The US Food and Drug Administration has ordered GlaxoSmithKline to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu vaccine FluLaval.
It is another serious blow to Britain’s biggest drugmaker, already reeling from corruption allegations in Poland, Iraq, Jordan, Lebanon and China, and facing a criminal investigation by the UK’s Serious Fraud Office into its sales practices. It also recently paid out £63m to settle US marketing allegations. Earlier this week GSK had to apologise for the pitch adopted by a marketing firm working for the FTSE 100 company to recruit unpaid interns for clinical trials in the UK.
In a warning letter to the British company, the FDA cited “deviations from current good manufacturing practice” in the manufacture of FluLaval at GSK’s Quebec-based subsidiary ID Biomedical, which makes the vaccine for Canada and the US.
Ebola is introduced into the human population through close contact with the blood, secretions, organs or other bodily fluids of infected animals. In Africa, infection has been documented through the handling of infected chimpanzees, gorillas, fruit bats, monkeys, forest antelope and porcupines found ill or dead or in the rainforest.
Ebola then spreads in the community through human-to-human transmission, with infection resulting from direct contact (through broken skin or mucous membranes) with the blood, secretions, organs or other bodily fluids of infected people, and indirect contact with environments contaminated with such fluids. Burial ceremonies in which mourners have direct contact with the body of the deceased person can also play a role in the transmission of Ebola. Men who have recovered from the disease can still transmit the virus through their semen for up to 7 weeks after recovery from illness.
Health-care workers have frequently been infected while treating patients with suspected or confirmed EVD. This has occurred through close contact with patients when infection control precautions are not strictly practiced.
Among workers in contact with monkeys or pigs infected with Reston ebolavirus, several infections have been documented in people who were clinically asymptomatic. Thus, RESTV appears less capable of causing disease in humans than other Ebola species.
However, the only available evidence available comes from healthy adult males. It would be premature to extrapolate the health effects of the virus to all population groups, such as immuno-compromised persons, persons with underlying medical conditions, pregnant women and children. More studies of RESTV are needed before definitive conclusions can be drawn about the pathogenicity and virulence of this virus in humans.
tandard, contact, and droplet precautions are recommended for management of hospitalized patients with known or suspected Ebola hemorrhagic fever (Ebola HF), also referred to as Ebola Viral Disease (EVD) (See Table below). Note that this guidance outlines only those measures that are specific for Ebola HF; additional infection control measures might be warranted if an Ebola HF patient has other conditions or illnesses for which other measures are indicated (e.g., tuberculosis, multi-drug resistant organisms, etc.).
Though these recommendations focus on the hospital setting, the recommendations for personal protective equipment (PPE) and environmental infection control measures are applicable to any healthcare setting. In this guidance healthcare personnel (HCP) refers all persons, paid and unpaid, working in healthcare settings who have the potential for exposure to patients and/or to infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air. HCP include, but are not limited to, physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual personnel, home healthcare personnel, and persons not directly involved in patient care (e.g., clerical, dietary, house-keeping, laundry, security, maintenance, billing, chaplains, and volunteers) but potentially exposed to infectious agents that can be transmitted to and from HCP and patients. This guidance is not intended to apply to persons outside of healthcare settings.
As information becomes available, these recommendations will be re-evaluated and updated as needed. These recommendations are based upon available information (as of July 30, 2014) and the following considerations:
- High rate of morbidity and mortality among infected patients
- Risk of human-to-human transmission
- Lack of FDA-approved vaccine and therapeutics