September 15 (Hfrance.fr) - Pfizer Inc (PFE.N) said US regulators should approve a dorecall of the COVID-19 vaccine it developed with German company BioNTech SA six months after the second dose due to the decreasing effectiveness of the shot over time, according to documents the drugmaker has submitted to the United States Food and Drug Administration.
The FDA released the documents Wednesday for review by an external expert panel to meet Friday to vote on the recommendation whether U.S. regulators should approve the additional injections.
Pfizer said data from its own clinical trials showed that the The vaccine's effectiveness was reduced by about 6 percent every two months after the second dose. He also indicated that the incidence of breakthrough cases in this trial was higher in people who received their injections earlier.
The manufacturer of drugs alsont pointed out real-world data from Israel and the United States show declining vaccine efficacy.
He said that 'a clinical trial of around 300 participants showed that the third dose generated a better immune response than the second dose. 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.
President Joe Biden has pushed for additional injections in the face of increasing hospitalizations and deaths from the highly contagious Delta variant, and set a target on September 20 to start giving 100 million booster shots.
But it is not clear to many scientists whether the additional shots are needed overall. Earlier this week, two scientists fromHigh-level vaccine officials from the FDA were among the authors of an article saying they did not believe the data was available. fully supports giving the shots. learn more One of these scientists - Marion Gruber, director of the Office of Vaccines Research and
Review - will speak at Friday's meeting.
Some US officials are hoping that the recalls could prevent mild cases and reduce virus transmission as well as serious infections, which could speed America's recovery. learn more
Some countries have already started COVID-19 recall campaigns. The United States has authorized iAdditional injections for people with vulnerable immune systems last month.
The FDA has yet to release the briefing with its take on the question.
" We are working to release all documents for this important meeting, many of which contain complex data, as quickly as possible, but we are releasing material throughout the day it will be finalized and available "said an FDA spokesperson. Report by Michael Erman, Supplementary report by Manojna Maddipatla in Bengaluru; Montage by Nick Zieminski and Chizu Nomiyama Editing by Chizu Nomiyama and Nick Zieminski
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