The authorization of the Moderna vaccine for adolescents delayed by the regulator in the United States – RT en français
| Local News | Google News
The American drug agency has notified the Moderna laboratory of its need for additional time to evaluate its anti-Covid vaccine intended for adolescents. In question, the risks of post-vaccination myocarditis after the second injection.
The Moderna laboratory indicated on October 31 that US health authorities were delaying the approval of its vaccine against Covid-19 for adolescents, in order to give itself time to better assess the risks of myocarditis.
On the evening of October 29, the US Medicines Agency (FDA) “informed Moderna that it needed additional time to assess recent international analyzes of the risk of myocarditis after vaccination,” Moderna said in a statement. This review of the Moderna vaccine for 12-17 year olds could last until January 2022, specifies the laboratory.
Moderna vaccine would present an increased risk of myocardial
A greater risk of myocardial inflammation has been described for Covid-19 vaccines, including Moderna, especially in young men and after the second dose. According to the Centers for Disease Prevention and Control (CDC) in the United States, these myocarditis following vaccination with mRNA vaccines are “rare and generally benign,” Moderna says.
The rival vaccine Pfizer / BioNtech has just been authorized in the United States to be injected, in lower doses, to children aged 5 to 11 years.
Moderna had already announced that he was waiting, before requesting the green light from the FDA for this age group, for the drug agency to decide on its vaccine for those under 18.
Breaking News Updates Yahoo news The authorization of the Moderna vaccine for adolescents delayed by the regulator in the United States – RT en français