Pfizer and BioNTech, which developed the first vaccine against Covid using the messenger RNA technique, announced on Friday that they had initiated a request with the United States Medicines Agency (FDA) for full authorization in people over 16 years old.
They currently only have an authorization for emergency use.
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A still conditional authorization
The health authorities had granted the serum a temporary or conditional authorization on December 11, intended to respond to an emergency situation such as the pandemic.
The latter can be revoked or modified if new data on efficacy or safety emerge later.
The boss of Pfizer, Albert Bourla, had indicated Tuesday when the publication of the results of his group want to file a new file for a full authorization this month.
The objective is to obtain the complete green light from the FDA "
in the coming months
," said Albert Bourla on Friday.
Such a procedure "
requires longer-term monitoring data to be accepted and approved,
" the statement said.
Clinical data to be updated
The filing of the file "
is an important step to achieve collective immunity and contain Covid-19 in the future,
" said Ugur Sahin, CEO of BioNTech.
The two groups will gradually provide the FDA with the most recent analyzes of the clinical trial, with data on the efficacy and safety of the vaccine six months after the injection of the second dose.
They will provide
additional data on the manufacturing process
“
in the coming weeks
”.
More than 170 million doses of the vaccine have since been delivered to the United States, the groups said in a statement Friday.
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