Pfizer booster pin hanging? Before Friday's review meeting, the FDA declined to say that there was a

Original title: Pfizer strengthening needle hanging? Before Friday's review meeting, the FDA declined to say that there was a lack of verified data
U.S. regulators may not give the green light to the new crown vaccine booster injection developed by Pfizer and biontech so soon.
The novel coronavirus pneumonia released by Pfizer FDA released an analysis article on Wednesday 15, 2011. The data from Israel and the United States showed that the vaccine had a decreased immune response to the new crown pneumonia after the second point vaccination of Pfizer vaccine in the face of the delta virus. The data showed that the vaccine had a six - to eight months' effect.
Pfizer believes that the existing data support Pfizer's previous application to the FDA, that is, about six months after the second injection of vaccine, it will inject a third injection to vaccinators over the age of 16. Pfizer also said that the third injection could restore the immune effectiveness to 95%.
On Wednesday, a document written by FDA staff was published on the FDA's official website. This document was released before the FDA vaccine and related biological products Advisory Committee (vrbpac) met on Friday to evaluate Pfizer's booster application.
In the 23 page document, FDA staff refused to say whether they supported Pfizer's enhanced injection of the new crown vaccine, saying that regulators had not reviewed all available data.
The document reads:
There are many studies that may be relevant, but FDA has not independently reviewed or verified the basic data or its conclusions. Including the data of the Israeli vaccination program, some of these studies will be summarized at the vrbpac meeting on Friday.
In the document, FDA Staff were also skeptical of the data mentioned by Pfizer, saying
It should be recognized that although observational research can make people understand the effectiveness of the real world, some known and unknown biases can affect their reliability. Moreover, the efficacy study of Pfizer and biontech bnt162b2 vaccine after authorization in the United States may best represent its vaccine effect on Americans.
FDA Staff said that some observational studies have considered that the immune efficacy of Pfizer vaccine against symptomatic infection or delta variant virus is decreasing over time, but other studies do not think so. Overall, data suggest novel coronavirus pneumonia cases in the United States are still protected from severe and death threats by the current vaccines authorized by the United States.
Before the release of the above documents by FDA Staff, the new coronal vaccine booster needle had just been poured cold water by many scientists recently.
On Monday, the lancet released a report jointly written by 18 scientists called "All Star" by the media. 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.
The Wall Street article mentioned earlier that among the scientists who wrote the above report, two were senior officials of the FDA of the U.S. Food and drug administration, Marion Gruber, director of the FDA vaccine research and evaluation office, and Philip Krause, her deputy. Both said they would step down later this year. Media sources 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 shots.
The media believe that the analysis of this latest report is a blow to the Biden government, which actively promotes the injection of reinforcement. The Biden administration is planning to provide booster injections to citizens who have completed vaccination for at least eight months from September 20, but this plan still needs the approval of FDA and CDC.
Dan Barouch, an immunologist at Harvard Medical School, commented that at present, the biomedical community has not reached a consensus on strengthening the injection for the general public, and some senior experts have different opinions. However, the Biden administration clearly believes that the needle needs to be strengthened.
From the stock price performance, Pfizer was not significantly hit by FDA Staff documents. Pfizer's share price opened low on Wednesday, fell more than 0.5% at the beginning of the new day, turned up less than half an hour after the opening, rose nearly 1.5% at the high of the day in the morning, and then retook most of the gains, with an increase of less than 0.5% in the afternoon.