FDA Advisory Committee to determine if COVID-19 vaccine boosters are now widely needed

The Federal Advisory Committee on Friday will determine whether third shots of the Kovid-19 vaccine are safe and provide protection against infections.

Presidential Advisor Dr. Klein said the extra shots at the source were “luxuries,” or an essential part of full protection against the virus. Anthony Fauci said this week.

Other federal officials, including him and President Joe Biden, believe it is time to start giving third shots to cover the fading defense.

Others, especially the World Health Organization’s general counsel, argue that Americans benefit greatly from getting early shots at vaccinators worldwide.

The Food and Drug Administration Advisory Committee will consider information from Pfizer and its German partner, Biontech, and decide whether companies 16 and older should be allowed a third vaccine dose.

In a rare open letter on the eve of the FDA committee meeting, CEO Albert Bourla showed that lab data and Israeli real-world evidence suggest that boosters play an important role in addressing the epidemic.

“The same dose and the same vaccine booster can achieve this significant protection boost,” Bourla wrote in a letter published on the Pfizer website Thursday morning.

However, FDA officials at this time were skeptical of the need for third shots.

In a brief summary of information provided to the committee and posted online on Wednesday, studies supporting the need for FDA boosters have not been conclusive and have not been conducted in the United States, which may see different results than other countries.

“Overall, the data suggests that currently US-licensed or authorized covid-19 vaccines provide protection against severe covid-19 disease and death in the United States,” the FDA report concluded.

In the United States, “more than 90%” of people hospitalized with Kovid-19 have not been vaccinated, although CDC director Dr. Kerr said that vaccinated people are beginning to catch mild forms of the disease. Rochelle Walenski said at the White House briefing last week.

It is unclear whether committee members, all experts in vaccine development and immunology, support these booster doses six months after the initial dose.

Although they decide the third dose is safe and effective, the Centers for Disease Control and Prevention and its own Advisory Committee – scheduled to meet Wednesday and Thursday – decide who should accept boosters and on what schedule.

Agencies are currently considering the Pfizer-biotech vaccine, which is a fully approved shot, although they are expected to review the Moderna vaccine soon.

Speaking to undergraduates Wednesday morning at the Massachusetts Institute of Technology, Fauci said he thinks people need three-dose Moderna or Pfizer-biotech vaccines to get adequate long-term protection against Kovid-19. . Other diseases, such as hepatitis B, require three-dose vaccine regimens for complete protection.

“We started with two doses because the vaccine must be quickly removed to save millions of lives, which it has already done,” he told the students. “But when we finally see it, as the dust settles, in my opinion and now many of my colleagues’ proper absolute rule is a three-dose rule as opposed to a two-dose regimen.”

Data from Israel, As Fauci notes, vaccine protection begins to fade over time, beginning in about six months, when people who are vaccinated first develop mild disease and then develop chronic disease.

Israel, which received most of the Pfizer-BioTech shots, was one of the first countries to launch a widespread vaccination against COVID-19 and has some excellent data on how well those vaccines hold up over time.

Israeli public health officials are expected to attend Friday’s meeting of the Vaccines and Related Biological Products Advisory Committee to explain their findings in detail.

Other public health and vaccine experts are less persuaded by the available data.

“I am convinced that protection from symptomatic infections is deteriorating,” said Dr. Kerr, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. But he is “less convinced of the deterioration of protection against acute disease.”

The purpose of the vaccine is not to prevent every symptom of the infection, but to protect people from the most severe consequences, according to Dr. Dawson. Anna Durbin said the Johns Hopkins in Baltimore studies experimental vaccines at LOVEBYLIFE School of Public Health.

Reading Syringe with Pfizer Kovid-19 Vaccine at Community College, Reading, Pa., Tuesday, September 14, 2021. (AP Photo / Matt Rourke)

“Right now,” he said in a Wednesday call with the media, “an indication that we don’t need an additional booster.”

There is no doubt that boosters are effective. “Does it improve your immune response? Do we see more headlines for the antibody? Yes. Does the safety data look good? Yes. Does that mean we need boosters? No.”

He said, “And we must not give up the most valuable resource possible,” unless the virus is stopped worldwide and COVID-19 cannot be prevented from coming to the United States.

In his letter, Pfizer CEO Bourla said the decision on boosters should be based on science, not on equal distribution. The introduction of boosters does not change how many doses each country receives, he said.

“Any commitments made to Pfizer will not change if the boosters are approved,” he said. “We respect everyone.”

His letter shows that booster doses are effective against the most contagious delta mutation, which now shows the addition of a third dose to all Covid-19 infections in US studies – the same vaccine-enhancers at the same dose for the first two shots, and protection against all variants of the virus.

Fauci said that the basic vaccine for students has been eliminated against the broad spectrum of protection; Otherwise, “you’re playing Whack-A-Mole with every new adaptation,” he said.

The third dose is as safe as the first twoPfizer-BioTech data, with approximately the same side effect profile. There is no information on third doses for 16 and 17-year-olds, but companies think they are similar to those over the age of 18, which are booster approved.

Jared Thompson, 20 Kent State University watches the first shot of the Fixer vaccine at Sequoia County Public Health on Wednesday, September 1, 2021 at the Vaccination Clinic in Akron.  Thompson said his motivation to get the vaccine was a KSU student.  As a first-shot recipient, he received a $ 100 Key Bank Gift Card.

Only Pfizer-BioTech booster shots are now considered because their vaccine is fully licensed by the FDA. The Moderna and Johnson and Johnson Vaccines are still only available under emergency use surveillance.

Fauci, which is expected to get full approval soon, released its own data on Wednesday in support of boosters in six months.

A study by Kaiser Permanente in Southern California found that the vaccine prevented 87% of COVID-19 cases and 96% of hospitalizations. Half of the people underwent delta transformation in the study.

Another study, which has not yet been peer reviewed, followed people who were in the company’s initial study on vaccine effectiveness, in which half of the volunteers received the active vaccine and half the placebo. They were vaccinated at the end of the trial, which means they got their shots after the first group.

Of the more than 14,000 people in each group, those who first got their shots were more likely to catch Kovid-19 and develop severe disease. Three people who received early shots were hospitalized and one died, indicating that protection against acute disease will begin to deteriorate over time.

There is still no information on whether people who received the single-dose J&J vaccine need a second shot.

Contact Karen Weintraub at kweintraub@usatoday.com and Elizabeth Weiss at eweise@usatoday.com.

The protection of health and patient safety is made possible in part by a grant from the Massimo Foundation for Competition in Ethics, Innovation and Health Care. The Massimo Foundation does not provide editorial input.

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