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U.S. Rolls Out COVID Vaccine for Young Children + More
U.S. Rolls Out COVID Vaccine for Young Children, Ending Long Wait for Some Parents
The United States on Wednesday started vaccinating children aged 5 to 11 against COVID-19, with roughly 28 million school-age kids now eligible for the shots that provide protection against the illness.
On Tuesday, the U.S. Centers for Disease Control and Prevention recommended the Pfizer Inc (PFE.N)/BioNTech SE shot for broad use in that age group after a panel of outside advisers voted in favor of it. read more
Still, it remains unclear how parents will react. Many people who have been vaccinated themselves are more divided over whether or not to vaccinate their own younger children given that severe COVID-19 is much less common for them.
U.S. CDC Director Backs COVID Vaccine for Children Ages 5 to 11
The director of the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday backed broad use of Pfizer‘s (PFE.N) and BioNTech’s COVID-19 vaccine in children ages 5 to 11, clearing the way for shots to go into young arms as soon as Wednesday.
The announcement comes hours after the advisers to the U.S. CDC unanimously supported the move, saying the benefits of the vaccine outweigh the risks. Much of their discussion stemmed from rare cases of heart inflammation that have been linked to the vaccine, particularly in young men.
Brothers, Ages 5 and 9, First Elementary Aged Kids to Get COVID Shot in Houston
Thousands of children ages 5 to 11 are already signed up for appointments across the Houston area.
Houston children as young as age 5 are now able to get the Pfizer COVID-19 vaccine — the first of these doses being administered Wednesday at Texas Children’s Hospital.
Five-year-old Paxton and his brother, 9-year-old Patrick Bowers, are believed to be the first kids in the 5 to 11 age group to receive the vaccine in Houston. They were given one-third of the dose given to teens and adults.
New Survey Shows Why Some Parents Are Against COVID Vaccine for Kids
Pfizer’s COVID-19 vaccine has been approved for children ages 5 to 11, but a new survey shows why some parents are against it.
The survey was put out by QuoteWizard by LendingTree, LLC, which showed nationwide, 60% of people surveyed say concerns over side effects will keep them from vaccinating their children.
Analysis: Country by Country, Scientists Eye Beginning of an End to the COVID Pandemic
As the devastating Delta variant surge eases in many regions of the world, scientists are charting when, and where, COVID-19 will transition to an endemic disease in 2022 and beyond, according to Reuters interviews with over a dozen leading disease experts.
They expect that the first countries to emerge from the pandemic will have had some combination of high rates of vaccination and natural immunity among people who were infected with the coronavirus, such as the United States, the UK, Portugal and India.
COVID Virus Does Not Infect Human Brain Cells, Study Suggests
The virus that causes COVID-19 does not infect human brain cells, according to a study published in the journal Cell. The findings will raise hopes that the damage caused by SARS-CoV-2 might be more superficial and reversible than previously feared.
The study contradicts earlier research that suggested the virus infects neurons in the membrane that lines the upper recesses of the nose.
This membrane, called the olfactory mucosa, is where the virus first lands when it is inhaled. Within it are olfactory sensory neurons (OSNs), which are responsible for initiating smell sensations. They are tightly entwined with a kind of support cell called sustentacular cells.
Some Parents Eager, Others Unsure as COVID Shot Approved for Kids
“We have a group of parents who are so excited that they want us to give them a call as soon as we have the vaccine so they can make appointments…and we have parents that are still questioning,” said Dr. Kimberly Montez, an assistant professor of pediatrics at Wake Forest School of Medicine in North Carolina.
Some parents have expressed concern about the lack of long-term data on the vaccine’s effects on children under 12. Others question its necessity given that severe COVID-19 is much less common for that age group, although many children have been hospitalized during the recent Delta variant wave.
Indian Home-Grown COVID Shot Wins WHO Emergency Use Approval
The World Health Organization (WHO) said on Wednesday that it has granted approval for Indian drugmaker Bharat Biotech’s home-grown COVID-19 vaccine for emergency use listing, paving the way for it to be accepted as a valid vaccine in many poor countries.
The decision had been delayed as the advisory group sought additional clarifications from Bharat Biotech before conducting a final risk-benefit assessment for the vaccine’s global use.
WHO’s Strategic Advisory Group of Experts on Immunization also recommended Covaxin’s use in two doses, with an interval of four weeks, in age groups 18 and above. These recommendations are in line with the company’s guidance.
True Spread of AY.4.2 Variant, Which Could Spread Faster, Unclear Due to Sequencing Issues
Current data on the spread of the AY.4.2 COVID-19 variant appears to be uncertain as scientists work to publish sequencing information.
AY.4.2, an offshoot of the Delta variant, has made headlines in recent weeks due to its rapid spread in the U.K. where it now accounts for around 12% of new sequenced samples.
It is identified by new main mutations in its spike protein: A222V and Y145H. While studies into AY.4.2 are still ongoing, some scientists have suggested it may be better at spreading than previous Delta versions.
Women Remain Most at Risk of Brain Vein Clots After J&J Vaccine + More
Women Remain Most at Risk of Brain Vein Clots After J&J Vaccine
Incidence of cerebral venous sinus thrombosis (CVST) remained a rare occurrence after the Johnson & Johnson COVID-19 adenovirus vector vaccine began being administered, researchers said.
Those at highest risk of CVST after receiving the Johnson & Johnson product in early 2021 were women ages 30 to 39 (26.52 per 100,000 person-years) and women ages 40 to 49 (29.48 per 100,000 person-years) — with women in general having a 5.1-fold higher risk after vaccination than they did before the COVID pandemic (13.01 vs 2.53 per 100,000 person-years, P<0.001).
CDC Panel Unanimously Recommends Pfizer COVID Vaccine for Kids Ages 5 to 11 in Critical Step Toward Clearance
A key Centers for Disease Control and Prevention advisory committee on Tuesday voted to recommend doses of Pfizer’s and BioNTech’s COVID-19 vaccine for children ages 5 to 11, one of the last steps before pediatricians can begin administering shots to as many as 28 million eligible kids in the U.S.
CDC Director Dr. Rochelle Walensky will now consider whether to accept the recommendation by the agency’s Advisory Committee on Immunization Practices. If she signs off, which is expected as early as late Tuesday, vaccinations for young kids could begin immediately.
White House Says 15 Million COVID Shots Will Roll Out to Children by Next Week
The United States is rolling out Pfizer/BioNTech COVID-19 vaccines for children aged 5 to 11 this week, but most of the 15 million shots being shipped initially are unlikely to be available before next week, the White House said on Monday.
Millions of doses specifically formulated for children of that age group will start arriving at distribution centers over the next few days, White House coronavirus response coordinator Jeff Zients said, and the federal government has purchased enough supply for all eligible 28 million children.
COVID: Medical Experts Step up After Dismissing Menstrual Changes
Thousands of women have reported temporary changes to their regular menstrual patterns, including delays, heavier vaginal bleeding or more physical pain. Irregularities have been reported with all vaccines and in various countries.
Following a chorus of calls, efforts are now underway to investigate potential links. Those reviewing the issue include the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), after it received reports by more than 30,000 women and two US-based medical researchers who have collected more than 140,000 reports so far.
Immunity From Both Vaccines, COVID Infection Last at Least Six Months: CDC
Immunity from COVID-19 lasts at least six months when one takes a vaccine or gets infected by the disease, according to a science brief released by the Centers for Disease Control and Prevention (CDC).
The brief looks at peer-reviewed and preprint data, as well as data that is unpublished by the CDC, to compare infection-induced immunity to vaccine-induced immunity.
The agency said that available evidence shows that those who are fully vaccinated and those who have previously had COVID-19 each have “a low risk of subsequent infection for at least six months.”
Elevated Risk of Clots in J&J Vaccine Recipients, Says Mayo Clinic Study
The Washington Times reported:
Recipients of the Johnson & Johnson COVID-19 vaccine were more likely to experience a rare blood clotting issue than persons in the general population before the pandemic, according to a study published Monday by JAMA Internal Medicine.
Mayo Clinic researchers gathered data on rates of the clotting disorder in Olmsted County, Minnesota, from 2001 to 2015 and compared it to rates of the issue among the population that received the one-shot J&J vaccine.
It found persons in the latter group were 3.5 more likely to develop cerebral venous sinus thrombosis (CVST) than the pre-pandemic group, after adjusting for factors such as sex and age to make a direct comparison.
Mild COVID Not Linked to Long-Term Cardiac Damage — Prospective Study Shows No Evidence of Myocarditis
Compared with seronegative healthcare workers, those who had generally mild SARS-CoV-2 had no differences in cardiac structure, function, MRI markers of myocarditis, or cardiac injury biomarkers 6 months later, James Moon, MD, of St. Bartholomew’s Hospital in London, and colleagues reported in JACC: Cardiovascular Imaging.
“Thus, screening in asymptomatic patients following nonhospitalized COVID-19 is currently not indicated,” the group concluded, pointing to it as yet more evidence counteracting an early but alarming finding that 78% of COVID survivors had lingering myocardial inflammation and other cardiac MRI abnormalities.
Monoclonal Antibody Cocktail Effectively Neutralizes Delta Variant: Study
In the first study to test the effectiveness of monoclonal antibody (mAb) cocktail against the dreaded Delta variant, Hyderabad-based AIG Hospitals along with the Asian Healthcare Foundation, CCMB Hyderabad and Institute of Life Sciences, has found that the therapy is able to neutralize the Delta variant and reduces severe disease and death in infected high-risk individuals by 100%.
Elaborating on the findings of the study, AIG Hospitals chairman Dr D Nageshwar Reddy said that 75% of the patients that received the mAb therapy became RT-PCR negative by Day 7 and 78% of patients got relieved of their clinical symptoms like fever, cough by the 7th day.
Also, none of the participants developed severe disease or died, there was no increase in inflammatory markers, which causes severe disease, in these patients and on follow-up none of the patients reported any post-Covid syndrome, Dr Reddy said.
It’s Harder to Justify COVID Vaccine for Children if Pandemic’s End Is Near + More
News Analysis: It’s Harder to Justify COVID Vaccine for Children if Pandemic’s End Is Near
The virus appears to be in retreat. New infections and deaths have both plunged more than 45% since a surge in September. And after multiple waves of infections, more than 1 in 4 U.S. residents have likely battled the coronavirus and gained some immunity as a result.
All that is good news, but it also means that widespread vaccination of the nation’s grade-school population offers less of an upside than it would have before.
That makes it harder to say there’s enough to be gained by the shot to offset the theoretical possibility of heart risks — a downside that’s not yet been measured.
Dr. Jeff Barke Warns Against Vaccinating Children Despite FDA’s Approval of Pfizer Vaccine
Dr. Jeff Barke, Board Certified Primary Care Physician, joined KUSI’s Jason Austell on Good Morning San Diego to discuss his analysis of vaccinating children with the COVID-19 vaccine.
While children have died from COVID-19, there is statistically zero risk of death in those who are less than 18 years of age, said Dr. Barke.
Many of those children also had existing comorbidities, Dr. Barke added.
Moderna Says FDA Needs More Time to Review Its COVID Vaccine for Teens
Moderna said the Food and Drug Administration will need more time to complete its assessment of the biotech company’s COVID-19 vaccine for children ages 12 to 17.
The agency is looking specifically at the risk of myocarditis in kids, Moderna said in a statement Sunday, and the review may not be completed before January 2022. Myocarditis is the inflammation of the heart muscle.
Moderna also said it will delay filing a request for emergency use authorization for a smaller dose of the vaccine for younger kids ages 6 to 11 while the FDA completes its review.
Millions of Kids’ Covid Vaccines Shipped Ahead of CDC Clearance
An estimated 15 million doses of kids’ vaccines will arrive at thousands of sites across the U.S. over the next week as the White House prepares for widespread inoculations if the Centers for Disease Control and Prevention signs off.
The Food and Drug Administration’s Friday authorization of the Pfizer Inc.–BioNTech SE vaccine for kids ages 5 to 11 was a “critical operational milestone” that allowed doses to start shipping, said Jeff Zients, who is President Joe Biden’s COVID-19 response coordinator.
A CDC advisory committee is meeting Tuesday and Wednesday to weigh whether to allow the shots. If it does, the CDC director has the final say on whether shots should be given to children.
Diet-Related Diseases Pose a Major Risk for COVID. But the U.S. Overlooks Them.
The same week British Prime Minister Boris Johnson was admitted to intensive care for COVID-19, two studies came out identifying obesity as a significant risk factor for serious illness and death. It was April 2020, and doctors were scrambling to understand why coronavirus gave some people mild symptoms and left others so sick they were gasping for air.
Other countries, too, have ramped up action as officials begin to recognize diet-related diseases such as obesity, hypertension and diabetes have made their citizens much more vulnerable during the pandemic.
In Washington, there has been no such wake-up call about the link between diet-related diseases and the pandemic. There is no national strategy.
America Has Lost the Plot on COVID
We know how this ends: The coronavirus becomes endemic, and we live with it forever. But what we don’t know — and what the U.S. seems to have no coherent plan for — is how we are supposed to get there.
We’ve avoided the hard questions whose answers will determine what life looks like in the next weeks, months, and years: How do we manage the transition to endemicity? When are restrictions lifted? And what long-term measures do we keep, if any, when we reach endemicity?
Nursing Home Residents Overlooked in Scramble for COVID Antibody Treatments
Of the dozens of patients Dr. Jim Yates has treated for COVID-19 at his long-term care center in rural Alabama, this one made him especially nervous.
The 60-year-old man, who had been fully vaccinated, was diagnosed with a breakthrough infection in late September.
At the first sign of the man’s symptoms, Yates had placed an order with the Alabama Department of Public Health for monoclonal antibodies, the lab-made proteins that mimic the body’s ability to fight the virus. But six days passed before the vials arrived, nearly missing the window in which the therapy works best to prevent hospitalization and death.
Toronto Students Told Not to Speak During Lunch to Reduce Spread of COVID
Parents of elementary school children in Toronto are expressing concern after their children were asked not to speak during lunch in an effort to curb transmission of COVID-19.
While the health and safety measure is meant to minimize aerosol transmission of the virus, some parents are concerned that the time, usually meant for socialization, is being replaced with screen time.
When reached for comment, the Toronto District School Board’s spokesperson, Ryan Bird, told CTV News Toronto that, “based on the advice of Toronto Public Health, we have required lunches to be brief and quiet.”
MaineHealth Network to Help Study Long-Term COVID Effects
Maine’s largest health network said Monday it will receive $1.5 million from the federal government to take part in a nationwide study about long-term effects of COVID-19.
The effort is called the Researching COVID to Enhance Recovery, or RECOVER, Initiative. It’s designed to learn why some people suffer prolonged symptoms or develop new or returning symptoms after the end of the acute phase of infection.
With COVID Rising Among Vaccinated, Health Experts Urge Booster Shots
New Hampshire Union Leader reported:
Nearly a third of those hospitalized with COVID-19 in New Hampshire in recent weeks were fully vaccinated, according to the state health department.
Lori Shibinette, commissioner of the Department of Health and Human Services, said last week that breakthrough cases among those vaccinated for COVID-19 are rising, as immunity from the vaccines wanes amid the spread of the aggressive Delta variant.
United Arab Emirates Approves Pfizer COVID Vaccine for Children Aged 5 to 11
The United Arab Emirates (UAE) has approved the Pfizer-BioNTech coronavirus vaccine for children aged between 5 and 11 on an emergency basis.
Until now, Sinopharm was the sole UAE-approved vaccine for young children aged 3 to 11.
A significant number of children aged between 12 and 17 have already received either Sinopharm or Pfizer, which were approved for teenagers earlier this year.
FDA Paves Way for Pfizer COVID Vaccinations in Young Kids + More
FDA Paves Way for Pfizer COVID Vaccinations in Young Kids
The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.
The FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.
One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youngsters should get vaccinated, with a final decision by the agency’s director expected shortly afterwards.
FDA Adviser Explains Why He Abstained From Vote on Pfizer’s COVID Vaccine for Young Children
All 17 others voted to advise the administration, or the FDA, to authorize the jab for children between the ages of 5 and 11. The agency already supported doing so and is expected to formalize the authorization soon. The Centers for Disease Control and Prevention would then decide which children should get the shot.
The vote was preceded by nearly eight hours of discussions and presentations, with multiple members expressing concern about the scant data on how the vaccine will affect the age group.
But Dr. Michael Kurilla, an expert on infectious diseases and pathology who directs a division inside the National Institutes of Health, was the only one who didn’t support the recommendation.
New Monoclonal Antibody Sharply Reduces Risk of Severe COVID Outcomes
The monoclonal antibody sotrovimab reduced the risk of hospitalization or death from COVID-19 by 85% compared with placebo, according to an interim analysis of a phase 3 clinical trial published yesterday in the New England Journal of Medicine.
In the double-blind, multicenter trial, non-hospitalized patients with symptomatic COVID-19 and at least one risk factor for disease progression were randomly assigned to receive either 500 milligrams of sotrovimab, a pan-sarbecovirus monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, or placebo.
Was NIH-Funded Work on MERS Virus in China Too Risky? Science Examines the Controversy
Questions related to the frustrating search for the origin of the COVID-19 pandemic keep creating commotion. Last week, the U.S. National Institutes of Health (NIH) placed one of its grantees, and itself, in the hot seat when it told Congress in a letter that the EcoHealth Alliance in New York City had failed to promptly report potentially worrisome results from a virology experiment done by a collaborator in China.
In a progress report for one of its grants, EcoHealth had mentioned an altered bat coronavirus made mice sicker than expected, a discovery it should have notified the agency of immediately, NIH asserted in a letter to Congress.
Latest Lancet Study Exposes Limits of Vaccines at Preventing COVID Infection
The Lancet has just released another study comparing the efficacy of COVID vaccines to the efficacy of protection provided by previous COVID infections. Their conclusion: while vaccines lower the risk of infections with the Delta variant within households, those who are fully vaccinated are still vulnerable to a ‘breakthrough‘ infection if somebody they live with gets infected.
What’s more, people who have been vaccinated against COVID can be equally as infectious as the unvaccinated, the study showed.
The new study, which was published Thursday in the Lancet, the British medical journal that published some of the earliest research on COVID, is one of few to use detailed infection data from actual examples of household transmission, and it showed that — as we noted above — the viral loads of both vaccinated and unvaccinated patients infected with COVID are “broadly similar.”
PRAC Assessing Further Data on Risk of Myocarditis and Pericarditis With mRNA Vaccines
European Medicines Agency reported:
EMA’s safety committee (PRAC) is assessing further data providing more information on the risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna).
Myocarditis and pericarditis are inflammatory conditions of the heart. Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain.
The committee has now asked the companies that market these vaccines to perform an in-depth review of all published data on the association of myocarditis and pericarditis, including clinical trial data, data from the literature and data available in the public domain.
G20 Set to Commit to Cutting Period to Develop Vaccines in Pandemic — Draft
Leaders of the world’s 20 largest economies are set to commit to supporting efforts to shorten to 100 days the period needed to develop new vaccines, drugs and tests in a pandemic, according to a draft joint document.
In normal circumstances developing vaccines takes more than a decade, but the COVID-19 pandemic spurred an unprecedented rush in research, trials and regulatory procedures that made it possible to have vaccines ready in less than a year.
Now G20 leaders want that period to be cut further.
COVID Cases Are Down 60% From Delta Peak. Still, Be Vigilant Heading Into Winter, CDC Director Says
Rates of COVID-19 cases, hospitalizations and deaths have sunk significantly in the U.S. since a wave driven by the highly contagious Delta variant peaked in September.
The U.S. has averaged 69,011 new cases a day over the last week — down about 60% from a peak in a Delta-driven wave (127,531) reached in mid-September, according to Johns Hopkins University data.
Breakthrough Infections Can Lead to Long COVID, New Research Suggests
Fully vaccinated people infected with the novel coronavirus can experience long-term symptoms, an experience otherwise known as “long COVID-19.”
Those who experience “breakthrough” infections — which happen when fully vaccinated people get COVID-19 — can experience persistent symptoms of COVID-19 long after infections, according to researchers at Oxford University.
The researchers in the U.K. reviewed data on nearly 20,000 U.S. COVID-19 patients for the study. Half of those patients were fully vaccinated. The study — which has not been peer-reviewed — has been published on medRxiv.
Exclusive: Tens of Millions of J&J COVID Shots Sit at Baltimore Factory — Sources
An estimated 30 million to 50 million doses of Johnson & Johnson‘s (JNJ.N) COVID-19 vaccine made early this year sits idle in Emergent BioSolutions Inc’s (EBS.N) plant in Baltimore awaiting a green light from U.S. regulators to ship, two sources familiar with the matter said.
Emergent, a contract drug manufacturer, is waiting for the U.S. Food and Drug Administration to approve release of those doses. The agency must still inspect and authorize the plant before Emergent can ship newly manufactured drug substances, one of the sources said.
G20 Want 70% Of World Vaccinated by Mid-2022, Sets up Pandemic Task Force
Finance and health ministers from the world’s 20 biggest economies (G20) said on Friday they would take steps to ensure 70% of the world’s population is vaccinated against COVID-19 by mid-2022 and created a task force to fight future pandemics.
They could not reach agreement on a separate financing facility proposed by the United States and Indonesia, but said the task force would explore options for mobilizing funds to boost pandemic preparedness, prevention and response.
The previous goal had eyed vaccinating 70% of the world’s population by the autumn of 2022.
A COVID Breathalyzer: Ohio State Researchers Develop New Test for Coronavirus
The Columbus Dispatch reported:
Wexner Medical Center researchers have created a breath test that appears to be highly accurate at rapidly screening patients for COVID-19.
The research team has applied to the U.S. Food and Drug Administration for emergency use authorization of the breathalyzer technology. Results from an initial study in patients were published Thursday in the medical journal PLOS ONE.
While the “gold standard” for diagnosing COVID is a PCR test that takes sometimes days to process in a lab, the breath test was able to detect the virus in patients within seconds, Dr. Matthew Exline, lead researcher and director of critical care at the medical center said in a press release.