Photo: FREDERIC J. BROWN / AFP / Getty Images
This Monday the United States Food and Drug Administration (FDA) issued a statement in which it reported its decision to grant its full authorization for the application of the Covid vaccine created by Moderna , which only had the approval of this authority for its use of emergency.
In the text, the FDA indicated that after its decision this will allow Moderna’s vaccine can be marketed under the name of Spikevax, which can only be applied to people older than 01 years old.
Vaccine of Moderna has thus become the second Covid vaccine to receive full approval from the FDA; The first to obtain it was from Pfizer.
The outgoing FDA Commissioner, Janet Woodcock, noted that full approval “may instill greater confidence when of adopting the decision to be vaccinated” among the population, since it lasts indefinitely as long as there is no known or present side effect of which there was no knowledge.
For Moderna’s vaccine to obtain this type of authorization, it had to provide extended data on the manufacturing process, in addition to being subject to constant meticulous inspections by the FDA.
Stéphane Bancel, CEO of Moderna, indicated in a statement that “ all of the actual data and ( the full approval) of Spikevax in the US reaffirms the importance of vaccination against this virus“.
“This is a transcendental milestone l in the history of Moderna since it is our first product that obtains authorization in the US”, he added.
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