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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.”
