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Covid News Watch
Heart Inflammation Risk in Children Elevated After Pfizer’s COVID Vaccine: Study + More
Risk of Heart Inflammation in Children Elevated After Receipt of Pfizer’s COVID Vaccine: Study
Children as young as 12 have an elevated risk of heart inflammation after receiving Pfizer’s COVID-19 vaccine, according to a new study.
Researchers with the U.S. Food and Drug Administration (FDA) and other institutions analyzed data from the FDA’s Biologics Effectiveness and Safety (BEST) Initiative and looked for safety signals after Pfizer vaccination for children aged 5 to 17 between 2021 and mid-2022.
They found that myocarditis, a form of heart inflammation, and pericarditis, a related condition, met the threshold for a safety signal for children aged 12 to 17 after dose 2 and dose 3. Pfizer did not respond to a request for comment. The study was published ahead of peer review on the medRxiv server.
Researchers sought to obtain medical records from the cases of myocarditis and/or pericarditis and obtained records for 37 of the 153 cases. Twenty-seven of those were confirmed as actual cases. Those children were hospitalized with a mean length of 2.8 days. Myocarditis/pericarditis set in within 7 days for most of the patients.
Pfizer CEO Reveals 2030 Growth Plan as Company Faces up to $18 Billion Revenue Hit From Generics
Pfizer CEO Albert Bourla laid out his plan Tuesday to keep the pharmaceutical giant growing through 2030, as the COVID-19 pandemic fades and the company faces generic competition for some of its blockbuster drugs.
Bourla said Pfizer is staring down an expected loss of between $16 billion and $18 billion in revenue from 2025 through 2030 as patent protections for some of its bestselling drugs expire. He acknowledged that some investors are skeptical of Pfizer’s future following two blockbuster years thanks to its COVID vaccine and antiviral treatment.
Bourla told analysts that Pfizer plans to add $25 billion to the company’s revenues by 2030 through recent acquisitions as well as the development of its in-house drug and vaccine pipeline. He highlighted three areas of focus — respiratory syncytial virus, migraines and ulcerative colitis.
Pfizer’s RSV vaccine candidates for older adults and infants have the potential to generate billions in revenue, Bourla said. Its vaccine for people ages 60 and older was 85% effective at preventing severe lower respiratory tract infections. And its vaccine for infants, which is administered to mothers late in their pregnancy, was 81% effective at preventing severe disease in the first 90 days of the baby’s life.
Swiss Drugs Regulator Looking Into Bubbles in COVID Booster Vials
Swiss drugs regulator Swissmedic said on Wednesday it is examining potential risks in connection with bubbles that appeared in vials of COVID-19 vaccine boosters retooled to target the Omicron variant of the coronavirus.
Swissmedic said it had been informed by vaccination centres of the appearance of bubbles during the preparation of the updated vaccine from Pfizer (PFE.N) and BioNTech (22UAy.DE) targeting the original version of the coronavirus and the BA.1 Omicron variant that led to a record surge in cases last winter.
“Vials of the batch concerned contained bubbles after being removed from the fridge,” said Swissmedic, adding that the phenomenon seems to be accentuated when the syringes were prepared several hours in advance.
Cantons and vaccination centers have been informed as a precaution, the regulator said. It added that it was looking into possible causes.
CDC Wants to Change ‘Antiquated’ Rules That Hamper Agency’s Ability to Fight COVID, Polio and Other Diseases
This summer, when the shocking news emerged that there was a case of polio in New York, the U.S. Centers for Disease Control and Prevention immediately turned to Shoshana Bernstein.
The agency urgently needed to increase polio vaccination rates in Rockland County, New York. And while Bernstein is neither a doctor nor a public health official, she is exactly what the CDC was looking for: a local vaccine educator who’s part of the Orthodox Jewish community, one of several groups that has a low vaccination rate.
Over the next few months, Bernstein spent hours and hours in meetings with CDC officials, including agency Director Dr. Rochelle Walensky, and then more time preparing presentations on education campaign ideas. She wasn’t paid a penny for her time.
It’s an old problem for the CDC: Despite having a multibillion-dollar budget, the agency doesn’t have authority from Congress to hire consultants in a timely way when an urgent situation arises. Walensky plans to appeal to Congress to allow for flexibility to do this kind of hiring in a crisis, similar to the authority vested in some other federal agencies.
AHA News: Heart Inflammation Risk Remains Rare After Third COVID Vaccine Dose
U.S. News & World Report reported:
A third dose of the Moderna or Pfizer COVID-19 vaccine poses no more risk of heart inflammation than a second dose, a large study suggests. The findings could help allay concerns about risk going up with each additional dose.
Cases were rare. Most appeared within seven days of vaccination and the patients recovered, found the study, which is being presented Saturday at the American Heart Association’s Scientific Sessions. The work is considered preliminary until full results are published in a peer-reviewed journal.
“It is an important question because, with additional doses of COVID-19 mRNA vaccines being recommended, it is essential to monitor its safety,” said Dr. Mingsum Lee, the study’s senior researcher and a cardiologist at Kaiser Permanente Los Angeles Medical Center.
Myocarditis has been considered a rare but serious potential side effect of COVID-19 vaccination, more often after a second dose than after the first, according to the Centers for Disease Control and Prevention.
High Blood Pressure Went up Even More Early in the Pandemic, Study Finds
People in the U.S. with high blood pressure saw their levels rise during the first eight months of the COVID-19 pandemic, a new study says.
Heart disease is the No. 1 killer in the world, and well-controlled blood pressure is the leading modifiable risk factor, according to the researchers in the new study, published Tuesday in the journal Hypertension.
The U.S. National Institutes of Health, which helped fund the study, said it is one of the most extensive looks at blood pressure trends from the beginning of the pandemic.
The COVID Boomerang. Study Finds Symptoms Recur More Often in Those Who Took Drug to Ease Illness.
The San Diego Union-Tribune reported:
You’ve been free of COVID-19 symptoms for two days. Then the coughing, fatigue and headaches return. Join the growing number of people experiencing what’s being called COVID rebound. And a new study by a team of UC San Diego researchers found that those who took the antiviral drug Paxlovid to alleviate their initial symptoms are more likely to see a recurrence.
A research letter that just appeared in the journal Infectious Diseases studied 158 San Diego County residents who received the drug early in their courses of illness. Of those, 108 saw their symptoms resolve for at least two consecutive days within a 28-day period after they became infected.
But that illness-free period was short-lived for 48 people, meaning that 44% reported those telltale signs of coronavirus infection resurfacing.
John Is Disabled, but He Can’t Access His Pension. Why? Long COVID Isn’t on the List
John is disabled. But his employer and pension scheme don’t know how to deal with him. Too sick to work, he has nevertheless been denied the ability to access his pension early — something that is offered for many other diseases and health conditions.
When COVID appeared I spent my time helping our members and employers keep working as safely as possible. Now, long COVID is the frontline of a new battle with unimaginative employers, risk-averse pension schemes and tick-box “People” departments.
Long COVID sufferers clearly have a serious and unpredictable disease that prevents them from working as they used to. But they are often denied exceptions and the ability to negotiate new conditions that would allow them to continue working.
Three Experimental Ebola Vaccines Head to Uganda
Three experimental Ebola vaccine candidates are being shipped to Uganda to aid in combatting the ongoing outbreak in the country, which has so far seen 129 confirmed cases and 37 deaths, according to the Ministry of Health of Uganda.
The species named “Sudan ebolavirus” does not have an approved vaccine available. The three experimental vaccine candidates being sent to Uganda are currently in development to protect against that species. As they help fight the current outbreak, their use in the country will also supply additional data for clinical trials.
Pfizer Predicts COVID Vaccines Will Remain ‘Multi-Billion-Dollar Revenue Generators’ + More
Pfizer Predicts COVID Vaccines Will Remain ‘Multi-Billion-Dollar Revenue Generators’
Pfizer has raised its forecast for annual sales of its COVID-19 vaccine by $2 billion to $34 billion on demand for Omicron-targeted boosters, helping allay some investor worries over growth for the vaccinations.
The U.S. drugmaker’s shares rose over 2.5% at one stage in the session as its third-quarter profit beat estimates, mainly due to better-than-expected sales of the vaccine. The upbeat earnings also sent shares of rival COVID-19 vaccine makers higher. Shares in Novavax and Moderna gained.
Sales of the COVID-19 vaccine have eased from pandemic highs on soft demand for the original shots, sparking concerns over demand over the next few years.
In response, Pfizer plans to roughly quadruple the price of the vaccine, which it sells with German partner BioNTech in the U.S. once the U.S. government stops buying doses and shifts to a private market.
CDC Director’s COVID Returns as Study Finds Such Rebounds Shockingly Common
Rochelle Walensky, director of the Centers for Disease Control and Prevention, has experienced a COVID-19 rebound — a return of mild symptoms and positive tests after completing a course of the antiviral drug Paxlovid and testing negative — the CDC announced today.
Walensky first tested positive on Oct. 21 and experienced mild symptoms. She completed a five-day course of Paxlovid, recovered and tested negative. But on Sunday, Oct. 30, her mild symptoms returned, and she once again tested positive, the agency reported.
Walensky now joins the ever-growing ranks of people reporting rebounds after Paxlovid, including high-profile rebounders such as President Biden and top infectious disease expert Anthony Fauci. But, according to a small study published in JAMA Network Open last week, rebounds may be surprisingly common in all COVID-19 cases — even those not treated with Paxlovid.
The study looked more closely at daily symptom data from 158 untreated people with COVID-19, who acted as a placebo group in a drug trial. They were followed for 28 days after their COVID-19 cases began. In that time frame, 108 of the 158 people — 68% — reported a recovery in which their symptoms fully resolved for at least two days. But, of those 108 people, 48 people — 44% — reported a return of symptoms before the end of the 28-day follow-up period.
‘Nothing but a Lie’: Beijing Responds to COVID Lab Leak Allegations, Blaming Them on ‘Anti-China Forces’
Just days after a Senate report was published outlining how the origins of COVID were more likely than not the result of a “research-related incident,” Beijing has gone on the defensive, blaming the lab-leak theory on “anti-China forces,” Bloomberg reported this weekend.
Foreign Ministry spokesman Zhao Lijian said on Monday that the idea that COVID leaked from a lab in Wuhan is “nothing but a lie.” According to Bloomberg, Zhao also said that China has maintained a consistent position on the origins of the virus, seemingly alluding to the idea that the virus originated in a Wuhan wet market.
Recall, just days ago, a Senate Committee on Health Education, Labor and Pensions interim report from Oct. 27, 2022, titled “An Analysis of the Origins of the COVID-19 Pandemic” revealed that the origins of COVID were more likely based in a lab as part of a “research-related incident” and not zoonotic.
This report came weeks after Dr. Richard Ebright of Rutgers University posted a damning chronology of circumstantial evidence that seemed to back up the lab-leak theory.
COVID Uses Our Proteins Against Us. A New Strategy Seeks to Block That.
With the United States headed into its third full winter of the pandemic amid fears that new variants will evade immunity from vaccines and prior infections, some scientists are seeking ways to blunt the coronavirus’s slippery evolution by blocking the human proteins it uses against us.
If the strategy works, it has the potential to address several shortcomings of current treatments and vaccines, including their inability to prevent infections and maintain effectiveness in the face of a changing virus. The approach could also protect people with immune systems too weak to tolerate vaccines.
The virus depends on our proteins to make copies of itself and perform other functions. Shutting off its access to a crucial protein would be like depriving a predator of food or oxygen. Moreover, since some human proteins are hijacked by multiple viruses, a single treatment could be used to fight a broad spectrum of illnesses.
In the past month alone, two studies have appeared supporting the promise of targeting human proteins in treating COVID-19 ― one published Tuesday in the journal Science Signaling, the other, which has yet to be peer-reviewed, posted on the science website bioRxiv.
No, It’s Not Just Like the Flu Vaccine
Dr. Vinay Prasad, a hematologist-oncologist and Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco, detailed 11 reasons why the COVID-19 boosters are not like annual flu vaccines.
Among them is the way each immunization is manufactured. Flu vaccines change yearly, based on expert predictions of what viral strains will be in circulation in North America. This is based on testing of the strains in circulation in Australia and other countries that have winter when it is summertime in North America.
The predictive nature of these vaccines is the reason why efficacy rates vary from year to year. When the vaccine is a good match (meaning it provokes immune responses to the strains that come to the United States), the efficacy rates can be quite high. Some years, however, the influenza vaccines try to offer protection against strains that do not circulate in the United States. In those years, flu vaccine efficacy is lower.
But, Prasad said, the situation with these COVID-19 boosters is quite different. The COVID-19 vaccines are not predictive. Rather, they are “built on strains that have already been to North America … It’s a fundamental difference,” he said. “So it’s not about what’s coming in the future, it’s about what’s been here in the past.”
In addition, the COVID-19 vaccine “is far more reactogenic,” Prasad said. Indeed, a quick look at both government data and peer-reviewed science shows that COVID-19 vaccines have much higher rates of adverse events than the flu vaccine.
Long COVID Is Affecting Women More Than Men, National Survey Finds
Long COVID is more common among women than men, according to federal data.
More than 17% of women have had long COVID at some point during the pandemic, compared with 11% of men, according to data from U.S. Census Bureau and National Center for Health Statistics published this month.
Long COVID was defined as experiencing symptoms for three months or more after infection. The most recent data was collected through an online survey of more than 41,000 adults during the two weeks ending Oct. 17.
Women were also more likely to suffer from more severe long COVID, the survey found. Some 2.4% of all women had symptoms that significantly limited their normal activities, compared with 1.3% of men, according to the data.
Could a Nose Spray a Day Keep COVID Away?
Anne Moscona, a molecular virologist, at Columbia University in New York City, and her colleagues have homed in on a compound that might foil SARS-CoV-2. Even better, it’s simply sprayed up the nose — no needle required.
The spritz developed by Moscona’s team is one of a raft of proposed nasal sprays to prevent SARS-CoV-2 infection. The sprays would be fast-acting and would be applied frequently, perhaps once or twice a day, to the site where the virus first takes hold — the nasal lining and throat.
Unlike vaccines, which train the recipient’s immune system to build long-lasting protection, the sprays are short-lived compounds that would directly block the virus’s ability to enter cells. Multiple research teams have shown that such sprays are effective at warding off SARS-CoV-2 infection in animals.
If effective in humans, these compounds would be a welcome addition to the limited arsenal that researchers have developed against the virus, says Donna Farber, an immunologist at Columbia University in New York City.
FDA Advisers Meet on Racial Disparities in Pulse Oximeters
The clip-on devices that use light to measure oxygen levels in the blood are getting a closer look from U.S. regulators after recent studies suggest they don’t work as well for patients of color. The clip-on devices that use light to measure oxygen levels in the blood are getting a closer look from U.S. regulators after recent studies suggest they don’t work as well for patients of color.
The devices, called pulse oximeters, usually snap onto a finger and are widely used in hospitals across the globe to help guide treatment. At-home versions became popular during the COVID-19 pandemic.
But several recent studies have raised concerns that the pigmentation in people’s skin can throw off the readings. In 2021, the Food and Drug Administration issued a warning about possible inaccuracies after a study found the devices tended to overestimate Black patients’ oxygen levels.
The FDA has convened a panel of experts to meet Tuesday to discuss “ongoing concerns” about the devices, recommendations for patients and doctors and ways to gauge accuracy.
Japan Approves Moderna’s COVID Vaccine for BA.5 Subvariant
Japan’s health ministry granted fast-track approval Tuesday for U.S. pharmaceutical company Moderna Inc.’s coronavirus vaccine tailored for the BA.5 subvariant now prevalent in the country.
It is the second bivalent vaccine approved in Japan for the Omicron subvariants BA.4 and BA.5, after the approval of Pfizer Inc.’s BA.5-tailored COVID-19 vaccine in October.
The health ministry plans to start delivering a total of around 3 million doses to municipalities in the final week of November.
In preparation for a projected eighth pandemic wave, the ministry plans to deliver a total of 102 million Omicron-tailored doses by the end of the year. Around 100 million people are eligible to receive them.
Pfizer’s RSV Vaccine, Given During Pregnancy, Protects Infants From Severe Illness
Pfizer announced Tuesday that its maternal RSV vaccine, given during pregnancy, protected infants from developing severe symptoms during the first six months after birth — a critical window of vulnerability.
The company plans to apply for approval of the vaccine before year’s end, with the hope that the shot could be the first vaccine to help protect infants against RSV — respiratory syncytial virus — as soon as next winter.
The data was announced in a news release and has not yet been published or peer-reviewed.
COVID Origins: Investigating a ‘Complex and Grave Situation’ Inside a Wuhan Lab + More
COVID Origins: Investigating a ‘Complex and Grave Situation’ Inside a Wuhan Lab
It was Toy Reid’s career as a China specialist for the Rand Corporation and as a political officer in East Asia for the U.S. State Department that taught him how to interpret a notoriously opaque language: the “party speak” practiced by Chinese Communist officials.
For 15 months, Reid loaned this unusual skill to a nine-person team dedicated to investigating the mystery of COVID-19’s origins. Commissioned by Senator Richard Burr (R-N.C.), the team examined voluminous evidence, most of it open source but some classified, and weighed the major credible theories for how the novel coronavirus first made the leap to humans.
An interim report, released last Thursday by the minority oversight staff of the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP), concludes that the COVID-19 pandemic was “more likely than not, the result of a research-related incident.”
As part of his investigation, Reid took an approach that was artful in its simplicity. Working out of the Hart Senate Office Building in Washington, DC, and a family home in Florida, he used a virtual private network, or VPN, to access dispatches archived on the website of the Wuhan Institute of Virology (WIV). These dispatches remain on the internet, but their meaning can’t be unlocked by just anyone. Using his hard-earned expertise, Reid believes he unearthed secrets that were hiding in plain sight.
COVID Vaccination a Cause of Guillain-Barré Syndrome? A Case Series
Guillain-Barré syndrome (GBS) is a rare autoimmune neuropathic disorder of peripheral nerves usually following an infection or on rarer occasions following vaccinations, but the exact underlying pathophysiology is still unclear.
GBS as an adverse effect of COVID-19 vaccination was not reported by the Vaccine Adverse Event Reporting System (VAERS), but an update was later released in the course of the pandemic from FDA news, reporting several patients developing GBS after receiving the COVID-19 vaccine. In this case series, we discuss five cases that developed the GBS post-COVID-19 AstraZeneca vaccine, along with its pathophysiology, management and outcome.
The five cases were reported to the Emergency Medicine Department (EMD) of Acharya Vinoba Bhave Rural Hospital (AVBRH), a tertiary care rural hospital situated in central India majorly catering to the population of the Vidarbha region of Maharashtra, India. All five patients received a non-replicating viral-vector Oxford/AstraZeneca ChAdOx1 nCoV-19 (AZD1222) COVID-19 vaccine.
By the Next RSV Season, the U.S. May Have Its First Vaccine
After decades of disappointment, four new RSV vaccines may be nearing review by the U.S. Food and Drug Administration, and more than a dozen others are in testing.
There’s also hope around a promising long-acting injection designed to be given right after birth to protect infants from the virus for as long as six months. In a recent clinical trial, the antibody shot was 75% effective at heading off RSV infections that required medical attention. And the relief could come soon: Dr. Ashish Jha, who leads the White House COVID-19 Response Task Force, told CNN that he’s “hopeful” there will be an RSV vaccine by next fall.
Babies have to be at least 6 months old to enter the trial, which is testing a vaccine developed at the National Institutes of Health — the result of decades of scientific research.
Forget About a Single Strain: The New COVID Calculus Is All About Viral Families
Gone are the simple early COVID pandemic days of 2020 — in terms of viral evolution, at least. The transfer of power used to be relatively straightforward from variant to variant, from the original strain to Alpha, to Delta, to Omicron — one washing over the world before another took over.
Now, it’s a battle royale between prominent viral “families” warring to keep power within the lineage. No single family — BA.5, XBB nor BQ — has achieved global success this fall. Not yet, at least.
As the virus behind COVID — namely the Omicron variety — mutates at an unprecedented rate, the focus of scientists has shifted from single strains to related groups of them.
Case in point: XBB, a combination of two different Omicron spawns that began surging in Singapore and Bangladesh in recent weeks. It has yet to arrive in the U.S., at least officially. But its grandchildren, XBB.1.1 and XBB.1.3 have, according to data from GISAID, an international research organization that tracks changes in COVID and the flu virus.
FDA Says Two Studies Showing Omicron Boosters Weren’t Much Better Than Old COVID Shots Were Too Small to Come to Any Conclusions
The Food and Drug Administration said two studies showing that the new Omicron boosters weren’t that much better than the old shots were too small to come to any real conclusions.
Scientists at Columbia and Harvard, in two independent studies, found the new boosters and the old shots basically performed the same against Omicron BA.5, raising doubts about whether the vaccines will live up to high expectations set by the Biden administration. The antibody responses were slightly higher with the Omicron boosters, though the studies concluded the difference wasn’t significant.
Dr. Peter Marks, head of the FDA’s vaccine division, said the studies are small and subject to limitations. Data from larger well-controlled studies are expected in the near future, he said. Pfizer and Moderna are conducting clinical trials on the new boosters and are expected to provide data later this year.
Why Does the U.S. Always Seem to Get Coronavirus Variants After Europe Does?
COVID cases have recently spiked in Europe, fueled by dropping temperatures, indoor socializing and an unwelcome brood of antibody-dodging Omicron subvariants. European health officials believe this may only be a taste of what’s to come this winter. Experts are warning these upticks overseas portend a wave in America, and not just because we’re more likely to get sick when we stay inside close to others.
The variants B.Q.1. and B.Q.1.1, which first showed up overseas, could specifically help drive the spread. “In the past, what’s happened in Europe often has been a harbinger for what’s about to happen in the United States,” Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, tells NPR. “So I think the bottom line message for us in this country is: We have to be prepared for what they are beginning to see in Europe.”
For much of the pandemic, events in Europe have indeed seemed to be a divination of what will happen next in the U.S. At the pandemic’s onset, the virus ripped through an unprepared Italy just a few weeks before it devasted New York City.
Why the Europe-to-U.S. trend persists is complex, say experts I spoke with, and they emphasized that there’s no definitive answer. “There are a lot of hypotheses out there that could explain it,” says Lauren Ancel Meyers, director of the COVID-19 Modeling Consortium at the University of Texas in Austin. One major factor is global travel patterns.
The End of Evusheld
In the United States, BA.5 — dominant since the end of spring — is slowly yielding to a slew of its siblings, among them BA.4.6, BF.7, BQ.1, and BQ.1.1; another subvariant, XBB, threatens to steal the spotlight from overseas. Whether all of these will divvy up infections in the next few months, or whether they’ll be pushed aside by something new, is still anyone’s guess.
Either way, the forecast looks a little grim. None of the new variants will completely circumvent the full set of immune defenses that human bodies, schooled by vaccines or past infections, can launch. Yet all of them seem pretty good at dodging a hefty subset of our existing antibodies.
For anyone who gets infected, such evasions could make the difference between being asymptomatic and feeling pretty terrible. And for the subset of people who become sick enough to need clinical care, the consequences could get even worse. Some of our best COVID treatments are made from single antibodies tailored to the virus, which may simply cease to work as SARS-CoV-2 switches up its form.
Past variants have already knocked out several such concoctions — among them, REGEN-COV, sotrovimab and bamlanivimab/etesevimab — from the U.S. arsenal. The only two left are bebtelovimab, a treatment for people who have already been infected, and Evusheld, a crucial supplement to vaccination for those who are moderately or severely immunocompromised; both are still deployed in hospitals countrywide.
But should another swarm of variants take over, these two lone antibody therapies could also be obsolete within months, if not weeks.
How to Solve the COVID Testing Data Problem
It’s not just fatigue that’s setting in, but something else — we’re no longer being advised to hold off on normal life for just a few more months, as many did until vaccines, until Delta subsided, until the first and second Omicron waves receded. At a recent symposium hosted by Harvard Medical School, biologists tracking the COVID pandemic forecast a long purgatory — the situation is much better than in 2020, but there’s no end in sight for the stream of new variants that keep evolving ways to evade immunity.
The only good news here is that technology is advancing, and people aren’t tired of adopting innovations. One of the best technologies for helping us assess local risk is sewage analysis. It’s emerged as the fastest and most reliable source of information about the surges and lulls in the pandemic, as well as which variants are taking over in which regions.
Popular sites for tracking the pandemic such as The New York Times COVID tracker have become less useful because they rely on PCR testing; most infected people, if they do test, are using antigen tests at home and not reporting the results.
EU Regulator Recommends Adding Heavy Periods to Side Effects of mRNA COVID Shots + More
EU Regulator Recommends Adding Heavy Periods to Side Effects of mRNA COVID Shots
A European Medicines Agency (EMA) committee on Friday recommended adding heavy menstrual bleeding to the list of side effects of mRNA COVID-19 vaccines made by Moderna (MRNA.O), as well as Pfizer (PFE.N) and its partner BioNTech (22UAy.DE).
Reports of heavy periods — bleeding characterized by increased volume and/or duration that interferes with the quality of life — have been observed during clinical trials, from cases in the real world and in medical literature, the EMA said.
The cases — which have mostly been non-serious and temporary in nature — have been reported after the first, second and booster doses of Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, it added.
The regulator has now concluded that there is at least a “reasonable possibility” that heavy menstrual bleeding is causally associated with these vaccines.
Senate GOP Report on COVID Origin Suggests Lab Leak Is ‘Most Likely’
A report from the staff of the top Republican on the Senate Health Committee strongly suggests the virus that causes COVID-19 was introduced to the world by a lab leak in China, though it offers little new evidence. The report from the office of Sen. Richard Burr (R-N.C.) concludes the emergence of the SARS-CoV-2 virus was “most likely the result of a research-related incident” in Wuhan, China.
The report cited gaps in previously published scientific research arguing in favor of a “natural” origin from infected animals, as well as safety concerns at the Wuhan lab.
“Critical corroborating evidence of a natural zoonotic spillover is missing. While the absence of evidence is not itself evidence, the lack of corroborating evidence of a zoonotic spillover or spillovers, three years into the pandemic, is highly problematic,” the GOP report stated.
Sen. Rand Paul (R-Ky.) and other Republicans on the committee say Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, is withholding important information.
White House Still Expects New COVID Boosters Will Offer Better Protection, but Two New Studies Cast Doubt
The White House’s top COVID-19 official says he still expects the protection against the Omicron BA.5 variant offered by the new COVID vaccine boosters will be better than their predecessors, despite two studies that appear to question that assumption. In an interview with CBS News, Dr. Ashish Jha also said he does not think another imminent change to the COVID boosters will be needed.
Jha’s comments come after researchers found, in two smaller groups of volunteers, data suggesting that the updated boosters provide only similar but not superior antibody boosts against BA.5, compared to the original vaccine formula.
Jha predicted that the “well-controlled trials” with “larger samples” now underway from vaccine makers could yield more favorable results about the boosters’ performance.
U.S. Government to Test Pfizer’s Paxlovid for Long COVID
The U.S. National Institutes of Health’s $1 billion RECOVER Initiative has picked Pfizer Inc.’s (PFE.N) antiviral drug Paxlovid as the first treatment it will study in patients with long COVID, organizers of the study said on Thursday.
The complex medical condition involves more than 200 symptoms ranging from exhaustion and cognitive impairment to pain, fever and heart palpitations that can last for months and even years following a COVID-19 infection.
According to details of the study, posted on Clinicaltrials.gov, the randomized, placebo-controlled trial will test Pfizer’s treatment or placebo in 1,700 volunteers aged 18 and older.
The trial will investigate a leading theory of the cause of long COVID, which holds that fragments of the virus persist in the tissues of some individuals, causing prolonged symptoms.
Why More and More Girls Are Hitting Puberty Early
During the coronavirus pandemic, pediatric endocrinologists saw a new surge of referrals for girls with early puberty. Recent retrospective studies from Germany and Turkey show that the number of these referrals doubled or even tripled during the lockdown periods of 2020 (this at a time when many families may have been avoiding non-emergency doctor’s visits for fear of COVID-19).
A paper published in August in the journal Frontiers in Pediatrics, which analyzed data from South Korea’s national statistics portal, found that the number of children diagnosed with precocious puberty almost doubled between 2016 and 2021, with a sharp post-2020 spike.
The rise in early puberty “is a phenomenon that is occurring all over the world,” Frank M. Biro, the former director of the adolescent-medicine division at Cincinnati Children’s Hospital Medical Center, told me. (Although there has also been a rise among boys, girls experiencing early puberty still vastly outnumber them.)
Early puberty is associated with a daunting list of adverse physical and psychological outcomes: various studies have suggested that early-maturing girls are at greater risk for developing obesity, breast cancer, eating disorders, depression and a range of behavioral issues. Especially in the midst of what is increasingly understood to be a post-COVID youth mental-health crisis, the startling new uptick in early puberty is troubling to some physicians and parents.
Canadian Cardiovascular Society Receives $1.6 Million to Study Myocarditis and/or Pericarditis After mRNA COVID Vaccination
Today, at the Canadian Cardiovascular Congress where more than 1,200 cardiovascular specialists and allied health professionals have gathered, Dr. Howard Njoo, Canada’s Deputy Chief Public Health Officer and Interim Vice-President of the Infectious Diseases Programs Branch announced funding to support a pan-Canadian study of the clinical and functional outcomes of adults and children who experienced myocarditis and/or pericarditis after receiving an mRNA COVID-19 vaccination.
The Canadian Cardiovascular Society (CCS) will receive $1.6 million from the Government of Canada to conduct the study. As a national organization representing more than 2,300 cardiologists, cardiac surgeons and other heart health specialists across the country, and with a broad network, the CCS is well positioned to lead this initiative.
The Checkup With Dr. Wen: What to Make of Emerging Coronavirus Variants
Since July, BA.5 has been the dominant coronavirus variant in the United States. That could soon change as several other variants are on the rise.
These variants are all spinoffs of Omicron. BA.4.6, a derivative of BA.4, constitutes more than 1 in 10 new infections in our country. Two derivatives of BA.5, BQ.1 and BQ.1.1., make up about 1 in 6 new infections. The BQ.1 lineage is doubling every week or so, and in New York and New Jersey, these variants are already nearly 30% of COVID cases.
Then there are BF.7 and BA.2.75, each in the single digits in the United States, and variants arising from abroad, such as the ominous-sounding XBB that led Singapore’s latest surge.
It’s not surprising that there are so many of them. Viruses mutate as they replicate, and there are new variants developing all the time. Most mutations don’t render the virus to be more evolutionarily fit, so those variants don’t take hold in the population.
People of Color Less Likely to Receive Paxlovid and Other COVID Treatments, According to CDC Study
People of color — especially Black and Hispanic people — were less likely to receive Paxlovid and other COVID-19 treatments, according to a study published Thursday by the U.S. Centers for Disease Control and Prevention.
The new study showed Black COVID-19 patients were 36% less likely than White patients to be treated with Paxlovid, and Hispanic patients were 30% less likely than non-Hispanic patients to receive the antiviral pill.
Nearly one in three White patients was prescribed Paxlovid, compared with about one in five Black and Hispanic patients and about one in four Asian and American Indian patients.
WHO: Tuberculosis Cases Rise for the First Time in Years
The number of people infected with tuberculosis, including the kind resistant to drugs, rose globally for the first time in years, according to a report Thursday by the World Health Organization.
Dr. Mel Spigelman, president of the non-profit TB Alliance, said more than a decade of progress was lost when COVID-19 emerged in 2020.
WHO also blamed COVID-19 for much of the rise in TB, saying the pandemic “continues to have a damaging impact on access to TB diagnosis and treatment.” It said progress made before 2019 has since “slowed, stalled or reversed.”