HomeWorldWorldEMA approves third dose of vaccine from Moderna from 18 years old

EMA approves third dose of vaccine from Moderna from 18 years old

The European Medicines Agency (EMA) gave the green light, this Monday, to the administration of the third dose of the vaccine from Moderna from 18 years old.

In a statement, the agency said that the data indicate that a third dose of “Spikevax” administered between six to eight months after the second “may lead to an increase in antibody levels in adults whose antibody levels were falling.”

Therefore, the EMA concludes that a booster dose of this vaccine, which consists of half the dose used in the first vaccination, could be considered.

According to the regulator, current data show that the side effects after the booster dose are similar to the second dose.

The European agency adds that “the risk of inflammatory heart disease or other very rare side effects after a booster is not known and is being carefully monitored“.

In early October, the EMA had already given the green light to the third dose of the BioNTech/Pfizer vaccine, which in Portugal began to be administered two weeks ago to people over 65 years of age.

This Monday, the Moderna it also announced positive results for its vaccine in children aged six to 11 years, data that it plans to present shortly to regulators of the drug with a view to authorization.

Clinical trials involving more than 4700 children between six and 11 years old “demonstrate a strong immune response” one month after the second dose, with robust levels of antibodies being detected, indicated the Moderna in a statement.

According to the company, the vaccine has a “favorable safety profile” and is “generally well tolerated”. Fatigue, headache, fever and pain at the injection site are the most common side effects in this age group.

We are looking forward to submitting the data. to the regulatory agencies of the world”, expressed the executive director of the Moderna, Stephane Bancel.

The vaccine dose for children was adjusted to 50 micrograms, half the dose for adults.

The 50 microgram strength corresponds to the booster dose (third dose) for adults that has been authorized in the United States.

The announcement made by Moderna of the results of clinical trials with children comes after the US laboratory Please have submitted a request authorization from the regulator to administer its vaccine to children aged five to 11 years.

The request will be considered by the US drug regulator (FDA) at a meeting scheduled for Tuesday.

THE Moderna clinical trials are also ongoing with children aged between six months and five years.

Covid-19 has caused at least 4,945,746 deaths worldwide, among more than 243.56 million new coronavirus infections recorded since the start of the pandemic, according to the latest agency report France-Presse.

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