The withdrawal of the vaccines

The Minister of Health, Professor Ferruccio Fazio, said yesterday that the Ministry has began to count the number of the unused vaccines in the Regions. This is the first step for the withdrawal of the vaccines. He said also that if the WHO doesn't declare  the phase 5 of the pandemic (we are in phase 6), the pandemic alarm can't be ended. He concluded that the final assessment of the pandemic in Italy is good if there won't be a new swine flu outbreak. Actually, there are some flu virus circulating in the country, but they are the flu type B viruses.

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.

What about the vaccine safety?

Maybe MF59 adjuvated vaccine, like the Focetria vaccine by Novartis, used in Italy against the swine flu, could protect people from more types of virus. In a paper published by Science Translational Medicine, researchers from FDA, Novartis and Vanderbilt University Medical Center in Nashville, said that the MF59 adjuvant can make the trick. They said that they can boost the efficacy of the vaccine against the avian virus adding the adjuvant. "MF59 adjuvant improves the immune response to a H5N1 vaccine by inducing qualitative and quantitative expansion of the antibody repertoires with protective potential" they write. So, the MF59 vaccine generates an immune response non only against the selected strain, but also against others. According to the journal, this can be really useful in large scale vaccination.

Ironically, the safety of the MF59 got questioned by Italians, that preferred to skip the vaccine against the swine flu. Right now the Minister of Health don't know what to do with all the stocked doses.

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.

The secret agreement

Altreconomia, an Italian magazine, has published on-line the “secret agreement” between the Italian government and the pharmaceutical company Novartis to buy 24 million doses of the swine flu vaccine. The article said that the agreement was too partial to Novartis, because the company was liable only for damages caused by defects of production, it was made no responsible for any delay in the production, and also because the vaccines were too expensive (168 million euro + VAT). These were the objections made by the article, that were reported by many other media. There's a feeling in Italy that the vaccination campaign has been a big business for the pharmaceuthical companies, not accetable given the mildness of the pandemic. The objections were first risen by a decision of Corte dei Conti, the court of law that checks that the financial government's acts are in accordance with the rules. The Corte dei Conti concluded that the government had to accept such unfavourable provisions because of the urgency of the matter. Actually, the timing of the production and delivery of the vaccines has been one of the troubles, but on this issue there's no debating.

Too late, too much

Today the Minister of Health, Professor Ferruccio Fazio, was asked in Parliament what to do with the unused doses of the swine flu vaccine. He was also questioned about the safety and efficacy of the vaccine itself, and about the costs of the campaign. Professor Fazio admitted that “the vaccine was available only when the first wave of the epidemic has begun”, and that the flu was, “thankfully”, really mild. These two facts have kept people away from the vaccine. Some 850,000 people got vaccinated, using a small fraction of the 10-million available doses. But there is this lesson of the swine flu, the vaccine supply was too late.

The Government expect to pay 184 million euros for 24 millions of doses, but the final figure could be less than that. According to the Minister, “the Government is evaluating some possibilities that could guarantee an appropriate use of the commitments decided by the Government against the swine flu.” The pronouncement isn't very clear, but it could mean the Government is going to sell the vaccine stock.

Too many doses

Yesterday the ANSA press agency, by l'Unità newspaper, covered a story about the mistrust of the flu vaccine. According to the poll conducted by Key-Stone, the 97% of Italians refuse to get the vaccine against the swine flu. The 25% refuse all kinds of vaccines, the 24 only the swine flu vaccine, while the 21% were advised by their doctors to not get the shot. More then half of the interviewed (59%) said that they have changed their hygienic habits, usually (in 80% of the cases) buying a disinfectant for the hands.
The vaccination campaign is now very slow. The Ministry of Health said that 821,000 people have been vaccinated, including the 15% of all the health care workers (159,093 people). The available vaccine doses are 10,047,421. The Ministry has also announced that it won't sell the vaccine stock to other countries.

An Italian vaccine

Italy have done well against the swine flu, and the country is ready to research a new universal vaccine against all the flu viruses. Yesterday the Deputy Minister of Health Ferruccio Fazio talked about the pandemic in Italy. Fazio said also that one of the goals of the Istituto Superiore della Sanità is the universal vaccine, active against all the influenza viruses. The target of the research will be the hemagglutinin, "the primary protein responsible for binding to receptor sites on the cell membrane, allowing the virion to enter the cell" (some weeks ago New Scientist published an article about this issue). Professor Fazio said also that Italy has spent for the vaccine campaign less money than other European countries, obtaining better results. However, it's too soon to draw conclusions: the number of cases is decreasing, and so the number of deaths, but the pandemic hasn't stopped yet, said Professor Fazio. In order to end  it it's important to continue the vaccination plan, he said. In Italy there's an high incidence only in Sardinia right now.

Flu toll above 100

The swine flu has came to its maximum in Italy, but the deaths are still increasing. The Ministry of Health has said that the deaths are 101 (27 in the Campania region). It said also that 494,915 people has been vaccinated, out of 5,030,851 available doses. More than 131,000 health care workers have been vaccinated, more or less 13%. Italian mass media have covered about a two years old  child who died in Lecce, Puglia region. Apparently, the child was healthy, before becoming infected.

A mutated flu virus in Norway

At least 68 flu-related deaths have been recorded by Italian Health Ministry, a high number in this time of year. Campania's health authority has reported 25 fatal cases, and it's the hardest hit region. The hospitalized cases have climbed to 489, while 241 people needed intensive care. Italian newspapers report today about a mutated version of the influenza virus, found in three patients in Norway, and this seems the most interesting thing of today. The Italian Deputy Health Minister, Professor  Ferruccio Fazio, is still inviting all the people at risk to get the vaccine shot. Today the newspapers cover also a story about a diet agains the flu. Black grapes, bananas, oranges and cauliflower can protect you, claims Fabio Firenzuoli, President of National Association of Phytotherapist Doctors. Also peppers work, if they are in different colours.

Swine flu at its peak: Week 46

Maybe the swine flu in Italy has reached its peak. Today InfluNet, the Italian surveillance network, has released updated datas for week 46, from November 9 to November 15. The incidence is 1.253%, a bit more than last week (1.227%). In the island of Sardinia  there's still one of the lowest incidences of flu cases (0.69%). The highest rate is again in Marche region (4.197%), followed by Abruzzo (3.492%), and Emilia-Romagna (1.917%), all in central Italy.

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.

Vaccine safety debated

In Italy people are arguing about the safety of the vaccination against the swine flu. This is the biggest debate, not the efficiency of the heath care system or the supply of antiviral drugs. Today the Italian news websites cover the unconfirmed death of a man in Germany after the vaccination. The Deputy Health Ministry Ferruccio Fazio keep reassuring that the vaccine is safe. He also announced that his sons will get the vaccine shot very soon.
Professor Franco Cuccurullo, Presidente of Consiglio Superiore di Sanità, has replied to the doubts risen by the consumer organization Codacons over the adjuvant used in the Focetria vaccine, containing squalene. Anyway, Codacons is collecting evidence of possible cases of adverse effects. The confirmed deaths of the pandemic have risen to 44.

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).

Slow vaccine campaign

Yesterday the Italian Association of General Doctors (FIMMG) has asked its associated to help the vaccination campaign. FIMMH also invited its members to be vaccinated.

“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.

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.

Vatican Radio: Too much alarm

Maybe there aren't new tidings, maybe the pandemic has become boring, but today the flu issue hasn't been the first one in the newscasts. The death toll is still rising, up to 25 fatal cases in yesterday's official report. Vatican Radio has blamed on media for what happened in Italy. “There has been too much alarm for the flu. And this is good only for pharmaceutical firms that produce the vaccine” said the radio channel One-Five Live. “Look at the alarmed way used by media to tell the story of people killed by AH1N1, without mentioning that almost all were patients affected by other illness” it said “scared people asked to be protected and governments, under pressure, buy great bulk of vaccine”. Actually, the newspapers have been reporting obsessively that the victims were all in the high risk group. And the vaccination campaign is targeting, after the health care workers, this group of people. Unfortunately, it looks like the vaccination was too late for some of them. The speaker of the radio seems to think that these deaths were't caused by the flu virus, but by other causes. The two doctors try to explain that this virus can be dangerous for people at risk and that the vaccine is really useful.

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.

Death toll rises in Naples

Other two fatal cases of swine flu occurred in Naples, Corriere del Mezzogiorno reports. A 42 years old, overweight woman died today at Cotugno Hospital, while a 72 years old woman, with respiratory disease died yesterday at Cardarelli Hospital. So the death toll in Naples has risen to 8. Italian newspapers are reporting all the deaths caused by the H1N1 virus, and maybe this can be alarming for the general public. The Deputy Minister of Health Ferruccio Fazio keeps assuring that all the people who died were already ill, and that healthy people should not worry. Another big issue is the vaccine campaign: in the past days Professor Fazio has blamed on local authorities for the delays in the vaccine distribution, while praising the producer, Novartis, for having sent the first batch of two million doses in advance of a fortnight.

Quite surprisingly, nobody talks about antiviral drugs. Maybe this is good luck for the Ministry. According to a study, "the antivirals stockpiled in Italy are sufficient to treat only 7 million individuals, corresponding to the 12% of the population." 

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.