As we told you a few weeks ago, Sanidad withdraws the Rotateq vaccine from the distribution channels in Spain, with the uneasy logic and multiple doubts of the parents who had already given a dose of the vaccine. In this situation, different scientific societies in Spain have prepared a consensus document which aims to clarify the doubts raised.
The Spanish Association of Pediatrics (AEP), the Spanish Association of Vacunology (AEV), the Spanish Society of Pediatric Infectology (SEIP) and the Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition (SEGHNP) have agreed this document that defines the opinion of its members, and of which several issues stand out.
Among them, that the withdrawal of distribution has occurred only in Spain, that the administration of vaccines can be completed while they are available in the market or that they expect the normal administration of these vaccines to be restarted as soon as possible.
Let's look at the most important points of this consensus document that you can read in full here.
- Societies want to convey a message of tranquility to the population and to pediatricians stating that all currently available data confirm that the findings of porcine circovirus DNA in rotavirus vaccines do not represent a health risk for children who have received them. and they do not affect their safety or effectiveness.
- Societies also justify with data the fact that these vaccines are recommended, given the criticisms received by a large part of the population, pointing out that they are unnecessary in our environment. According to the document, rotavirus infection is an important cause of childhood morbidity, and it is the first cause of severe diarrhea and hospitalization for diarrhea in Spain, although in Europe and Spain, good socio-sanitary conditions favor that Rotavirus infection is not associated with mortality.
- They also provide data from studies that justify vaccination as the only useful preventive strategy against this disease and establish its cost-effectiveness balance by taking into account the indirect cost that the disease causes to families and society.
- Vaccines available against rotavirus have demonstrated, both in developing and developed countries, their efficacy and safety in preventing this infection.
Can I complete the doses of Rotarix and Rotateq?
- In pharmacies, vaccines may still be available: they have not been withdrawn, what has been done has been to prevent the entry of new lots, which implies shortage of supplies shortly. But both vaccines, Rotarix and Rotateq, are still authorized. The recommendations are that no new vaccinations be initiated, but that the doses of those already started can be completed:
new vaccinations against rotavirus should not be initiated. Infants who have started vaccination can complete it while sufficient doses are available in the pharmacy channel.
Now, given the logical impact of these facts for parents, I ask you Would you complete the doses initiated in your children?
Rotarix and Rotateq are still administered normally in the rest of the world
- International organizations such as the World Health Organization (WHO), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have extensively assessed the implications of these findings and, unanimously, have concluded that both The presence of virus DNA in vaccines does not represent a problem for human health and has established that there is no reason to limit its use, so they do not recommend any change in the use of such vaccines.
The consensus document is useful to highlight that vaccines are recommended by WHO and by different European societies and that they are included in the systematic vaccination schedules of several countries with different degrees of public funding.
- Since the AEMPS decision limits the availability of these vaccines in Spain, the AEP, the AEV, the SEIP and the SEGHNP consider that, as soon as possible, the vaccination against rotavirus should be restarted because it is considered a health offer desirable for all children in our country.
Reasons for the limitation of Rotarix and Rotateq in Spain
Then we ask ourselves, Why in Spain has the use of vaccines been restricted? Why does the Spanish Medicines Agency establish the recommendation not to initiate new vaccination guidelines against rotavirus at this time? The reasons are found in this document, and are the following:
- Rotavirus disease does not cause mortality in Spain and has no serious consequences from a public health perspective
- Vaccination is not included in the calendar of systematic vaccinations of the Interterritorial Council of the National Health System
- The presence of circovirus DNA fragments in these vaccines is not desirable, although this finding represents only a quality problem of the final product that does not affect its safety.
Conclusions
For generalized doubts about whether the doses of the vaccines already started can be continued, the answer is yes, in the rest of the world and in Spain while vaccines remain in pharmacies (surely they have already been used up in many of them).
As we can see, this consensus document has the clear purpose of combining positions, of justifying, before the flood of doubts and criticisms, the recommendation of vaccines, but above all to reassure parents.
And establish common guidelines for health professionals who, I say, will also be quite disoriented in this Swing news about Rotarix and Rotateq vaccines.
Some news that have undoubtedly undermined parents' confidence in vaccination in general and that it will certainly have some impact on the habits related to vaccines. mandatory, despite the fact that scientific societies insist that non-mandatory does not mean that they are not recommended and recommended vaccines for children.
Because, even if they tell me that If I have started the vaccination doses with Rotarix or Rotateq I can complete them (In fact this is being done in the rest of the world in which these vaccines are administered), as a mother I doubt very much that she did. And what is certain is that the face of stupefaction, concern and discomfort for this situation would take time to erase me.
Official Site | Aeped
In Babies and more | Free route for “suspicious” rotavirus vaccines, Rotarix vaccine preventive withdrawal, Rotavirus vaccine approved
)
