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FDA approves new Covid vaccines for Pfizer, Moderna

Suzanne Downing
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FDA approves new Covid vaccines for Pfizer, Moderna

While characterizing them as different from the boosters people have received to ward off Covid, the Food and Drug Administration approved a new Covid shot on Monday, one that will be pushed to the public along with their seasonal flu vaccines.

The FDA is attempting to normalize the Covid shots as the same as other vaccines that people get throughout their lives, starting in infancy.

The FDA says the new vaccines are formulated to more closely target currently circulating variants and to provide better protection against serious consequences of Covid-19, including hospitalization and death.

“Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5,” the FDA said in its statement.

The shots will be given to people 5 years of age and older regardless of previous vaccination with a Covid-19 formula, if it has been two months since their last dose of any Covid-19 shot.

Also:

  • Individuals 6 months through 4 years of age who have previously been vaccinated against Covid-19 are eligible to receive one or two doses of an updated mRNA Covid-19 vaccine (timing and number of doses to administer depends on the previous Covid-19 vaccine received). 
  • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech Covid-19 Vaccine or two doses of the updated authorized Moderna Covid-19 Vaccine.
  • The FDAsays it is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment says it demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.
  • Individuals who receive an updated mRNA Covid-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA Covid-19 vaccines as described in the respective prescribing information or fact sheets, the agency says.
  • The updated vaccines are expected to provide good protection against Covid-19 from the currently circulating variants, the FDA says. “Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of Covid-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.”
  • The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Sept. 12, to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals. 
  • Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.

“Vaccination remains critical to public health and continued protection against serious consequences of Covid-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech Covid-19 vaccines are no longer authorized for use in the United States.

Ketchikan American Legion building burns overnight

Suzanne Downing
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Ketchikan American Legion building burns overnight

The Ketchikan Police Department and the Ketchikan Fire Department are seeking information about a fire that engulfed the American Legion Hall in downtown Ketchikan at about 1:21 am on Sunday.

“We are asking anyone who may have witnessed the incident or has video surveillance footage of the area to come forward with information. Your cooperation could be instrumental in helping us determine the cause of the fire and ensure the safety of our community,” the police department said.

Update: Police arrested Joseph Schacher Jr., 28, and he is currently jailed at the Ketchikan Correctional Center. He has been in trouble with the law previously for assault, harassment, and violating conditions of release.

The Joseph T. Craig American Legion Post 3, more than 100 years old, was pouring smoke out of its attic space, causing fire alarms in the neighborhood to go off, when fire crews arrived. The inferno was fought for hours.

Ketchikan Fire Department was aided by the North and South Tongass Volunteer Fire Departments. One firefighter ended up at the hospital due to shortness of breath, but police say that no one was believed to be in the building at the time of the fire.

In photos posted online, it appears that the American flag quilt that hangs on the wall was still standing and recognizable.

Photo credit: Hunter Davis, via Facebook. The flag quilt on the wall of the American Legion.

National battle brews over parents’ right to know gender choice of their children at school

SENIOR CONTRIBUTOR
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National battle brews over parents’ right to know gender choice of their children at school

By TOM GANTERT | THE CENTER SQUARE

A battle over parental rights is brewing across the country and at the forefront is the gender choice of children while enrolled in public schools.

In California and New Jersey, the government has gone to court to shield parents from knowing what gender their children have chosen while at school.

In other states, such as Michigan and Pennsylvania, the policies on parental notification are left up to the individual school districts to determine. In Ann Arbor public schools in Michigan, the district does not require parental notification of a student’s transition or use of different pronouns. Just five miles away in Dexter Community Schools, the district doesn’t have any policy regarding parental notification. 

Arkansas, California, Hawaii, Iowa, Kentucky, Louisiana, Maine, Montana, Nebraska, South Carolina and Texas had bills introduced in 2023 that would require districts to disclose a trans student’s gender identity to parents, according to the National Center for Transgender Equality.

“It’s disgusting that we now have union-controlled politicians fighting to keep sexual secrets from other people’s children,” said Corey DeAngelis, a senior fellow at the American Federation for Children, in an email to The Center Square. “These radicals believe children are the property of the State, and many of them won’t reverse course any time soon because it’s part of their deeply held socialist views. The far left has infiltrated the government school system and they are using it for ideological indoctrination as opposed to education. These extremists see the school system as a means of raising other people’s children with their own worldview, and they won’t stop without accountability.” 

In California, Attorney General Rob Bonta filed a lawsuit in August against Chino Valley Unified School District when that district adopted a mandatory gender disclosure policy. San Bernardino County Superior Court Judge Thomas Garza last week ordered that the Chino Valley district stop its policy. 

“Every student has the right to learn and thrive in a school environment that promotes safety, privacy, and inclusivity – regardless of their gender identity,” Bonta said in a news release. “We’re in court challenging Chino Valley Unified’s forced outing policy for wrongfully and unconstitutionally discriminating against and violating the privacy rights of LGBTQ+ students. The forced outing policy wrongfully endangers the physical, mental, and emotional well-being of non-conforming students who lack an accepting environment in the classroom and at home. Our message to Chino Valley Unified and all school districts in California is loud and clear: We will never stop fighting for the civil rights of LGBTQ+ students.” 

Anchorage School District has secret forms for children’s gender identity that parents will never see due to interpretation of HIPAA laws

The Rev. Benita Ramsey, executive director of Rainbow Pride Youth Alliance, said disclosing gender choices made by students was “life-threatening.” 

“Schools should be a safe place for all students. Chino Valley’s effort to force the outing of LGBTQ+ students without their consent is unconstitutional and will cause unnecessary and life-threatening harm to LGBTQ+ youth,” Ramsey said in a media release. “These policies are meant to silence and intimidate queer and trans youth from expressing themselves at school. We will always stand alongside our youth.” 

Orange Unified School District enacted a policy at its Sept. 7 school board meeting that mandates school staff notify parents on their children’s decisions involving gender. Exceptions to the parental notification policy are if the student is 12-years or older and objects to the parents being informed or if the staff feels the student’s well being would be threatened by informing the parents.

In New Jersey, Attorney General Matthew Platkin filed a civil rights complaint in May against three school districts because their policies required school staff to notify parents of the gender identity of their children. 

“In New Jersey, we will not tolerate any action by schools that threatens the health and safety of our young people. Without question, the discriminatory policies passed by these Boards of Education, if allowed to go into effect, will harm our kids and pose severe risk to their safety,” Platkin said in a news release. “Simply put, these policies violate our laws, and we will not relent in protecting our LGBTQ+ community – especially our children – from discrimination.”

Read the Anchorage School District transgender policy here.

New Mexico governor sued over her ban on guns in Albuquerque

Suzanne Downing
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18
New Mexico governor sued over her ban on guns in Albuquerque

The National Foundation for Gun Rights, the legal wing of the National Association for Gun Rights, has sued the governor of New Mexico after she ordered that all who carry guns in Albuquerque are committing a crime, except for those weapons that are carried by the police.

Late Friday, Gov. Michelle Lujan Grisham ordered a 30-day ban on open and concealed carry of firearms in public places in Bernalillo County, where 50% of the population is hispanic.

Grisham called gun violence a public health emergency, but critics say the real problem is the Democrat governor’s soft-on-crime policies.

Grisham also said she will be sending New Mexico State police officers to the city to enforce what she calls a “civil order.” Violation of her gun ban would be considered a misdemeanor, and subject to a fine of $5,000.

Albuquerque resident Foster Haines, who is a member of the National Association for Gun Rights, is the lead plaintiff, arguing that Grisham has violated the Second Amendment of the U.S. Constitution. The lawsuit refers to a U.S.Supreme Court decision this year that ruled against New York’s concealed carry law.

Sheriff of Bernalillo County John Allen, who is generally anti-gun and endorsed by Everytown/Moms Demand Action, is not sure he can enforce the order:

“While I understand and appreciate the urgency, the temporary ban challenges the foundation of our constitution, which I swore an oath to uphold,” he said. “I am wary of placing my deputies in positions that could lead to civil liability conflicts, as well as the potential risks posed by prohibiting law-abiding citizens from their constitutional right to self-defense.”

The Albuquerque Police Department issued this statement: “The governor issued a 30-day state order that limits gun possession in Bernalillo County, including the City of Albuquerque. The governor made it clear that state law enforcement, and not APD, will be responsible for enforcement of civil violations of that order.” 

The district attorney in Albuquerque, appointed by Grisham, is also not on board with the governor.

“As an officer of the court, I cannot and will not enforce something that is clearly unconstitutional. This office will continue to focus on criminals of any age that use guns in the commission of a crime,” said Bernalillo County District Attorney Sam Bregman, a former party officer for the Democrats.

The governor also ordered monthly inspection of firearms dealers across the state and other measures. Since 2019, Grisham has signed several bills advanced by Democrats that reduce the citizens’ access to firearms, including a “red flag” law in 2020 that allows police to take guns away from people they believe are a threat to themselves or others.

Police state: New Mexico’s Democrat governor bans all guns in Albuquerque, except for police

Anchorage Assembly to consider former waste transfer site for homeless navigation center

Suzanne Downing
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41
Anchorage Assembly to consider former waste transfer site for homeless navigation center

The Sept. 12 meeting of the Anchorage Assembly will again take up consideration of a navigation center for the homeless in Anchorage, a concept that has been advocated for by Mayor Dave Bronson’s since he was elected, but which has been blocked by the hostile Assembly majority that is bent on destroying the mayor and has used the homeless crisis as a weapon.

Assemblyman Randy Sulte says that a navigation center, a place where homeless can be directed toward housing, social services, and health care, could be set up at the former waste transfer site on 56th Ave.

The center would be situated in midtown, the heart of Assemblywoman Meg Zaletel’s district. She runs the Anchorage Coalition to End Homelessness, a nonprofit that pays her well over six figures to oversee the city’s homeless industrial complex. The coalition has proven largely ineffective in addressing homelessness.

Recently, Solid Waste Services opened up a new waste transfer site at 1208 E. 56th Ave, and vacated the one next door at 1140 E. 56th. The vacated site is 448,000 square feet of fenced area, with a sheltered maintenance garage building of about 14,400 square feet and a two-story administration building of about 4,800 square feet, which has offices, bathrooms, showers, a kitchen, and lockers that were once used by waste management workers.

Sulte is asking the Assembly to approve a resolution that asks the mayor to make a good-faith effort to evaluate the site for use as a navigation center.

The mayor’s original plan, approved of and mostly funded by the Assembly, was never built after the Assembly’s hostile majority became incensed that the mayor had gone ahead with site preparation work at the Elmore and Tudor Roads site he had chosen for the navigation center, without final procedural approval. Instead of having the center ready for last winter, the homeless had to go back to the Sullivan Arena, and the project has now been abandoned because of the Assembly’s change of heart.

Even though the materials for the proposed Elmore-Tudor center had been agreed to and mostly paid for by Assembly appropriation, they sit in warehouses in Eagle River and in materials yards in the Lower 48, ever since the hostile majority pulled its support.

Currently, tent and trailer encampments are spread throughout greenbelts and byways of Anchorage, as temperatures drop into the mid-40s at night. The standoff by the hostile Assembly has pushed the homeless crisis into the fall of 2023, giving the mayor few choices for how to keep homeless people safe.

Mayor Bronson has already stated that the Sullivan Arena, now cleaned up and repaired after being used as cold-weather emergency shelter since 2020, will not be used again for that purpose. He wants to return it to an entertainment venue, the purpose for which taxpayers approved when it was built. The destruction of the property by the vagrants and addicts that used it over the past three years was costly to repair.

The Sulte resolution would repurpose a recently vacated public building and property and would ask the mayor to request an appropriation from the Assembly to remodel the site.

Homeless navigation centers are low-barrier emergency shelters that also connect homeless people with services and pathways to permanent housing. The clients for these types of shelters are typically those who are at the bottom of the economic rung, who have severe drug and alcohol problems, mental health issues, and no families willing or able to take them in. Low barrier means that there are few rules or requirements for sobriety, as there are in most shelters.

The Assembly meets at the ground floor of the Loussac Library on 36th Avenue, and meetings begin at 5 pm.

Assembly to strip final $100,000 from homeless navigation center to pay for more help at sprawling encampments

Fifth Circuit Appeals Court overrules lower court on government’s bad advice against Ivermectin for Covid

SENIOR CONTRIBUTOR
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25
Fifth Circuit Appeals Court overrules lower court on government’s bad advice against Ivermectin for Covid

Last week, the Fifth Circuit Court of Appeals reversed a lower court’s ruling that had said sovereign immunity protects the Food and Drug Administration from any liability for telling the public to stop taking Ivermectin, a drug that is relatively safe when used correctly, well-studied, and has been used by many for the prevention and treatment of Covid-19.

Judges Clement, Elrod, and Willett wrote, “FDA argues that the Twitter posts are ‘informational statements’ that cannot qualify as rules because they ‘do not ‘direct’ consumers, or anyone else, to do or refrain from doing anything.’ We are not convinced.”

“We are very pleased with this development and extremely proud of our colleagues for taking a stand against a government health agency that is clearly overstepping its authority,” said Pierre Kory, M.D., M.P.A., president and chief medical officer of the Front Line COVID-19 Critical Care Alliance.

“The FDA’s campaign against ivermectin continues to be used as an excuse by hospitals to deny access to a lifesaving treatment and weaponized by medical boards to threaten the licenses of doctors who stray from the mainstream to prescribe a drug that has been proven in controlled trials to safely treat hundreds of thousands of patients around the world,” he said.

The lawsuit, Apter et al v. Dep’t. of Health and Human Services, was brought by Robert Apter, MD, Mary Talley Bowden, MD, and FLCCC co-founder, Paul E. Marik, MD, and first filed in the U.S. District Court on June 2, 2022.

The lawsuit stated that the FDA acted outside of its authority and illegally interfered with the doctors’ ability to practice medicine with an aggressive effort to stop the prescribing of ivermectin for the prevention and treatment of COVID-19. The case was later dismissed by the court citing that the FDA had “sovereign immunity,” giving the agency absolute protection from any wrongdoing or harm in directing the public, including health professionals and patients, to not use ivermectin, a drug that has received full FDA approval for human use. Earlier this year, Apter et al filed an appeal in the U.S. Court of Appeals for the Fifth Circuit requesting the Court reverse the lower court’s dismissal of the lawsuit.

The Court’s reversal was issued last week with the ruling stating, the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

The ruling goes on to say the “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”

And finally, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”

“The work of the legal team at Boyden Gray has been nothing short of superb,” Kory added. “We are very fortunate to have them on the side of our doctors in this case.”

It’s certain the federal government will appeal to the U.S. Supreme Court.

The Fifth Circuit Court’s ruling can be found here: https://covid19criticalcare.com/wp-content/uploads/2023/09/Apter-Reversal-22-40802_Documents.pdf

The FLCCC filed its amicus brief in support of the lawsuit in February of this year. A copy of the brief can be found here: https://covid19criticalcare.com/wp-content/uploads/2023/02/FLCCC-Apter-v-HHS-Amicus-2-13-23-FINAL.pdf

Feds admit in court: Doctors have the right to prescribe Ivermectin for Covid

Tom Boutin: Assembly is wrong to try to force new city hall on voters again

GUEST CONTRIBUTOR
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Tom Boutin: Assembly is wrong to try to force new city hall on voters again

By TOM BOUTIN

I urge voters to once again turn down the full faith and credit long-term bond ballot measure for a new City Hall.

A project requesting the leveraging of all private real estate, residential and commercial, needs to have broad and deep support, but this downtown office building clearly does not have that.

Moreover, effectuating a lien immediately after residential property assessments increased so much this year, as commercial property assessments did last year, may be unscrupulous and is afflicted security for bonds.

Is it coincidental that City and Borough of Juneau leadership increased assessed values on private property when intending to sell bonds against property taxes – and without reducing the mill rate appropriately? Didn’t we vote this down less than a year ago?

Yes, and I think the best and most concise explanation was given when an AM radio interviewer this past summer asked the then-departing city manager that question. He emphatically answered, “so what?” Juneau leadership undeniably doesn’t care what we think.

That same city manager then sought and obtained money to better educate us this time around, indicating he believes we voted it down because we’re uninformed and/or stupid. One woman told me she voted no only because the ballot didn’t give her an option to vote hell no.

Wherever I go I hear additional voter concerns. Exempting debt payments from the mill rate cap detracts from already flagging Assembly credibility. A public debt issuer should first build a reputation for truthfulness and transparency.

Another concern is that voters are supposed to believe that this project is immune from the inflation that has increased the cost of seemingly all other Alaska public capital projects by 80% or more during the past three to six years. I worry that this city government would run out of bond proceeds when construction is only half complete.

Then, believing they have taxpayers over a barrel, the Assembly could say they need to sell completion bonds — possibly doubling the amount of debt. Insidiousness of that sort would be completely in character. Note that long-term interest rates have doubled, but the Assembly is silent about that. (One can hope that the election will bring veracity to the Assembly and raise the overall integrity.) There are many alternatives to borrowing against the full value of private property.

If, as the Assembly claims, eliminating space now rented by city government will meet bond payments then that should be the security for the debt rather than our property taxes — our homes and businesses. State and municipal debt in Alaska has been secured by lease payments, theater tickets, mineral production, fishing license fees, airport landing fees, electricity sales, student loan payments, energy production and governmental enterprise earnings.

However, as a Juneau voter I disagree with most debt right now because it allows profligate spending to continue while burdening a future generation with the invoice.

This Assembly makes frequent high-dollar bets and expenditures without asking what voters think. Only when they want to secure bonded indebtedness with our full faith and credit, using the assessed value of our property, do they ask for our opinion and commitment. When we disapprove they ask us again, spending our money to re-educate us.

Please vote no on this ballot measure and please vote very carefully on the Assembly races.

Tom Boutin is a Juneau resident who has served as chief of staff for the Alaska State Bond Committee, the Alaska State Pension Investment Board and the Alaska Retirement Management Board. He also was the CEO of the Alaska Industrial Development and Export Authority, a state-owned bank. In addition, he worked for many years in the forest products industry.

Pelosi, age 83, will run for another two years, saying she needs to promote ‘San Francisco values’

Suzanne Downing
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55
Pelosi, age 83, will run for another two years, saying she needs to promote ‘San Francisco values’

Former House Speaker Nancy Pelosi announced on Friday that is is seeking reelection to the House in 2024, and that she will be part of a Democrat all-hands-on-deck push to regain the majority, now held by Republican.

Pelosi, 83, made the surprise announcement in San Francisco, which she has served for decades. She also posted on X/Twitter her intentions to run.

“Now more than ever our City needs us to advance San Francisco values and further our recovery. Our country needs America to show the world that our flag is still there, with liberty and justice for ALL. That is why I am running for reelection — and respectfully ask for your vote.”

Pelosi was born March 26, 1940, and will turn 84 during next year’s campaign cycle. If she succeeds in winning another term, she will be nearly 87 at the end of that term.

Downing: Father Time is coming for the gerontocracy

Police state: New Mexico’s Democrat governor bans all guns in Albuquerque, except for police

SENIOR CONTRIBUTOR
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144
Police state: New Mexico’s Democrat governor bans all guns in Albuquerque, except for police

Gov. Michelle Lujan Grisham announced on Friday an order that temporarily outlaws firearms, both openly and concealed, in Albuquerque and throughout Bernalillo County for the next 30 days.

This sweeping measure applies regardless if individuals possess a firearm permit.

Grisham, a Democrat, issued the executive order Thursday, categorizing gun violence as a public health emergency in the state of New Mexico.

During a Friday press conference, she admitted that legal challenges are likely to this unprecedented order and expressed doubt about its legality.

The order states that “no person, other than a law enforcement officer or licensed security officer, shall possess a firearm, either openly or concealed, within cities or counties averaging 1,000 or more violent crimes per 100,000 residents per year since 2021.”

The order’s immediate effect is limited to the city of Albuquerque and Bernalillo County, as clarified Grisham. Enforcement will primarily be carried out by the New Mexico State Police. Grisham emphasized that their presence in the state’s largest city will be “significant” over the coming month to ensure compliance.

Violating this public health order is expected to result in misdemeanor charges, according to Grisham. The order does not pertain to possession of firearms on private property or at licensed gun dealers.

This order came after a shooting incident near Isotopes Park in Albuquerque, where an 11-year-old boy was killed in an incident believed to be a road rage dispute.

Second Amendment and constitutional advocates are expected to sue the governor over the infringement upon the U.S. Constitution.

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