FDA releases pre-conference materials for Pfizer's new crown vaccine booster vaccination expert meeting, skeptical about booster vaccination

According to the pre-conference information released by the US FDA on September 15, FDA scientists doubted whether it is necessary to provide a booster clip for all people who have received Pfizer's new crown vaccine
.

The FDA will hold an expert meeting on September 17 to debate who needs additional booster vaccination and when it needs booster vaccination

In the document, FDA's own scientists seem to be skeptical of the need for widespread use of booster vaccination
.

They said that overall, “data shows that the new crown vaccine currently licensed or authorized in the United States can still provide protection against severe new crown disease and death in the United States

The data in the pre-conference information undoubtedly contributed to the current fierce debate surrounding millions of people around the world being vaccinated against the new crown: if the protective effect of the vaccine weakens, do people need to add booster shots? Some areas have not received the first dose of vaccine.
When should the booster be given? Should this decision vary depending on age and whether people have other health conditions?

On the one hand, pharmaceutical companies and some researchers pointed out that data shows that the effectiveness of vaccines to protect all infections is waning, and the third shot will increase the effectiveness of protection
.

On the other hand, it was pointed out that these vaccines are still effective in preventing hospitalizations and deaths, indicating that there is no need for booster vaccination

The FDA expert panel's recommendations for booster vaccination are not binding, but the FDA may consider them
.

If the FDA authorizes an intensified injection, the decision on whether to vaccinate widely will be transferred to the Advisory Committee on Immunization Practice (ACIP) convened by the Centers for Disease Control and Prevention (CDC) for discussion.

The director and deputy director of the FDA's Office of Vaccines have recently announced that they will leave their posts soon.
This move is believed to be due to differences between them and the government over the issue of booster vaccines
.

[The director and deputy director of the FDA's Office of Vaccines will leave their posts one after another.

In a briefing document released on Wednesday, Pfizer stated that the effectiveness of its vaccine is declining and that the effectiveness of the third dose of the vaccine will return to the 95% level seen in clinical trials
.

According to recent data from Israel, the vaccine’s effectiveness against SARS-CoV-2 (the disease-causing virus of the new crown) has dropped from 95% in January to 39% in June
.

In an analysis of Pfizer's own Phase 3 trial, the incidence of breakthrough cases was higher in patients who received the second dose of vaccine before December 2020 than in patients who received the second dose of vaccine after March 2021

Pfizer also released new data from a study conducted by Kaiser Permanente in Southern California, which showed that the weakening of the vaccine’s effectiveness may be because the vaccine becomes less effective over time, rather than because the new delta variants The vaccine is more resistant
.

In Kaiser's data, the protective efficacy of the vaccine in preventing SARS-CoV-2 delta variant infection dropped from 93% of people who were vaccinated less than one month ago to 53% of people who were vaccinated four months ago
.

For the other variants, this drop is from 97% to 67%

FDA scientists stated in the briefing that “it should be recognized that although observational studies can help understand the effectiveness of protection in the real world, known and unknown deviations can affect its reliability
.

Because of these biases, some studies may be more effective than others.

The FDA document evaluated the safety of the third dose of vaccine and pointed out that there are no answers to certain questions
.
For example, it is not known whether the third dose of the vaccine will increase the incidence of myocarditis and pericarditis.
This side effect is mainly seen in men under 40
.
FDA scientists pointed out that “it is not clear whether Comirnaty (the brand name of Pfizer vaccine) increases the risk of myocarditis/pericarditis or other adverse reactions after booster vaccination
.
These risks and related risks must be considered when assessing the benefits and risks.
Uncertainty
.
"

British studies

British studies

At the same time, the United Kingdom was the first country to start using Western-developed vaccines for vaccination.
The analysis of the protective efficacy of vaccines in the U.
K.
provides further support for the view that there is no need to vaccinate everyone at present
.
A peer-reviewed analysis by the Department of Public Health of the United Kingdom [1] found that even in healthy elderly people, the protection of Pfizer vaccines against hospitalization and death is still high
.
The authors of the British study concluded that “in view of the continued high vaccine protection efficacy against hospitalizations and deaths, in the current epidemiological situation, the third additional benefit for these more serious outcomes is limited
.
” They added, but the vaccine The protective effect "may continue to weaken over time, and the longer interval between the second vaccination and the third vaccination may have a greater impact on more serious outcomes
.
"

The paper revealed that the most significant reduction in protection occurred in people 65 years and older with serious health problems
.
The article is based on a comparison of the vaccination status of nearly 1.
5 million people who tested positive for the new crown and nearly 3.
3 million people who tested negative
.
The author stated, “We indicated that the protective effect of individuals in the clinical risk group faded the most, which shows that whenever booster vaccination is recommended, priority should be given to booster vaccination for this group of people
.
”

Despite these findings, the British Joint Committee on Vaccination and Immunization recommended on Wednesday that everyone who was vaccinated first when the vaccine was introduced in the UK in December last year should receive a booster 6 months after the second vaccination
.
People included in the priority list of UK booster vaccination include people living in long-term care facilities, adults 50 years and older, front-line medical staff and social workers, people aged 16 to 49 with underlying health conditions, and those with immune function An adult who lives with a low person
.

[1] Andrew, N.
, Tessier, E.
, Stowe, J.
, Gower, C.
, Kirsebom, F.
, Simmons, R.
, .
.
.
& Bernal, JL Vaccine effectiveness and duration of protection of Comirnaty, Vaxzevria and Spikevax against mild and severe COVID-19 in the UK.

[1] Andrew, N.
, Tessier, E.
, Stowe, J.
, Gower, C.
, Kirsebom, F.
, Simmons, R.
, .
.
.
& Bernal, JL Vaccine effectiveness and duration of protection of Comirnaty, Vaxzevria and Spikevax against mild and severe COVID-19 in the UK.