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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.
