Decide the fate of Biden government's strengthening needle program! FDA meets to review Pfizer's App

Date:09-18  Hits:  Belong to:Hot news
Original title: decide the fate of Biden government's strengthening needle program! FDA meets to review Pfizer's Application
On the afternoon of Friday, 17th Eastern time, a meeting of FDA expert consultants of the U.S. Food and Drug Administration will decide whether the Biden government can start the plan of strengthening needle injection in the United States next week.
Pfizer has novel coronavirus pneumonia application to FDA, hoping that after second months of vaccination, FDA will be allowed to authorize third vaccinations for the 16 year old vaccinated person, who is newly developed with the German partner BioNTech, for the new crown vaccine. The vaccine is approved by the BioNTech.
At the meeting on Friday, about 20 external scientific advisers of the FDA vaccine and related biological products Advisory Committee (vrbpac) will review the information about the decline of Pfizer vaccine effect after a period of time and how vaccinators receive booster shots.
These consultants will listen to Pfizer's report and will also consider the control scientific research data of booster needle. They will vote on Friday afternoon to decide whether Pfizer's clinical data are safe and effective and support FDA's approval of booster needle application.
The Biden administration plans to provide booster injections to citizens who have completed vaccination for at least eight months from September 20, that is, as soon as next Monday, but this plan still needs the approval of FDA and CDC.
According to the latest news, the FDA meeting on Friday is putting at risk the important actions of the Biden government's anti epidemic plan.
Some media quoted informed sources as saying that the possible result of this Friday's FDA meeting is that expert consultants suggest that only high-risk people, such as medical workers or the elderly over the age of 65, should be allowed to inject booster needles.
Before the FDA meeting on Friday, the lancet released a report jointly written by 18 scientists called "All Star" by the media on Monday. It believes that strengthening the needle is not necessary for most people who have been vaccinated. Now it is more necessary to let non vaccinated people use the current vaccine to produce immunity.
According to previous articles on Wall Street, among the authors of the above lancet report, two are from the FDA, Marion Gruber, director of the FDA vaccine research and review office, and Philip Krause, her deputy scientist. Both said they would step down later this year. The media said that these two were also FDA officials who opposed the trump administration's acceleration of authorizing the use of the new crown vaccine last year. Their resignation may be to oppose the introduction of booster injections.
Also before the meeting on Friday, the staff analysis document released by the FDA on Wednesday refused to support Pfizer's statement on whether to strengthen needle injection of new crown vaccine, but said that the FDA had not independently reviewed or verified the basic data and its conclusions.
The document wrote that although observational studies can make people understand the effectiveness of the real world, some known and unknown biases can affect their reliability. The post authorization Pfizer vaccine effectiveness study in the United States may best represent its immune effect on Americans. This statement is considered that the FDA questions the Israeli research data mentioned in Pfizer's report.
The widely cited local research data in Israel show that the effectiveness of Pfizer vaccine against infection will weaken over time.
Before the end of the FDA meeting on Friday, US stocks' new crown vaccine concept stocks have collectively fallen. Pfizer partner biontech once fell more than 7%, Moderna also fell more than 7%, Novavax fell more than 2% and Pfizer fell more than 1%.
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