FDA Panel Votes 16–3 Against Approving Pfizer COVID-19 Booster Shots

The U.S. Food and Drug Administration (FDA) advisory panel on Friday voted 16-3 to recommended against providing booster shots of the Pfizer COVID-19 vaccine for individuals aged 16 and older.

Article by Jack Phillips from our premium news partners at The Epoch Times.

Throughout the meeting, independent scientists to the FDA struck a skeptical tone on the need for boosters, or third doses, for Pfizer’s mRNA COVID-19 vaccine for the general public. The advisory panel’s discussion is the first major test for the Biden administration’s vaccination agenda as top health officials last month announced they would try to roll out boosters for everyone by Sept. 20.

While U.S. health officials, some other countries and vaccine makers have argued that boosters are needed, many scientists, including some inside the FDA and the U.S. Centers for Disease Control and Prevention (CDC), have disagreed. Booster doses have been previously recommended by the CDC for immunocompromised individuals.

But to boost arguments against boosters being recommended for the general population, an FDA slide said the risk of COVID-19 for a or healthy 30-year-old is just 0.0004 percent, or 1 in 250,000. Some recommended a booster for older individuals but several experts said they want more data about whether the booster shots can contributed to myocarditis.

Dr. James Hildreth, a voting member on the FDA expert panel, said that he “[has] a serious concern of myocarditis in young people,” referring to a type of heart inflammation. The FDA previously issued warnings that while rare, Pfizer and Moderna vaccines could cause myocarditis among younger individuals.

“I honestly don’t think there is enough good quality data at this point to make an informed decision,” Brittany Kmush, an epidemiologist at Syracuse University, said of the Israeli study, noting the 12-day follow-up period and the variability of the authors’ estimates.

And another FDA advisor, Dr. Melinda Wharton, meanwhile, echoed Hildreth’s concerns and said she would “not feel comfortable” with recommending boosters to younger people due to the risk of myocarditis. Younger people are not at risk of developing severe illness from COVID-19 or becoming severe breakthrough cases, she noted during the panel.

Earlier this week, the FDA uploaded Pfizer’s arguments that cited studies in Israel and the United States suggesting that the COVID-19 vaccine’s efficacy drops over time and said that booster doses are necessary to deal with new virus variants.

“Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier in the vaccination campaigns compared to those who have been vaccinated more recently,” Pfizer said during a presentation, uploaded to the FDA website.

Israeli studies indicate that the “observed decrease of vaccine effectiveness against COVID-19 infections is primarily due to waning of vaccine immune responses over time rather than a result of the Delta variant escaping vaccine protection,” Pfizer’s presentation said.

But in response to the Pfizer data, FDA researchers said hours later the initial vaccine doses are sufficient and suggested that boosters may not be needed now.

An analysis by Israeli scientists published on Wednesday found that among 1.1 million people age 60 or older who had been fully vaccinated at least five months earlier, those who received a booster were less likely to be infected or become severely ill than those who did not get the third shot.

The pharmaceutical giant concluded that its vaccine efficacy wanes over time, and a third dose of its mRNA shot works to boost it. They argued that 1.8 million more severe cases of COVID-19 would occur in the United States in 2021 without a booster dose for the general population.

But in a study published by The Lancet on Sept. 13, two senior FDA vaccine reviewers who are expected to leave the agency soon and more than a dozen top researchers argued that booster shots aren’t needed for the general population. They argued that potential side-effects from the extra doses could outweigh the benefits, stating that such a phenomenon would actually increase vaccine hesitance. The two FDA officials involved in the research, Marion Gruber and Phil Krause, submitted their resignations last month, officials confirmed.

“Current evidence does not … appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” their study reads. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations.”

Those researchers also expressed concern that the boosters may cause more side-effects for individuals, which would increase the hesitancy of unvaccinated individuals in getting the vaccine—not just the booster.

As of Friday midday trading, shares of Moderna Inc. and BioNTech plunged by around 4.93 percent and 4.91 percent, respectively.

Reuters contributed to this report.

Plandemic, Voter Fraud, Afghanistan: All Parts of The Great Reset

If you still consider “conspiracy theorist” to be a pejorative, you’re not paying enough attention.

What do Covid-19, 2020 (and beyond) election fraud, and our disastrous abandoning of American citizens in Afghanistan have to do with one another? They’re all parts of the globalist plan to usher in a new era of Neo-Marxism in a depopulated world. This is The Great Reset unfolding before our eyes, and the only way we can stop it (other than through constant prayer) is to stand together and spread the truth.

Covid-19’s attachment to The Great Reset is obvious, though we continue to post about it daily. Voter fraud is a bit less obvious but nonetheless easy to recognize when we understand that people like Joe Biden, Justin Trudeau, and Emmanuel Macron are pushing to “Build Back Better” under the precepts of Neo-Marxism.

The Afghanistan betrayal in August, 2021, is harder to associate with The Great Reset, but it’s definitely just as attached. We can see this is the unwillingness of the Biden regime to extend the deadline to withdraw despite American lives put clearly in harm’s way. We can see it in the needlessly abandoned military equipment that was conspicuously left intact; disabling a Black Hawk takes minutes but they were given to the Taliban in pristine working condition. Then, there’s the pallets of hundred dollar bills left for them. If you think all of this was just irresponsible governance, you probably think Barack Obama is out of politics, too.

Weakening America’s standing in the world and empowering the Chinese Communist Party and others to engage fully with our enemies in a globalist cabal are beneficial to the architects of The Great Reset, and both happened in one fell swoop in August.

These truths need to be spread. As a conservative network of news outlets, we are swimming upstream against the forces of mainstream media. We are getting canceled across the board by Big Tech. We will continue to spread the truth to millions, but we desperately need help to spread the truth to a wider range of people. This is where you come in.

The best way you can help us grow and continue to bring proper news and opinions to the people is by donating. We appreciate everything, whether a dollar or $10,000. Anything brings us closer to a point of stability when we can hire writers, editors, and support staff to make the America First message louder. Our Giving Fuel page makes it easy to donate one-time or monthly. Alternatively, you can donate through PayPal or Bitcoin as well. Bitcoin: 3A1ELVhGgrwrypwTJhPwnaTVGmuqyQrMB8

Our network is currently comprised of nine sites:

• NOQ Report
• Conservative Playlist
• Truth. Based. Media.
• Freedom First Network
• Based Underground
• Uncanceled News
• American Conservative Movement
• Conservative Playbook
• Our Gold Guy

We are also building partnerships with great conservative sites like The Liberty Daily and The Epoch Times to advance the message as loudly as possible, and we’re always looking for others with which to partner.

Also, we could use contributions of content. If you write or want to start writing and you share our patriotic, conservative, America First ideology, contact us. The contact form on this and all pages on the site goes directly to me.

Some of our content is spread across multiple sites. Other pieces of content are unique. We write most of what we post but we also draw from those willing to allow us to share their quality articles, videos, and podcasts. We collect the best content from fellow conservative sites that give us permission to republish them. We’re not ego-driven; I’d much rather post a properly attributed story written by experts like Dr. Joseph Mercola or Natural News than rewrite it like so many outlets like to do. We’re not here to take credit. We’re here to spread the truth.

While donations are the best way to help, you can also support us by buying through our sponsors:

• MyPillow: Use promo code “NOQ” to get up to 66% off AND you’ll be helping a patriotic, America First company.
• Freedom Phone: Use promo code “MAGA” and get $50 off AND you’ll be helping a patriotic, America First company.
• OurGoldGuy: Tell them we sent you in your request to buy gold and it will help us… AND (wait for it) you’ll be helping a patriotic, America First company.

We know we could make a lot more money if we sold out like so many “conservative” publications out there. You won’t find Google ads on our site for a reason. Yes, they’re lucrative, but I don’t like getting paid by minions of Satan (I don’t like Google very much if you couldn’t tell).

Time is short. As the world spirals towards The Great Reset, the need for truthful journalism has never been greater. But in these times, we need as many conservative media voices as possible. Please help keep NOQ Report and the other sites in the network going. Our promise is this: We will never sell out America. If that means we’re going to struggle for a while or even indefinitely, so be it. Integrity first. Truth first. America first.

Thank you and God Bless,
JD Rucker

Bitcoin: 32SeW2Ajn86g4dATWtWreABhEkiqxsKUGn