September 15 (Hfrance.fr) - Scientists from the United States Food and Drug Administration said on Wednesday that the booster doses of (PFE.N) The COVID-19 vaccine may not be necessary, even if the third shot generates an immune response in recipients.
FDA staff said in a document prepared for outside advisers that there is still no evidence that the effectiveness of Comirnaty - Pfizer's COVID-19 vaccine developed with Germany's BioNTech SE - is declining.
"Some studies by observation suggested a decrease in the efficacy of Comirnaty over time against symptomatic infection or against the Delta variant, whileothers did not "they said in the document.
" However, overall, data indicates that currently licensed or licensed in the United States COVID-19 vaccines still provide protection against severe COVID-19 illness and death in the United States. "
FDA staff said the booster dose met conditions predefined by the regulator. to show that the shot generated an immune response.
However, they said in the document that authorization for the recalls should also take into account the ability to prevent hospitalization and death, as well as the dynamics of the pandemic in the United States.
The agency released the document on Wednesday for review by an external expert panel that will meet on Friday to decide whether or not to recommend that US regulators d 'approveround of additional shots.
The view of FDA staff mirrors that of many scientists who have questioned whether the recalls are needed in the Together, even though President Joe Biden has called for additional injections in the face of the upsurge in hospitalizations and deaths caused by the highly contagious Delta variant of the coronavirus.
Biden set a target on September 20 to begin administering 100 million boosters in the United States.
After FDA meeting , a group of advisers from the U.S. Centers for Disease Control and Prevention plan to meet next week to make its recommendation, according to White House Press Secretary Jen Psaki. .
PFIZER WISHES BOOSTER APPROVAL
Pfizer, in a document that he aprepaired for the meeting, argued that US regulators should approve a booster shot of his vaccine for use six months after the second dose due to declining efficacy over time.
Pfizer said data from its own clinical trials showed that the vaccine 's effectiveness decreased 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 company also highlighted real-world data from Israel and the United States showing a decrease in the effectiveness of the Pfizer / BioNTech vaccine.
The US drug maker said in a clinical trial of around 300 participants, the third dose generated a better immune response thanthe second. He also highlighted data from the recently launched booster program in Israel to show that a third dose restores high levels of protection against the virus.
Earlier this week, two of the FDA's top vaccine scientists were among the authors of an article saying they don't believe the current data supports the shots. One of those scientists - Marion Gruber, director of the FDA's Office of Vaccine Research and Review - will speak at Friday's meeting.
Some U.S. officials hope boosters could prevent mild cases and reduce virus transmission as well as reduce hospitalizationns and deaths related to COVID-19, which could accelerate America 's recovery.
Some countries have already started recall campaigns of the COVID-19. The United States authorized additional injections for people with vulnerable immune systems last month. Reporting by Michael Erman, additional reporting by Manojna Maddipatla in Bengaluru; Edited by Nick Zieminski, Chizu Nomiyama and Bill Berkrot
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