By Jondi Gumz
On July 13, the U.S. Food and Drug Administration granted emergency use authorization to the NovaVax Covid-19 vaccine for people 18 and older who are unvaccinated, and No-vavax said orders can be placed as of July 25.
About 21% of the U.S. population and 20% of people in California are unvaccinated.
Novavax won’t be available for a few more weeks, but state health officials urge Californi-ans who have not yet been vaccinated to make an appointment at myturn.ca.gov
Unlike other vaccines using messenger RNA, Novavax injects a lab-made version of the coronavirus’ spike protein, with compounds from the Soapbark tree, to stimulate the im-mune system to produce antibodies and T-cells.
According to the National Institutes of Health, the Novavax clinical trial recorded 63 cases among 10,000 people who got a placebo and 14 cases among 20,000 people who got a vaccine. Investigators classified 10 cases in the placebo group as moderate and four as se-vere. There were no moderate or severe cases in the vaccine group.
In California, test positivity dipped from 16.4% to 15% while active cases in Santa Cruz County increased in the past 10 days from 2,040 to 2,197.
Reinfections are a factor; 12% of cases in the United Kingdom are people getting Covid for a second or even a third time as the coronavirus evolves.
About 78% of cases nationwide are BA.5, according to the U.S. Centers for Disease Con-trol and Prevention.
This variant is more contagious than the original 2020 coronavirus, evading protection from mRNA vaccines designed for the initial virus, which has mutated to become less deadly.
In the past month, three more Santa Cruz County residents died, bringing the total to 268. The last six deaths were people who were vaccinated, according to the county dashboard, all 65 or older with medical conditions.
Cases
Santa Cruz County cases have rolled up and down, 1,715 on May 23, then 1,472 on May 26 and 1,705 on June 13, then 1,871 on June 30, then 2,040 on July 11 and now 2,197.
Santa Cruz County reports 58,000+ cases since the pandemic began.
Cases spurted up after Memorial Day, Father’s Day and Fourth of July; the highest daily count of the summer, 198 on July 5, is low compared to the Jan. 20 peak of 1,312.
Santa Cruz County updates the numbers on Mondays and Thursdays.
On Tuesday, the state reported 23 people hospitalized with Covid in Santa Cruz County, none in intensive care.
California reports 4,800 people hospitalized. The Department of Public Health says half are due to Covid, with the other half coming to the hospital for another reason and testing posi-tive.
On the CDC Covid tracker, Santa Cruz County reports 91.5% of residents age 5 and up have at least one shot and 83.4% fully vaccinated.
Fully vaccinated means having two shots (Pfizer or Moderna) or one Johnson & Johnson shot. All were developed for the initial Covid-19 strain, which is no longer circulating.
Santa Cruz County is now rated “high” risk of transmission by the U.S. Centers for Dis-ease Control and Prevention on its Covid tracking map along with the rest of California and most of the U.S.
Subvariants of omicron and waning immunity from vaccines are behind the latest wave of cases, affecting people who were vaccinated, including celebrity Kourtney Kardashian, ac-tor Hugh Jackman, and Mick Jagger.
Workers in California testing positive with no symptoms can return to work in five days with a negative test; those with symptoms can return once 10 days have passed since symp-toms began.
California test positivity, 23% in January from Omicron, fell to 1.7% then peaked at 16.4% and hospitalizations — 20,000 in January —dropped to 950 before rising.
$3.2 Billion Deal
On June 30, the U.S. Food and Drug Administration told Covid vaccine-makers that changes to booster shots for fall must target Omicron subvariants BA.4 and BA.5, as they then accounted for 52% of new cases.
The FDA announcement came a day after the Biden administration announced a $3.2 bil-lion deal to buy 105 million doses of Pfizer’s Covid vaccine for the fall.
On July 5, Los Angeles Superior Court Judge Mitchell Beckloff struck down the Los An-geles Unified School District’s Covid-19 student vaccine mandate. He found that only the state – not a school board — can require students to be vaccinated to attend in-person school.
Attorney Arie Spangler, representing the father of a 12-year-old, said the ruling “confirms that individual school districts do not have the authority to impose vaccination requirements in excess of statewide requirements.”
In the Soquel Union Elementary School District, students will go back to school Aug. 10.
In California’s 2022-23 school guidance, masks and vaccination are recommended, not re-quired.
Misinformation Bill Hearing
An Aug. 1 hearing is scheduled for AB 2098, declaring it is “unprofessional conduct” for a doctor to give patients “misinformation” or “disinformation” about Covid-19, risks, prevention, treatment and vaccines. The hearing is before the Senate Appropriations Committee.
Unprofessional conduct charges can result in discipline by the Medical Board.
President Biden’s Sept. 9 order requiring 3.5 million federal employees to be vaccinated for Covid-19 is on hold. The 17 judges on the 5th U.S. Circuit Court of Appeals in New Orleans are expected to take up the matter the week of Sept. 17.
Attorney Bruce Castor Jr., representing the American Federation of Government Employees Local 918, said the Constitution doesn’t allow president to bypass Congress except in wartime.
Young Children & Covid
In June, the U.S. Food and Drug Administration authorized emergency use of Covid-19 vaccines from Pfizer-BioNTech and Moderna for children 6 months to 5 years old, joining seven other countries. Eligibility starts at age 2 in Cuba and Venezuela, and age 3 in Chile, Argentina, Bahrain, Hong Kong and China.
A Chile-based study of 500,000 children, not yet peer-reviewed, found the vaccine was 38% effective in preventing infections in kids ages 3-5 during the Omicron wave.
As for preventing hospitalizations, it was 64.5% effective and preventing intensive care admission 69% effective.
In Santa Cruz County, parents who want their children under 5 to receive Covid-19 vac-cines should contact their doctor.
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 CDC.
More than 1 million people in the U.S. have died of Covid, so young children represent a tiny percentage of deaths.
In June, the American Association of Pediatrics reported that in 46 states plus Puerto Rico, the percentage of child Covid cases resulting in death was 0.00%-0.02%.
A Kaiser Family Foundation survey in April found only 18% of parents of children under 5 plan to vaccinate them immediately.
Kaiser Health News reports Pfizer’s 2021 revenue was $81.3 billion, roughly double its revenue in 2020, and its mRNA vaccine holds 70% of the U.S. and European markets. This year, Pfizer expects more than $50 billion in global revenue from its Covid vaccine and its antiviral Paxlovid.
That revenue could grow if Covid vaccines are added to the CDC vaccine schedule for children. See www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html
Public health officials say the scientific consensus is that Covid vaccines are safe, but some are skeptical about science provided by drug-makers to federal regulators.
Dr. Marty Makary and Dr. Tracy Beth Heeg, writing in Common Sense, contend clinical trials by Pfizer and Moderna provided weak and inconclusive evidence to federal regulators on their vaccines for children under 5.
Using a three-dose vaccine in 992 children between the ages of six months and 5 years, Pfizer found no statistically significant evidence of vaccine efficacy, the doctors wrote. “For children six months to 2 years, the trial found that the vaccine could result in a 99% lower chance of infection—but that they also could have a 370% increased chance of being infect-ed,” Makary and Heeg wrote.
Moderna’s study on 6,388 children with two doses claimed efficacy of 4% against asymp-tomatic infections in children 6 months to 2 years and 23% for children 2 to 6 years old—neither result was statistically significant.
Against symptomatic infections, Moderna’s vaccine showed statistically significant effica-cy: For children 6 months to 2 years, 50%, and for children 2 to 6 years old, 42%.
Dr. Philip Krause, former deputy FDA chief for vaccine, told Fact Check, “Even if the vac-cines aren’t very effective in protecting against mild disease … that doesn’t mean they won’t be effective in protecting against severe disease.”
Doctors and researchers affiliated with The Children’s Union told UK regulators that vac-cines are “totally inappropriate for small children in 2022.”
They said the trial results were based on just three participants in the younger age group (1 vaccinated and 2 placebo) and just seven participants in 2–4-year-olds (2 vaccinated and 5 placebo).
They noted that “the vast majority of this young age group have already been exposed to SARS-CoV-2 repeatedly and have demonstrably effective immunity.”
In the UK, children age 5 to 11 are eligible for Covid vaccine; no decision has been an-nounced on vaccine for children under 5.
Data Analysis
The CDC was expected to analyze data from the Vaccine Adverse Event Reporting System for “safety signals” from Covid-19 vaccines, based on an early briefing document, but the agency is not.
Roger Andoh, the CDC FOIA officer, responded June 16 to a Freedom of Information Act request, saying “no PRRs were conducted by CDC. Furthermore, data mining is outside of the agency’s purview, staff suggest you inquire with FDA.”
The VAERS 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.
The Public Readiness and Emergency Preparedness Act, a 2005 law allows the Health and Human Services Secretary to provide legal protection to companies making or distributing vaccines unless there’s “willful misconduct” by the company. This protection lasts until 2024.
Dr. Matthew Oster of the CDC reported this year that the VAERS database received 1,991 reports of myocarditis after one dose of mRNA-based Covid-19 vaccine and 1,626 met the CDC definition for probable or confirmed myocarditis.
His 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 vaccina-tion 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.
Test to Treat
Santa Cruz County offers “Test to Treat” sites open to anyone regardless of insurance or documentation status, including the county office, 500 Westridge Drive, Watsonville. 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 1,025 on May 23, and now 300.
The 14-day positivity rate peaked at 12.25% on January, dropped to .79%, and now is up to 10.45%.
The Santa Cruz County Office of Education has completed 537,500 tests with Inspire Di-agnostics.
For those who test positive and are at risk of severe illness, the CDC recommends asking your doctor for a prescription for Paxlovid, the Pfizer pills given emergency use authoriza-tion by the FDA in December. Merck’s Lagevrio also got emergency use authorization for mild to moderate Covid.
Paxlovid is what President Joe Biden took to recover from a Covid Omicron variant. His symptoms were mild, a runny nose, dry cough and fatigue.
See Paxlovid side effects at: www.fda.gov/media/155051/download
The Omicron variants are less deadly than the Delta variant, which raged in 2021.
Santa Cruz County reported 43 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 as are people 85 and older.
Testing
The Santa Cruz County Office of Education 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. n
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Total COVID cases: 2,197
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COVID Deaths: 268
As of July 25
Age
85 and older: 117 • 75-84: 62 • 65-74: 47 • 60-64: 15 • 55-59: 4 • 45-54: 10 • 35-44: 8 • 25-34: 5
Underlying Conditions
Yes: 218 • No: 50
Vaccinated
Yes: 34 • No: 234
Race
White 155 • Latinx 90 • Asian 16 • Black 3 • Amer Indian 1 • Hawaiian 1 • Another 2
Gender
Men: 137 • Women: 131
Location
At facility for aged: 117 • Not at a facility: 151