Doses of the Pfizer/BioNTech vaccine for kids ages 5 through 11 have already arrived in Michigan and providers are ready to start giving the shots as early as Wednesday, pending approval by the CDC.

The federal Food and Drug Administration granted emergency use authorization for the children's vaccine on Friday, but health care providers are waiting for sign-off from the federal Centers for Disease Control and Prevention before administering the shots.

CDC Director Rochelle Walensky is expected to possibly grant approval Tuesday after a committee of advisers meets with the CDC to discuss the children's vaccine.

Gov. Gretchen Whitmer's administration pre-ordered about 287,700 doses to be ready for the eventual federal approvals, and Michigan Department of Health and Human Services spokeswoman Chelsea Wuth said the doses started to arrive on Monday.

"We will be ready (Wednesday) to start vaccinating pending approval," Wuth said Tuesday. "MDHHS is excited about potential authorization of the Pfizer COVID-19 vaccine for children ages 5-11.

"We know COVID-19 vaccines are safe and effective and the way out of this pandemic."

Each dose contains about a third of the amount of vaccine used for adolescents and adults, according to the FDA. Children will need two shots to be fully vaccinated.

The regimen was approved by the federal Food and Drug Administration on Friday, a move that was greeted with relief by some parents and trepidation by others. The vaccine was found to be 90.7% effective in clinical trials.

About 3,100 children participated in clinical trials that studied the vaccine's safety and efficacy in 5 through 11-year-olds, the FDA reported. No serious side effects have been detected so far in ongoing studies.

Whitmer last week ordered the state departments of Health and Human Services and Licensing and Regulatory Affairs to "take all appropriate action" to make the vaccine available to kids as soon as they're eligible to receive it.

The children's vaccine will be available at pharmacies, doctors' offices and local health departments, according to MDHHS.

"With over 4,000 providers in the state, there should be no problem finding a vaccine," Wuth said. "Our initial supply is expected to last through the end of the year, and we will be able to order more before then from CDC."

https://www.detroitnews.com/story/news/local/michigan/2021/11/02/michigan-poised-vaccinate-kids-ages-5-11-wednesday/6250460001/

>>14906987

>>14907077

seconded

Not even hiding the plot at this point

https://fivethirtyeight.com/features/were-tracking-trumps-and-harriss-popularity-ahead-of-the-2024-presidential-election-yes-its-early/

https://twitter.com/chuckgrassley/status/1455180010646646786?s=21

The Marine Corps has shut down its active duty law enforcement battalions as it continues to transform from a force focused on the Middle East to one prepared to play a role in a future war against a near-peer adversary.

On Oct. 1, the 3rd Law Enforcement Battalion, stationed out of Okinawa, Japan, was deactivated as part of the Marine Corps’ Force Design 2030 plan.

“It’s been my honor to serve as a Marine Corps officer … but it was a dream to come back and command this great unit,” Lt. Col. Bryce Carter, the battalion’s last commanding officer, said during the deactivation ceremony. “To be in a forward-deployed law-enforcement battalion is a special treat. We were the maneuver element for III MEF. When they needed a conventional force to do real-world operations, we were the first ones they called every time.”

RELATED

The battalion was the final of the three law enforcement battalions to deactivate as part of Force Design 2030, with the 2nd Law Enforcement Battalion shutting down shop on Dec. 17, 2020, and 1st Law Enforcement Battalion closing down on Oct. 1, 2020.

“This capacity is excess to our current needs, which can be met by the remaining force with some adjustments in current operational practice,” a summary of the Corps’ planned Force Design 2030 moves said of the law enforcement battalions.

https://www.armytimes.com/news/your-marine-corps/2021/10/28/all-3-marine-law-enforcement-battalions-are-now-deactivated/

Key Highlights

• South Korea and the United States are running a large-scale air exercise around Korea

• Reports suggest the maneuvers will last for five days

• Represent a return to the large-scale collaboration of this kind between the two nations that was scaled back dramatically as Washington attempted to negotiate with North Korea about its nuclear weapons program.

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The drills, the name of which is unknown, began yesterday, according to a South Korea official, talking anonymously to the Yonhap news agency. In a statement to the agency, the Republic of Korea Air Force (ROKAF) said: “We cannot comment on the exercise as it is one that is not disclosed to the media.” The U.S. military has so far not released any information either.

Reports suggest the maneuvers will last for five days and involve ROKAF F-15Ks and F-16s alongside U.S. Air Force F-16s, among a total of around 200 aircraft involved, but that no equipment or troops have been deployed from the U.S. mainland to take part.

The permanent U.S. Air Force combat aircraft presence in South Korea is based around two fighter wings:

1. The 8th Fighter Wing at Kunsan Air Base, with two squadrons of Block 40 F-16C/Ds,

2. The 51st Fighter Wing at Osan Air Base, with one squadron each of F-16C/Ds and A-10Cs.

Other assets include a squadron that operates U-2S spy planes and a detachment of HH-60G combat rescue helicopters.

In the past, these regular exercises were run under the nickname Vigilant Ace and were the largest joint air training maneuvers between South Korea and the United States; they also had a notably high profile in the media. Typical missions practiced include air defense, long-range strike, air infiltration, and close air support of ground forces.

Notes on Pyongyang

Currently, it seems that Pyongyang is unwilling to engage with the United States and drop its ongoing missile development programs, which have only accelerated in recent months. These have included, at last count, a new submarine-launched ballistic missile, a hypersonic boost-glide vehicle missile system, a railcar-based missile launcher, and a ground-launched cruise missile.

At the same time, as long as South Korea continues its own missile efforts, then the North will likely still point to what it sees as “double standards.”

–

Notes on South Korea

For South Korea, moreover, there has also been an increasing focus on military independence and self-sufficiency, including a renewed push to break South Korea fully away from the United States in terms of control of the military during the tenure of President Moon Jae In, which will end next year.

It is questionable whether running exercises under what’s essentially a media blackout will be an effective way of allaying the North’s skepticism over its adversaries’ intentions. On the other hand, it’s clear that, after several years of toned-down drills, the U.S. and Republic of Korea Air Forces are once again staging drills involving hundreds of planes.

https://www.thedrive.com/the-war-zone/42971/hundreds-of-south-korean-and-u-s-warplanes-are-conducting-a-secretive-exercise-in-korea

>>14907457

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues.

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

https://www.zerohedge.com/covid-19/falsified-data-pfizer-vaccine-trial-had-major-flaws-whistleblower-tells-peer-reviewed

https://www.bmj.com/content/375/bmj.n2635