The 'Rotarix' rotavirus vaccine returns to pharmacies after six years

If you ask any mother or father today about rotavirus vaccine, which is the virus that most commonly causes moderate or severe acute gastroenteritis in children, surely everyone, or most, tells you that it is called Rotateq, which costs about 70 euros and is given in three doses. However, since 2006, there are two vaccines that were marketed in Spain: Rotateq Y Rotarix, with a different composition, different price and also different administration pattern.

In 2010 both were withdrawn from the market because they found traces of DNA from viruses called porcine circovirus types 1 and 2 (PCV-1 and PCV-2). First they removed the Rotarix and a couple of months later the Rotateq, leaving the parents who had started the vaccination without the option of completing it even though it was not considered dangerous.

At the end of that same year, Sanidad decided to re-allow the commercialization of the Rotateq vaccine, which has been administered to date. Now, he returns to the pharmacies Rotarix, six years after his withdrawal.

What happened to those circoviruses?

Well, the analyzes performed on both vaccines found DNA fragments of those viruses. Apparently, they had never appeared because in previous, less specific tests, they were not observed. By improving the analyzes, both vaccines showed those fragments that, despite not being considered dangerous, were considered not to be there.

As a preventive measure, the Spanish Medicines Agency withdrew both vaccines, because they considered it appropriate to wait for more data on the possible risks that these circoviruses could cause in babies.

Months later the WHO, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). published a report in which they said that the presence of these swine virus fragments did not represent a health problem and that there was no reason to limit the use of Rotarix or Rotateq.

However, AEMPS only gave Rotateq a green light, leaving the other vaccine without the necessary permits to continue being commercialized, while the rest of the world allowed the administration of both vaccines.

What is the Rotavirus vaccine for?

Well, precisely to prevent a baby from getting a gastroenteritis caused by the rotavirus virus. Actually it is a mild disease compared to other vaccines, but it is very common. It is estimated that at five years of age all children have ever caught (once or more, because a child can be infected several times) a rotavirus diarrhea.

The severity, in any case, depends a lot on the child's age, because a baby will almost certainly require a hospital admission to prevent the risk of dehydration, but a child of 3 or 4 years, for example, can probably pass the disease at home, where he will suffer a diarrhea of ​​several days of evolution.

The Spanish Association of Pediatrics recommends it every year because it considers that the risk benefit ratio is very positive and that is why he adds it to the Vaccination Calendar, although it is not subsidized by the Spanish government and it is the parents who have to buy it if they want it for their children.

And what is the guideline and price of the Rotarix?

The vaccine schedule Rotateq, which has been in the market for years, we all know it: there are 3 doses that must be administered before 32 weeks of life, the first one being administered between 6 and 12 weeks. The price of each vaccine is € 69.50, so the three doses that complete the vaccination cost 208,50€.

The pattern of Rotarix We no longer have it so clear, precisely because we have not seen it for 6 years. Well, being a different vaccine, also valid because trials in Europe show an efficacy against the most severe forms of gastroenteritis of 95.8% during the first year of life, the pattern changes.

As we read in the data sheet it is administered in two doses. The first dose should be administered from 6 weeks of age and there should be an interval of at least 4 weeks between doses. It is recommended that the administration of vaccines be terminated before 16 weeks of life, although there is room for up to 24 weeks of life.

The price of the Rotarix vaccine is € 93.66, which when administered in two doses is a total price of vaccination of 187,32€.