza virus becoming pandemic," said USGS scientist Hon Ip, PhD, in a USGS news release. "The lack of protection against the seal virus from the annual seasonal vaccine highlights the risks posed by this H3N8 group of viruses."
The authors conclude, "The prevalence of H3N8 viruses in birds and multiple mammalian species including recent isolations from pigs and evidence that it was a past human pandemic virus make the need for surveillance and risk analysis of these viruses of public health importance."
Sep 3 Nature Comm abstract
Sep 3 USGS news release
Jul 31, 2012, CIDRAP News story "Novel H3N8 strain found in dead seals may pose human threat"
More outbreaks of the new H5N6 avian flu strain in Vietnam
Two new outbreaks of highly pathogenic H5N6 avian flu have been reported in Vietnam, according to a report today from the World Organization for Animal Health (OIE). The OIE posted its first report of H5N6 in Vietnam on Aug 8, calling it a new avian flu strain; two other outbreaks were reported on Aug 22.
The current outbreaks involved village flocks. The first flock, in the Gio Linh district of Quang Tri province in north central Vietnam, lost 350 birds to H5N6 among 1,550 susceptible birds. The remaining 1,200 birds were destroyed to prevent disease spread.
The second outbreak, in Son Tinh district, Quang Ngai province in the south-central coastal part of the country, involved 200 bird deaths in a 1,100-bird flock. The remaining 900 were culled.
The apparent morbidity and mortality rate for the two farms was 20.75%, and the apparent case-fatality rate was 100%. Control measures undertaken include control of wildlife reservoirs, movement control in the country, screening, and disinfection of the infected premises.
Sep 4 OIE report
Aug 22 CIDRAP News scan on prior outbreak
Aug 13 CIDRAP News scan on prior outbreak
Reproduction number in recent pandemics was less than 2
The reproduction numbers in the last four influenza pandemics have ranged from 1.46 to 1.80, according to a meta-analysis today of 111 studies by researchers with the US Centers for Disease Control and Prevention and the Institut Pasteur in Paris.
The reproduction number, or R value, is the average number of additional cases caused by each infected person over the course of an outbreak.
The researchers, according to their report in BMC Infectious Diseases, found that the median R values for the most recent pandemics were as follows:
- 1918: 1.80 (24 studies)
- 1957: 1.65 (6 studies)
- 1968: 1.46 (4 studies)
- 2009: 1.46 first wave, 1.48 second wave (57 studies)
In addition, 24 studies noted a median R value of 1.28 for seasonal flu, and 4 studies reported R values of six novel influenza strains, with four of the six being less than 1.
Sep 4 BMC Infect Dis meta-analysis