Vaccine, the popular one

The swine flu vaccine is really unpopular in Italy. According to the Ministry of Health, at the end of January just 851,549 people were vaccinated. Most of them had one single dose, while 47,013 people got two doses. The Ministry has an huge surplus of vaccine, that nobody knows how to use. As a matter of fact, only a small amount of the 1,047,421 available doses has been given. The data of the previous vaccinatation campaign, against a 'common' flu virus, is much higher. In the 2008-2009 campaign the 19.1% of the population got the shot, almost 11,5 millions of people. Anyway, in that case the elderly were also offered, after many years of targeted public communication. In the swine flu campaign instead only old people with other medical conditions were included, and only in the last phase of the campaign. Moreover, this has been the first time that healthy young people, aged 18-27, have been offered the flu vaccine.

On persuading Novartis

Sergio Dompè, the president of the association of pharmaceutical industry (Farmindustria), hopes that Novartis and the Italian government will reach a new agreement to change their contract and to convert the swine flu vaccine supply in something else. Instead of buying other doses, the government will buy other products. Dompè said that, considering the actual need, it's understandable to find a way to make more efficient the expenditure (184 million euros). He also added that he will try to persuade Novartis to change the contract. Only 865,000 people in Italy got the swine flu shot, while some 10 millions of doses are stocked. Other 14 millions of doses have been ordered but not yet delivered.

Media: Poland refuses the flu vaccine

Today the main piece of news is about Poland that is "calm and unvaccinated." Italian online media are really interested in this story:

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 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 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.

Campania hit by swine flu

According to the Ministry of Health, the fatal cases of swine flu are 53. Fifty people were in the risk group.Very few people have been vaccinated, only 150,000 people out of 3,000,000 avalaible doses. The websites of many newspapers aren't covering the pandemic in the front page any more, apart from ilmattino.it, newspaper of Campania region, where occured 23 deaths. Meanwhile, the flu articles are in the top 20 news of GoogleNews.
The press release of the government has also announced that 40 million of antiviral drugs doses are avaiable, but this issue is not currently debated.

Doubts about vaccine safety

The Italian consumers organization Codacons has asked the Ministry of Health to prove the safety of the flu vaccine, the Focetria vaccine made by Novartis. Codacons doubts that  a producer can make and test a flu vaccine in four months. Another point is the use of the MF59C.1 adjuvant, containing squalene. In Italy Codacons is a well known union, but in such a scientific matter it's a bit confused (and confusing).
The European Medicines Agency (Emea) has already explained the procedure of the ‘mock-up’ vaccines: in the first step Emea has evaluated a flu vaccine containing a different strain, the H5N1, and when the WHO declared the pandemic, the vaccine producer has replaced the strain in the mock-up vaccine with the pandemic H1N1 strain.
The second issue is more complex. "Clinical trials with MF59C.1 adjuvanted H5N1 vaccine have shown that the vaccine is adequately immunogenic in children older than 6 months up to 17 years with an acceptable safety profile." wrote Emea about the safety of the adjuvant system in children. So, it's ok for children.

More murky is the evidence of safety in pregnant women. Emea wrote:

"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).

The vaccination campaign starts everywhere

Two fatal cases of swine flu have been confirmed today, in Umbria and in Campania. The death toll is now 34. The Deputy Health Minister Ferruccio Fazio has asked newspapers "to not rise useless alarms", while insisting that people in the risk group should get the vaccines, which "are safe and are used around the world." There are large differences in the vaccine distribution to population in Italy. Some regions, for example Sardinia, will start tomorrow the first phase of the vaccination campaign, while other regions have already proceeded at step two. However the outbreak has already caused 700,000 flu cases.

Vaccination program on time?

Can the vaccination program against swine flu be on time? According to a recent study, it can be expected “an autumn/winter wave in the Northern hemisphere strikingly earlier than expected”. In Italy the peak time of the pandemic will occur from 17 October to 23 November. “The analysis shows the potential for an early epidemic peak occurring in October/November in the Northern hemisphere, likely before large-scale vaccination campaigns could be carried out” write the authors. The simulations refer to a worst-case scenario, with no antiviral drugs used.
This is quite worrying. “The vaccine has been expected for the beginning of November” has said pharmacologist Silvio Garattini, interviewed by Agi press agency. “The trouble is that the pandemic has reached Italy earlier than expected, and if it carries on like, that the vaccine could be useless, because protection develops after 15 days from the shot”. According to the expert, it's necessary that all the Italians in the high risk groups get the shot by the middle of November, but this goal is "almost impossible".
This is a grim forecast, but for once it looks like based on sound science.

24 million doses of vaccine

The vaccination campaign against H1N1 virus has started. In some places it's just at the beginning, while in others it has already moved on the second stage. In Liguria the newspaper Il Secolo XIX explains that next Monday in Genoa doctors and other health workers will be vaccinated. Lombardia region is already at phase two of the process, so they will call pregnant women and people under 65 affected by chronic diseases.

Emilia-Romagna region is still completing stage one. Tuscany is operating at the second stage, while carrying out stage one, as Asca press agency reports. Abruzzo region doesn't seem to have received the vaccine against the pandemic flu.

In South Italy Puglia will start the campaign on Monday, first health personnel and pregnant women. The island of Sardinia too has to begin stage one

So, the campaign is on, but it has been carried on speedily in some regions and sluggishly in other parts of the country.

According to Agi press agency, the Minister has distributed one million doses of the pandemic vaccine. To vaccinate the health workers and other essential workers it expect to use 8 millions doses. At the end of the campaign it will distributed 24 million doses.

Flu death in Naples

More details about the patient who died yesterday in Naples after being infected by H1N1 flu virus. He was a doctor, affected by anaemia, obesity and cardiac disease. On Monday he was admitted at Cotugno Hospital because of pneumonia. According the local newspaper Il Mattino, he didn't got vaccination because the regional health units have run out of the doses, primarily used for health care workers. The Italian Deputy Minister of Health Ferruccio Fazio said in an interview that the pandemic has started off and that in some part of Italy,, especially in South Italy, the vaccination campaign is late.
Personally, I don't understand who is late, the vaccine manufacturer, the national health structure or the local one.