11 January update on Swine flu vaccination - 11/1/2010

link to EMEA report - 6th January;

link to Notice extending vaccination period;

link to form for reporting adverse reactions;

Dear Doctor,

We thank you as most of you are collaborating and cooperating with us and advising your patients suffering from chronic disease who are at most risk of developing complications to influenza to take the vaccine. Unfortunately we are receiving phone calls from some patients who are confused and ask for our advice because a handful of doctors who clearly are not well informed and are not reading all the information we have sent, who are advising them against the vaccine.

Vaccinations have proven over the years to save people’s lives who otherwise would have succumbed to infections with serious consequences including death. Our job as doctors is to save lives and though so far many influenza cases have proven to be mild, over 2550 persons in Europe alone have died. We had two previously healthy young adults in their 30s who unfortunately have died because of H1N1. I do not think any of us would like to lose a patient of theirs to influenza.

No vaccine is 100 % effective and they can have possible adverse effects like all medication or interventions but all data so far collected from over 26 million persons vaccinated in Europe ( of which 17 million were with Pandemrix) have shown that the adverse effects are minor effects and rare adverse effects are in fact rare. WHO, ECDC, EMEA are recommending this vaccine because all available information has shown it to be a safe and effective vaccine.

The Health authorities have worked very hard to obtain this vaccine for the Maltese population – your patients so please recommend it to your patients to protect them against H1N1 and help reduce the morbidity and mortality associated with it.

We are extending the vaccine for another week for high risk groups. ( see press release attached).

Health care professionals are especially encouraged to report the following adverse events following immunization to Pandemrix to the Medicines Authority. I am inclosing the form which you can send electronically.

- Fatal or life-threatening adverse reactions

- Unexpected adverse reactions that are serious (i.e., require or prolong hospitalization, result in persistent disability or incapacity, or causes a birth defect)

- Adverse events of special interest: anaphylaxis, Bell's palsy, convulsions, demyelinating disorders, encephalitis, Guillain-Barré syndrome, neuritis and vasculitis.

I am also sending the latest pharmacovigilant update by EMEA.


Dr Tanya Melillo Fenech MD Msc(HSM)Dip(HSM)

Public Health Specialist

Head of Infectious Disease Prevention and Control Unit


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