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Tracking Vaccine Safety

 
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PostPosted: Fri Dec 04, 2009 9:46 am    Post subject: Tracking Vaccine Safety Reply with quote

The European Medicines Agency has started providing a weekly update on adverse reactions to the H1N1 vaccine and other related information.

Status on Nov. 27, 2009

In the EU, it is estimated that about 10 million people have been vaccinated so far. The vaccine adverse effects reported so far have mainly been symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the expected safety profile of the three vaccines.

New clinical trial data showed greater incidence of fever following the second dose of Pandemrix in infants from 6 months to 35 months. An assessment of these data is ongoing.

As of 19 November, WHO had received vaccination information from 16 of around 40 countries conducting national H1N1 pandemic vaccine campaigns. Based on information in these 16 countries, WHO estimates that around 80 million doses of pandemic vaccine have been distributed and around 65 million people have been vaccinated

Celvapan
As of 27 November, a total of 160 reports and 414 reactions have been received by EudraVigilance. A total of 3,399,200 doses have been distributed to EU Member States through 16 November.
* Headache, nausea, malaise, vomiting, malaise, hypersensitivity, fever, paraesthesia, dyspnoea, arthralgia and myalgia have been among the most frequently reported suspected adverse reactions since the authorisation of the vaccine.
* Reports in children included anaphylactic reactions and hypersensitivity have been received.
* Since the start of use of Celvapan one case report has been received with a fatal outcome. There is no indication that the vaccine contributed to this death.
* No signal of a new safety issue has been detected since authorisation.


Focetria
As of 27 November, a total 1,371 reports and 5,228 reactions have been received by EudraVigilance. According to company information dated 16 November, 10 million doses have been distributed through 2 November 2009.2 It is estimated that about 4.5 million of doses have been administered.
* Headache, fever, nausea, fatigue, dizziness, vomiting, chills, injection site reactions, myalgia, pain in extremity and dyspnoea have been among the most frequently reported suspected adverse reactions since the authorisation of the vaccine.
* Twelve reports have been received with a fatal outcome. There is no indication that the vaccine contributed to these deaths.
* One case of cerebral haemorrhage has been received. It concerned a patient of 76 years, and the information currently available does not suggest that the vaccine caused the event.
* Three cases of severe anaphylactic reactions have also been received.
* No signal of a new safety issue has been detected since authorisation.

Pandemrix
As of 27 November a total of 2,301 reports and 6,269 reactions have been received by EudraVigilance. According to information received from the marketing authorisation holder dated 19 November, the total number of doses distributed was 39.3 million and the total number of people vaccinated was estimated to be around 5.7 million through 17 November 2009.
* Fever, headache, nausea, vomiting, fatigue, injection site reactions, myalgia, arthralgia, paraesthesia, dizziness, pain in extremity, diarrhoea, chills, dyspnoea, malaise, cough, anaphylactic reaction and hypersensitivity have been among the most frequently reported adverse reactions since the vaccine has been authorised.
* New clinical trial data showed greater incidence of fever (above 38°C), local reactions (pain, redness, swelling) and drowsiness/irritability/loss of appetite following the second dose of Pandemrix in infants from 6 months to 35 months. An assessment of these data is ongoing.
* Since the start of use of Pandemrix as an authorised vaccine, a total of 55 case reports have been received by the EudraVigilance system which have a fatal outcome. There is no indication that the vaccine contributed to those deaths.
* EudraVigilance has received a total of 24 cumulative cases of pregnancy related events such as abortions, intrauterine deaths, stillbirths, foetal hypokinesia and premature birth. Those cases are being investigated further. There currently is no evidence of a causal link between the vaccine and reported events.
* EudraVigilance has received 26 paediatric cases of anaphylactic reactions/hypersensitivity (24 cases aged from 0 to 17 years, and 2 with age unknown). Anaphylaxis is a rare expected adverse reaction to Pandermix.
* Up to 27 November, three reports of Guillain-Barré syndrome were received. Two were later not confirmed and one is under investigation. There is no evidence to suggest that the vaccine causes Guillain-Barré syndrome.
* A case of heart transplant rejection from Sweden was received. Further information was requested and health authorities are seeking advice from transplant immunologists.

Tamiflu
From 1 April to 27 November 2009, a total number of 705 reports and 1,029 reactions have been received in Eudravigilance.
According to information received from the marketing authorisation holder dated 5 November 2009, the patient exposure during the period October 2008 to September 2009 was 10.4 million patients.

* The adverse reaction reports received are consistent with the safety profile described in the Product Information.
* Since April 2009, 137 case reports have been received by the EudraVigilance system with a fatal outcome following Tamiflu use. In the fatal cases, the causal association with oseltamivir treatment cannot be established. It should be noted that healthcare professionals are actively encouraged to report events following administration of medicinal products and purely coincidental events (e.g. due to underlying medical conditions) that would have occurred anyway, in the absence of therapy, will be reported.

http://www.emea.europa.eu/pdfs/influenza/78468109en.pdf

Home for weekly updates: http://www.emea.europa.eu/
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PostPosted: Fri Dec 04, 2009 10:23 am    Post subject: Reply with quote

My summary:
reports and "reactions" per million vaccinations (deaths,cause unclear):
Celvapan:~20,+50,(~0.5)
Focetria:305,1162,(2.7)
Pandemrix:404,1100,(10)
Tamiflu:70,100,(14)
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