A conflict of interest surrounds the recommendation to vaccinate children against the flu

The Spanish Pediatric Association (AEP) has taken an important qualitative leap this fall in its recommendations on flu vaccination. For the first time, the scientific society calls to vaccinate all children between six months and five years of age, a decision that has been received with surprise by some medical sectors and that comes when regulatory bodies evaluate whether or not to approve the vaccine pediatric disease against coronavirus.

The AEP proposal goes beyond the position of the Ministry of Health, which only considers necessary (and finances) the vaccination of minors with risky pathologies or who coexist with people who suffer them. Families who wish to immunize their children must receive the prescription from their pediatrician and assume the cost of the vaccine. The available ones cost about 15 euros per dose and the first year requires two, although in the following years one is enough. The target population amounts to about 2.3 million children. Scientific societies such as the Spanish Association of Vaccination (AEV) and the Spanish Society of Public Health and Health Administration (Sespas) do not share the recommendation of the AEP and follow the criteria of the Ministry.

Regarding the medical debate, open for years on this vaccine, the controversy around the conflicts of interest that arise when scientific societies issue recommendations that have important economic repercussions while receiving large economic contributions from pharmaceutical companies benefited from their positions. The AEP and its foundation received in 2020 a total of 363. 000 euros from two of the largest manufacturers of pediatric flu vaccines, GSK and Sanofi. Last year the two companies also allocated other 253. 000 euros to other associations of regional and primary care pediatricians.

In this case, in addition, the 12 members of the Vaccine Advisory Committee (CAV-AEP) that approved the recommendation also admit to having received payments from the industry in the last five years, according to the declaration of interests included in the recommendation. The data published by the sector offer more precise and up-to-date details: six of them received last year between 5. 000 and 14. 000 euros from GSK and Sanofi, three other smaller amounts (less than 1. 000 euros) and three plus no amount.

Of the 12 members of the Committee, all declare that they have been paid in the previous five years for participating in “teaching activities subsidized ”by vaccine manufacturers; eight are or have served on advisory boards of pharmaceutical companies (mostly from GSK); six have contributed to company trials or clinical studies; and in four cases the relationship with the industry is limited to having been invited to events or training courses. Only one of them makes it clear in the declaration of interests that “since he is a member of the CAV-AEP, he has not accepted any direct sponsorship from any pharmaceutical laboratory for any activity.”

Ildefonso Hernández, spokesperson for Sespas, defends that “as a general rule, it is neither good nor desirable for scientific societies to make recommendations of this type that go beyond what is established by the health authorities because it is something that generates confusion among citizens and that may end up causing pressure unnecessary and interested in the health system ”. This specialist highlights that the matter “acquires special relevance when there are conflicts of interest in the people who make these recommendations.”

Abel Novoa, coordinator of the bioethics working group of the Spanish Society of Family Medicine and Comunitaria (Semfyc) recalls that “the objective is not to prevent collaboration with the industry, but rather that there is good governance in this area.” “There are many examples of instruments so that the different actors can interact without conflicts of interest that could cast doubt on their impartiality. Prestigious magazines such as JAMA, for example, do not allow those who sign the articles that establish the protocols and indications for disease management to have any conflict. Another example is the committees for the evaluation of possible conflicts, which many scientific societies have developed in other countries but not yet in Spain ”, he specifies.

In a written response, the AEP defends that its recommendations “They are always based on scientific criteria” and that “it avoids the support of the activities of the industry in which there is no other interest than the purely commercial one”. Regarding the charges of the members of the Vaccine Advisory Committee, the AEP maintains that the relationship of its members with the industry “is subject to the Ethical Framework of society”, although these specialists “in the exercise of their professional freedom, may participate in other activities as experts in their field and in their personal capacity. ”

The AEP assures that it had already planned to recommend universal vaccination of children from six months to five years of age last year, but that it decided wait because then he prioritized “the vaccination of the elderly and risk groups.” Despite this, the society asked the Ministry of Health last February to include children in the vaccination calendar. A request that has not been answered, but that the AEP will continue to “request until they are.”

A GSK spokesperson considers that “it does not make sense to deduce that these collaborations condition the clinical criteria of the health professionals ”and highlights that“ collaboration between the pharmaceutical industry, health professionals and scientific and medical societies is particularly important ”for“ research and development of new drugs and vaccines, and their proper use ”. “We believe that the interrelationships between the pharmaceutical industry and health professionals and health organizations are essential and benefit everyone,” says Sanofi.

The World Health Organization (WHO) recommended in 2012 vaccination of children against influenza, although this measure – adopted shortly after the pandemic threat of influenza A – has not been followed by many countries and the coverage achieved in those that have done so are generally low.

Although the AEP assures that the European Center for Disease Control and Prevention (ECDC) has also recommended this measure since that year —some technical documents from those dates evaluated whether the measure could be helpful in some situations – an agency spokesperson does not confirm. “The European Union and the Member States have not agreed on a joint recommendation on vaccinating children,” he stated in writing. Denmark, Finland, Latvia and some German states are the only ones in the European Union – apart from the United Kingdom, which abandoned it in February 2020 – that have universal vaccination programs for children.

According to the AEP, “there is sufficient scientific evidence to recommend universal influenza vaccination in children from 6 to 59 months.” The reasons are that this measure “provides the child with individual protection and favors family and community protection”, since “preschool and school children are the main spreaders of influenza outbreaks.” The hospitalization rate for healthy children is “one in a thousand cases,” add pediatricians.

The Ministry of Health and other scientific societies, on the contrary, think that childhood vaccination of children healthy do not present a favorable cost-benefit balance given the low severity of the clinical pictures developed by the minors. “It is a vaccine with a reduced effectiveness, which protects about half of those who receive it. It is indicated in people for whom the flu is really a risk, but this is not the case of children ”, concludes José Tuells, coordinator of the Sespas vaccines working group.

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