Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
Coroner Probes Moderna Vaccine Link to Young Melbourne Woman’s Death
Moderna has engaged its own medical expert as it faces an inquest in Victoria, which is investigating whether a 21-year-old woman died because of its COVID-19 vaccine. The pharmaceutical company’s lawyers appeared before the Coroners Court in Melbourne today for a hearing into the death of Natalie Boyce.
Boyce received her third COVID-19 jab on February 18, 2022, which was the Moderna mRNA vaccine, counsel assisting Jessika Syrjanen told the court. About a week later, she went to see a GP after vomiting for five days, suffering aching pain and at one point fainting. In the following weeks, Boyce went to the hospital and a medical center as her symptoms of vomiting, pain and fainting persisted.
On March 5, she went to Mulgrave Private Hospital, after suffering chest pain and shortness of breath, and was transferred to The Alfred where she was diagnosed with fulminant myocarditis.
The 21-year-old’s condition deteriorated after she underwent surgery to remove a clot, and then during an MRI she suffered a heart attack.
She could not be revived and Boyce was declared dead on March 27. A forensic pathologist performed a post-mortem on Boyce, finding she died from acute myocarditis infarction.
New ‘One-and-Done’ Vaccine Method Could Protect Infants — From COVID, Flu — With Just a Single Shot, Study Suggests
Researchers are pitching a new vaccine method for infants that offers continued protection with just a single dose, even if the virus mutates, according to a new study that could set the stage for “universal vaccines.”
This new vaccine strategy — tested on mice — also uses a modified version of a virus, but instead of relying on the body’s usual immune system response, it uses small interfering RNA molecules (siRNA), which stop the spread of disease, to create separate vaccines that target different diseases, according to a study published Monday in the Proceedings of the National Academy of Sciences.
Diseases thrive because they produce a protein that can block the production of siRNAs, but the new vaccine strategy creates and uses a mutant virus that can’t produce these proteins, which allows the body’s siRNAs to weaken the virus, regardless of whether it mutates and makes a new variant.
The research team from the University of California, Riverside, believes because this strategy doesn’t rely on the body’s immune response to disease, it will also be suitable for babies, whose immune systems are still developing.
The researchers intend to create this vaccine as a nasal spray rather than a shot. “Respiratory infections move through the nose, so a spray might be an easier delivery system,” Hai said. There’s already an approved nasal spray flu vaccine that’s shown to be as effective in children as flu shots, according to the CDC. Several research teams are working on nasal COVID-19 vaccines, and both China and India have approved the use of nasal sprays in the form of boosters.
Only One Harm From mRNA COVID Vaccines, Report Determines — Independent Reviewers Reject Causal Links to Infertility, Myocardial Infarction, Stroke
Independent reviewers confirmed a causal relationship between the first mRNA COVID-19 vaccines and myocarditis and also determined that, more broadly, intramuscular shots can cause a series of shoulder injuries.
At the same time, the National Academies of Sciences, Engineering, and Medicine (NASEM) committee rejected a causal relationship between the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 (Comirnaty and Spikevax, respectively) mRNA COVID vaccines and female infertility, Guillain-Barré syndrome, Bell’s palsy, thrombosis with thrombocytopenia syndrome (TTS), and myocardial infarction.
The evidence was also deemed enough to reject a causal link between the Pfizer vaccine and ischemic stroke. There was insufficient data to say the same for the Moderna one, however, according to a report commissioned by the Health Resources and Services Administration (HRSA), a subagency of the HHS.
In 2022, Pfizer and Moderna had their first-generation mRNA COVID vaccines replaced by bivalent versions blending protection against the ancestral COVID strain and the Omicron BA.4/5 subvariants circulating at the time. They were not as widely adopted as the original vaccines and were initially suspected of a potential stroke risk until suspicion turned to high-dose or adjuvanted flu shots instead.
For its present report, NASEM also reviewed the evidence for two other COVID-19 vaccines, the Johnson & Johnson (J&J) adenovirus vector vaccine (Ad26.COV2.S) and the Novavax protein-based vaccine (NVX-CoV2373). The verdict: the J&J vaccine may cause TTS and Guillain-Barré syndrome (this vaccine was withdrawn from the market in 2023) while evidence for the Novavax shot was insufficient to accept or reject a causal relationship with any of the 19 side effects of interest.
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday.
The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.
The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients’ injuries and deaths, as described in a KFF Health News investigation late last year.
Weedkiller Manufacturer Seeks Lawmakers’ Help to Squelch Claims It Failed to Warn About Cancer
Stung by paying billions of dollars for settlements and trials, chemical giant Bayer has been lobbying lawmakers in three states to pass bills providing it a legal shield from lawsuits that claim its popular weedkiller Roundup causes cancer.
Nearly identical bills introduced in Iowa, Missouri and Idaho this year — with wording supplied by Bayer — would protect pesticide companies from claims they failed to warn that their product causes cancer if their labels otherwise complied with the U.S. Environmental Protection Agency’s regulations.
But legal experts warn the legislation could have broader consequences — extending to any product liability claim or, in Iowa’s case, providing immunity from lawsuits of any kind. Critics say it could spread nationwide.
“It’s just not good government to give a company immunity for things that they’re not telling their consumers,” said Matt Clement, a Jefferson City, Missouri, attorney who represents people suing Bayer. “If they’re successful in getting this passed in Missouri, I think they’ll be trying to do this all over the country.”
Senators Demand Answers From Drugmaker About Discontinuation of Popular Insulin Levemir
Three U.S. Senators say they are “alarmed” Novo Nordisk discontinued U.S. sales of a popular insulin brand and are demanding answers from the pharmaceutical giant they say left patients without an affordable substitute.
In a letter Tuesday to Novo Nordisk’s top executives, Sens. Jeanne Shaheen, D-N.H., Raphael Warnock, D-Ga., and Elizabeth Warren, D-Mass., said the company’s decision to discontinue Levemir, a long-acting insulin, “failed to take into consideration patient access to affordable, long-acting insulin substitutes.”
Last November, Novo Nordisk announced it would stop selling the injectable FlexPen version of Levemir this month and halt sales of Levemir vials by December 2024. The decision to discontinue Levemir was announced just before Novo Nordisk’s 65% list price cut of Levemir took effect on January 1.
Novavax Comes Under Pressure From Activist Investor as COVID Sales Fall Short
Activist investor Shah Capital, which owns 6.7% of Novavax‘s stock, has claimed that the vaccine developer has been “historically mismanaged” as the firm tries to install new members onto the biotech’s board.
Shah Capital said that for more than a year it has tried to address “self-inflicted problems which have undermined the success and sustainability of the company,” according to an April 15 public letter. The investor also claimed that Novavax’s board has been unresponsive to those efforts.
The firm also argued that Novavax’s stock is “now trading at a near record low.” The biotech’s shares are currently trading at $4.22 on Monday morning, above the $3.50 mark they sunk to in February, but far below the $200 plus realms the stock was floating in at the height of the pandemic.
FDA to Review 5-in-1 Meningococcal Vaccine Candidate
British drugmaker GSK announced today that the U.S. Food and Drug Administration (FDA) has accepted an application for review of the company’s 5-in-1 meningococcal vaccine.
GSK‘s MenABCWY vaccine candidate will target the five groups of Neisseria meningitidis bacteria (meningococcal serogroups A, B, C, W, and Y) that cause most cases of invasive meningococcal disease (IMD) globally. It combines the antigenic components of GSK’s well-established meningococcal vaccines, Bexsero and Menveo.
The company says combining the protection offered by these vaccines into a single vaccine will reduce the number of injections, simplify immunization, and help increase series completion. Just under 12% of U.S. adolescents have had the required two doses of Bexsero, which provides protection against meningococcal group B, the most common group of IMD-causing bacteria in U.S. adolescents and young adults. Menveo prevents IMD caused by meningococcal groups A, C, Y, and W-135.
GSK says the FDA will make a decision on whether to approve the vaccine in February 2025.
Boehringer Replaces Bayer as Germany’s Largest Drugmaker on Jardiance Gains
Boehringer Ingelheim on Tuesday overtook Bayer (BAYGn.DE) as Germany’s largest drugmaker when the unlisted company reported a currency-adjusted gain in 2023 pharmaceutical sales of 10.3% to 20.8 billion euros ($22.11 billion).
Diversified rival Bayer reported in March that 2023 sales at its pharmaceuticals division slipped 6% to 18.1 billion euros, as gains from prostate cancer drug Nubeqa and kidney drug Kerendia were offset by declines in China.
Growth at Boehringer’s pharma unit, driven by diabetes drug Jardiance and lung drug Ofev, pushed 2023 group sales, also including its animal health business, up 9.7% at constant currencies to 25.6 billion euros.
Boehringer’s Jardiance group of products managed in a partnership with Eli Lilly (LLY.N) made 7.4 billion euros in annual sales, a currency-adjusted surge of 31%. Jardiance, used to treat diabetes, heart failure and chronic kidney disease, competes with AstraZeneca‘s (AZN.L) Farxiga.
Novel Chlamydia Vaccine Shows Promise in Early Trial — Fourfold Seroconversion Rate of 100% in All Active Vaccine Groups
An investigational vaccine against chlamydia (CTH522) induced neutralizing antibodies in all participants who received it, and with no major safety concerns, results of a phase I trial showed.
A 100% fourfold seroconversion rate occurred in all groups receiving CTH522, a recombinant vaccine containing the major outer membrane of Chlamydia trachomatis, with no seroconversion in placebo recipients, reported Katrina Pollock, PhD, of Imperial College London, and colleagues.
The findings of this trial are “compelling,” said Wilhelmina Huston, PhD, of the University of Technology in Sydney, in an accompanying comment. “A vaccine against chlamydia is widely agreed to be an essential public health control measure for both sexually transmitted and ocular infections.”
Statistical analyses, including between-group comparisons, were limited by the small sample size, according to the study authors. But “tantalizing insights were gained that might inform future chlamydial vaccine trials,” Huston wrote. “Dosing regimens that cover multiple administration rounds are influential on the outcomes, and it will be worth investing upfront in distinctive dosing and administration groups in future studies (at a larger scale).”
