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‘Odds Are High’ FDA Will Approve COVID Vaccines for Kids Under 12 During Next School Year + More
‘Odds Are High’ FDA Will Approve COVID Vaccines for Children Under 12 During Next School Year
About five months after the vaccines were made available to the public, emergency use authorization was opened up to children as young as 12.
This week the surgeon general announced that the ‘odds are high’ that The Food and Drug Administration would approve COVID-19 vaccines for children under 12 during the next school year …
During a recent episode of the ‘Skimm This’ podcast, Surgeon General Murthy was asked during a lightning round of questions, “What are the odds that a vaccine for kids under 12 will be approved during the next school year?”
“I think the odds are high,” he responded, despite his inability to elaborate further.
VAERS Latest Data Include 2 New Reports of Teen Deaths Following COVID Vaccine, as Total Reports of Deaths Exceed 12,000
Data released today by the Centers for Disease Control and Prevention (CDC) showed the total number of reports (including foreign and U.S.) of deaths following COVID vaccination, across all age groups, surpassed 12,000.
The data comes directly from reports submitted to the Vaccine Adverse Event Reporting System (VAERS), the primary government-funded system for reporting adverse vaccine reactions in the U.S.
Every Friday, VAERS makes public all vaccine injury reports received as of a specified date, usually about a week prior to the release date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Physician Speaks Out Against ‘Vaccine Mandates for All’ — Especially Children and Those With Natural Immunity
Dr. Marty Makary, a professor at Johns Hopkins University School of Medicine and editor-in chief of MedPage Today, is pushing back against the growing drumbeat for mass vaccinations and COVID vaccine mandates.
In an interview with U.S. New & World Reports, Makary said mandating vaccines for “every living, walking American” is not well-supported by science. Makary also expressed concerns about the two-dose vaccine regimen for adolescents.
Makary’s interview this week took place as more public and private employers join the vaccine mandate chorus — the federal government is requiring the jab for federal employees, hundreds of colleges are requiring proof of vaccination for students, the U.S. Department of Defense is gearing up to require COVID vaccines for military members, New York is mandating the vaccine for indoor businesses and some of America’s largest employers are requiring employees get vaccinated or risk losing their jobs.
Challenge to Indiana University Vaccine Mandate Reaches Supreme Court
A lawyer representing Indiana University students asked the Supreme Court Friday to block the school’s vaccine mandate that is set to take effect this fall while the appeals process plays out.
The filing marks the first time the justices have been asked to weigh in on the issue as private and public entities are increasingly requiring vaccines in the wake of a new surge of the virus caused by the Delta variant.
The university requires students to be vaccinated unless they qualify for exemptions. If they are exempted, they must wear masks and undergo testing twice a week.
Biden Team’s Misguided and Deadly COVID-19 Vaccine Strategy
The Biden administration’s strategy to universally vaccinate in the middle of the pandemic is bad science and badly needs a reboot.
This strategy will likely prolong the most dangerous phase of the worst pandemic since 1918 and almost assuredly cause more harm than good – even as it undermines faith in the entire public health system.
Four flawed assumptions drive the Biden strategy. The first is that universal vaccination can eradicate the virus and secure economic recovery by achieving herd immunity throughout the country (and the world). However, the virus is now so deeply embedded in the world population that, unlike polio and smallpox, eradication is unachievable. SARS-CoV-2 and its myriad mutations will likely continually circulate, much like the common cold and influenza.
Moderna Presses for COVID-19 Boosters as Federal Health Officials Warm to an Extra Dose for Some People
The level of protection provided by Moderna’s COVID-19 vaccine is nearly as high at six months as it is right after vaccination, but the company said vaccinated people will still need booster shots before the end of the year.
“A dose three of a booster will likely be necessary to keep us as safe as possible through the winter season in (the) Northern Hemisphere,” Moderna President Stephen Hoge told investors, according to a FactSet transcript of the company’s Thursday earnings call.
Hoge cited the widely circulating delta variant, which is more than two times as contagious as the original strain of the virus, and the company’s understanding that vaccine-induced immunity may wane.
Potential Military Vaccine Mandate Brings Distrust, Support
The Associated Press reported:
Since President Joe Biden asked the Pentagon last week to look at adding the COVID-19 vaccine to the military’s mandatory shots, former Army lawyer Greg T. Rinckey has fielded a deluge of calls.
His firm, Tully Rinckey, has heard from hundreds of soldiers, Marines and sailors wanting to know their rights and whether they could take any legal action if ordered to get inoculated for the coronavirus.
“A lot of U.S. troops have reached out to us saying, ‘I don’t want a vaccine that’s untested, I’m not sure it’s safe, and I don’t trust the government’s vaccine. What are my rights?’” Rinckey said.
FDA Expected To Recommend Boosters for Immunocompromised Americans Within Weeks: Source
Within the next few weeks, the U.S. Food and Drug Administration is expected to recommend a plan for immunocompromised Americans to get a COVID-19 booster shot, a senior government official familiar with the agency’s planning told ABC News on Thursday.
The plan is expected by early September, if not sooner, the government official said.
New CDC-Funded Pilot Program in Georgia Uses Public Art to Increase Confidence in COVID-19 Vaccination
The Centers for Disease Control and Prevention reported:
To help build confidence in and increase demand for COVID-19 vaccination, Centers for Disease Control and Prevention (CDC) is partnering with the Georgia Department of Public Health (DPH) and several other organizations on an innovative community initiative leveraging local artists as trusted vaccine messengers.
The COVID-19 Georgia Arts pilotexternal icon is a unique collaboration between CDC, the David J. Sencer CDC Museum, DPH, Community Organized Relief Effort (CORE) Georgia, and two local arts organizations – Dashboardexternal icon and Living Wallsexternal icon – to increase vaccine uptake through public art. A series of recently launched art installations and events will continue throughout August in select neighborhoods in cities including Atlanta, Savannah, and Athens. Some of the events – which focus on communities disproportionately impacted by COVID-19 – will feature pop-up vaccination sites, providing convenient opportunities to access COVID-19 vaccines.
After Months of Vaccine Incentives, Nation Changes Course
Life may be about to get tougher for the unvaccinated — and it’s not only because of their significantly increased risk of getting COVID-19 and becoming very sick.
A rising chorus of states, cities and private sector titans have implemented new vaccine requirements for their employees and patrons. It marks a new, less negotiable phase in the fight against the coronavirus, after months of cajoling and material goodies leading the vaccination campaign.
Will NC Minors Who Want a COVID-19 Vaccine Need a Parent’s Consent? Bill is Headed to the Governor.
Winston Salem Journal reported:
On Thursday, North Carolina’s General Assembly approved Republican-sponsored legislation that would require parental consent for 12- to 17-year-olds to get a COVID-19 vaccine.
The state House fast-tracked House Bill 96, which passed on a 106-5 vote.
All five members of the Forsyth County House delegation voted for passage — Republicans Donny Lambeth, Lee Zachary and Jeff Zenger, and Democrats Amber Baker and Evelyn Terry.
Senators voted 42-0 Tuesday for HB96, which began as legislation to expand the number of vaccines and medications pharmacists can administer.
First 16 and 17-Year-Olds (in UK) Begin to Get Vaccine Invites
Sixteen and 17-year-olds across the UK are now being invited to book their Covid vaccine.
GPs in England have been told they can contact this age group, while invites are also being sent out in Wales.
In Northern Ireland, walk-in centres are now open to older teenagers, and in Scotland they can register their interest online.
Meanwhile, new figures show most patients in hospital with COVID in England continue to be unvaccinated.
The opening of vaccinations to 16 and 17-year-olds in England comes amid a drive to encourage young people to get jabbed.
Mother of 5-Month-Old Who Got COVID From Vaccinated Family Member: ‘We Were So Careful’ + More
Mother of 5-Month-Old Who Got COVID From Vaccinated Family Member: ‘We Were So Careful’
Kristy Callaway, who resides in Corpus Christi, told Houston’s CBS affiliate KHOU 11 she and her husband took all the recommended precautions throughout the COVID-19 pandemic — taking extra care due to her pregnancy and the birth of their son, Emmett.
After she and her husband were vaccinated, they began visiting with vaccinated family and friends, however, her 5-month old baby caught the novel coronavirus after a recent trip to see family members in Galveston County.
“We were so careful and I thought we were doing all the right things,” Callaway told KHOU 11. The mother explained she and her husband didn’t see family or friends throughout the pregnancy to avoid any risks. She didn’t have a baby shower.
New South Wales Woman, 34, Dies of Rare Condition After Astrazeneca Vaccine
A NSW woman in her 30s has died from a rare blood clotting condition after receiving the first dose of the COVID-19 AstraZeneca vaccine.
The woman, aged 34, died on Wednesday from a confirmed case of thrombosis with thrombocytopenia syndrome (TTS), the government’s Therapeutic Goods Administration (TGA) revealed in a report on Thursday. …
It is not known whether the woman had any underlying health issues.
Moderna Says a 3rd Dose of Its COVID-19 Vaccine Will Be Needed Before Winter
Vaccine maker Moderna believes people who received two doses of its COVID-19 vaccine will need a third dose before winter as a booster shot.
The company said Thursday it is also working on a single shot that would provide an annual booster for COVID-19, as well as flu and the respiratory condition RSV.
“We believe that increased force of infection resulting from Delta, non-pharmaceutical intervention (NPI) fatigue, and seasonal effects (moving indoors) will lead to an increase of breakthrough infections in vaccinated individuals,” the company said in an investor presentation posted to its website.
Fully Vaccinated Man Dies of COVID in West Virginia
A man who was fully vaccinated against coronavirus has passed away in West Virginia, health department officials have said.
The Kanawha-Charleston Health Department said the “breakthrough infection” led to the death of a 76-year-old man with an underlying health condition.
WSAZ reported that the man died of complications of the virus and passed away at a medical facility.
Fauci: If Community Spread Doesn’t Get Under Control, U.S. ‘May Sooner or Later Get Another Variant’
If the U.S. does not get control over community spread of the Delta COVID variant, the nation will continue to see more variants that evade the protection of the vaccines, according to Dr. Anthony Fauci, chief medical adviser to the White House.
“That will happen, George, if we don’t get good control over the community spread which is the reason why I and my colleagues keep saying and over again, it is very important to get as many people vaccinated as we possibly can,” Fauci told “GMA” anchor George Stephanopoulos Thursday.
“People who say, ‘I don’t want to get vaccinated because it’s me and I’ll worry about me, I’m not having any impact on anybody else,’ that’s just not the case,” Fauci said.
Mississippi Sheriff, Fully Vaccinated, Dies After Testing Positive for COVID
The sheriff of Mississippi’s largest county has died, almost two weeks after he tested positive for COVID-19 amid an outbreak of the illness at a jail he oversaw …
The sheriff’s office announced July 23 that Vance had tested positive for COVID-19 and was in quarantine at home. It was not immediately known whether that illness caused his death …
The Clarion Ledger reported that Vance had been vaccinated against COVID-19, and he tested positive as cases of the virus were spreading rapidly at the Hinds County jail.
‘I’m Not Dying, but I’m Pretty Darn Sick’: Breakthrough COVID Cases, While Rare, Frustrate Vaccinated Marylanders
The Baltimore Sun via Yahoo!News reported:
They followed all the guidance, took every precaution, but got COVID-19 anyway.
Christina Van Norman and David Coe had resumed small gatherings — finally — of their fully vaccinated friends in their home in Montgomery County, where coronavirus transmissions were relatively low.
The day after the last event, she felt run-down. Two days later she had a fever and body aches, and a rapid test confirmed that the infection wasn’t a seasonal cold but the coronavirus. Her husband soon tested positive and they alerted their guests.
“We thought we were vaccinated and safe, and that’s the scary part,” Van Norman said. “I’m not dying, but I’m pretty darn sick and absolutely spreading it to others.”
FDA Aims to Give Final Approval to Pfizer Vaccine by Early Next Month + More
FDA Aims to Give Final Approval to Pfizer Vaccine by Early Next Month
President Biden said last week that he expected a fully approved vaccine in early fall. But the FDA’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.
Giving final approval to the Pfizer vaccine — rather than relying on the emergency authorization granted late last year by the FDA — could help increase inoculation rates at a moment when the highly transmissible Delta variant of the virus is sharply driving up the number of new cases.
Rock Band, Offspring, Boots Drummer for Refusal to Get COVID Vaccine — Even Though He Has Natural Immunity
Pete Parada, drummer for the Californian rock band Offspring, said he was ousted from the band because he refused to get a COVID vaccine, despite having already had COVID and acquiring natural immunity.
In an Instagram post, Parada said:
“Since I am unable to comply with what is increasingly becoming an industry mandate, it has recently been decided that I am unsafe to be around, in the studio and on tour. I mention this because you won’t be seeing me at these upcoming shows. I also want to share my story so that anyone else experiencing the agony and isolation of getting left behind right now knows they’re not entirely alone.”
Vaccine Mandates for Kids Could Be the Next Big Back-to-School Fight
Ensuring that vaccines are ready for all children by year end is “our best hedge against preventing a nasty variant of the future,” says William Gruber, Pfizer’s senior vice president for vaccine clinical research and development. “There will be a risk-benefit assessment as we see where the pandemic is at that particular time.”
The risk-benefit discussion promises to become even more pointed when COVID immunization expands to younger kids — and if schools begin to implement mandatory vaccination, as they already do for any number of diseases. Already, the rates for children are falling along red and blue lines, much as they have for adults. To help end the pandemic in the U.S., the Biden administration will have to keep trying to build confidence among hesitant parents, continue vaccinating older children, and speedily deploy shots for younger ones. If the rollout succeeds, it could redefine the global approach to the fight against COVID.
Are Vaccines Driving the Surge in New COVID Infections?
The Vaccine Reaction reported:
A recent study published by King’s College in London, which operates the ZOE COVID Study app to monitor COVID infection and vaccination rates, found that, as of July 15 there was an average of 15,537 new daily symptomatic cases of COVID-19 among partly or fully vaccinated people in the UK — an increase of 40% from the previous week’s total of 11,084 new cases.
Infections in vaccinated people in UK are outpacing infections in the unvaccinated.
The Zoe COVID Study, led by epidemiologist Tim Spector, M.D., of Kings College in London, estimated that there were 17,581 new daily symptomatic cases of COVID-19 in unvaccinated people, or 22% less than the previous week’s total of 22,638 new cases. According to a press release issued by the study’s authors, “With cases in the vaccinated group continuing to rise, the number of new cases in the vaccinated population is set to overtake the unvaccinated in the coming days.”
Most Unvaccinated Americans Believe Coronavirus Vaccine Poses Greater Health Risk Than the Disease, Poll Finds
The Washington Post via MSN reported:
The Kaiser Family Foundation released a survey Wednesday that found there was a big split between unvaccinated and vaccinated adults in what they perceived as the bigger threat during the pandemic.
Just over half of unvaccinated adults (53 percent) said they believed getting vaccinated posed a bigger risk to their health than getting infected with the coronavirus. “In contrast, an overwhelming majority (88 percent) of vaccinated adults said that getting infected with COVID-19 is a bigger risk to their health than the vaccine,” the report found.
Unvaccinated adults were also much less worried about the more transmissible Delta variant and had less confidence in the safety and effectiveness of the vaccines compared with those who got the shots, according to the KFF survey.
Fauci Floats Pill to ‘Knock Out’ COVID Early
Top U.S. infectious diseases expert Dr. Anthony Fauci on Tuesday said he’s looking into an oral COVID treatment to “knock out” the disease in patients in its early stages, given once daily for seven to ten days.
Few Children Suffer From Long-Term COVID-19 Symptoms, According to New U.K. Research Conducted Last Year
A new study primarily conducted in 2020 and before the emergence of the delta variant has shown that few children who become sick with COVID-19 suffer the long-term symptoms that have plagued some adults.
The research, published in The Lancet Child and Adolescent Health on Tuesday, is based on data from 1,734 U.K. children between the ages of 5 and 17 years old whose parents voluntarily use the ZOE COVID Study smartphone app.
Those children in the study tested positive for COVID-19 and were symptomatic between Sept. 1, 2020, and Jan. 24, 2021. The most common symptoms reported were headache, fatigue, loss of smell, and a sore throat. Median symptom duration lasted around six days, though it was slightly longer — 7 days — for children aged 12 to 17. Symptoms for those aged five to 11 were shorter, lasting five days.
Don’t Want a Vaccine? Be Prepared to Pay More for Insurance.
A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players — and neither team’s players will be paid.
But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.
20,595 Dead 1.9 Million Injured (50% Serious) Reported in European Union’s Database of Adverse Drug Reactions for COVID-19 Shots
The European Union database of suspected drug reaction reports is EudraVigilance, and they are now reporting 20,595 fatalities, and 1,960,607 injuries, following COVID-19 injections.
A Health Impact News subscriber from Europe reminded us that this database maintained at EudraVigilance is only for countries in Europe who are part of the European Union (EU), which comprises 27 countries.
The total number of countries in Europe is much higher, almost twice as many, numbering around 50. (There are some differences of opinion as to which countries are technically part of Europe.)
FDA Plans ‘Sprint’ to Accelerate Review of Pfizer Vaccine for Full Approval + More
FDA, Under Pressure, Plans ‘Sprint’ to Accelerate Review of Pfizer’s COVID Vaccine for Full Approval
Under heavy pressure, the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizer’s application for the formal approval of its COVID-19 vaccine, a senior agency official told STAT.
Pfizer’s vaccine is currently cleared under a so-called emergency use authorization, which allows the company to sell the vaccine for as long as COVID-19 is considered a public health emergency. But with COVID-19 still raging, and its spread now fueled by the Delta variant, lawmakers and prominent health experts have urged the FDA to expedite full approval of Pfizer’s vaccine, saying it would be a powerful tool in convincing the unvaccinated to get their shots and in giving businesses and other entities a stronger legal foundation to impose vaccine mandates.
Scientist: ‘What We’re Seeing Is Virus Evolution 101’ — Delta Variant More Transmissible, Not More Deadly
The Centers for Disease Control and Prevention (CDC) on July 27, issued an update on breakthrough infections, stating they “happen in only a small proportion of people who are fully vaccinated, even with the Delta variant.”
The CDC’s statement, however, stands in contrast to what the director of Israel’s Public Health Services told viewers of the CBS program “Face the Nation” on Sunday — that 50% of new infections reported in Israel are from fully vaccinated people.
Delta Infections Threaten Herd Immunity Vaccine Strategy
Epidemiologists are adjusting their expectations for the future course of the pandemic after data from a recent outbreak in Massachusetts in the U.S. suggest that while vaccination remains highly protective against the worst consequences of infection, it may not be sufficient on its own to stop the spread of the delta variant.
Testing conducted among Massachusetts residents during an outbreak in Provincetown, a popular weekend getaway spot, from July 3 to 17 found that 75% of those infected were fully vaccinated, in a state where 69% of adults were fully vaccinated.
FDA Authorizes COVID Antibody Treatment as Preventive After Exposure
People at considerable risk of developing severe COVID-19, including millions of Americans with compromised immune systems, now have the option of receiving a preventive monoclonal antibody treatment if they have been or are at risk of being exposed to the coronavirus.
The Food and Drug Administration’s action on Friday brings hope to the estimated 3 percent of Americans who are immunocompromised, including those with autoimmune diseases, HIV patients, cancer patients and organ transplant recipients, who may still be vulnerable to COVID even after being fully vaccinated.
This is the first time an injectable coronavirus antibody treatment has been approved for use as a prevention of COVID after someone has been exposed to the virus.
International System Makes It Easier for Healthcare Professionals, Consumers to Report Vaccine Injuries
Children’s Health Defense reported:
Children’s Health Defense (CHD) has joined with Doctors for COVID Ethics and other organizations around the globe to encourage and make it easy for healthcare professionals and vaccine recipients to report injuries and adverse reactions to any vaccines, including COVID vaccines.
CHD and Doctors for COVID Ethics urge all healthcare professionals who are aware of a vaccine adverse event, and anyone who suspects they have suffered any kind of adverse side effect — from any vaccine — to report these injuries. This information is critical in the assessment of vaccine safety.
Gene Splicing Pathogens to Make Biological Weapons Is Illegal — But Nobody Is Enforcing the Law
Brandeis University scientists are making dramatic progress with techniques for “gene splicing” — modifying the genetic makeup of organisms.
This work includes bioengineering pathogens for medical research, techniques that also can be used to create deadly biological weapons. It’s an overlap that’s helped fuel speculation that the SARS-CoV-2 coronavirus was bioengineered at China’s Wuhan Institute of Virology and that it subsequently “escaped” through a lab accident to produce the COVID-19 pandemic.
Lilly’s COVID Drug Reduces Death Risk in Patients on Ventilator
Eli Lilly and Co. said new data from a Phase 3 trial showed its COVID-19 drug, baricitinib, was shown to reduce deaths in patients receiving mechanical ventilation.
The study, which involved a cohort of 101 adult patients, found those on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who were given the drug and standard of care were 46% less likely to die by day 28 compared to those who received a placebo and standard of care.
Those Virus Sequences That Were Suddenly Deleted? They’re Back
The New York Times via Yahoo!News reported:
A batch of early coronavirus data that went missing for a year has emerged from hiding.
In June, an American scientist discovered that more than 200 genetic sequences from COVID-19 patient samples isolated in China early in the pandemic had puzzlingly been removed from an online database. With some digital sleuthing, Jesse Bloom, a virus expert at the Fred Hutchinson Cancer Center in Seattle, managed to track down 13 of the sequences on Google Cloud.
Army Gives Pfizer $3.5B Contract to Make 500 Million COVID Vaccine Doses
The Pentagon announced Monday the U.S. Army had awarded Pfizer a $3.5 billion contract to manufacture 500 million doses of its COVID-19 vaccine by the end of next year for distribution around the world.
The order matches the number of Pfizer-BioNTech vaccine doses purchased by the US government under an agreement announced last year by the Trump administration. Last month, Pfizer announced that the latest batch of 200 million doses would be delivered between October of this year and April of 2022.
Israeli Scientist Says COVID Could Be Treated for Under $1/Day
Ivermectin, a drug used to fight parasites in third-world countries, could help reduce the length of infection for people who contract coronavirus for less than a $1 a day, according to recent research by Sheba Medical Center in Tel Hashomer.
Prof. Eli Schwartz, founder of the Center for Travel Medicine and Tropical Disease at Sheba, conducted a randomized, controlled, double-blinded trial from May 15, 2020, through the end of January 2021 to evaluate the effectiveness of ivermectin in reducing viral shedding among nonhospitalized patients with mild to moderate COVID-19.