CDC Director: “We Fell Short”

By Jondi Gumz

For 75 years, CDC and public health have been preparing for Covid-19, and in our big moment, our performance did not reliably meet expectations … we fell short in many ways… We had some pretty public mistakes, and so much of this effort was to hold up the mirror … to understand where and how we could do better.”

That’s Dr. Rochelle Walensky, director since January 2021 of the federal Centers for Disease Control and Prevention, sharing plans last week for change at the agency, which has a $12 billion budget, 11,000+ employees, and a mission to protect Americans from disease outbreaks.

In April, she tapped a top federal official to review the CDC and make recommendations. James Macrae of the Health Resources & Services Administration reported findings in mid-June, focusing on “how CDC can better translate science and data into actionable policy and communications during a public health emergency.”

The changes include:

• Increasing use of preprint scientific reports rather than waiting for research to be peer-reviewed and published by the CDC’s Morbidity and Mortality Weekly Report.
• Keeping leaders devoted to outbreak response on for at least six months — to address turnover.
• Creating a new executive council to help Walensky set strategy and priorities.
• Establishing an office to smooth partnerships with other agencies.
• Appointing Mary Wakefield, 68, the No. 2 administrator at Health and Human Services under President Obama, to implement changes.

On July 29, attorneys settled the nation’s first class action lawsuit for healthcare workers over a Covid-19 vaccination mandate, for $10.3 million.

NorthShore University HealthSystem in Chicago agreed to compensate 500 current and former healthcare workers denied religious exemptions and claimed discrimination; each person is to receive $260,000. They were represented by Liberty Counsel of Orlando. The settlement must be approved by federal District Court.

On Aug. 18, federal judge Steven Merryday in Florida granted a classwide preliminary injunction against the federal government’s Covid vaccine mandate for all U.S. Marines, active and reserve.

Liberty Counsel of Orlando represented 3,733 Marines in the 18,600-member force who were denied religious accommodations from COVID vaccination.

The 1993 Religious Freedom Restoration Act grants them evaluations “to the person” but the Marine Corps provided “formularized denial” in “boilerplate letters,” the judge wrote. Some Marines object that “the Covid-19 vaccine was developed from cell lines derived from electively aborted fetuses,” the judge wrote, and the Marine Corps dismissed those objections by saying fetal cells were not used in the manufacture or present in the vaccine. “This finding says nothing about … the theological consequences of that use,” the judge wrote.

“No denial demonstrates that accommodating a particular applicant will meaningfully impede the readiness of the 95% vaccinated force,” the judge added.

On Aug. 19, Dr. Robert Malone, who helped develop the mRNA technology used in Covid-19 vaccines, filed a lawsuit alleging defamation and seeking $50.35 million in compensatory and punitive damages from The Washington Post, owned by Jeff Bezos.

Malone, an outspoken critic of Covid-19 vaccines, cited a Jan. 24 article by The Washington Post headlined, “A vaccine scientist’s discredited claims have bolstered a movement of misinformation.”

The article, published the day after the “Defeat the Mandates” rally in Washington, D.C., draws on Malone’s speech at the event.

Malone is asking for a jury trial.

On Aug. 22, Dr. Anthony Fauci said he will step down in December as director of the National Institute of Allergy and Infectious Diseases, which awards millions in grants to researchers, chief of the NIAID Laboratory of Immunoregulation and White House medical advisor.

At 81, he has worked 54 years in government service. He is working on a memoir.

Meanwhile, the Covid positivity rate, ICU cases and hospitalizations are declining in California and locally.

Soquel Union Elementary School District, where classes began Aug. 10, reports one student case and 21 staff cases. Masks and vaccination are recommended, not required.

Since July 26, wastewater data in Santa Cruz County shows Covid-19 Omicron levels plunging.

The number of active cases in Santa Cruz County dropped from 2,197 to 1,217 in the last six weeks, and after a 5-week stretch of no fatalities, two deaths were reported. Seven of the last eight deaths were people who were vaccinated, according to the county dashboard, all 65 or older with medical conditions.

The county updates the numbers on Mondays and Thursdays.

On Wednesday, the state reported 15 people hospitalized positive for Covid in Santa Cruz County, including two in intensive care.

With 61,000+ county cases, natural immunity may be a factor.

Santa Cruz County is rated medium for transmission by the U.S. Centers for Disease Control and Prevention on its COVID tracking map. Monterey County and parts of Florida are rated high, but eastern California counties are rated low.

California reports 80.1% of the population have had at least one shot.

On the CDC Covid tracker, Santa Cruz County reports 91.9% of residents age 5 and up have at least one shot and 83.7% fully vaccinated.

Fully vaccinated means having two shots (Pfizer or Moderna) or one Johnson & Johnson shot. All were developed for the initial Wuhan Covid-19 strain, which is no longer circulating.

On Aug. 22, Pfizer applied to the U.S. Food and Drug Administration requesting emergency use authorization of a booster dose targeting the Omicron subvariant BA.4/BA.5 — currently the most pervasive — for those 12 years of age and older. That change was requested by the FDA.

The Biden administration has a $3.2 billion deal to buy 105 million doses for fall.

In August, the CDC relaxed Covid-19 guidance noting an estimated 95% of Americans 16 and older have some immunity, either from vaccination or infection.

The “test-to-stay” in school protocol was eliminated for students exposed to the coronavirus but not fully vaccinated. Exposures now require masking, not quarantine.

Last year, the State of California said the U.S. Food and Drug Administration must give full approval of vaccines before rulemaking to require the Covid-19 vaccine. That has not happened; vaccines have been made available with the FDA granting emergency use authorization.

Los Angeles Superior Court Judge Mitchell Beckloff ruled in July that only the state can require students to be vaccinated to attend in-person school.

The very contagious variant BA.5 and waning immunity from vaccines boosted cases this summer. The CDC reported BA.5 comprised 88.9% of cases in August, with 4.3% being BA.4.

BA.5 drove “reinfections,” people vaccinated and boosted getting Covid for a second or even a third time as the coronavirus evolves.

With the U.S. averaging 390 deaths a day, compared to 3,000 last winter, there is no evidence this subvariant causes more serious illness.

Cases

Santa Cruz County cases are on a rollercoaster, 1,705 on June 13, then 2,000 on June 27, and 1,871 on June 30, then 2,040 on July 11 and now 1,217.

Cases jumped after holidays but the high of 199 on July 5 and again July 18 is low compared to 1,312 on Jan. 20.

California hospitalizations from Omicron peaked in January at 20,000, plummeted to 950, rose and now are declining.

The state reports 3,100 people hospitalized. The Department of Public Health explains about half are due to Covid, with the other half coming to the hospital for another reason and testing positive.

The state reports test positivity, 23% in January, fell to 1.7% before rising to 16.1%, then falling to 10%.

Lawsuits

Nick Rolovich, the football coach fired by Washington State University for refusing to get the Covid-19 vaccine, filed a lawsuit claiming wrongful termination and is seeking $25 million, according to KREM-TV.

Rolovich, who is Catholic, was denied a religious exemption after the governor mandated state employees get the vaccine.

He was paid $3.2 million per year and had three seasons left on his contract. The athletic director said he was fired for “just cause.”

In July, Dr. Douglas Mackenzie, a surgeon in Santa Barbara County, and Physicians for Informed Consent, sued William Prasifka, executive director of the Medical Board of California, challenging attempts to sanction physicians who disagree with governmental Covid-19 edicts.

At a school board meeting in August 2021 via Zoom, Mackenzie said, “We are not going to get to zero Covid ever. We can’t make it disappear with a vaccine, especially one that may improve symptoms, but as we are seeing, won’t stop reinfection or transmission.”

The Medical Board closed the investigation after the lawsuit was filed. Mackenzie contends his comments are protected by the First Amendment.

His attorney Richard Jaffe expects a hearing on a preliminary injunction motion at the end of September or mid-October.

Assembly Bill 2098 was proposed to make it a disciplinable offense for a physician to publicly challenge public health Covid edict. Mackenzie contends that would violate the First Amendment. The bill was shelved Aug. 1.

Feds for Medical Freedom, which represents federal employees and contractors, is awaiting appellate review in New Orleans of President Biden’s Sept. 9, 2021 order requiring 3.5 million federal employees to be vaccinated for Covid-19.

The group, which has about 6,000 members, contends the president overstepped his authority.

Young Children & Covid

About 941,000 children under age 5 in the U.S. have received at least one COVID-19 vaccine dose, according to the CDC. This is about 4.8% of the 19 million children in this age group.

In California, 2.2% of kids under 5 have been vaccinated.

Seven countries offer vaccines to the youngest children. Eligibility starts at age 2 in Cuba and Venezuela, and age 3 in Chile and Argentina, Bahrain, Hong Kong and China.

In Santa Cruz County, parents who want their children under 5 to receive Covid-19 vaccines should contact their doctor.

The Santa Cruz County Office of Education and county Public Health hosted two town halls for parents on the vaccine for children under 5. Listen at https://santacruzcoe.org/town-halls-covid-19-vaccine-for-under-5-year-olds/

Covid has claimed the lives of many elders, those 85 and older with medical conditions, but relatively few children, 442 children age 4 and under, according to the federal Centers for Control & Prevention.

More than 1 million people in the U.S. have died of Covid, so young children represent a tiny percentage of deaths.

Could it be that young children represent an untapped windfall for the drug-makers?

It all depends on whether these vaccines are added to the CDC vaccine schedule for children. See www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html

Data Analysis

The CDC was expected to analyze data from the Vaccine Adverse Event Reporting System for “safety signals” from Covid-19 vaccines.

This database, https://vaers.hhs.gov/, is where health care providers are to report adverse events after a vaccine. It was created after Congress passed a law in 1986 protecting vaccine manufacturers from civil personal injury lawsuits and wrongful death lawsuits resulting from vaccine injuries.

An early briefing document said, “The CDC will perform Proportional Reporting Ratio (PRR) data mining on a weekly basis or as needed.”

This would compare the proportion of an adverse event after getting a specific vaccine vs. the same adverse event after another vaccine. A higher rate would serve as a safety signal to trigger investigation.

On June 21, Josh Guetzkow, a PhD at Hebrew University, posted the CDC response to his Freedom of Information Act request asking about this data mining.

FOIA Officer Roger Andoh’s June 16 letter said that “no PRRs were conducted by CDC. Furthermore, data mining is outside of the agency’s purview, staff suggest you inquire with FDA.”

Guetzkow called PRRs “one of the oldest, most basic and most well-established tools of pharmacovigilance.”

Omicron Less Deadly

The Omicron variants are less deadly than the Delta variant, which raged in 2021.

Santa Cruz County reports 45 Covid deaths after Omicron, compared to 225 as of Dec. 15, before Omicron.

One statistic is similar: 79% to 81% of those who died had medical conditions.

Why do people fear Omnicron?

They may have a medical condition (diabetes, obesity, asthma, high blood pressure).

Half of Americans do, so they are at higher risk for severe Covid illness.

So are people 85 and older.

Myocarditis

In a 2022 report in the Journal of American Medical Association online, Dr. Matthew Oster of the CDC reported the government’s VAERS database received 1,991 reports of myocarditis after one dose of mRNA-based Covid-19 vaccine and 1,626 met the CDC’s definition for probable or confirmed myocarditis.

Oster’s conclusion: “The risk of myocarditis after receiving mRNA-based Covid-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered.”

Myocarditis is inflammation of the heart, which can lead to clots, a stroke or heart attack.

Public health officials say the scientific consensus is that Covid vaccines are safe, but some are skeptical about relying on science from drug-makers, which saw profits rise in 2021.

Analysts say Pfizer has been one of the largest winners in the last two years, doubling revenue to $81 billion in sales in 2021 due to its Covid vaccine. This year, it’s selling Paxlovid, a Covid pill that has a higher price per dose.

Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act, a 2005 law allowing him to provide legal protection to companies making or distributing critical medical supplies such as vaccines unless there’s “willful misconduct” by the company. This protection lasts until 2024.

Test to Treat

Santa Cruz County offers “Test to Treat” sites, open to anyone regardless of insurance or documentation status. For an appointment, visit https://lhi.care/covidtesting/.

According to the Santa Cruz County Office of Education, cases in local schools peaked at 4,407 on Jan. 27, dropped to 44 on April 1, rose to 1,150 on May 25, dropped to 235 on Aug. 7, and now 401.

The 14-day positivity rate, 12.25% on January, dropped to .79%, rose to 9.63% and now is 3.21%.

The Santa Cruz County Office of Education, which has completed 556,200 tests with Inspire Diagnostics, offers drive-though testing for students, staff and families at:

Cabrillo College, Aptos, Parking Lot K, Monday to Friday 9 a.m. to 5 p.m. and Saturday 9 a.m. to 3 p.m.

Santa Cruz County Office of Education, 399 Encinal St., Santa Cruz, Monday to Friday, 9 to 5 p.m. Saturday, 9 a.m. to 3 p.m.

See: https://tinyurl.com/get-tested-santa-cruz.

Booster shots: https://myturn.ca.gov/

Vaccine providers: www.santacruzhealth.org/coronavirusvaccine.

Local information: www.santacruzhealth.org/coronavirus or (831) 454-4242 from 8 a.m. to 5 p.m. Monday through Friday.

•••
Total COVID cases: 1,217
•••
COVID Deaths: 270
As of Aug. 22

Age
85 and older: 118 • 75-84: 62 • 65-74: 48 • 60-64: 15 • 55-59: 4 • 45-54: 10 • 35-44: 8 • 25-34: 5

Underlying Conditions
Yes: 220 • No: 50

Vaccinated
Yes: 35 • No: 235

Race
White 157 • Latinx 90 • Asian 16 • Black 3 • Amer Indian 1 • Hawaiian 1 • Another 2

Gender
Men: 138 • Women: 132

Location
At facility for aged: 117 • Not at a facility: 153