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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.
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.
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.
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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.
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.
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Most Accurate Pollster From 2020 Drops Final Numbers
by JD Rucker
Atlas Intel, which was hands down the most accurate public poll during the 2020 election, just dropped its final poll of the season. It points to landslide victory for Donald Trump. If Kamala Harris is able to win Minnesota and Virginia, two blue states that are in jeopardy of being…
A Kamala Harris Victory Means Green New Deal Lawfare
by Daily Signal
Expect Kamala Harris’ Justice Department to wage Green New Deal lawfare if she is elected president on Nov. 5. As with every last issue pertaining to this election, Harris has not said much about the substance of her climate policy. But a review of her record suggests she’d be amenable…
The Moral and Spiritual Issues That Demand Our Votes
by Harbingers Daily
As a pastor and a preacher, I want to urge all Christians this election season: Get out and vote. I believe it is our duty as citizens of our state and country, but I also believe it’s especially important given the issues represented in this election. Many of these are…
No Matter the Final Vote, This Election’s Biggest Loser May Be the Legacy News Media
by Just The News
In the sultry days of summer 2020 as Donald Trump contemplated a second term, his aides engaged in a quiet conversation with members of the emerging digital media about an audacious idea. The goal was to bypass the traditional news media who monopolized the White House Correspondents Association press room…
Democrats Unveil Dark, Diabolical Plans to Prevent Trump From Retaking White House – Even if He Wins!
by WND
With results from the 2024 presidential election now imminent, Democrats have been vocal in their plans to subvert the will of the American people and prevent former President Donald Trump from retaking the White House if he pulls out a win over his Democratic rival Vice President Kamala Harris. In…
Trump Doesn’t Rule Out Banning Certain Vaccines if He Wins Election
by The Epoch Times
Former President Donald Trump in a new interview did not rule out banning some vaccines if he wins the upcoming election. “Well, I’m going to talk to him and talk to other people, and I’ll make a decision,” Trump told NBC over the weekend when asked if banning vaccines would…
Trump, Republicans Pin Hopes on Record Early Voting in North Carolina
by Jeff Louderback, The Epoch Times
(The Epoch Times)—In his final North Carolina rally of the 2024 campaign, former President Donald Trump predicted he would win the state where he prevailed in 2016 and 2020. “North Carolina’s reliable for me,” Trump said at Dorton Arena in Raleigh, the first of four stops on Election Day Eve….
If Godly People Don’t Vote, Godless People Will: The Christian Case for Voting
by The Blaze
Do Christians have a spiritual responsibility to vote? Allie Beth Stuckey of “Relatable” and the senior pastor of Lakepointe Church, Josh Howerton, believe the answer to that question is a resounding “yes.” “I’ll gently venture out on a limb,” Howerton tells Stuckey. “I think Christians have a spiritual responsibility to…
Here’s Proof the FBI Protected Biden in 2020, and Why Congress is More Important Than the White House
by PJ Media
You won’t find it reported on the A-section pages of the New York Times or the Washington Post even though it is quite likely the most significant report produced by any investigative committee in Congress since the Church Committee in 1976. For those who need a refresher, the investigative committee…
The Media Made Sure This Election Was Never Going to Be Free or Fair
by The Federalist
The corrupt news media lied to voters on behalf of Democrats over and over ensuring an unfair election. How can we ever return to normal? It’s truly awe-inspiring to watch the news media berate Republicans, down to the very end, over the “free and fair” election we’re most certainly not…
“It’s Not Going to Be Close”: Mark Halperin Says One Key Voter Group Will Decide the Election
by Harold Hutchison, Daily Caller News Foundation
(DCNF)—Journalist Mark Halperin said on Monday that the turnout of women would decide the presidential election between former President Donald Trump and Vice President Kamala Harris. Trump leads Harris by 0.1% in a head-to-head matchup, according to the RealClearPolling average of polls from Oct. 11 to Nov. 3, with Trump’s…
It Was the Night Before the Election, and Everyone Was Freaking Out
by Michael Snyder
(End of the American Dream)—I have never seen so much doubt, worry, anxiety, fear and panic as we approach a presidential election. All over the country, people are freaking out right now. Democrats are freaking out because the early voting numbers are so dramatically different from 2020. Republicans are freaking…