The FDA said that the data of Pfizer booster injection still need to be reviewed, although the Biden administration of the United States plans to start distributing vaccine boosters to the general population next week. In another document released on Wednesday, Pfizer argued that the third dose of COVID-19 vaccine could restore the protection rate to 95% six months after the second dose.

FDA says Pfizer booster data still needs to be reviewed 1 US Food and Drug Administration (FDA) staff on Wednesday refused to make a statement on whether to support Pfizer COVID-19 vaccine booster, saying that US regulators have not verified all available data.

"There are many potential related studies, but the FDA has not independently reviewed or verified their basic data or conclusions," FDA staff wrote in a 23-page document posted on the agency's website. "Some of these studies, including data from Israel's vaccination program, will be summarized at the meeting of the Advisory Committee on Vaccines and Related Biological Products (VRBPAC) in September 1."

According to the staff, some observational studies show that the effectiveness of Pfizer COVID-19 vaccine against symptomatic infection or delta mutation will decrease with time, while other studies have not reached such a conclusion.

"Overall, the data show that the COVID-19 vaccine currently licensed or authorized in the United States can still protect patients from serious diseases and deaths," they wrote.

The data being reviewed by the FDA include data from Israel, and the observational study published by Israeli researchers shows that the effectiveness of Pfizer vaccine against COVID-19 infection has weakened over time.

In another document released on Wednesday, Pfizer argued that the third dose of COVID-19 vaccine could restore the protection rate to 95% six months after the second dose. However, FDA staff seem to be skeptical about this data because observational studies do not follow the same standards as formal clinical trials.

"It should be recognized that although observational research helps to understand the effectiveness of the real world (vaccine), known and unknown deviations will affect its reliability," FDA staff said. "In addition, the study on the effectiveness of BNT16B2 vaccine based on US authorization may most accurately represent the effectiveness of the vaccine in the United States."

The above staff report is intended to inform VRBPAC. VRBPAC will hold a meeting this Friday to review Pfizer's request to provide COVID-19 booster shots to the public.

Biden's administration has indicated that it hopes to provide COVID-19 vaccine booster to the American people as early as next week, and is now waiting for FDA approval. However, the plan has been repeatedly criticized by scientists and other health experts. Experts say that the data cited by federal health officials are not convincing, and it is too early for the government to promote the booster.

Dan baruch, an immunologist at Harvard Medical School, said that at present, the biomedical community has not reached a * * * understanding about the general public joining COVID-19 enhancer.

In addition, a group of scientists, including two senior FDA officials and WHO, published a paper in The Lancet magazine on Monday, arguing that there is no need for the public to strengthen needle injection at present. Experts said that although the efficacy of COVID-19 vaccine against minor diseases may be weakened over time, the protection against serious diseases still seems to exist.

On Tuesday, the Director-General of WHO, Tedros Adhanom Ghebreyesus, once again called on rich countries to stop vaccinating the public with COVID-19 booster vaccine, with a view to providing more COVID-19 vaccine to poor countries and regions with low immunization rates.

The FDA said that Pfizer's data needs to be re-examined. The Delta virus strain continues to wreak havoc in the United States, and the country has encountered a severe milestone in the process of fighting the COVID-19 epidemic: the death toll in COVID-19 in the United States exceeds 660,000, which is equivalent to 1 person death for every 500 Americans in COVID-19. According to American media, this is a sobering number. On the other hand, the Biden administration plans to start distributing vaccine enhancers to the general public next week. Pfizer vaccine also said that the effectiveness of the vaccine will weaken over time, and people are advised to strengthen the injection.

On June 4th, 2020 10, local time, 20,000 chairs were placed on the lawn outside the White House in Washington, D.C. to commemorate the more than 200,000 COVID-19 victims in the United States.

Another severe milestone in America!

1 out of every 500 people died in COVID-19.

According to American media reports, the United States has encountered another severe milestone in the fight against the devastating COVID-19 epidemic: since the country first reported the confirmed case of COVID-19, more than 660,000 people have died in COVID-19, which is equivalent to 1 person in COVID-19 for every 500 Americans.

According to the data of Johns Hopkins University, by the evening of 14, 6,63913 people had died in COVID-19. According to the data of the US Census Bureau, as of April 2020, the population of the United States is 33140,000.

According to American media, this is a sobering figure, because American hospitals are trying to cope with the number of patients in COVID-19, and more and more children are struggling with COVID-19. Since early summer, the mortality rate has greatly increased because highly contagious delta species have become the mainstream.

According to the data of Johns Hopkins University, as of 14, in the past week, the average number of new cases in the United States exceeded 152300, which was more than three times the lowest average level on June 22, 2026 (1 1303 cases per day). There are 1.805 COVID-19 deaths every day in the United States in a week, which is much higher than the lowest average level this year (2 1.8 cases) reached on July 5.

In addition, with the opening of schools in various parts of the United States, the number of children infected in the country has surged, causing concern. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on June 4th that the combination of masks and vaccination is the way to keep children in school.

Pfizer says vaccine effectiveness decreases with time.

Can FDA approve the application of booster injection?

On the other hand, the Biden administration plans to distribute vaccine fortifiers to the general public from the 20th, but it is still doubtful whether the US regulators will approve this measure.

On June 5438+05, the staff of the US Food and Drug Administration (FDA) refused to make a statement on whether to support Pfizer fortifier, saying that all available data had not been verified.

The latest data submitted by Pfizer was also released by FDA on June 5438+05. In this report, Pfizer showed evidence that the third dose of vaccine is safe and necessary for most Americans.

In a 52-page report, Pfizer said that the effectiveness of the mRNA vaccine will weaken over time, but the booster can produce an immune response similar to that after the second dose of vaccine.

Pfizer said that real data from Israel showed that the third dose of vaccine could restore a high level of protection to COVID-19, with an effective rate of 95%. These data were collected from July 1 day to August 30, when Delta was spreading in the country.

The company said that the fortifier they applied for was "for people over 16 years old" and suggested that "the fortifier should be vaccinated about 6 months after the second dose of vaccine".

FDA's Advisory Committee on Vaccines and Biological Agents (VRBPAC) will hold a meeting on June 5438+07 to review the data submitted by Pfizer about its fortifier and decide whether to recommend vaccination to the general public.