September 15 (Hfrance.fr) - Scientists from the United States Food and Drug Administration said on Wednesday that a third booster dose of (PFE.N) COVID-19 vaccine generates higher immune response in recipients, but stopped short of saying that additional injections are usually needed.
FDA staff members said in a document prepared for outside advisers that Comirnaty - the COVID-19 vaccine developed by Pfizer with BioNTech SE from Germany - met pre-specified conditions that the regulator set to show that the shot generated an immune response.
Whether the vaccine 'Efficacy is declining and if boosters are nnecessary, this has not been proven, the agency said.
"Some observational studies have suggested a decrease in the 'effectiveness of Comirnaty over time against symptomatic infection or against the Delta variant, while others have not, "they said in the paper. "However, overall, the data indicates that COVID-19 vaccines currently licensed or authorized in the United States still provide protection against severe COVID-19 illness and death in the United States.
The FDA released the document Wednesday for review by an external expert panel that will meet on Friday to vote on the recommendation whether US regulators should approve the additional round of gunfire.
Pfizer, in a document it prepared for the meeting, argued that US regulators should approve a recall of hisvaccine for use six months after the second dose due to decreased efficacy over time.
Pfizer said data from its own clinical trials have shown that the vaccine's efficacy is reduced by about 6% every two months after the second dose. He also said that the incidence of breakthrough cases of COVID-19 in this trial was higher among people who received their injections earlier.
The drugmaker also highlighted real-world data from Israel and the United States showing decreased vaccine effectiveness.
The US drug maker said in a clinical trial of around 300 participants, the third dose generated a better immune response than the second. He also highlighted data from the recently launched recall program in Israel to showst that a third dose restores high levels of protection against the virus.
President Joe Biden has pushed for additional injections in the face of the 'increased hospitalizations and deaths from the highly contagious Delta variant, and set a target on September 20 to start giving 100 million booster shots in the United States.
But it is not clear to many scientists whether additional injections are needed overall.
Earlier this week, two of the FDA's main vaccines scientists were among the authors of an article saying they don't believe the current data helps to draw. learn more One of these scientists - Marion Gruber, director of theFDA vaccine research and review - will speak at Friday's meeting.
Some US officials are hoping that boosters could prevent mild cases and reduce transmission of the virus as well as reduce serious infections, which could speed up America 's recovery.
Some countries have already started campaigns to COVID-19 reminder. The United States authorized additional injections for people with vulnerable immune systems last month. Report by Michael Erman, additional reporting by Manojna Maddipatla in Bangalore; Editing by Nick Ziemin ski, Chizu Nomiyama and Bill Berkrot
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