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Despite a serious outbreak of swine flu in neighboring Ukraine, the Polish government played it cool last week. Polish Health Minister Ewa Kopacz announced that she was not planning to stock up on swine-flu vaccine until it had been properly tested.The safety of the flu vaccine, in Italy the Focetria by Novartis, is still strongly debated. The daily government's report have updated the death toll to 62.
"The A/H1N1 vaccine is being produced by three companies, none of which has been able to assess its long-term effects. Their testing lasted a relatively short amount of time. It is not known whether [the vaccine] is safe for children and pregnant women," the health minister explained at a press conference last week.
"The non-clinical program included studies where the MF59C.1 adjuvant was given alone, or in combination with non-influenza antigens. This included specifically designed studies with administration before pregnancy, at the time of mating, as well as later during pregnancy in rabbits. It was shown that the doses of MF59C.1 applied did not induce reproductive toxicity for the dam or the foetuses. Experience with these adjuvants in pregnant women is very limited. In the pregnancy clinical database of Novartis, a limited number of pregnancies occurred in females of childbearing potential exposed to at least one dose of a MF59C.1 adjuvanted vaccine (either influenza vaccine or not). No occurrence of congenital abnormalities was reported, but the experience is too limited to draw conclusions."So, it looks like Codacons could be right about the vaccine safety in pregnant women. The adjuvant has been tested in rabbits, not women . On the other hand, one should consider the risk of becoming infected while pregnant. So, it's up to every woman to choose. But the Italian Focetria leaflet doesn't help. Strange enough, the Italian leaflet ("Tell your doctor if you may be pregnant, plan to become pregnant. You should discuss with your doctor whether you should receive Focetria) is less clear from the English Focetria leaflet ("Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant. You should discuss with your doctor whether you should receive Focetria).
“We invite every member to be active in order to facilitate the vaccination of the people in risk group and to get yourself vaccinated against the swine flu” wrote the national secretary of the FIMMG, Giacomo Milillo, in a letter sent to the 27,000 doctors enrolled to the Federation. “The start of the campaign, scheduled on November 15, it is not still at top speed and in many local health unit (Asl) there are some difficulties to begin the campaign. In some regions it has been decided to entrust the vaccination to the general doctors, in others this task has been assigned to local centers. It is not important who will give the vaccine against the swine flu, but the realization of a adequate vaccination cover. Therefore, it is fundamental that the message to the population is clearest and the most similar as possible. It is not a corrected and responsible professional behavior – wrote Milillo - to diffuse doubts on the emergency of the vaccine and perplexities that are not based on reliable sources of reference and rather contribute to create a climate of confusion that could put to risk the vulnerable groups of the population. Our vaccination is necessary to contribute to the protection of the population, in particular of the chronic ill ones who we assist. The advantage that the vaccination have for people at risk (chronic ill, women to the second and third trimester of pregnancy) is infinitely larger then possible theoretical risks. The doubts on the emergency of the vaccine are groundless and pretext: the adjuvant contained has been given to million persons in the past (more than 40 million) and has only recorded three or four cases of serious reactions. The contained mercury amount in the vaccine dose vaccinates is comparable to the amount we eat in one or two tuna cans.”In Italy many doctors refuse the vaccine. According to La gazzetta del Mezzogiorno, newspaper of Bari city, in the Puglia Region only 7% of health care workers has been vaccinated.
I write this blog to compare national experiences, to raise awareness of mutual problems, and to improve science communication. Please, any help will be appreciated!