A government plan to boost vaccination rates and introduce a series of new vaccines in Italy has triggered protests from doctors and some public health experts. The National Vaccination Plan for 2016–18 (PNPV) would instantly make Italy a European frontrunner in vaccination, but experts have questioned the need for several of the vaccines, and some suspect the hand of industry behind the government's new enthusiasm. Meanwhile, physicians worry about provisions in the PNPV that might punish them if they don't fully cooperate.
The controversy reached a climax on 27 November when the Italian Medicines Agency (AIFA) suspended Sergio Pecorelli, the president of its board and one of the authors of the new plan, because of alleged conflicts of interest. According to the Italian daily La Stampa, which first reported the suspension, Pecorelli never told AIFA that he is an adviser for a venture capital firm that invests in drug companies. Pecorelli also authored booklets, sponsored by Sanofi Pasteur and published by a health foundation on whose board Pecorelli serves, about the benefits of vaccination and healthy lifestyles. (Pecorelli did not respond to ScienceInsider's request for commnent.)
The Italian government has defended the PNPV as an adequate answer to the nation’s dropping vaccination rates. Less than 86% of Italian children now receive the measles shot, for instance. The new plan “is a matter of national security and public health,” Italian health minister Beatrice Lorenzin told Italy's Chamber of Deputies in October.
The plan says that physicians working in the public health care system will be monitored for their support of the new vaccination strategy, and could be sanctioned if they don't comply—although it spells out neither inappropriate behavior nor the punishment. “This is just crazy,” says Costantino Troise, head of the Anaao Assomed, a union that represents 22,000 doctors working in the public health sector. “I don’t see how a complex public health issue, [such] as the drop in vaccination coverage, could ever be solved by sanctioning physicians."
Also controversial is the plan to bar children from attending school if they haven't received all of their shots. Lorenzin, the health minister, has acknowledged that this part of the plan, which could clash with children's right to education, needs more discussion.
The right list?
Meanwhile, some aren't convinced that all the new shots in the plan are a good investment. Among them is a vaccine against rotavirus, which causes diarrhea; although an important killer of children in developing countries, the virus is rarely fatal in the Western world. Introducing a new vaccine may cause more parents to forgo vaccination of their children altogether, warns AIFA Director General Luca Pani, who wasn't involved in the plan; he believes it's better to first focus on boosting coverage rates for current vaccines. The World Health Organization's Strategic Advisory Group of Experts on Immunization has recommended the rotavirus vaccine for all children, however, and 10 other European countries and the United States have already introduced it.
There are also doubts about the introduction of a meningococcal disease B (menB) vaccine for infants. MenB was approved in Europe in 2013 but so far only the United Kingdom has introduced it country-wide. A report by Italy's National Institute of Health (ISS) issued earlier this year said that although the vaccine has an "acceptable risk/benefit profile both in children and teenagers,” and a "good immunogenicity profile," "several questions remain open" regarding its clinical effectiveness, the long-term immunogenicity, and the effect of vaccination on the pathogen's circulation. Although “ISS is the leading scientific body of the Italian National Health Service," its misgivings about MenB were "blatantly ignored," says Vittorio Demicheli, head of the vaccination program of the Piemonte region and a member of the Cochrane Collaboration's former Vaccines Field.
The PNPV, which would double government spending on vaccines to €620 million annually, would also introduce nationwide varicella shots for newborns; a vaccine protecting against four meningococcus strains for teenagers; a herpes zoster vaccine for adults at risk; two pneumococcal vaccines for people over 65; hepatitis A and influenza for children and adults at risk; and vaccines against human papillomavirus, up to now only available to girls, for boys at age 12. The plan “finally puts Italy at the forefront when it comes to vaccinations," says Giuseppe La Torre, an epidemiologist at Sapienza University of Rome.
But Maurizio Bonati, the head of the Department of Public Health at the Mario Negri Institute for Pharmacological Research in Milan, says much of the scientific and economic reasoning behind the plan is unclear. “Almost every vaccine on the market is in the new schedule,” he says. “I don’t see a national strategy behind all that, just a list of vaccines.” The plan was written by a panel that included the now-suspended AIFA President Pecorelli, ISS President Walter Ricciardi, and the members of a permanent internal advisory commission at the Ministry of Health. Few in the scientific community knew about the panel before the plan emerged, Bonati says.
Questions about industry influence
Worries that industry had a say in the PNPV were fueled by the striking resemblance of the plan's vaccination schedule to a “lifetime schedule” of annual vaccinations produced in 2014 by by four scientific societies that Demicheli says receive funding from the pharmaceutical industry, and were also consulted for the PNVP. "That's not a secret, and it's not a sin,” Demicheli says. “However, to imagine that [the societies] are completely independent sounds a little ridiculous." Such links can erode public trust and fuel conspiracy theories, Demicheli says.
The societies haven't denied that they accept industry money, but the PNPV panel insists that industry funding didn't influence the plan in any way. Demicheli "insinuates that the authors of the plan simply acted on pressure from the industry or, even worse, bribery,” the panel wrote in an open letter.
Amelia Beltramini, a journalist and blogger, has pointed out that half of the authors of the lifetime vaccination schedule, including some of those who consulted for the PNPV, also declared personal financial ties to the vaccine industry in published scientific papers, as did ISS President Ricciardi. Ricciardi did not respond to a request for comment from ScienceInsider.
*Correction, 13 December, 1:10 a.m.: A previous version of this story incorrectly implied that meningococcal disease B is caused by a virus.