Infectious human mumps is an inflammation of the parotid glands caused by viruses of the Paramyxoviridae family, which is known from classical Greek times. Once suffered and overcome the disease, the acquired immunity is usually permanent. The same happens in the case of vaccination.

The first inactivated vaccine, authorized in 1948, was applied between 1950 and 1978 but its use was gradually abandoned because it only induced short-term immunity. So in 1967, began the use of regulated vaccination against mumps with live attenuated vaccines, although epidemic outbreaks among vaccinated people aged 5-9 years and 10-19 years leaded to a change in the vaccination plan, giving a first vaccine administered between 12 and 14 months and a booster dose at 4 to 6 years.
Several virus strains have been used for the preparation of vaccines:

1) Jeryl Lynn 1 strain
2) Jeryl Lynn 2.12 strain
3) RIT-4385 strain, a spread clone more and highly purified of the Jeryl Lynn 1 strain
4) Leningrado-3 strain
5) Leningrado-Zagreb strain, an attenuated version of the previous

6) Rubini strain
7) A silvestre strain
8) G3 strain
9) S-79 strain
0) Hoshino strain
1) Torii strain
2) Miyahara strain

In 1967 it was authorized the use of Jeryl Lynn attenuated vaccine, since 1980 also the vaccine prepared with Leningrad strain (culture in guinea pig kidney or in quail egg) and Leningrad-Zagreb strain (culture in chick embryo fibroblast cells). From 1985 the Rubini strain is used (culture in diploid cells, attenuation in embryonated chicken eggs and adaptation to the human diploid cell line MRC-5).

Epidemiological studies of the surveillance systems in Switzerland, Portugal and Italy, between 1986 and 1993, showed that all the used strains have a protective efficacy of 90% in the short term (seroconversion rates) except Rubini strain, which protection rate was significantly lower (55.3%).

Despite these unfavorable reports the General Subdirection of Ordination and Pharmaceutical Assistance of the General Directorate of Pharmacy and Health Products of the Ministry of Health and Consume, approved on July 1st 1993 using a live attenuated vaccine, registration number 59.590 and national code 777.037, containing the Rubini strain, which marketing authorization was not revoked until March 22nd 2004, almost 11 years later, including a review of the CPR in December 2002. This happened four months after the publication of Royal Decree 83/1993, about drug financing by the Social Security or the National Health System state funds, being Regina Revilla Pedreira the General Director and Jose Antonio Griñan the Health Minister.

During these 11 years (1993-2004) and in 2006 and 2013 were also detected cases of low efficiency in Spain.
So in 1998 two outbreaks of mumps were detected in two municipalities, Almoradí (Alicante) and Manacor (Baleares), affecting a significant number of people. These outbreaks were characterized by a high rate of incidence in children aged 2 to 5 years, from which a 93% had been vaccinated. Despite this fact, the vaccine remained on the market.
During the period 2006-2007 there was a general increase in mumps presence in all Spanish regions.
In 2013, from January 1^st until June 9^th, 9600 people have been infected by this contagious viral disease, compared to 4111 people who did so in the same period in 2012.

During the analysis of the situation the director of the Coordinating Center for Health Emergency Alerts of the Ministry of Health, Fernando Simón, stated that in 2013 there has been a widespread increase of mumps and that the reason for these outbreaks, which now occur every five to seven years, is related to the population susceptible to the disease, either because they have not been vaccinated, (although the percentage of the population that does is about 97-98%), or because the vaccine given between 1993 and 1999 made with the Rubini strain and authorized by the Ministry of Health and Consume has not fully protected them. The population with greatest risk to suffer mumps are the people who are currently between 14 and 20 years old.

At the 12^th Transparency blog from January 17th 2011 in Veterinaria Digital we discussed the phenomenon of the “revolving door” by which people who worked for the administration start working in the private sector in companies whose business is related to the regulatory activity of his former position.

We invite to whom it may concern to investigate presumed relationships between people involved in the case of the vaccine containing the Rubini strain and previous or subsequent relationships with industry or industry mangement, taking into account that it is a public health case with epidemic outbreaks presumably related to the lack of efficacy of a product approved in Spain.