https://safirsoft.com FDA advisors are Pfizer Green Lights for people over 65 and at-risk groups

The commission completely refused to approve the amplifiers for all persons 16 years of age and older.

A panel of FDA independent advisors unanimously approved (18-0) a Pfizer/BioNTech COVID booster dose. 19 vaccines for people 65 years of age or older, as well as people at high risk based on an underlying disease and/or occupational exposure (eg health care workers). It is recommended that booster doses be given at least six months after completion of the initial dose.

If the FDA goes ahead with the advisory panel's recommendation - which it likely will - it will be recommended for both groups under the Emergency Use Authorization.

Prior to the vote on licensing the two groups, the committee rejected the idea of ​​approving the amplifiers for everyone aged 16 and over by a vote of 16 to 16.

Overall, the Vaccines and Related Products Advisory Committee Biologics (VRBPAC) - I felt there was too little safety data to evaluate, especially for young adults at high risk for the rare side effects of the COVID-19 vaccine in or around carditis (myocarditis and pericarditis). In addition, the Committee considered that there was no convincing evidence that the vaccine's overall protection against severe illness, hospitalization and death had been reduced to the point that vaccination was required. "The third dose is likely to be beneficial," Ofer Levy, a VRBPAC voter who specializes in infectious diseases at Harvard University, told everyone after the negative vote. "It's currently true for people who are immunocompromised. I think, in my opinion, it's good for older people and may eventually be shown to the public. I don't think it's still there in terms of the data. Is it." The vote came after a tumultuous day-long meeting in which members of the advisory committee appeared to hope to boost the green light for the general public. Last month, the Biden administration announced ahead of an FDA review that it was ready to offer vaccine boosters starting September 20. The announcement is said to have caused frustration and anger within the watchdog, with two prominent vaccine regulators announcing their resignations. Vaccine efficacy

Among those resignations is Marian Gruber, current director of the Food and Drug Administration's Office of Vaccine Research. At the start of today's meeting, he thanked his staff and noted that this was probably their last meeting at VRBPAC. In his opening speech, he stressed that the decision to adopt a booster dose depends on whether the drug is "safe," which includes "assessing whether the benefits outweigh the risks." In young people, the question remains whether myocarditis/pericarditis is more likely to increase with the potential benefits of the third dose, given that younger men are now less likely to develop serious disease than older men. They appeared to have high levels of protection from the first two doses. CDC epidemiologist Sarah Oliver presents a set of data showing that the effectiveness of the vaccine against infection has diminished over time, but that protection against hospitalization remains strong. Comparing the effect of pre-delta vaccine in adults over 18 years of age with the most recent post-delta data, the range of vaccine efficacy against infection decreased from 72 to 92% before delta to 39 to 84% after delta in July. For hospital admissions, the effect of pre-Delta vaccination ranged from 84% to 97% and decreased to 75% to 95% in July after Delta. In adults together, the effect of the vaccine remains strong and is 88% more effective for people over 75 years of age. However, Dr. Oliver referred to Qatar data showing that hospitalization protection was reduced in people aged 60 or older after 25 weeks of vaccination, although the confidence interval is very large. Similarly, Israeli experts have provided data that vaccine efficacy continues to decline over time, with older groups receiving less protection against severe disease. Israel is about three months ahead of the United States in vaccinating a large part of its population. Therefore, this country is considered the carrier of the effectiveness of the vaccine. On July 30, Israel dealt a heavy blow to all people aged 16 and over, starting with the elderly, according to data showing poor protections on a large scale. At the time, Israeli data showed that the boosters reduced approved cases in people over 60 and reduced the relative risk of serious illness in that age group by more than 10 times. Unfortunately, there is not enough time for young people to produce useful safety data that can inform decisions in the United States.

Data Concerns

In another instance, Jonathan Stern, a statistician at the University of Bristol, cautioned at this meeting against underestimating a vaccine's efficacy in the real world due to a variety of confounding factors. These include different characteristics of vaccinated people compared to unvaccinated people, as well as previous COVID infections protecting unvaccinated people. Estimation of the effect of a vaccine can be influenced by the time individuals are vaccinated, the risk factors for each group, the wave of infection and the timing of vaccination waves. Many of these factors can make the vaccine less effective than it already is. For example, the people who were the first to receive the vaccine included people with weakened immune systems, so an increase in infection and severe illness may indicate a problem with weak immune responses in this population, rather than a general decrease in protection. Total.

In addition, it is important to note that Israel defines severe illness differently than the United States, and counts people with high respiratory rates and blood oxygen levels below 94 percent. Studies in the United States often define severe illness as patients who need treatment in a hospital or intensive care unit, or who die from an infection. Infection decreased but this protection from hospitalization was not diminished. The company argued that Israeli data were declining, indicating that the boosters were preventing an increase in severe illness and death among vaccinated individuals. Only 306 people between the ages of 18 and 55 participated in it. The data show that the third dose increases antibody levels to similar levels if no more than subsequent doses are observed. Similarly, the side effects of the third dose were similar to those seen after the second dose, and the most common side effects included injection site pain, fatigue, headache, chills, and muscle aches. Overall, Israeli data show that VRBPAC indicates that the elderly will soon be at greater risk of serious illness, hospitalization and death, and stimulant doses can be safely protected. But with such little information about the safety of the younger groups without a clear and increased risk of serious disease in those young groups, members were not convinced that it should now be expanded to all people 16 years of age or older.

Final Decisions

Members reach out to people over 65 in their final discussions, as well as those at high risk. Pieces and definitions are shaky. The committee had no specific information about the age group involved, and some committee members suggested people over 50 or 60 years old. Finally, the Food and Drug Administration rewrote the last voting question, which included a 65-year hiatus. In addition, the Committee considers that individuals at high risk of developing severe underlying conditions, given the potential for further reduction and the need to protect health care systems from severe stress, is essential. Who can qualify under these conditions has yet to be determined by the CDC's advisory committee -- the Advisory Committee on Immunization -- which is set to meet on September 22. Similarly, VRBPAC believes that people were more likely to develop infections due to occupational exposure, given that imaging amplification may reduce the risk of infection and transmission. With hospitals across the country under pressure from the Delta coronavirus, the commission wanted to ensure that health care workers, frontline workers and teachers were given maximum protection - once again - to protect public health care systems.

Although today's decision may give some hope that there will be a stronger green light for the boosters, the committee was pleased to follow the flag and resist any pressure from the Biden government.

“I think this should show the public that the members of this committee are independent of the FDA and, in fact, we are bringing our voices to the negotiating table,” said Archana Chatterjee, VRBPAC Voter and Dean of Chicago Medical School. . Arnold Munto, President of VRBPAC, noted that if booster doses with EUA are permitted, the data will be reviewed in the near future to determine if and when a booster is available to the group.

FDA advisors are Pfizer Green Lights for people over 65 and at-risk groups
fda-advisors-are-pfizer-green-lights-for-people-over-65.html

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