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What did Ema decide on the third Modern dose

3 years ago babelfish

What did Ema decide on the third Modern dose

The Ema has authorized to proceed with the third dose of the Moderna vaccine for immunocompromised people over 12, but clarifies the difference with the recall

Green light from the European Medicines Agency (Ema) at the third dose of the Moderna vaccine (Spikevax) after at least 28 days from the second for immunocompromised people aged 12 years and over. Here are the results of the studies and the details of the EMA.

WHAT MODERN SAYS ABOUT THE THIRD DOSE

The US pharmaceutical company through its website reports that a growing number of studies have shown the benefit of an extra dose in immunocompromised individuals. In particular, according to a recent double-blind randomized controlled study of 120 subjects who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas), a third dose of Moderna's serum improves response. immune compared to placebo, so much so that it was generally well tolerated.

“We recognize the need to protect immunocompromised individuals who are at the highest risk of serious disease from Covid. It is promising to see recent studies showing that a third dose of the Moderna vaccine can improve the immune response in this important population, ”said Stéphane Bancel, Moderna's chief executive. "We remain committed to helping end the pandemic with our mRNA vaccine."

THE RESPONSE OF THE EMA

The EMA, as written on its official website , has given the green light to both Moderna than to Pfizer. You can then proceed with the third injection at least 28 days after the second dose.

THE EFFECTS OF THE EXTRA DOSE

While there is no direct evidence that the ability to produce antibodies in these patients protects against Covid-19, the extra dose is expected to increase protection in at least some patients. However, the EMA will continue to monitor all the data that will emerge on its effectiveness.

The product information for both vaccines will be updated to include this recommendation.

RECALL AND EXTRA DOSE

The EMA also clarified that it is important to distinguish between the extra dose ( extra dose ) for people with a weakened immune system and the booster dose for people with a normal immune system.

For the latter, in fact, the Committee for Medicinal Products for Human Use has evaluated Pfizer data showing an increase in antibody levels when a booster dose is administered approximately 6 months after the second dose in people aged 18 to 55 years. Based on these data, the Committee concluded that booster doses can be considered at least 6 months after the second dose for people aged 18 and over.

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/che-cosa-ha-deciso-lema-sulla-terza-dose-moderna/ on Wed, 06 Oct 2021 09:55:06 +0000.