FDA issues warning over GSK’s flu vaccine plant in Quebec
The US Food and Drug Administration (FDA) has issued a warning to GlaxoSmithKline (GSK) over cleanliness shortcomings at its plant in Ste. Foy, Quebec, which makes Canada's seasonal flu vaccine, the Canadian Press reported today.
The letter, dated Jun 12, details concerns at ID Biomedical Corp., a GSK subsidiary that produces Flulaval influenza vaccine at the Quebec plant. Deficiencies noted by the FDA relate to potential lack of sterility and microbial contamination.
The agency found several types of bacteria, mostly Ralstonia pickettii and species of Achromobacter. Some bacteria were isolated from the plant's purified water system. The letter also noted that vaccine lots produced in 2011 through 2014 contained high endotoxin levels.
The deficiencies "are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product and intermediates," the letter states.
In the letter the FDA gives GSK 15 working days to address the problems or explain the delay. It also requests a meeting with senior GSK and ID Biomedical management. GSK said in a statement that it is making progress in addressing the FDA's concerns, according to the Canadian Press story.
Jun 24 Canadian Press story
Jun 12 FDA warning letter
A mix of pathogens caused pneumonia in 2013 Hajj participants
A variety of different viruses and bacteria, but not MERS-CoV, were associated with severe pneumonia in participants in the 2013 Hajj, Saudi Arabian researchers reported yesterday in the International Journal of Infectious Diseases.
The authors collected sputum samples from all patients who were admitted to 15 healthcare facilities in Mecca and Medina with severe bilateral pneumonia during the pilgrimage. They used polymerase chain reaction to test for MERS-CoV (Middle East respiratory syndrome coronavirus) and also screened the samples for up to 22 other pathogens.
The report says 38 patients met the study criteria. They were mostly older (mean age, 58.6 years) and male (68.4%), and all were from developing countries.
MERS-CoV was not found in any of the samples, but 26 of the 38 tested positive for other pathogens. Bacterial pathogens were found in 22 of the 26 samples (85%) and viruses in 21 (81%); 21 samples contained more than one pathogen.
The most common virus was rhinovirus, found in 58% of the positive samples, followed by influenza A (23%) and human coronaviruses (19%). The leading bacterial species were Haemophilus influenzae (58%), Streptococcus pneumoniae (54%), and Moraxella catarrhalis (36%).
The authors concluded that the etiology of severe community-acquired pneumonia during the Hajj is complex.
No confirmed MERS-CoV cases were identified in connection with last year's Hajj, but this year's upcoming Umrah and Hajj pilgrimages have stirred concern because of the increase in MERS-CoV cases in April and May.
Jun 23 Int J Infect Dis abstract
Youngest kids, chronically ill stand out in pneumonia readmission profile
A study published yesterday in Pediatrics found that readmission in kids hospitalized with pneumonia is common, especially in the youngest children and those with chronic medical conditions.
Researchers from seven states and the District of Columbia looked at records of children hospitalized with pneumonia at 43 hospitals that are part of the Pediatric Health Information System from Jan 1, 2008, to Dec 31, 2011. They focused on all-cause readmission within 30 days of discharge and pneumonia-specific readmission. During the study period, 82,566 youngsters were hospitalized with pneumonia.
The readmission rate for all causes was 7.7% and for pneumonia was 3.1%. Rates were higher in children younger than 1 year old, those with previous hospitalizations, those who had longer initial hospitalizations, and those with complicated pneumonia.
Kids with chronic conditions were 3 times more likely to be readmitted for any cause and 1.8 times more likely be rehospitalized for pneumonia.
More than a third of the readmission occurred within 1 week of hospitalization, which the researchers said shows the importance of increased discharge guidance and coordinating care with outpatient health providers.
The group also found that repeat hospitalizations for pneumonia were costly, accounting for 16% of all costs for pneumonia in kids.
Jun 23 Pediatrics abstract
NIH grant explores new polymyxin options for superbug infections
The National Institutes of Health (NIH) has awarded an international research team $4.4 million to explore new ways to use the antibiotic polymyxin to battle antibiotic-resistant gram-negative bacterial infections without harmful effects, the University of Buffalo announced yesterday in a news release.
The team based at the University of Buffalo also includes researchers from Australia and Weill Cornell Medical College in New York City.
Polymyxins were developed more than 50 years ago and were used in the past before toxic effects to the kidneys and nervous system were known. Plasma concentrations at recommended doses aren't effective for treating critically ill patients, and researchers have seen evidence that resistance even to polymyxins is increasing.
With no new drugs in the pipeline for treating antibiotic-resistant infections, experts are reassessing a possible role for polymyxins. The team will use a Hollow Fiber Model System at the University of Buffalo that mimics antibiotic concentrations in critically ill patients' blood.
Brian Tsuji, PharmD, who is leading the research team, said in the release that the model will also allow scientists to study the drug combinations over the same 14-day period for treating patients with bacterial pneumonia.
"This will allow us to address the public health disaster of antimicrobial resistance and to fight these deadly infections in severely ill patients where no traditional treatments exist," he said.
Jun 23 University of Buffalo press release