Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
White House Faces Uphill Challenge Getting Kids Under 5 Vaccinated
The Biden administration faces an uphill battle to convince parents to give COVID-19 shots to children under 5 years old.
More than a year and a half after the first vaccines were authorized for adults, federal regulators and outside advisory panels will finally meet on Wednesday to examine data from Moderna and Pfizer-BioNTech about their shots’ effectiveness in the youngest children.
If all goes well and the vaccines get authorized, the administration is planning a massive public education campaign to help make sure parents can have their questions answered and learn about the importance of getting their children vaccinated.
Military Official Predicted mRNA COVID Vaccines Might Be Paused Over Heart Inflammation
A U.S. military official predicted a pause in the administration of the Moderna and Pfizer COVID-19 vaccines could happen if more cases of post-vaccination heart inflammation were detected, according to newly obtained emails.
Harry Chang, a U.S. Army lieutenant colonel, made the prediction on April 27, 2021 — the same day the director of the U.S. Centers for Disease Control and Prevention (CDC) said the agency was not seeing a safety signal when it came to heart inflammation experienced after getting a COVID-19 vaccine.
Chang noted the pause in the administration of the Johnson & Johnson vaccine over blood clots and said an increased number of heart inflammation issues could trigger a similar action. “Increased reported numbers and media attention is likely to trigger a safety review pause by ACIP/FDA,” he added, referring to the Advisory Committee on Immunization Practices, which advises the CDC on vaccines, and the U.S. Food and Drug Administration (FDA), which decides whether to clear immunizations.
Chang was talking to Tricia Blocher, an official at the California Department of Public Health, and other California and military officials. He was reacting to a story about the U.S. Department of Defense detecting a higher-than-expected number of cases of heart inflammation in troops following COVID-19 vaccination.” The email was one of 19 pages of messages obtained by The Epoch Times through a Freedom of Information Act request.
Pfizer, Moderna COVID Vaccines Are Effective in Young Children, FDA Says — Here’s How They Differ and What Happens Next
Three doses of Pfizer’s vaccine and a two-doses of Moderna’s shot are safe and effective in preventing illness from COVID-19 in young children, according to assessments provided by the Food and Drug Administration, in a possible signal that the agency is gearing up to approve COVID vaccinations for the youngest Americans later this week.
In a briefing document published on Sunday, the FDA said the three doses appeared to be 80.4% effective in preventing illness in the age group. In its assessment, the FDA noted the available data supported the effectiveness of Pfizer’s three-dose regimen in preventing COVID illness in children under the age of five.
In a similar assessment released on Friday, the drug regulator found two doses of Moderna’s vaccine to be safe and effective for use in children under the age of six. Moderna’s two doses reported a much lower 50.6% efficacy in preventing illness.
A key caveat in the Pfizer findings was that only 10 participants — eight in the placebo group and two in the vaccinated group — reported illness during the trial, which is below the threshold required to accurately determine efficacy. Additionally, the efficacy may not be directly comparable as the vaccine trials were carried out during different times.
A New Test Can Help Reveal if You’re Immune to COVID
How much protection do you currently have against COVID-19? The answer depends on so much: whether you’ve already had COVID-19 (and if so, how long ago); whether you’ve been vaccinated (and if so, how many times, and how recently); whether you have any medical conditions that could weaken your immune system; and so on. Even antibody testing only approximates immunity to COVID-19, so there’s no simple way to know.
But an international group of researchers recently developed a different tool to help assess COVID-19 immunity: a blood test that can measure T cells, white blood cells that work alongside virus-fighting antibodies to mount an immune response. Their work is described in a new study published in Nature Biotechnology.
T-cell testing for the SARS-CoV-2 virus isn’t totally new — the U.S. Food and Drug Administration granted emergency-use authorization to another T-cell test, called T-Detect, last year — but it tends to be labor- and time-intensive, says study co-author Ernesto Guccione, a professor of oncological sciences at New York City’s Tisch Cancer Institute at Mount Sinai. His group aimed to simplify it by using technology that is widely accessible and can turn around results in less than 24 hours.
The Mental Health Crisis Afflicting American Youth Demands Healthcare Reforms
U.S. Surgeon General Vivek Murthy issued a stark warning in December: America’s youth are in the midst of a “devastating” mental health crisis, suffering from skyrocketing rates of depression and anxiety.
Our healthcare system, which for too long has slighted mental healthcare, is woefully unprepared for the heartbreaking surge in troubled kids arriving in emergency rooms and psychiatric facilities: Lower insurance reimbursement rates for mental healthcare providers and hospitals have translated into fewer providers and less access. And as weak as the mental healthcare system is for adults, for children and adolescents it’s even worse.
Decades of overlooking mental healthcare can’t be overcome quickly. But the surgeon general’s warning ought to be a wake-up call to regulators and insurance companies that higher payments for mental health providers can’t wait any longer.
The statistics are grim. Average wait times for initial assessment, ongoing therapy and medication services are all longer for children than for adults. While an adult may typically wait 12.7 weeks for therapy, a child may be delayed by more than 15 weeks.
Many Baby Formula Plants Weren’t Inspected Because of COVID
U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020, according to federal records reviewed by The Associated Press.
When they finally did get inside an Abbott Nutrition formula plant in Michigan after a two-year gap, they found standing water and lax sanitation procedures. But inspectors offered only voluntary suggestions for fixing the problems, and issued no formal warning.
Inspectors would return five months later after four infants who consumed powdered formula from the plant suffered bacterial infections. They found bacterial contamination inside the factory, leading to a four-month shutdown and turning a festering supply shortage into a full-blown crisis that sent parents scrambling to find formula and forced the U.S. to airlift products from overseas.
The gap in baby formula plant inspections, brought on by the COVID-19 pandemic, is getting new scrutiny from Congress and government watchdogs investigating the series of missteps that led to the crisis.
COVID Funding Pries Open a Door to Improving Air Quality in Schools
Many U.S. schools were in dire need of upgrades — burdened by leaking pipes, mold and antiquated heating systems — long before the COVID-19 pandemic drew attention to the importance of indoor ventilation in reducing the spread of infectious disease.
So, one might assume school districts across the nation would welcome the opportunity created by billions of dollars in federal COVID-relief money available to upgrade heating and air-conditioning systems and improve air quality and filtration in K-12 schools.
But a report released this month from the Centers for Disease Control and Prevention found most U.S. public schools have made no major investments in improving indoor ventilation and filtration since the start of the pandemic. Instead, the most frequently reported strategies to improve airflow and reduce COVID risk were notably low-budget, such as relocating classroom activities outdoors and opening windows and doors, if considered safe.
The CDC report, based on a representative sample of the nation’s public schools, found that fewer than 40% had replaced or upgraded their HVAC systems since the start of the pandemic. Even fewer were using high-efficiency particulate air, or HEPA, filters in classrooms (28%), or fans to increase the effectiveness of having windows open (37%).
Understanding Long COVID Will Take the Lived Experiences of Long Haulers
I went from training for the Big Sur 21-miler to barely being able to climb a flight of stairs in just six months. The cause? COVID-19 or, more specifically, long COVID.
As a researcher, I want to know how this happened and, more importantly, how to fix it. I’m not alone. The “fix it” question is on the minds of as many as 23 million Americans and 100 million people worldwide who have experienced long COVID, which has emerged as a new chronic illness.
Understanding COVID-19 and long COVID requires the kind of gold-standard research that has been fielded for other conditions, like HIV and Guillain-Barré syndrome. But it will also take the lived experiences that people with it have accumulated, along with so-called real-world evidence. Only with this combination can the scientific and public health communities arrive at real answers that finally bring the support and long-term care needed by people with this perplexing condition.
Far From Being ‘Post-Pandemic,’ U.K. COVID Cases Are on the Rise Again
U.K. COVID-19 cases have risen for the first time in two months, according to new data, which warns of a possible further spike ahead. It comes at a time when Health Secretary Sajid Javid has dubbed the country “properly post-pandemic.”
Javid on Saturday told The Times newspaper that COVID-19 was “no longer a pandemic,” describing it as “endemic” like the flu and other viruses. “We should be proud as a country of how we tackled it,” he added.
The uptick recorded by the ONS was likely driven by the original Omicron variant BA.1 and the newer variants BA.4 and BA.5.
Sanofi Says Next-Gen COVID Booster Shot Has Potential Against Main Variants
French drugmaker Sanofi (SASY.PA) said on Monday an upgraded version of the COVID-19 vaccine candidate it is developing with GSK (GSK.L) showed potential in two trials to protect against the virus’s main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot.
While the two companies’ first experimental COVID shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that is molded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations.
Sanofi said this new vaccine candidate was shown to significantly boost antibody levels against a number of variants of concern, when given to trial participants who had an initial course of mRNA vaccines, a type made by BioNTech-Pfizer (22UAy.DE)(PFE.N) and Moderna (MRNA.O).
Valneva Shares Plunge as European COVID Vaccine Deal Flounders
Valneva (VLS.PA) shed around a quarter of its market value on Monday after the French drugmaker warned that the future of its COVID-19 vaccine was in jeopardy.
Valneva has been trying to salvage a deal with the European Commission (EC) which has indicated it would terminate an advance purchase agreement for up to 60 million doses.
