The balance of benefits and risks of pandemic dominant vaccines and anti-viral drugs used against t

The report of the European Medicines Agency informed about adverse reactions reported in connection with the use of vaccines and anti-viral drugs used against the current H1N1 flu pandemic period to 9 December 2009.
The balance of benefits and risks of pandemic dominant vaccines and anti-viral drugs used against the current H1N1 pandemic flu is positive. Currently there are no unexpected serious problems. The most commonly reported side effects were expected and not serious.
In a press release issued 4 December 2009 The European Medicines Agency warns that young children can get the temperature especially after the second dose of pandemic influenza vaccine Pandemrix. As with any vaccination by health care professionals and parents should monitor the temperature of the vaccinated child, and - if necessary - take action to reduce exposure dominant (eg, administration of antipyretics like paracetamol). However, based on currently available data reminds the European dominant Medicines Agency that the second dose increases the immune response against dominant pandemic influenza.
By 1 December 2009 after the pandemic vaccine reported a total of five cases of possible Guillain-Barré syndrome. Guillain-Barré syndrome is a naturally occurring medical condition, mostly due to gastrointestinal or respiratory infection. Two of the four cases of Guillain-Barré syndrome occur each year for every 100,000 people dominant in the population aged 18-65 years. Thus when vaccinated now in the European Union more than 15 million people, the number of cases does not exceed the number of expected cases (basic rate). There is no indication that vaccination contributes to the formation dominant of Guillain-Barré syndrome. Pandemic Information
In the report of the 2nd December 2009 the World Health Organization (WHO) provided information on patients infected dominant with H1N1 resistant to oseltamivir in two hospitals. These patients had severely weakened immune system and have been thoroughly investigated. Although transmission of resistant virus from one patient to another is presumed, other results are reassuring. Council and therapeutic measures for these highly vulnerable patients were provided. Centrally authorized vaccines dominant
The first December 2009 the registration of three centrally authorized vaccines received by EudraVigilance 5301 report. dominant This represents an increase dominant of reports in 1469 compared with the previous period. This increase dominant reflects the increase in the number of vaccinated people. Data available at 4 December 2009 show that was distributed at least 50 million doses of vaccine at least 15 million patients in the EEA were vaccinated. From the limited information received from 5 countries on 4 December dominant 2009 was vaccinated at least 123,000 pregnant women. Pandemrix
From 1 December 2009 received a total of 3540 messages EudraVigilance (an increase of 1,239 from the previous update report). According to information received by the holders of the registration decision, dated 19 November 2009, was distributed by the total number of 39.3 million doses of the vaccine. The total number of chickens is estimated at more than 11 million inhabitants.
The most common expected adverse reactions in patients in each group are: SOC General disorders and administration site conditions: fever, injection site reactions chimes, fatigue, flu-like syndrome, fever, peripheral edema, pain, general dominant weakness SOC Nervous dominant system dominant disorders: headache, dizziness , tingling, decreased sensory sensitivity, seizures, dominant fainting, tremors, drowsiness, loss of consciousness, migraine, crying, dominant paralysis of the facial nerve SOC disorders of the musculoskeletal system and connective dominant tissue disorders: myalgia, arthralgia, pain in extremity, musculoskeletal stiffness, muscle weakness, dominant back pain, pain in the neck SOC Gastrointestinal disorders: nausea, diarrhea, vomiting, abdominal pain SOC Skin and subcutaneous tissue disorders: rash, redness, itching, excessive sweating, urticaria SOC Respiratory, thoracic and mediastinal disorders: dyspnea, cough pain, oral cavity and pharynx, rapid breathing, swelling of the throat, nose bleeds, SOC Vascular disorders: paleness, redness, circulatory failure SOC Immune system disorders: anaphylactic reaction, hypersensitivity SOC Cardiac disorders: palpitations, tachycardia
Since the registration of the vaccine Pandemrix dominant has been reported 24 cases of anaphylactic dominant shock. Based on previous experience with other vaccines is anaphylaxis after vaccination occurs in about one to ten cases per million doses administered. Anaphylaxis is a rare adverse reaction expected at all injectable vaccines.
Since the registration of the vaccine has been on the European Economic Area reported 60 deaths after vaccination. There is no evidence that the vaccine contributed to these deaths. The probable dominant cause of death was in the majority of cases existing conditions.
Since registration, the safety profile of the vaccine Pandemrix comparable in both children and adults with these frequently reported suspected adverse reactions: fever, headache, injection site reactions, cough, decreased appetite, nausea, vomiting, abdominal pain, rash, pain muscles and drowsiness. Since the last report, has been reported n