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AstraZeneca Ordered to Disclose Data Regarding Its COVID Vaccine
Following the authorization of the coronavirus vaccine developed by the British-Swedish company AstraZeneca, concerning reports emerged. The vaccine, known as “Vaxzevria,” was associated with severe side effects in extremely rare instances.
Some individuals vaccinated experienced thrombosis in the brain or abdominal organs, resulting in fatalities. Initially believed to predominantly affect young women, the vaccine was initially advised only for individuals over 60 in Germany and later not recommended at all.
Questions arose regarding what AstraZeneca knew about these occurrences and whether they could have been prevented. A woman from Upper Franconia, who suffered from thrombosis in the intestine and fell into a coma after receiving the AstraZeneca vaccine in March 2021, demanded not only compensation from the pharmaceutical company but also the disclosure of documents from the clinical trials.
A partial victory was achieved by the woman before the Bamberg Higher Regional Court. On Monday, a civil chamber ruled that the company must provide comprehensive information regarding all known effects and side effects of its coronavirus vaccine, specifically those relevant to the plaintiff’s clinical condition. This encompassed any additional findings gathered between the vaccine’s approval in December 2020 and February 2024.
The clinical condition of the plaintiff is referred to as “thrombosis with thrombocytopenia syndrome” (TTS). This severe thrombosis, occurring extremely rarely not only after vaccinations with AstraZeneca’s COVID vaccine but also with the similar vaccine from Johnson & Johnson, is accompanied by a decrease in blood platelets. It appears to stem from antibodies formed post-vaccination attacking the blood platelets. Both AstraZeneca and Johnson & Johnson’s COVID vaccines are based on modified cold viruses.
Surveys Spotlight Pregnant Women’s Drop in Confidence Over COVID Vaccines
A new study details dramatically lower confidence in COVID-19 vaccine safety in pregnant and recently pregnant women in 2023 compared to 2021, despite evidence to the contrary, according to findings published yesterday in JAMA Network Open.
Overall, 76.8% (95% confidence interval [CI], 71.5% to 82.2%) reported one or more COVID-19 vaccinations. All participants identified as female, and the average age was 31.7 years. A total of 356 (29.0%) identified as Black race, 555 (45.2%) identified as Hispanic ethnicity, and 445 (36.3%) preferred the Spanish language.
The weighted estimates of somewhat or strongly agreeing that COVID-19 vaccines are safe decreased from Wave 1 to 2 for respondents who reported having received at least one vaccine dose (76% in Wave 1 compared to 50% in Wave 2). Among non-Hispanic White respondents, the drop was from 72% to 43%; Spanish-speaking Hispanic respondents went from 76% to 53%.
“The general trends we observed among those who had received at least 1 COVID-19 vaccine and among racially, ethnically, and linguistically diverse groups are concerning,” the authors said. “These differences, despite accruing evidence of COVID-19 vaccine safety in this high-risk group, are concerning for clinicians and public health officials.”
Could a Vaccine Solve the Opioid Crisis?
Congressman David Schweikert introduced a bill that would provide a prize for the successful development of a vaccine “to prevent, treat, or mitigate opioid, cocaine, methamphetamine, or alcohol use disorder.”
The draft legislation, H.R. 7827, referred to the committee on March 26, would also require the health and human services secretary to give “priority review” for regulatory approval to any anti-drug vaccine candidate and reward the first successful applicant with public funds.
While vaccines are usually associated with providing increased immunity against pathogens, researchers are already studying whether they could use the same biological mechanisms to stop intoxicants from having an effect on the brain.
Experts say that anti-drug vaccines are not only possible but — depending on the substance they are aiming to counteract — are potentially quite promising. Scientists at several American universities are currently working to develop vaccines against fentanyl, while a team in Brazil is working on a jab to curtail the effects of cocaine.
Lady Gaga Ad Sparks Backlash
Lady Gaga’s new Instagram promo has caused controversy online, with fans dubbing the singer a “Big Pharma sellout.”
On April 9, the pop star — born Stefani Germanotta — shared her latest commercial with Nurtec ODT, a migraine drug produced by the pharmaceutical brand Pfizer, which created a COVID-19 vaccine with the German biotech BioNTech. In recent years, celebrities who have partnered with the company have been criticized online by vaccine skeptics and conspiracy theorists.
However, the partnership has caused outrage in the video’s comments section, with several Instagram users accusing the Grammy winner of selling out. One commenter wrote, “Remember when you said you didn’t want to be just a money-making machine?” “Less lady pharma more lady gaga,” a user wrote.
This is the second time Gaga has collaborated with Pfizer to promote Nurtec ODT. Her first commercial for the drug was released in June and sparked a similar backlash online.
Moderna Jumps as Vaccine Shows Benefit in Head and Neck Cancer in Early Study
Moderna (MRNA.O) shares rose 8% to a three-month high on Tuesday after the company’s individualized cancer vaccine developed with Merck (MRK.N) showed a positive response in an early-stage trial in patients with a type of head and neck cancer.
The vaccine, designed to train the immune system of patients to recognize and attack specific mutations in cancer cells, earlier showed promise in treating melanoma in a mid-stage study.
The vaccine, designed to train the immune system of patients to recognize and attack specific mutations in cancer cells, earlier showed promise in treating melanoma in a mid-stage study.
Moderna shares have risen nearly 14% so far this year, after a slump last year, as the company advances several vaccines such as its shots against respiratory syncytial virus and cancer therapy to help offset a sharp decline in COVID product sales.
Acetaminophen Use in Pregnancy Not Linked With Autism, ADHD — Large Swedish Cohort Study With Sibling Analysis Suggests Previous Ties Were Due to Confounders
Taking acetaminophen (Tylenol) during pregnancy was not associated with the development of autism or attention deficit-hyperactivity disorder (ADHD) in children, a large Swedish nationwide cohort study found.
Sibling control analyses of ever-use versus no use of acetaminophen revealed no associations (HR 0.98, 95% CI 0.93-1.04 for autism; HR 0.98, 95% CI 0.94-1.02 for ADHD; and HR 1.01, 95% CI 0.92-1.10 for intellectual disability), Brian Lee, PhD, of the Drexel University Dornsife School of Public Health in Philadelphia and colleagues reported in JAMA.
In recent years, there has been a slew of lawsuits claiming that taking acetaminophen in pregnancy causes autism or ADHD in children. However, in December, the judge handling the consolidated mass tort litigation barred expert witnesses from testifying since they did not adequately support these claims with evidence.
Still, some smaller studies had found ties between acetaminophen use in pregnancy and autism or ADHD, and in 2021, a consensus statement cautioning against using acetaminophen in pregnancy was published in Nature Reviews Endocrinology, though many physicians thought the statement sent the wrong message to patients.
New Drug Could Slash Blood Triglyceride Levels
U.S. News & World Report reported:
A new drug can slash triglyceride levels nearly in half by targeting a genetic driver of high fat levels in the bloodstream, researchers said.
The injectable drug, olezarsen, lowered triglyceride levels by 49% at the 50 milligram (mg) dose and by 53% at the 80 mg dose compared to a placebo, researchers reported on April 7 in the New England Journal of Medicine. The findings were presented simultaneously at the American College of Cardiology’s annual meeting in Atlanta.
Olezarsen inhibits the activity of APOC3, a gene that typically restrains the liver’s ability to filter triglycerides out of the bloodstream, the researchers said.
Researchers said larger and longer-term studies are needed to further assess olezarsen, particularly the drug’s ability to prevent heart attacks and strokes.
