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The Biden administration has decided most Americans should get a COVID vaccine booster dose eight months after they received their second shot, despite consensus among U.S. health experts last month there wasn’t enough data to recommend boosters for the general population.
Officials are planning to announce the decision as early as this week and a third dose could be offered as early as mid-September, according to administration officials familiar with the discussions.
Doses would only begin to be administered widely once the U.S. Food and Drug Administration (FDA) formally approves the vaccines — an action expected to happen for the Pfizer vaccine within weeks.
The administration’s goal is to let Americans who received the Pfizer or Moderna vaccines know they will need additional protection against the Delta variant responsible for the surge of U.S. COVID cases.
The first boosters are likely to go to nursing home residents, healthcare workers and emergency workers, followed by older people who were near the front of the line when vaccinations began late last year and then the general population.
Federal health officials are waiting for more data before offering guidance for Johnson & Johnson vaccine recipients. However, officials expect a booster will also be needed.
Pfizer and BioNTech said Monday a third dose is safe and elicits an antibody response at levels that “significantly exceed” those seen in individuals who receive two doses of the jab.
Federal health officials have been actively looking at whether booster doses for the vaccinated would be needed as early as this fall, reviewing case numbers in the U.S. and Israel, where preliminary studies suggest the vaccine’s protection against serious illness is waning among those vaccinated in January.
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The announcement comes just days after the Centers for Disease Control and Prevention (CDC) voted to recommend COVID booster shots for certain immunocompromised patients.
On Aug. 12, the FDA amended Emergency Use Authorization of Pfizer and Moderna’s COVID vaccines to authorize a booster shot for this population.
Pfizer CEO confident third dose will increase immunity, no phase 3 data
According to Kaiser Health News, Pfizer lacks late-stage clinical trial results to confirm a booster will work against COVID variants, including Delta — which now accounts for 93% of new infections across the U.S.
Pfizer in July announced its global phase 3 trial — which assesses the safety, efficacy and immunogenicity of a third dose — but the trial’s completion date isn’t until 2022. Phase 3 results generally are required before regulatory approval.
“We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that,” Jerica Pitts, Pfizer’s director of global media relations, said last week.
Moderna’s clinical trial “designed to assess the safety, reactogenicity and immunogenicity of a delayed vaccine boost” has an estimated primary completion date of May 28, 2023, and study completion date of 2025.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia and an adviser to the National Institutes of Health and FDA, said the pharmaceutical industry’s rush to recommend boosters for the public is “a little frustrating.”
Even if a booster is found to be safe, Offit said, the U.S. effort should focus on “vaccinating people who are unvaccinated.” In any case, decisions about boosters do not rest with vaccine makers, he said.
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As The Defender reported July 1, the CDC’s advisory committee last month said there wasn’t enough evidence to recommend booster shots, even as Pfizer reassured investors during an earnings call boosters would be needed long after the pandemic ends.
The COVID-19 working group of the CDC’s Advisory Committee on Immunization Practices (ACIP) said June 23, they would recommend booster shots only if there’s a demonstrated decline in efficacy –– not just a waning antibody response.
The expert panel determined there was no evidence to suggest a booster was needed, but the nation’s top public health officials would continue to monitor the situation.
Pfizer argued boosters would be required “as antibody blood concentration wanes, to ensure the broad population can’t carry the virus and thus quench the epidemic faster,” Bernstein analysts, led by Ronny Gal, wrote to clients June 28.
That’s not the industry’s standard, and it’s also not what the CDC’s ACIP suggested at its meeting June 23, analysts wrote.
“Clinical presentation of myocarditis cases following vaccination has been distinct, occurring most often within one week after dose two, with chest pain as the most common presentation,” said Dr. Grace Lee, co-chair of VaST.https://t.co/1CYufBl3yd
— Robert F. Kennedy Jr (@RobertKennedyJr) June 23, 2021
Pfizer executives met with U.S. senior scientists and regulators July 13, to press their case for quick authorization of COVID booster vaccines amid pushback from federal health agencies who said the extra doses were not needed.
“Nothing has really changed,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Chris Cuomo after the meeting. “The CDC and the FDA said that based on the data that we know right now, we don’t need a boost.”
Officials said more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary.
Boosters serve as key revenue driver for COVID vaccine manufacturers
COVID booster shots are expected to serve as a key revenue driver in the years to come for Pfizer and Moderna. Pfizer executives have assured investors the company sees the vaccine market evolving as the pandemic wanes, and will likely be able to charge more per dose than it was getting under pandemic supply deals.
Pfizer has been working on two different booster strategies it anticipates could carry sales beyond the immediate pandemic need — a third 30 mg dose of its current vaccines and an updated vaccine that targets the South African variant.
Pfizer said last week if a third dose couldn’t combat the Delta or other variants, the drugmaker is prepared to come up with a “tailor-made” vaccine within 100 days.
Pfizer last month announced it expects to pull in $33.5 billion in COVID vaccine revenue this year.
According to Reuters, Pfizer, along with German partner BioNTech, and Moderna have together locked up COVID vaccine supply agreements worth more than $60 billion in sales, just in 2021 and 2022. The agreements include supply of the initial two doses of their vaccines as well as billions of dollars in potential boosters for wealthy nations.
Analysts forecasted revenue of more than $6.6 billion for Pfizer’s COVID vaccine and $7.6 billion for Moderna in 2023, mostly from booster sales. They eventually see the annual market settling at around $5 billion or higher, with additional drugmakers competing for those sales.
As The Defender reported in May, pharmaceutical companies and their CEOs have made billions from COVID vaccines, massive compensation packages and questionable stock sales while reassuring investors that plans were underway for boosters and annual shots.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
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The Dangers of Speaking the Truth Diminish If We Work Together
It’s becoming harder and harder for patriots to ignore the deep suppression of truth that’s happening in America today.
In all of my years in journalism, I have never received as many threats or been attacked by big companies like Google and Facebook as I have in 2021. I’d say that ever since we started covering widespread voter fraud, government-endorsed Pandemic Panic Theater, vaccine cover-ups, Critical Race Theory, and the various Neo-Marxist and Satanic agendas at play, I’ve been targeted more in months than the entirety of my life prior.
Speaking the truth is getting harder with so much censorship and suppression rampant. Prior to 2020, I was not a “conspiracy theorist” or an “anti-vaxxer,” but if there’s one thing the onslaught of exposed lies have taught us in the last 18 months, it’s that we cannot take what we’re told by the “arbiters of truth” at face value. There’s an agenda behind every message, a narrative driving every story, and a series of gigantic cover-ups designed to keep the masses in the dark.
This is why we’re building a network of news outlets that are willing to go against the narrative and expose the truth. We need help. We’re establishing strong partnerships with like-minded news outlets and courageous journalists. Even as Big Tech suppresses us, the honest messages they’re trying to quash are finding their way to the eyes and ears of patriots across the nation. With the help of new content partners like The Epoch Times and The Liberty Daily, we’re starting to see a real impact.
Our network is currently comprised of nine sites:
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- NOQ Report
- Conservative Playlist
- Truth. Based. Media.
- Freedom First Network
- Based Underground
- Uncanceled News
- American Conservative Movement
- Conservative Playbook
- Our Gold Guy
Some of our content is spread across all of these 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.
I’ve said much of this before. From time to time I reframe this request for assistance by taking the most relevant message of the day and adjusting the story accordingly. We’ve discussed this network in previous articles. Now, it’s time to talk about help. First and foremost, we need financial assistance detailed below. But we could also use more writers who are willing to volunteer their thoughts for the sake of spreading the message. Those who are interested should contact me directly.
As far as money, we’re looking better than we have in the recent past, but we are currently experiencing a gap between revenue and expenses that cannot be overcome by click-ads and MyPillow promos alone (promo code “NOQ” by the way).
To overcome our revenue gap and keep these sites running, our needs fluctuate between $2200-$7800 per month. May, 2021, for example, was amazing and we almost broke even. June, revenue was sluggish at best and we had to make up a big difference out of our pockets. But we’re not just trying to get out of the red. If and when we start getting enough contributions to expand, we will do just that. Very few get into journalism to try to get rich and we’re definitely not among those who do. Our success is driven by spreading the truth, profitable or not.
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
Time is short. As the world spirals towards radical progressivism, 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,
We don’t allow Google ads here. We won’t post foot fungus treatments or soft-porn ads like other conservative news outlets. We WILL support MyPillow because they love America. You can support them and me by using promo code “JDR” at checkout.
Yes, We Need Your Help
I hate being “that guy” who asks people to donate because I think our conservative news network is so crucial, but here I am…
When I left my cushy corporate job in 2017, I did so knowing that my family would have to make sacrifices. But I couldn’t continue to watch the nation slip into oblivion and was inspired by President Trump’s willingness to fight the good fight even at his own personal expense. What I didn’t realize then is that conservative media would be so heavily attacked, canceled, and defunded that the sacrifices would be extreme.
Many in this nation are struggling right now even though we weren’t struggling just a few years ago. I’m not alone. But I wake up every morning and operate the sites we’ve been able to build because there’s really no other choice. I refuse to be beholden to Big Tech like so many other conservative news outlets, which is why you won’t see Google ads here. With that said, it’s often challenging to pay the bills and it’s even harder to expand so we can get the America First message out to a wider audience.
The economic downturn has forced me to make a plea for help. Between cancel culture, lockdowns, and diminishing ad revenue, we need financial assistance in order to continue to spread the truth. We ask all who have the means, please donate through our new GiveSendGo. Your generosity is what keeps these sites running and allows us to expand our reach so the truth can get to the masses. We’ve had great success in growing but we know we can do more with your assistance.
We currently operate:
- NOQ Report
- Conservative Playlist
- Uncanceled News
- Based Underground
- Truth Based Media
- Five other conservative news sites
I would even be willing to entertain investments and partnerships at this stage. I’ve turned them down in the past because editorial purity is extremely important. I’ll turn them down again if anyone wants us to start supporting RINOs or avoid “taboo” topics like voter fraud, vaccines, or transgender supremacy. But I’d talk to fellow America First patriots who want to help any (or all) of our 10 news sites. Hit me up at jdrucker (at) substack (dot) com if you’re interested.
For those who have the means and just want to help keep the mission of spreading a conservative, Christian message to the nation, please consider a generous donation.