https://www.theepochtimes.com/mkt_breakingnews/cdc-director-agencies-urgently-working-on-covid-19-vaccine-for-younger-children_3995309.html

https://outline.com/EdM9pS

CDC Director: Agencies Urgently Working on COVID-19 Vaccine for Younger Children

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky says the federal health agency is working quickly on a COVID-19 vaccine for younger children between the ages of 5 and 11.

“We’re waiting for the companies to submit the data to the FDA, we’re anticipating that will happen in the fall,” she told the “Today Show” on Sept. 13. “We will look at that data from the FDA, from the CDC, with the urgency that we all feel for getting our kids vaccinated and we’re hoping by the end of the year.”

Her comments contrast with health advisory panels in several other countries, including the United Kingdom, that haven’t recommended COVID-19 shots for children aged 5 to 11. In the United States, the Food and Drug Administration (FDA) has granted emergency authorization to vaccinate children aged 12 to 17.

Last week, FDA executives, including Acting Commissioner Janet Woodcock and Center for Biologics Evaluation and Research chief Peter Marks, said in a statement that the agency will carefully look at data for younger children once it becomes available.

The officials said the FDA is then “prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” adding that “the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers.”

Should the CDC hand down a recommendation that younger children get vaccinated, it’s likely that some school districts will mandate them for in-person classes. Already, the Los Angeles Unified School District last week voted to mandate vaccines for children aged 12 and up in order to attend classes on campus.

But in other countries, some officials have noted that children have an extremely low risk of becoming seriously ill, hospitalized, or dying from COVID-19, the illness caused by the CCP (Chinese Communist Party) virus.

The UK Joint Committee on Vaccination and Immunisation (JCVI) earlier in September said it will take a “precautionary approach,” saying that “given this very low risk, considerations on the potential harms and benefits of vaccination are very finely balanced.”

In June, scientists from University College London, as well as the Universities of York, Bristol, and Liverpool, discovered that most children who died of COVID-19 had underlying health problems. Overall, the COVID-19 mortality rate among children is 2 deaths per 1 million children in England, they found.

“We hope this data will be reassuring for children and young people and their families,” said Dr. Elizabeth Whittaker, from the Centre for Paediatrics and Child Health and Imperial College London, reported the BBC. She said that even after the emergence of the Delta variant, it hasn’t affected the child mortality rate.

>>14577233

https://www.youtube.com/watch?v=EVlVG8C18yY

>>14577243

>so what

lil nas with the throw back

https://theweek.com/delta-variant/1004816/the-white-house-fda-and-cdc-are-evidently-not-on-the-same-page-on-covid-19

The White House, FDA, and CDC are evidently not on the same page on COVID-19 booster shots

The Biden administration has been preparing to roll out COVID-19 booster shots on Sept. 20 for most fully immunized adults, assuming the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) agree. The FDA will weigh the evidence for a Pfizer-BioNTech booster shot at a public meeting on Friday, but internal tensions between the FDA, White House, and CDC are already spilling into the open.

Everyone agrees the level of antibodies from the vaccines wanes over time, but there is disagreement over whether approving a third shot is necessary right now, given the other layers of protection from the vaccines and the mildness of most breakthrough infections. Several countries have already approved booster shots for the general population, and Israel is preparing to offer some people a fourth shot.

But in the U.S., the White House COVID-19 task force and FDA "have repeatedly accused CDC of withholding critical data needed to develop the booster shot plan," Politico reports. Some CDC officials view the White House timeline on booster approval as unrealistic.

The "FDA's frustrations with CDC are longstanding and predate the pandemic," Politico notes, but the two agencies are "trying to align" better, especially after the departure of two top FDA vaccine regulators, Marion Gruber and Philip Krause. "The pair announced their retirements this month, in a move that one former official attributed to frustrations with CDC's role in the booster plan."

But Krause and Gruber were among a group of international scientists who argued in British journal The Lancet on Monday that it is premature to offer everyone booster shots.

Universal booster shots may be needed eventually, the Lancet group wrote, but right now other parts of the immune system revved up by the vaccines, like T-cells and memory B cells, are providing really robust protection even as antibody levels decline. They also suggested there could be adverse reactions from repeated vaccinations, and argued that vaccines would be better used to immunize people around the world with no access.

Georgetown University's Larry Gostin said the Lancet paper "throws gasoline on the fire" in the booster shot debate, but the FDA shrugged it off. "We are in the middle of a deliberative process of reviewing Pfizer's booster shot supplemental approval submission," the FDA said, and "as noted in the article, the views of the authors do not represent the views of the agency."

>>14577268

>Krause and Gruber were among a group of international scientists who argued in British journal The Lancet on Monday that it is premature to offer everyone booster shots.

https://twitter.com/TheLancet/status/1437402964919001088

Even for the #DeltaVariant, vaccine efficacy against severe #COVID19 so high that booster doses for general population are not appropriate at this stage in the pandemic.

Expert review of evidence to date by intl. group of scientists:

https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb-assets/Lancet/pdfs/S0140673621020468-1631529799470.pdf

>>14577275

>Krause and Gruber

https://www.biocentury.com/article/639085/departure-of-top-fda-vaccine-regulators-a-huge-loss-cber-director-marks-says

Departure of top FDA vaccine regulators a ‘huge loss,’ CBER Director Marks says

Resignation announcements Tuesday from FDA’s two most senior regulators responsible for oversight of vaccines, Marion Gruber and Phil Krause, surprised their colleagues at FDA, as well as vaccine developers and members of the public.

Gruber and Krause.

Dr. Marion Gruber, the director of the FDA’s vaccines office, will retire at the end of October, and her deputy, Dr. Philip Krause, will leave in November, according to an email that Dr. Peter Marks, the agency’s top vaccine regulator, sent to staff members on Tuesday morning. One reason is that Gruber and Krause were upset about the Biden administration’s recent announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot, according to people familiar with their thinking.

Neither believed there was enough data to justify offering booster shots yet, the people said, and both viewed the announcement, amplified by President Joe Biden, as pressure on the FDA to quickly authorize them.

>>14577281

According to official reports, Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, are set to resign in October and November.

The two published a viewpoint in The Lancet on Monday along with other experts worldwide, arguing, that, “Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics. Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

Gruber and Krause said they and other health officials are outraged that the CDC and Advisory Committee on Immunization Practices (ACIP) was spearheading decisions that should be the sole responsibility of the FDA.

President Biden’s chief medical advisor Dr. Anthony Fauci and others said available data indicated protection begins to wane over time and boosters were needed.

Gruber and Krause said they finally decided to step down after the Biden administration went ahead with a booster program starting the week of September 20 – without FDA approval and against scientific evidence.

>>14577274

>https://www.shropshirestar.com/news/world-news/2021/09/14/greek-authorities-probe-plane-crash-that-killed-witness-in-netanyahu-trial/

Greek authorities probe plane crash that killed witness in Netanyahu trial

Haim Geron, a former senior official at Israel’s ministry of communications, and his wife Esther were killed in the crash off Samos.

Greek authorities are investigating a private plane crash that killed a prosecution witness in the corruption trial of former Israeli prime minister Benjamin Netanyahu.

Haim Geron, a former senior official at Israel’s ministry of communications, and his wife Esther were killed in the crash on Monday off the island of Samos.

The Israeli foreign ministry identified the victims, both aged 69, adding that consular officials and the ministry are working with the family to return the bodies.

Mr Geron was one of more than 300 witnesses that prosecutors listed for Netanyahu’s trial on corruption charges.

He is accused of accepting expensive gifts from wealthy associates, allegations he denies.

Greece’s air accident investigation and aviation board is investigating the causes of the crash, officials said.

The single-engine Cessna 182 took off from Haifa, Israel, and crashed near Samos Airport.

“Shortly before landing, communication with the control tower on Samos was lost and the Civil Aviation Authority informed the search and rescue centre about the loss of communication,” the authority said in a statement.

The bodies of the two Israeli occupants were recovered by the coast guard several hours later, with the help of divers.

Netanyahu, now the opposition leader in Israel’s parliament, has denied all the accusations and mocked the size of the witness list.

>>14577294

>someone is losing their nerve

https://www.arkansasonline.com/news/2021/sep/14/plan-to-push-for-3rd-shots-draws-dissent/

Plan to push for 3rd shots draws dissent

Two departing Food and Drug Administration regulators argued in a review published Monday that none of the data on coronavirus vaccines so far provided credible evidence in support of booster shots for the general population. Their assertion revealed significant disagreement between career scientists at the agency and top Biden health officials, who have already started planning a broad booster campaign for this fall.

The experts reviewed studies of the vaccines' performance and concluded the shots are working well despite the extra-contagious delta variant, especially against severe disease.

"Even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission" at this stage of the pandemic, they concluded.

The opinion piece, published in The Lancet, was written by an international group of vaccine experts including Dr. Philip Krause and Marion Gruber, longtime FDA scientists who recently announced that they would leave the agency.

It comes days before an advisory committee is to publicly discuss and vote on whether the FDA should approve additional doses of Pfizer-BioNTech's vaccine for people ages 16 and up and illustrates the intense scientific debate about who needs booster doses and when, a decision the U.S. and other countries are grappling with.

https://www.youtube.com/watch?v=ssfIbJ7dPyg

>>14577325

>The opinion piece, published in The Lancet, was written by an international group of vaccine experts including Dr. Philip Krause and Marion Gruber, longtime FDA scientists who recently announced that they would leave the agency.

Experts argue against booster shots ahead of FDA meeting

CNBC's Meg Tirrell joins Shep Smith to report on the U.S. plan to give booster shots for Covid, even as experts argue against the shots ahead of an FDA panel meeting.

https://endpts.com/breaking-in-a-major-blow-to-vaccine-efforts-senior-fda-leaders-stepping-down-report/

In a major blow to vaccine efforts, senior FDA leaders stepping down

Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.

The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.

A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.

FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”

“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”

In a letter from Marks to staff, he explained:

Janet Woodcock told Endpoints that she wishes Gruber and Krause well and thanks them for their significant service.

>>14577355

PEBKAC is forever

If it hadn't been for Cotton-Eye Joe, I'd been married long time ago.

Where did you come from, where did you go?

Where did you come from, Cotton-Eye Joe?

>>14577373

>>14577390

>>14577392

>https://twitter.com/stevenvoiceover/status/1437445272758636549