Modern vaccine for adolescents: the FDA is stalling and the stock market is suffering
What happens to Moderna while the FDA postpones the decision on the vaccine to adolescents for the risks related to myocarditis
While Novavax celebrates the authorization of its vaccine in Indonesia , Moderna pays the consequences of the postponement of the decision by the Food and Drug Administration (FDA) about the use of its serum on adolescents.
THE FDA TAKES TIME
The FDA, in fact, has not yet authorized the use of Moderna's vaccine on adolescents between the ages of 12 and 17. The pharmaceutical company said that the agency will continue to evaluate the recent analyzes.
The hesitation is due to the risks associated with heart problems such as myocarditis and pericarditis. This is not a definitive 'no' as the FDA has taken additional time to better evaluate recent international analyzes on the connection between the cases that have occurred and vaccination.
Moderna, which applied for clearance in June, however, may not receive a new verdict before January. It took the FDA about a month to clear Pfizer's vaccine for teens ages 12 to 15.
THE REACTION OF MODERN
"The safety of vaccine recipients is of paramount importance to Moderna," the company writes on its website. "The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence."
On the same occasion, Moderna also reported that it will delay submitting the application for children between the ages of 6 and 11, despite announcing last week that its vaccine produced a powerful immune response in that age group. .
… AND THAT OF THE BAG
The consequences of the FDA's decision were felt on the stock market, where the Moderna stock took the hit. The company, writes Milano Finanza , “listed on the Nasdaq loses 4.80% to 328.7 dollars per share. Considering that at the close of Friday it was trading at 345.2, the decline in capitalization is around 7 billion dollars ”.
WHAT IS THE EU DOING?
The European Medicines Agency (EMA), on the other hand, approved Moderna's vaccine for use in adolescents in July. But since then, several European countries have paused the use of the vaccine in under 30s, expressing concern over the risk of myocarditis.
HOW MANY TEENAGERS HAVE ALREADY RECEIVED MODERN?
Moderna, however, reports that more than 1.5 million teens worldwide have received his vaccine and that data so far does not suggest an increased risk of myocarditis.
However, some studies carried out in Israel and the United States have linked mRna vaccines to rare and transient cases of myocarditis, with a higher risk linked to the Moderna vaccine.
The results also suggest that the incidence is higher in boys aged 16 to 29, while the risk appears to decrease in children aged 12 to 15, and is expected to be even lower in younger children, according to the report. New York Times by Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's Vaccine Advisory Committee.
WHAT THE EXPERTS SAY
Offit believes that myocarditis as a result of the vaccine is rare, mild and resolves quickly. Covid, on the other hand, he added, is much more likely to cause myocarditis because the virus can infect and damage the lining of the heart.
Pediatrician Claire Boogaard, reported by Cbc News and who oversees the vaccination campaign at the Children's National Hospital in Washington, also said about the Pfizer vaccine that it is "very safe" for children and has no doubts about the use of the technology. mRNA vaccine.
"All vaccines do – Boogaard said – is to give your body the ability to build a response to something that is not harmful so that it can protect you against something that is."
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-moderna-agli-adolescenti-la-fda-temporeggia-e-la-borsa-soffre/ on Tue, 02 Nov 2021 15:37:37 +0000.