Covid News Watch
FDA Delays Moderna Vaccine for Teens Until Heart Condition Studied + More
U.S. FDA Delays Decision on Moderna’s COVID Vaccine for Adolescents
The U.S. health regulator is delaying its decision on authorizing Moderna Inc’s (MRNA.O) COVID-19 vaccine for adolescents to check if the shot could increase the risk of a rare inflammatory heart condition, the Wall Street Journal reported on Friday.
The U.S. Food and Drug Administration (FDA) has been inspecting the risk of the condition, myocarditis, among younger men vaccinated with Moderna’s shot, especially versus Pfizer‘s vaccine, after certain Nordic countries limited use of the shot, the report said, citing people familiar with the matter.
The agency has not yet determined whether there is heightened risk, and the delay could be several weeks, though the timing was unclear, the report said.
Colin Powell, First Black U.S. Secretary of State, Dies of COVID Complications Amid Cancer Battle
Colin Powell, the first Black U.S. secretary of state whose leadership in several Republican administrations helped shape American foreign policy in the last years of the 20th century and the early years of the 21st, has died from complications from COVID-19, his family said on Facebook. He was 84.
“General Colin L. Powell, former U.S. Secretary of State and Chairman of the Joint Chiefs of Staff, passed away this morning due to complications from COVID 19,” the Powell family wrote on Facebook, noting he was fully vaccinated.
Dozens of Lawsuits Seek to Force Hospitals to Treat COVID With Ivermectin
There have been at least two dozen lawsuits filed around the U.S. demanding hospitals give ivermectin, a deworming drug, to COVID-19 patients, The Associated Press reported.
The lawsuits follow much of the same format; families have gotten a prescription for the drug, but hospitals refuse to use it on the patients, many of whom are on a ventilator, close to death, the news outlet noted.
Many of the lawsuits are filed by Ralph Lorigo, an attorney in Buffalo, N.Y. who says doctors “are not gods because they wear white jackets,” adding that he takes issue with the choice not to use ivermectin on patients, according to the AP.
Fauci Allegedly Misled Trump Administration on Gain-of-Function Research in Wuhan: Book
A new book from an investigative Australian reporter dives into how Dr. Anthony Fauci reportedly misled the Trump administration on gain-of-function research in China.
“Fauci’s public persona as a cautious, careful medical professional is contradicted by his central role in kickstarting exceptionally fraught gain-of-function research in the United States after the ban introduced in the Obama era, along with his role in funding coronavirus research in China in unsafe laboratories. Laboratories that intelligence agencies suspect may have sparked the pandemic,” Sharri Markson details in her new book, “What Really Happened In Wuhan.”
WHO Says It ‘Cannot Cut Corners’ in Approving India’s Covaxin Shot
The World Health Organization on Monday asked for further data from India’s Bharat Biotech to consider the company’s request for an emergency-use listing for its COVID-19 shot, saying the WHO could not “cut corners” in making a decision.
Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July. The vaccine was given emergency-use authorisation in India in January even before the completion of a late-stage trial, which later found the shot to be 78% efficacious.
Valneva Says Its COVID Vaccine Shows Similar Protection to AstraZeneca’s, Fewer Side Effects
Valneva SE (VLS.PA) on Monday said its experimental COVID-19 vaccine demonstrated efficacy “at least as good, if not better” than AstraZeneca‘s (AZN.L) shot in a late-stage trial comparing the two, with significantly fewer adverse side effects.
Valneva, among a handful of drugmakers testing their vaccines against one already in use, is hoping its candidate, which uses more traditional technology than the mRNA vaccines, could be a more reassuring option for Europeans still reluctant to be immunised. read more
Israel to Give AstraZeneca Vaccine to Those Affected by Pfizer
Israel will start offering the option of receiving a coronavirus AstraZeneca vaccine starting from Thursday, the Health Ministry announced Monday.
The vaccine will be available with a specific medical referral, which will be given to those who cannot receive an mRNA vaccine for medical reasons or who have experienced significant side effects after Pfizer, or in other special circumstances.
The vaccine by AstraZeneca is based on a different technology than Pfizer’s and Moderna’s, which are both messenger RNA vaccines. AstraZeneca uses a weakened animal virus as a viral vector, and it contains the coronavirus spike protein so that the body’s cells will be able to recognize it and produce antibodies.
Vaccines, Masks? Japan Puzzling Over Sudden Virus Success
Almost overnight, Japan has become a stunning, and somewhat mysterious, coronavirus success story. Daily new COVID-19 cases have plummeted from a mid-August peak of nearly 6,000 in Tokyo, with caseloads in the densely populated capital now routinely below 100, an 11-month low.
The bars are packed, the trains are crowded, and the mood is celebratory, despite a general bafflement over what, exactly, is behind the sharp drop.
Japan, unlike other places in Europe and Asia, has never had anything close to a lockdown, just a series of relatively toothless states of emergency.
Mexico City Lowers Pandemic Alert to Lowest Level
Mexico’s capital returned to the lowest level on its COVID-19 pandemic warning system Monday for the first time since June. In practice, the shift from the yellow to green category changes meant only small changes to daily life.
Mask wearing is still common in streets of the city of 9 million, but the rhythm of life in the capital has long since regained a high degree of normalcy.
Massive outdoor events, which had been operating at 75% capacity, now face no capacity restrictions, though attendees will still be required to wear masks. The move comes just weeks ahead of Mexico City hosting a Formula 1 race.
Why COVID Boosters Weren’t Tweaked to Better Match Variants
More COVID-19 booster shots may be on the way — but when it’s your turn, you’ll get an extra dose of the original vaccine, not one updated to better match the extra-contagious Delta variant.
And that has some experts wondering if the booster campaign is a bit of a missed opportunity to target Delta and its likely descendants.
“Don’t we want to match the new strains that are most likely to circulate as closely as possible?” Dr. Cody Meissner of Tufts Medical Center, an adviser to the Food and Drug Administration, challenged Pfizer scientists recently.
COVID Vaccine Trials Set to Begin for Children as Young as 6 Months + More
COVID Vaccine Trials Set to Begin for Children as Young as 6 Months
A new phase of COVID-19 vaccine trials is set to begin for children as young as six months by the end of October. Dr. Myron Levin a professor of pediatric medicine at CU School of Medicine who specializes in infectious disease and vaccinology will lead the study for the Moderna vaccine.
“I don’t think we will have trouble enrolling and we will enroll as many as we can but I’m guessing we won’t be able to accommodate everyone who wants to be in the study,” Levin said.
Levin is hopeful that the next step will begin by the end of October and results about safety and efficacy could be released by the first of the year.
Fully Vaccinated Man Dies From COVID
The Tafoya family is dealing with a loss they thought was impossible. Lawrence Tafoya, the anchor of the family of six kids, eight grandkids, and 13 great-grandchildren, died from COVID-19 earlier this month.
Lawrence was 74 years old. His kids say he was healthy, didn’t have any underlying conditions, and was still running his general contracting business. They say he was even still roofing.
Tafoya says his day started having flu-like symptoms in early September. Since he was fully vaccinated against COVID, they thought it was just the flu. But things changed within a week.
UK Infection Rates for Vaccinated Overtake the Unvaccinated as Delta Variant Spreads
COVID-19 infection rates are now higher among the vaccinated population in the UK according to new government data, however hospitalization rates continue to be higher among the unvaccinated.
A vaccine surveillance report released by the UK Health Security Agency shares data calculated between weeks 36 and 39 of 2021. The report shows cases are higher in those who have been double vaccinated in all age groups over 30 years old.
The Latest: Pfizer Seeks European OK for Child Vaccines
The pharmaceutical companies Pfizer and BioNTech say they have requested that their coronavirus vaccine be licensed for children aged 5 to 11 across the European Union. If authorized, it would be the first opportunity for younger children in Europe to be immunized against COVID-19.
In a statement on Friday, Pfizer and BioNTech said they had submitted data to the European Medicines Agency, including late-stage results from a study testing their COVID-19 vaccine in more than 2,200 children aged six months to 11 years, using a lower dose than what’s normally given to adults.
U.S. FDA Advisers Unanimously Back Second Shot of J&J COVID-19 Vaccine
Outside advisers to the U.S. Food and Drug Administration on Friday voted unanimously to recommend regulators authorize a second shot of Johnson & Johnson‘s (JNJ.N) COVID-19 vaccine to better protect Americans who received the one-dose vaccine.
The FDA’s Vaccines and Related Biological Products Advisory Committee backed the shots for all J&J recipients aged 18 and older at least two months after their first dose.
More COVID Boosters Are on the Horizon. But Not Everyone Will Need One, Experts Say
Moderna‘s EUA request mirrored the groups authorized to receive a booster dose of Pfizer’s mRNA vaccine. Third doses of the Moderna and Pfizer COVID-19 vaccines are already authorized for some immunocompromised people.
Yet some experts are noting that while antibodies may wane over time, the initial two-dose regimen for both vaccines is still holding up against severe COVID-19 infection.
Dr. Paul Offit, a member of the FDA Vaccines and Related Biological Products Advisory Committee that held the vote, told CNN’s Wolf Blitzer on Thursday that proper expectations need to be set about what vaccines are supposed to do and how they remain effective.
“We have to define what’s the goal of this vaccine. If the goal of this vaccine is protection against serious illness, meaning the kind of illness that causes you to seek medical attention or go to the hospital or the ICU, the current vaccines, as two-dose vaccines, are doing exactly that,” he said. “So, you don’t really need a booster dose at least as far as those data are concerned.”
Local Expert Says COVID Vaccine Can Cause Rare Heart Condition in Kids, but Still Recommends Shot
The push continues from health officials around the country for Americans to get vaccinated against COVID-19.
But some parents are hesitant to get their children the shots because of a rare heart condition being seen in kids around the globe.
Myocarditis is a rare health condition that causes inflammation around the heart. 6 News spoke with a doctor at the University of Michigan who is considered a specialist in the field. He says Roughly 1 in 20,000 children who get a second dose of a COVID-19 vaccine develop myocarditis.
South Africa to Vaccinate Teenagers With Single Dose of Pfizer — Health Minister
South Africa will start vaccinating children between the ages of 12 and 17 next week using the Pfizer (PFE.N) vaccine, the health minister said on Friday, as the country looks to ratchet up inoculations ahead of final year examinations.
However, Phaahla said that on the advice of its vaccine advisory committee the government would only give teenagers a single shot of Pfizer’s normal two-shot regime due to concerns that it may affect the heart.
Study Says Johnson & Johnson Vaccine Immune Response Is More Durable Than Pfizer and Moderna
The Boston Globe via MSN reported:
As the U.S. Food and Drug Administration’s advisory panel discusses on Friday whether to recommend Johnson & Johnson booster doses, new research suggests the one-shot vaccine produces a more durable immune response than the Pfizer-BioNTech and Moderna shots, which have been found to wane over time.
The findings, published Friday in the New England Journal of Medicine, come from a study of a few dozen people at Beth Israel Deaconess Medical Center in Boston, which analyzed blood samples of fully vaccinated people two to four weeks after vaccination, and then eight months later.
Study: Home Monoclonal Antibody Program Averted COVID Hospital Care
A research letter today in JAMA Network Open describes how nurses in Michigan may have reduced emergency department visits and hospitalizations of high-risk COVID-19 patients by coordinating at-home administration of neutralizing monoclonal antibodies (MABs) during the spring 2021 surge.
From February to May 2021, three nurses at St. Joseph Mercy Health System in Ann Arbor reviewed new positive COVID-19 test results and provider referrals from the system’s hospitals to determine if patients were eligible for MAB administration under the Food and Drug Administration emergency use authorization (EUA).
Age-Adjusted Mortality at Just 2004 Levels (Despite Media Claims That COVID Is ‘Worse Than the 1918 Flu’)
Last week, the media again tried to ratchet up the public’s fear over COVID-19 by labeling it more deadly than the 1918 flu epidemic.
If we actually look at disease mortality proportionally to the population, the 1918 epidemic was far worse than COVID. Considering that the U.S. population in 1918 was one-third its current size, we find that deaths per million from the flu epidemic totaled about sixty-five hundred per million. COVID, by comparison, currently comes in — in the official numbers — around twenty-two hundred per million.
But this is all part of a larger pattern — one well embraced by the media — of presenting information with as little context as possible. One such example was the reporting on suicide rates in 2018, which ignored everything but the most recent trend.
Report: New WHO COVID Origin Investigation Team Includes Another Peter Daszak Minion
The World Health Organisation (WHO) recently put together a new team of researchers to ‘investigate’ the origins of COVID-19, pertaining specifically to the lab leak theory, and declared that this time conflicts of interest would be avoided. However, one of the leading members is a scientist who signed EcoHealth Alliance head Peter Daszak’s infamous Lancet letter which attempted to shut down the theory before it had even been looked into.
The Washington Free Beacon notes that Germany’s Institute of Virology head, Christian Drosten is on the latest WHO team, and that he “signed a controversial letter dismissing the idea that the virus emerged from a Chinese lab as a ‘conspiracy theory.’”
FDA Panel Unanimously Recommends Moderna COVID Booster Shots for At-Risk Adults + More
FDA Panel Unanimously Recommends Moderna COVID Booster Shots for At-Risk Adults
A key Food and Drug Administration advisory committee unanimously recommended Thursday giving booster shots of Moderna’s COVID-19 vaccine to people age 65 and older and other vulnerable Americans, a crucial step before the U.S. can start administering third shots to some of the more than 69 million people who originally received that vaccine.
The nonbinding decision by the FDA’s Vaccines and Related Biological Products Advisory Committee would bring guidelines for Moderna in line with third shots of Pfizer and BioNTech’s vaccine. Those shots were authorized less than a month ago to a wide array of Americans, including the elderly, adults with underlying medical conditions and those who work or live in high-risk settings like health and grocery workers.
Video: Fauci Claims No ‘True Basis’ in Concerns Over Long-Term COVID Vax Side Effects
In another display of ignorance on the science, Anthony Fauci declared Wednesday that there is no “true basis” for concerns over potential long-term side effects of COVID vaccines, despite there being no long-term studies to take data from.
While speaking on a virtual call in concert with CDC Director Dr. Rochelle Walensky and U.S. Surgeon General Vivek Murthy, Fauci was asked by a caller if pilots have any ‘valid concerns’ after it was suggested that many are remaining unvaccinated to avoid potential long-term side effects that may infringe on their ability to fly.
“Pilots at American and Southwest Airlines in particular are arguing that some pilots may be reluctant to get vaccinated because of potential of career-ending side effects,” the caller stated, adding “They’re concerned that there could be long-term side effects that could cause them to then lose their medical certification and also lose their jobs and their livelihoods. So is this a valid concern?”
Gambian Women’s Voices on COVID Vaccines: ‘We Are Afraid’
The TRY Oyster Women’s Association represents more than 500 women, many of whom are reluctant to get vaccinated against COVID-19. These women fish under darkness of night without fear but are anxious about the vaccine. They say they can’t miss a day of work if it means being sidelined — even briefly — because of side effects from the jab.
“I’m not convinced to accept the vaccine. My mind did not accept it; this is why I said I will not take the vaccine.”
Worst Emergency Blood Shortage Since 2015 Caused by Pandemic: American Red Cross
The American Red Cross (ARC) recently issued a public call to action due to a plummeting national inventory of blood donations amidst the COVID-19 pandemic.
“The Red Cross is now facing an emergency blood and platelet shortage. Blood donor turnout has reached the lowest levels of the year as many have delayed giving amid a return to the workplace and in-person learning, as well as a recent surge in COVID-19 cases across the country due to the Delta variant,” Jodi Sheedy, senior director of Biomedical Communications at the ARC, wrote in an email to Fox News.
A Mom Who Hasn’t Gotten Vaxxed — and Might Not Vaccinate Her Kids — Explains Herself
When I first heard about the COVID vaccine, I thought it was a little bit worrisome. I mean, it was a good thing — I’m not an anti-vaxxer. My kids take the flu shot, they have all their other vaccinations. But it was a little bit concerning to me because the research process was just so fast. And then, when it opened the doors to the kids, I was just really leery about it, because what’s it going to be like in 10 years?
I’m not saying that I won’t ever get them vaccinated. We might go next weekend. I’m just super hesitant because I wish that there was just a little more time in between the research and the distribution. I did read an article about how scientists had been researching these kinds of vaccines for a long time, which is why they produced it as quickly as they did. But when it’s your kids, it’s easy not to be logical. It’s an emotional decision.
A Drugmaker Backed by the Company That Owns Marlboro Cigarettes Plans to Launch the World’s First Plant-Based COVID Vaccine
The world’s first plant-based COVID-19 vaccine could reach Canada’s drug regulator by the end of the year.
Leading Japanese drugmaker Mitsubishi Tanabe Pharma said Tuesday that Medicago, its Quebec-based subsidiary that developed the shot, would apply for Canadian approval by the end of 2021, the Financial Times reported.
Marlboro cigarette brand manufacturer Philip Morris International part-owns Medicago, according to the Financial Times.
Johnson & Johnson Vaccine Recipients May Be Better Off with a Booster of Pfizer or Moderna: FDA
People who received Johnson & Johnson’s single-dose COVID-19 vaccine may be better off getting a booster shot of Pfizer or Moderna‘s vaccine rather than a second dose, according to data reviewed by the Food and Drug Administration.
The FDA went through two studies — one from Johnson & Johnson, which has been testing the effectiveness of a second dose of their vaccine and another that looked at following the Johnson & Johnson vaccine with a booster shot of Pfizer or Moderna, which are mRNA vaccines that use a different delivery system to create antibodies that protect against COVID-19.
WHO: Tuberculosis Deaths Rise for 1st Time in Over a Decade Due to COVID
The number of deaths from tuberculosis rose last year for the first time in more than a decade, the World Health Organization said Thursday.
Why it matters: The data underscores the COVID-19 pandemic’s toll on tackling other, preventable diseases worldwide.
Driving the news: The WHO said the uptick in deaths from tuberculosis is largely driven by fewer people getting tested and treated for the disease due to the healthcare system’s focus on fighting the COVID-19 pandemic.
China Warns Against ‘Manipulation’ of WHO Virus Probe
China’s Foreign Ministry on Thursday warned against what it called possible “political manipulation” of a renewed probe by the World Health Organization (WHO) into the origins of the coronavirus, while saying it would support the international body’s efforts.
The WHO on Wednesday released a proposed list of 25 experts to advise it on next steps in the search for the virus’ origins after its earlier efforts were attacked for going too easy on China, where the first human cases were detected in late 2019.
Foreign Ministry spokesperson Zhao Lijian said China would “continue to support and participate in global scientific tracing and firmly oppose any forms of political manipulation.”
Moderna Has Become the World’s Vaccine Boogeyman
Moderna is under fire for not doing enough to vaccinate the world, particularly low-income countries — and the Biden administration is being criticized for not doing enough to force Moderna’s hand.
Why it matters: Low-income countries are desperate for more vaccines, and experts warn that higher levels of global spread will increase the likelihood of a vaccine-resistant variant emerging.
Driving the news: A top Biden official publicly threatened Moderna with more aggressive government action if it doesn’t voluntarily provide enough vaccines to the global initiative COVAX at not-for-profit prices, which the administration has asked it to do.
White House Tells States to Prepare for COVID Vaccinations in Young Children + More
White House Tells States to Prepare for COVID Vaccinations in Young Children
The White House told governors to start preparing to vaccinate children as young as 5 by early next month in anticipation of clearance of Pfizer‘s COVID vaccine for the age group in the coming weeks, a White House official said.
The Biden administration has purchased 65 million pediatric doses of the Pfizer/BioNTech vaccine, enough to vaccinate the estimated 28 million children who would be eligible should the Food and Drug Administration approve Pfizer’s request to vaccinate children ages 5 to 11, said an official of the Department of Health and Human Services.
Saliva Test May Predict COVID Severity Among Children, Penn State Research Finds
The Philadelphia Inquirer reported:
A simple saliva test may be able to determine which children are at greater risk of developing severe COVID-19 symptoms, according to early research findings by doctors at Pennsylvania State University.
While the vast majority of children who contract the virus experience only mild symptoms or none at all, early identification of those who are at risk of developing severe cases would help doctors better monitor and intervene before children become critically ill, said Steven Hicks, a pediatrician at Penn State Health Children’s Hospital and coauthor of the study.
‘Major Step Forward’ in COVID Fight as ‘Highly Potent’ Antibody Found to Eliminate Virus
The stunning breakthrough was made by researchers at the Lausanne University Hospital (CHUV) and the Swiss Federal Institute of Technology Lausanne (EPFL). They discovered a “highly potent” monoclonal antibody that targets the spike protein of the disease and is “effective at neutralising all variants of concern.” Their findings are published in the prestigious journal Cell Reports.
Antibodies are specialised, Y-shaped proteins released by the immune system like a lock-and-key to the body’s foreign invaders.
This newly discovered antibody is said to be “one of the most powerful” identified so far.
FDA Grapples With Timing of Booster for J&J COVID Vaccine
The Food and Drug Administration said Wednesday it is wrestling with whether and when recipients of the single-shot Johnson & Johnson COVID-19 vaccine need another dose — at six months or as early as two months.
In an online review, FDA scientists didn’t reach a firm conclusion, citing shortcomings with J&J’s data, including little information on protection against the extra-contagious Delta variant of the coronavirus.
44,400 Breakthrough Cases Recorded in Indiana; 420 Fully Vaccinated Residents Have Died
International Business Times reported:
Nearly 45,000 people in Indiana have been infected with COVID-19 despite being fully vaccinated, with more than 400 dying from the virus, according to the state’s health department.
In the latest data published Thursday, 44,479 breakthrough COVID-19 cases have been recorded since the beginning of the pandemic — 5,303 more cases since the update on Sept. 30. The total number of cases represents 1.348% of the state’s fully vaccinated population.
China to Test Thousands of Wuhan Blood Samples in COVID Probe
China is preparing to test tens of thousands of blood bank samples from the city of Wuhan as part of a probe into the origins of COVID-19, according to a Chinese official. The move comes amid increasing calls for transparency over the emergence of the virus.
The store of up to 200,000 samples, including those from the closing months of 2019 were pinpointed in February this year by the World Health Organization’s panel of investigators as a possible source of key information that could help determine when and where the virus first crossed into humans.
The samples are kept in the Wuhan Blood Center, and are thought to span 2019, providing real-time tissue samples from a wide swathe of the population in the Chinese city where SARS-CoV-2 is thought to have first infected humans.
Nearly 45,000 Breakthrough COVID Cases Reported in Mass. Since July
Nearly 45,000 fully vaccinated Massachusetts residents have now tested positive for COVID-19 and 345 of them have died, according to the latest state data on breakthrough cases published Tuesday.
The Department of Public Health has tracked a cumulative 44,498 confirmed COVID-19 infections among those fully vaccinated in the state to date.
Watch: Merck’s COVID Pill Could Transform Treatment. Here’s How It Works
Earlier this month, study results showed that molnupiravir, Merck’s investigational antiviral pill, cut hospitalization rates of COVID-19 patients by about half. Molnupiravir is the first oral treatment that has shown promise in treating COVID-19. Another antiviral, remdesivir, can only be administered intravenously.
“Having an oral option will be a big change,” said Benjamin Gewurz, associate director of the Ph.D. program in virology at Harvard Medical School. “Some people could just take a pill rather than having an IV or injection of some sort. And that’s what would be a huge, huge advance.”
Virginia Teen Claims She Received 6 Doses of Pfizer Vaccine
A teenage girl from Salem claims she received six doses of Pfizer’s COVID-19 vaccine at a CVS pharmacy.
NBC affiliate WSLS reports that Ellaica Desdura was getting the vaccine so she could travel to the Philippines. But when she was getting the shot, she told WSLS that she was given the full vial of the Pfizer vaccine.
The incident led to EMS crews being called to the scene. The family told WSLS that Ellaica did not go to the hospital but experienced arm swelling, irregular heart rate and nausea.
WHO Announces New Expert Group to Investigate Origins of COVID and Other Outbreaks
The Washington Post via MSN reported:
The World Health Organization on Wednesday named 26 scientists to a new advisory body devoted to understanding the origins of COVID-19 and other future outbreaks, marking a change in approach for the world’s top global health body to one of the most politically sensitive issues of a pandemic that has killed more than 4.8 million people.
The group includes scientists from the United States and China, as well as 24 other nations, and will be formalized after a brief period of public consultation. It is set to consider not only the big, unresolved question of the novel coronavirus — how did it first infect humans? — but it will also establish a framework for future outbreaks involving other pathogens so that similar big questions are not left unresolved again.
