Login
Covid News Watch
Novavax COVID Vaccine Clears Key Step on Path to FDA Authorization + More
Novavax COVID Vaccine Clears Key Step on Path to FDA Authorization After Committee Endorses the Shot
Novavax’s two-dose dose COVID-19 vaccine for adults ages 18 and older cleared a key step on the path toward Food and Drug Administration authorization on Tuesday.
The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention to recommend authorization of the shot for use in the U.S. after an all-day public meeting in which they weighed safety and effectiveness data. The FDA usually follows the committee’s recommendations, though it is not obligated to do so. The agency could clear Novavax’s vaccine for distribution in the U.S. as soon as this week.
The Centers for Disease Control Prevention would still need to sign off on the shots before pharmacies and other health-care providers can start administering them to people.
Pennsylvania Governor Tests Positive for COVID-19 for Second Time
Pennsylvania Gov. Tom Wolf (D) tested positive for COVID-19 on Monday for a second time but is experiencing “mild” symptoms.
He tweeted Monday night that he is “grateful” that he recently received a second COVID-19 booster shot and will be isolating at his home in accordance with guidance from the Centers for Disease Control and Prevention.
The Food and Drug Administration authorized a second booster shot in late March for anyone aged 50 or older after at least four months have passed since their first booster.
Moderna Announces First Participants Dosed in Phase 3 Study of Seasonal Influenza Vaccine Candidate (mRNA-1010)
A biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participants have been dosed in a Phase 3 study of the Company’s seasonal influenza vaccine candidate (mRNA-1010). The trial is expected to enroll approximately 6,000 adults in Southern Hemisphere countries.
“We are pleased to begin this Phase 3 study of our seasonal influenza vaccine candidate, mRNA-1010, our fourth mRNA vaccine candidate to begin a pivotal Phase 3 study. mRNA-1010 is the first of several influenza vaccine candidates we are developing with the aim of iteratively improving traditional vaccines by inducing broad and robust immune responses. We believe our mRNA platform, with the flexibility and speed of our manufacturing process, is well-positioned to address the significant unmet need in seasonal flu,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“Influenza vaccines are a key pillar in our respiratory vaccine strategy that includes the development of combination candidates targeting multiple viruses in a single vaccine, including influenza with SARS-CoV-2 and respiratory syncytial virus. With the start of dosing for its mRNA-1010 program, Moderna now has four programs in late stage Phase 3 studies, including its SARS-CoV-2 booster, RSV, seasonal flu and CMV vaccine candidates. Beginning in the fall of 2022, the Company’s Phase 3 pipeline could lead to three respiratory commercial launches over the next two to three years.”
Omicron Sub-Variants BA.4 and BA.5 Account for up to 13% of COVID Variants in U.S. – CDC
The BA.4 and BA.5 sub-variants of Omicron are estimated to make up nearly 5% and 8% of the coronavirus variants in the United States as of June 4, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.
The two sublineages, which were added to the World Health Organization’s monitoring list in March and designated as variants of concern by the European Centre for Disease Prevention and Control (ECDC), were present in all U.S. regions.
Last month, South African scientists found that the sublineages of the Omicron coronavirus variant can dodge antibodies from earlier infection well enough to trigger a new wave.
Court Bans Expert From Alleging Cover-Up of COVID-19 Chinese Lab Origins
A scientist who accused a COVID-19 expert of hiding that the virus originated in a Chinese lab has been banned from spreading “fake news” after a legal challenge.
Hamburg-based nanoscience specialist Professor Dr. Roland Wiesendanger alleged in an interview with German magazine Cicero, published in February of this year, that Professor Dr. Christian Drosten from Berlin’s Charite Clinic was consciously refusing to tell people the truth about the origin of the COVID-19 virus.
Wiesendanger further alleged there was evidence that a botched experiment at a Chinese lab was at the core of the pandemic.
Study: Ineffective Blood Oxygen Readers Have Endangered Black and Latino COVID-19 Patients
Black and Latino patients experienced significant delays in obtaining life-saving COVID-19 treatments due to a popular medical device that inaccurately reads darker skin tones, according to a study released last week in JAMA Internal Medicine.
The report shows that pulse oximeters, a device that clips onto a person’s fingertips and reads oxygen levels, is more likely to produce inaccurate results in Black, Latino and Asian Americans than in white patients. The device can make patients of color appear healthier than they actually are, researchers said.
“Not only less accurate, but in particular, more optimistic,” Tianshi David Wu, a co-lead author of the study and assistant professor of pulmonary medicine at Baylor College of Medicine in Texas, told NBC News. “In this study we found that minority patients appeared healthier than they really were based on this bias in pulse oximetry.”
Suicide-Related Ambulance Calls Rose By More Than 50% During COVID, Australian Study Finds
Suicide-related ambulance presentations in Australia increased by more than 50% in the first year of the COVID-19 pandemic, new research suggests.
Analysis of ambulance data between March 2020 and March 2021 found a significant and sustained increase in attendances for suicide attempts, suicidal ideation and self-harm compared to before the pandemic.
The study, published as a preprint that has not yet been peer-reviewed, drew on data from the National Ambulance Surveillance System. Its findings contrast with previous data showing that the rate of death by suicide decreased in Australia in 2020 compared to the previous year.
U.S. Wasted Over 82 Million COVID Vaccine Doses + More
The U.S. Has Wasted Over 82 Million COVID Vaccine Doses
Pharmacies, states, U.S. territories and federal agencies discarded 82.1 million COVID vaccine doses from December 2020 through mid-May — just over 11% of the doses the federal government distributed, according to data the Centers for Disease Control and Prevention shared with NBC News. That’s an increase from the 65 million doses the CDC told the Associated Press had been wasted as of late February.
Two retail pharmacy chains, CVS and Walmart, were responsible for over a quarter of the doses thrown away in the United States in that time period, in part due to the sheer volume of vaccine they handled.
Studies Link Incurable Prion Disease With COVID Vaccine
Studies on COVID-19 vaccines have suggested links between Creutzfeldt-Jakob disease (CJD) — an incurable and fatal prion disease — and getting the COVID-19 vaccine.
A recent French pre-print on CJD and COVID-19 vaccination has suggested that the COVID-19 vaccine may have contributed to the emergence of a new type of sporadic CJD disease that is a lot more aggressive and rapid in disease progression as compared to the traditional CJD.
CJD is a rare disease caused by an abnormal protein in the brain called a prion.
Prions naturally occur in the brain and are usually harmless, but when they become diseased or misfolded, they will affect nearby prions to also become misshapen, leading to deterioration of brain tissue and death.
The disease is incurable as once one prion becomes infected, it will continue to propagate to other prions with no treatment capable of stopping its progress.
Contract Manufacturer Emergent Says J&J Breached Vaccine Contract
Contract manufacturer Emergent BioSolutions Inc (EBS.N) said on Monday U.S. drugmaker Johnson & Johnson (JNJ.N) had breached an agreement by failing to buy the minimum quantity of COVID-19 vaccines made by the company.
Emergent said J&J had failed to provide required forecasts for the amount of vaccines it needed and had wound down the agreement instead of fulfilling minimum requirements. If the agreement is terminated, Emergent said J&J would owe it roughly $125 million to $420 million.
The use of J&J’s COVID-19 vaccine has been stalled in the United States as the Food and Drug Administration in May had significantly restricted its use due to safety concerns.
People With Diabetes 4 Times More Prone to Long COVID
U.S. News & World Report reported:
Diabetes increases the odds that a COVID-19 infection will be severe, and folks with diabetes may be up to four times more likely to develop long-lasting symptoms, new research suggests.
“Though more data is needed, some early studies suggest that diabetes may be a risk factor for long COVID, and thus careful monitoring of people with diabetes for development of long COVID may be advised,” said study author Jessica Harding, an assistant professor of epidemiology at Emory University School of Medicine in Atlanta.
Long COVID symptoms run the gamut from fatigue, shortness of breath and cough to brain fog, dizziness and changes in taste or smell. These symptoms may come and go or persist and can last for months after the initial COVID infection, according to the U.S. Centers for Disease Control and Prevention.
Exactly how diabetes can add to the risk for long COVID is not fully understood, but many theories exist.
COVID Cases Are Rising in Many States. What Experts Say Makes This Summer Different.
Shortly before the start of the third summer of the pandemic, the USA is undergoing a sixth wave of COVID-19 cases. Compared with previous surges, this one looks more like a swell, health experts said.
The rise in cases reported in the Northeast in recent weeks appears to have peaked, but upward trends continue in at least 21 states, according to a USA TODAY analysis of Johns Hopkins University data. Health experts said cases are likely higher because of underreported home tests.
Although cases are rising, health experts said hospitalizations remain in check. There are about 350 deaths reported per day based on a seven-day average, which is more than a hundred deaths less than this time last year, according to Johns Hopkins University data.
Many Children Aren’t Getting the Vision Screening They Need
Eye exams for children are required under federal law to be covered by most private health plans and Medicaid. Vision screenings are mandated for school-age children in 40 states and the District, and 26 states require them for preschoolers, according to the National Center for Children’s Vision and Eye Health at Prevent Blindness, a nonprofit advocacy organization.
Still, many children who are struggling to see clearly are being overlooked. The pandemic has only exacerbated the issue since in many places classes moved online, and for many students in-school vision screenings are the only time they get their eyes checked.
Even when campuses reopened, school nurses were so swamped with coronavirus testing that general screenings had to be put to the side, said Kate King, president-elect of the National Association of School Nurses.
“The only kids who were getting their vision checked were the ones who were complaining about not being able to see,” King said.
The Missing Part of America’s Pandemic Response
Many parts of the U.S. government, including its leading scientific agencies, are being blamed for the country’s chaotic and disorganized response to COVID-19. The CDC’s muddled and mistaken messaging about masks, testing and the mechanism of viral spread sowed public confusion. The FDA’s extreme caution about approving boosters may have slowed the deployment of those vital measures.
But a nation’s ability to weather a pandemic also depends upon its underlying ability to make major scientific discoveries, even — or especially — during moments of crisis. Success is not just a matter of luck; historically, the United States has made a series of strategic decisions that put researchers in a position to make timely breakthroughs.
Yet amid the biggest health crisis in 100 years, the National Institutes of Health (NIH), the $42-billion-a-year engine of our nation’s biomedical-research infrastructure, has been strangely quiet.
Severe COVID Cases ‘More Likely in Highly Polluted Areas’
People who contract COVID-19 are more likely to suffer severe symptoms if they have been exposed to air pollution for long periods.
A study found that people who live in places where there are high levels of the atmospheric pollutant nitrogen dioxide had higher chances of ending up in intensive care units (ICUs) or of needing mechanical ventilation after they had caught COVID.
Nitrogen dioxide is released into the atmosphere when fossil fuels are burned, and the gas is known to have harmful effects on people’s lungs. In particular, endothelial cells — which form a thin membrane lining the inside of the heart and blood vessels — become damaged, and this inhibits the transfer of oxygen from inhaled breath to a person’s blood.
Push for Normalcy Wins out in COVID Wars
As Americans start a third summer living amid the specter of the coronavirus, their attitude on the pandemic has shifted. Even as infections rise to levels that are four to five times higher than the same point last year, the push for normalcy is winning out.
Now, almost all masks or vaccine requirements have been deliberately abandoned or overturned in court. The U.S. is averaging about 100,000 new cases every day, but movie studios are releasing summer blockbusters to packed theaters, families are celebrating weddings, and bars and restaurants are full.
Living with the threat of a COVID-19 infection has become the new normal for Americans who are ready to move on.
India Approves Biological E. COVID Shot as a Booster
India has approved Hyderabad-based drugmaker Biological E’s COVID-19 vaccine as the first mix-and-match booster dose in the country, the company said on Saturday.
The Drugs Controller General of India (DCGI) gave the nod for the Corbevax vaccine to be administerd as a booster shot to people age 18 years and over who have already received two doses of either AstraZeneca Plc’s (AZN.L) Covishield or Bharat Biotech’s Covaxin.
U.S. FDA Flags Risk of Heart Inflammation After Novavax COVID Vaccine + More
U.S. FDA Flags Risk of Heart Inflammation After Novavax COVID Vaccine
U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc’s (NVAX.O) vaccine, even as the company’s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.
“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines,” the FDA staff wrote in briefing documents released on Friday.
The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an “important identified risk” in its materials. The company had not yet agreed to do so.
Doctors Accuse FDA of Unlawfully Blocking Their Ability to Treat COVID Patients With Ivermectin
A group of doctors has filed a lawsuit against the Biden administration claiming it unlawfully attempted to block the use of ivermectin in treating COVID-19.
It names the Department of Health and Human Services, HHS Secretary Xavier Becerra, the Food and Drug Administration (FDA), and FDA Commissioner Robert M. Califf as defendants.
In the filing, plaintiffs Mary Talley Bowden, Paul E. Marik, and Robert L. Apter argued that by publicly ordering health professionals and patients to avoid ivermectin, the FDA both acted outside of its authority and inhibited the doctors’ ability to practice medicine.
The filing emphasizes that the case is not about the efficacy of ivermectin in treating COVID-19: rather, it said, “it’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.”
A Growing Number of Young People Are Attempting Suicide by Self-Poisoning
A new study published in the journal Clinical Toxicology has looked more closely at a particular method of attempted suicide — self-poisoning — and turned up some disturbing results: From 2015 to 2020, suicide attempts by ingesting toxic substances or overdosing on medications soared by 26% among people ages 6 to 19.
The research, led by Dr. Jennifer Ross, a medical toxicologist at the University of Virginia School of Medicine, relied on figures from the National Poison Data System, which aggregates information from the country’s 55 state and territorial poison control centers.
From 2015-2020, there were 514,350 calls to poison control centers involving children ages 6-19 who, according to the control centers’ guidelines for suspected suicide attempts, had “an exposure resulting from the inappropriate use of a substance for self-harm or self-destructive” reasons.
Not every segment of the 6 to 19 age group was hit equally hard. The greatest increase in self-poisonings occurred among 10 to 12 year olds, with numbers leaping 109% in the five-year study period.
White House: 1st Shots for Kids Under 5 Possible by June 21
The Biden administration said Thursday that children under 5 may be able to get their first COVID-19 vaccination doses as soon as June 21, if federal regulators authorize shots for the age group, as expected.
White House COVID-19 coordinator Ashish Jha outlined the administration’s planning for the last remaining ineligible age group to get shots. He said the Food and Drug Administration’s outside panel of advisers will meet on June 14-15 to evaluate the Pfizer and Moderna shots for younger kids. Shipments to doctors’ offices and pediatric care facilities would begin soon after FDA authorization, with the first shots possible the following week.
Jha said states can begin placing orders for pediatric vaccines on Friday, and said the administration has an initial supply of 10 million doses available. He said it may take a few days for the vaccines to arrive across the country and vaccine appointments to be widespread.
Gun Suicide Soars as Cause of Death Among Youth: Report
The rate of young people taking their own lives with firearms in the U.S. has increased faster than for any other age group, and the youth suicide rate is at its highest point in more than 20 years, according to a new gun violence prevention report by Everytown For Gun Safety and first obtained by ABC News.
While firearm suicide overall increased about 2% during the pandemic, the rate among young people increased 15% and nearly half of all suicide attempts by young people involve a gun, researchers with Everytown For Gun Safety found.
Experts have not pinned down exactly what is causing more young people to turn to suicide with guns, the report notes. But increased anxiety and depression, likely exacerbated by the pandemic, along with the impacts of social media and cyberbullying are among the theorized drivers.
Pfizer and Moderna Rapidly Falling out of Favor as Americans’ Favorite Brands: Report
What a difference a year makes: Pfizer and Moderna were riding high in Americans’ minds last year, but a new report from The Harris Poll shows how both have fallen from grace.
In 2021, Moderna ranked third and Pfizer came in at No. 7 in the annual Axios survey, undertaken by The Harris Poll, that focuses on Americans’ favorite brands in what it calls the 100 “most visible companies.”
But in 2022, the two are on a downward spiral. Pfizer has dropped 37 places to 44th on the list, while Moderna has fallen out of the top 100 completely. In 2020, Moderna didn’t place at all, while Pfizer was 61st.
Why Boosted Americans Seem to Be Getting More COVID Infections
As COVID-19 cases began to accelerate again this spring, federal data suggests the rate of breakthrough COVID infections in April was worse in boosted Americans compared to unboosted Americans — though rates of deaths and hospitalizations remained the lowest among the boosted.
It serves to illustrate a tricky reality facing health authorities amid the latest COVID-19 wave: even many boosted Americans are vulnerable to catching and spreading the virus, at a time when officials are wary of reimposing pandemic measures like mask requirements.
Melatonin Poisoning Reports Are up in Kids, Study Says
Researchers are drawing attention to a rise in poisonings in children involving the sleep aid melatonin — including a big jump during the pandemic.
Last year, U.S. poison control centers received more than 52,000 calls about children consuming worrisome amounts of the dietary supplement — a six-fold increase from about a decade earlier. Most such calls are about young children who accidentally got into bottles of melatonin, some of which come in the form of gummies for kids.
Reported melatonin poisonings have been increasing for at least a decade, but the largest increases happened after the COVID-19 pandemic hit the United States in 2020. Between 2019 and 2020, the count shot up 38%.
CDC Has Recommended Booster Shots for Those 50 and Over. But Only 17.5% of Those Eligible in Mass. Have Gone Ahead and Done It.
The Boston Globe via MSN reported:
The U.S. Centers for Disease Control and Prevention has recommended that people 50 and older get a second COVID-19 booster shot, but so far Massachusetts residents have not jumped at the opportunity.
Only about 471,000 people 50 and older in Massachusetts have gotten a second booster shot, or about 17.5 percent of the 2.7 million people in that age group, according to data from the state’s Department of Public Health.
The data come from the state’s weekly vaccination report, which is updated every Thursday.
Pfizer’s Paxlovid Reduces COVID Risk in Seniors Regardless of Vaccine Status — Study
Pfizer Inc.’s (PFE.N) antiviral treatment Paxlovid reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, according to a new study in Israel conducted during the rise of the Omicron variant of the coronavirus.
The treatment, however, was not found to prevent severe illness among younger adults, according to research from Clalit Health Services, Israel’s largest healthcare provider.
Senior citizens who had no prior immunity — meaning they were neither vaccinated nor recovered from a previous COVID case — saw an 86% drop in hospitalizations with Paxlovid. Those who had prior immunity also benefited, but at a lower rate of 60%.
COVID Deaths in Africa May Fall 94% in 2022, WHO Model Shows
The number of deaths from the coronavirus in Africa may fall 94% to 22,563 this year if current variants and transmission rates remain the same, according to a World Health Organization model.
The fall in deaths, from an estimated 350,000 in 2021, comes even though as many as 73% of people will be infected. This reflects the less lethal nature of the Omicron variant in relation to the delta strain and the protection people have from prior infections and vaccination, the WHO said in a statement on Thursday. The modeling exercise used data from the 47 nations included under WHO’s Africa region.
Africa has the lowest vaccine coverage against the virus of any continent, with just 17.1% of the population having had a full course of inoculations, according to the Africa Centres for Disease Control and Prevention.
Pfizer Again Asks FDA to Authorize COVID Shots for Kids Under 5 + More
Pfizer Again Asks FDA to Authorize COVID Shots for Kids Under 5
Pfizer-BioNTech said Wednesday that it asked the Food and Drug Administration (FDA) to authorize its COVID-19 vaccine for children ages 6 months to 4 years — the only group that remains ineligible for vaccination.
The request will be now considered by the FDA, which will review the data and could grant emergency use authorization for the age group later this month.
The FDA’s advisory group, called the Vaccines and Related Biological Products Advisory Committee, is scheduled to convene on June 15 to offer guidance on the pediatric doses.
More Than Two-thirds of People Have COVID Antibodies, WHO Says
More than two-thirds of the world’s population probably have significant levels of COVID-19 antibodies, meaning they have either been infected or were vaccinated, the World Health Organization (WHO) said.
So-called seroprevalence rates surged to 67% in October from 16% in February 2021, the WHO said, in a summary of studies from around the globe. Given the emergence of the fast-spreading omicron variant, the figure is probably even higher now.
The WHO’s roundup offers a snapshot of how well the world is increasing resistance to the pandemic. While vaccines provide only modest protection against infection from omicron, the WHO still urged countries to boost vaccination rates, especially for people in high-risk groups, because immunization gives higher levels of protection against severe disease than a previous COVID infection.
Local Governments Turn Away $73 Million in Federal Pandemic Aid
From small towns to big cities, every government across the U.S. was offered a slice of $350 billion in federal coronavirus relief funds to help shore up their finances, cover pandemic-related costs and invest in community projects.
Officials in 1,468 local governments effectively said “no,” turning away a potential total of $73 million, according to an Associated Press analysis of data compiled from every state. The declined money ranged from $177 for the one-person village of Monowi, Nebraska, to $3.9 million for DeWitt County, Texas, population about 20,000.
The city of West Alton, Missouri — a community of more than 500 at the confluence of the Mississippi and Missouri rivers — turned down a potential $106,341 in federal aid. Though the rejected amount was almost half the size of the city’s budget, there wasn’t much discussion about accepting it during a city council meeting.
Older Americans Bore Brunt of COVID Deaths During the Omicron Wave
From the onset of the COVID-19 pandemic, the elderly have borne the brunt of the virus’ deadly wrath.
Now, newly updated federal data shows that despite widespread vaccination among seniors, virus death rates among older Americans surged to near-record levels during the first omicron wave.
Over 90% of seniors have been fully vaccinated, but about 30% of those fully vaccinated have yet to receive their first booster shot. To date, just under 10 million Americans 65 and older have received their second booster — representing about 28.5% of those who had already received their first shot.
COVID Infection Risk Lower for Those With Food Allergies, Study ‘Unexpectedly’ Finds
A new study “unexpectedly” found the risk of becoming infected with COVID-19 is lower for those with food allergies.
The research sought to determine whether asthma and allergic diseases — including food allergies, allergic rhinitis and eczema — were linked to COVID-19 infection, according to the Human Epidemiology and Response to SARS-CoV-2 (HEROS) study. These conditions were self-reported by participants and diagnosed by doctors.
In fact, people with food allergies are 50% less likely to develop COVID-19, according to the research, which was funded by the National Institutes of Health and published May 31 in the Journal of Allergy and Clinical Immunology.
Dogs May Be Better at Detecting COVID-19 Than Nasal PCR Tests, Study Finds
Trained dogs may be able to detect COVID-19 more effectively than nasal swab PCR tests, according to new research.
A study published on Wednesday by the peer-reviewed Plos One journal found that canines were able to better detect the presence of COVID than PCR antigenic tests in both symptomatic and asymptomatic people.
In the study, trained dogs were able to detect COVID in 97% of symptomatic cases and nearly 100% of asymptomatic cases.
Peter Hotez Says His Recent COVID Case Shows Just How Transmissible Subvariant BA 2.12 Is
The Houston Chronicle reported:
Three weeks ago, Dr. Peter Hotez announced he’d tested positive for COVID-19.
Hotez — dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Center for Vaccine Development at Texas Children’s Hospital — has been among the more public faces providing information over the past two-plus years.
Hotez admitted that having been vaccinated and boosted, he started venturing back to public events, and his number finally came up.