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Leaked Contracts: Pfizer Shifted Risk to Government, Maximized Profits

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Pfizer, the first vaccine maker to receive FDA approval for a COVID shot, has used its power to “shift risk and maximize profits,” according to a consumer advocacy group that obtained secret government contracts.

Public Citizen found that only five of the 73 deals Pfizer has made worldwide for its COVID-19 vaccine have been formally published by governments, and they have “significant redactions,” DailyMail.com reported.

“The contracts offer a rare glimpse into the power one pharmaceutical corporation has gained to silence governments, throttle supply, shift risk and maximize profits in the worst public health crisis in a century,” Public Citizen alleges in its report.

The Manhattan-based pharmaceutical company “consistently place Pfizer’s interests before public health imperatives.”

Public Citizen accuses Pfizer of including secret language blocking donations of its own doses, opposing an intellectual property waiver that could have allowed for the sharing of technology, having ‘unilateral authority for other decisions’ and more. (Read more from “Leaked Contracts: Pfizer Shifted Risk to Government, Maximized Profits” HERE)

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Judge Rejects Husband’s Plea for Ivermectin for Critically Ill Wife

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A Florida judge, deeming that it was inappropriate for him to be determining the level of dosage of Ivermectin for a critically ill woman, rejected for the second time in three days a petition from the woman’s husband requesting that the Palm Beach Gardens Medical Center administer Ivermectin.

Palm Beach County Circuit Judge James Nutt requested that Ryan Drock and the hospital try to resolve the dispute themselves, arguing, “The parties are directed to confer and, if possible, agree how this matter can expeditiously proceed to final resolution,” The Palm Beach Post reported, adding, “If the correct legal papers are ‘squared away,’ Nutt said he would be willing to hold a hearing to explore why Drock, who is in the intensive-care unit tethered to oxygen, might benefit from ivermectin.” . . .

The Daily Beast reported:

Though Nutt suggested he would consider a request for a temporary injunction “given the gravity and urgency of the case,” he hinted that it could also be unsuccessful in court. “It is not a right to substitute one’s judgment as to which treatments must [be] made available by others,” said the judge. “There is no right, constitutional or otherwise, of a patient to substitute one’s judgment for a medical professional.”

(Read more from “Judge Rejects Husband’s Plea for Ivermectin for Critically Ill Wife” HERE)

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U.S. Soldiers, Including Navy SEALS, Suing Biden

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Liberty Counsel on Friday announced a class action lawsuit on behalf of members of all five branches of the U.S. military – the Army, Navy, Air Force, Marines and Coast Guard – against President Joe Biden over his orders they take the experimental COVID shots or face dishonorable discharge.

“The Biden administration has no authority to require the COVID shots for the military or for federal employees or civilian contractors,” explained Mat Staver, Liberty Counsel chairman.

“Nor can the Biden administration pretend that the federal Religious Freedom Restoration Act and the First Amendment do not apply to its unlawful mandates. The commander-in-chief must end this shameful treatment and abuse of our brave military heroes. Forcing the COVID shots without consent or consideration for their sincere religious beliefs is illegal.”

The action in U.S. District Court in Florida is on behalf of two Navy SEALs, a Navy EOD Officer, a Navy Senior Chief Petty Officer, a Navy Chaplain, two Marine Lt. Colonels, two Marine Lance Corporals, an Air Force Major, an Air Force Technical Sergeant, an Army National Guardsman, an Army Colonel, and a Coast Guard Lieutenant.

It seeks a temporary restraining order preventing Biden and his appointees from “enforcing, threatening to enforce, attempting to enforce, or otherwise requiring compliance with the Federal COVID-19 Vaccine Mandate…” (Read more from “U.S. Soldiers, Including Navy Seals, Suing Biden” HERE)

Photo credit: Gage Skidmore https://www.flickr.com/photos/gageskidmore/48548497852

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Documents: FDA Purchased Baby Heads and Other Body Parts

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Hundreds of pages of U.S. Food and Drug Administration records obtained under a Freedom of Information Act case brought by government watchdog Judicial Watch reveal the U.S. government was buying the heads of unborn babies, and other body parts, for its “humanized mice” project.

The watchdog organization announced this week it has obtained 198 pages of records from the FDA confirming the purchase plans for “human fetal heads, organs and tissue.”

The “supplies” came from Advanced Bioscience Resources, and many of the deals were reached between Perrin Lawton, of ABR, and Kristina Howard, an officer with the FDA.

The lawsuit over the records had sought “all contracts and related documentation on disbursement of funds, procedural documents and communications between FDA and ABR for the provision of human fetal tissue to be used in humanized mice research.”

A federal court recently ordered the government to provide more details about the purchase of the human body parts, “including ‘line item prices,’ or the price per organ the government paid to ABR,” Judicial Watch said. (Read more from “Documents: FDA Purchased Baby Heads and Other Body Parts” HERE)

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Two Senior FDA Officials Resign Over Biden Administration Booster Shot Plan

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Two senior officials have resigned from their positions within the US Food and Drug Administration over frustrations with the Biden administration’s plans to move forward with recommending COVID-19 booster shots without their prior approval, according to a report.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause are set to leave the agency this fall, with sources telling Politico that the two officials were at odds with the FDA’s top vaccine official, Peter Marks, and were discontented over the roles of the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices in decisions that they believed should be handled by the FDA.

According to trade publication Endpoints, the officials felt they were sidelined on major decisions, that the administration’s plan for boosters was jumping the gun, and that Marks should have pushed for the FDA to have more autonomy on the matter.

Marks played a leading role in helping the administration craft its August announcement of calls for an additional vaccine for most adults after eight months.

Marks announced the resignations in a letter to colleagues obtained by Endpoints.

(Read more from “Two Senior FDA Officials Resign Over Biden Administration Booster Shot Plan” HERE)

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Pediatrics Group Urges FDA OK of COVID-19 Vaccines in Younger Kids

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The American Academy of Pediatrics is urging the FDA to quickly expand authorization of COVID-19 vaccines to younger age groups, citing rising cases due to the fast spreading delta variant and risk of poor outcomes following infection.

“We need to be approaching the trials and authorization of the COVID vaccine for children with the same urgency that we did with adults,” Dr. Lee Savio Beers, president of the AAP, told ABC co-hosts. “Just as it’s a serious disease in adults, it can be a very serious disease in children.”

Pfizer has said it intends to request emergency approval for use of its vaccine in kids aged 5 to 11 by the end of September, with plans to submit data on younger kids aged 6 months to 5 years “shortly thereafter.” The FDA had requested drugmakers behind authorized COVID-19 vaccines broaden the size of pediatric clinical trials to better detect for rare adverse events. Moderna previously told Fox News that it expects “to have a package that supports authorization in winter 2021/early 2022” for kids under 12. Reports have noted agency officials intend to see the first shots in kids under 12 by winter or early 2022.

Beers, however, argued the original trial size offered enough safety and efficacy data for the FDA to weigh a decision on expanded authorization. (Read more from “Pediatrics Group Urges FDA OK of COVID-19 Vaccines in Younger Kids” HERE)

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Pentagon to Mandate Vaccine for Military Members, With or Without FDA Approval; Here Are the Companies Requiring Proof of COVID Vaccine

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By The Federalist. Amid the spread of the delta variant and Democrats pushing the notion that more lockdowns are imperative, the Biden administration confirmed Monday that all members of the United States military are required to get vaccinated against the coronavirus by Sept. 15.

“I will seek the president’s approval to make the vaccines mandatory no later than mid-September, or immediately upon” the Food and Drug Administration (FDA) approving them, “whichever comes first,” Defense Secretary Lloyd Austin wrote in a memo to troops Monday, unveiling the mandate.

Austin also wrote, “I will not hesitate to act sooner or recommend a different course to the President if l feel the need to do so. To defend this Nation, we need a healthy and ready force.”

There are 1.3 million active-duty troops. It is unclear how the Pentagon chief’s remarks bode with Democrats’ continuous calls to “follow the science,” given that the FDA concerns itself with regulating “public health.” (Read more from “Pentagon to Mandate Vaccine for Military Members, With or Without FDA Approval” HERE)

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Here Are the Companies Requiring Proof of COVID Vaccine

By Yahoo News. The number of companies requiring Covid-19 vaccination for their workers continues to increase as the Delta variant raises new safety concerns.

United Airlines, Microsoft, Uber, Jefferies Group, and Tyson all announced vaccination policies for their office and in-person workforce. Some states are also requiring certain state employees to get vaccinated.

They follow last week’s announcements from Big Tech. Facebook and Google both said U.S.-based staffers must provide proof of Covid-19 vaccination, while Twitter confirmed to Forbes that it requires in-person employees to prove their vaccination status after the company closed its headquarters and delayed its reopening plans.

Restaurateur and Union Square Hospitality Group CEO Danny Meyer also announced last week that not only employees but patrons who wish to dine indoors at the group’s full-service restaurants in New York City and Washington, D.C., will be required to show proof of vaccination beginning September 7. . .

Short of mandates, companies and organizations alike are also offering cash incentives and on-site vaccinations to help ramp up vaccinations among their workers. Others have warned of penalties for staying unvaccinated, like the National Football League which is fining unvaccinated athletes nearly $15,000 for every pandemic safety measure infraction. (Read more from “Here Are the Companies Requiring Proof of COVID Vaccine” HERE)

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FDA Clears This COVID Vaccine for 12 to 15 Year-Olds; Healthy Teen Gets Blood Clots In Brain After Shot (VIDEO)

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By Townhall. In an announcement made late Monday afternoon, the Food and Drug Administration announced it was including those aged 12 to 15 in the emergency use authorization for the Pfizer-BioNTech COVID vaccine.

Acting FDA Commissioner Janet Woodcock called the expanded clearance “a significant step in the fight against the COVID-19 pandemic,” adding Monday’s announcement is “bringing us closer to returning to a sense of normalcy and to ending the pandemic” and that “parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data” in making their decision.

Under the amended emergency use authorization, adolescents 12 to 15 years old will be eligible to receive the same dosage as those 16 and up following the same two-dose regimen given three weeks apart. (Read more from “FDA Clears This COVID Vaccine for 12 to 15 Year-Olds” HERE)

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Healthy Teenager Gets Blood Clots In Brain After Shot

By WND. A mother in Utah is warning parents about the possible dangers of COVID-19 vaccines after her 17-year-old, basketball-playing son got a shot and developed three blood clots in and near his brain. . .

The mother is Cherie Romney of Draper, Utah.

“The hardest thing was I let him get that shot. And he was healthy and well before,” she told the station. “But you question it, you can’t help but question it when it all goes wrong.” . . .

Everest Romney, 17, felt his neck swell the day after his COVID-19 Pfizer vaccine shot and he then experienced severe headaches, the report said. , ,

She eventually took her son, a Corner Canyon High School basketball player, for tests. Doctors discovered two blood clots inside his brain and one on the outside. (Read more from “Healthy Teenager Gets Blood Clots In Brain After Shot” HERE)

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FDA Recalls Pet Food After After at Least 28 Dogs Die From Toxic Mold

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The Food and Drug Administration has recalled some pet foods from Sportmix after at least 28 dogs died and eight others fell ill from products with high levels of toxic mold.

The agency warned pet owners and animal specialists Wednesday that certain varieties of the brand’s pet food “may contain potentially fatal levels of aflatoxin.”

Aflatoxin is a mold that can grow on corn and other grains used in pet foods, the agency said.

Symptoms from aflatoxin poisoning include sluggishness, loss of appetite, diarrhea and vomiting, the agency said. (Read more from “FDA Recalls Pet Food After After at Least 28 Dogs Die From Toxic Mold” HERE)

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Trump Administration Authorizes Use of Convalescent Plasma Treatment for COVID-19

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President Trump announced Sunday that the Food and Drug Administration granted emergency use authorization for convalescent plasma, a treatment that health experts believe could treat COVID-19.

“Today’s action will dramatically expand access to this treatment,” Trump said during a news conference in the White House. “Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective.”

The FDA announced shortly before Trump’s appearance that it had granted emergency use authorization of the experimental treatment, in which doctors take blood from a patient who has recovered from COVID-19 and whose body has antibodies that it created to fight the virus. Doctors then take the liquid part of the blood from the healthy patient, called plasma, and transfuse it into the blood of those who need treatment.

Physicians have been using convalescent plasma transfusion to treat infectious diseases for more than 100 years. It has not yet been clinically proven to treat the coronavirus disease, but the therapy has proven to be safe. The FDA said there is reason to believe the treatment could shorten recovery time and lessen the severity of the disease, adding that the potential benefits of the therapy outweigh the risk.

“We saw about a 35% better survival in the patients who benefited most from the treatment, which were patients under 80, who are not on artificial respiration,” Health and Human Services Secretary Alex Azar said Sunday. “We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients is a major advance.” (Read more from “Trump Administration Authorizes Use of Convalescent Plasma Treatment for COVID-19” HERE)

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