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If Bird Flu Starts to Spread Among People, Existing Vaccines May Be Inadequate, Experts Say
Wild birds and poultry flocks alike continue to drop dead from the highly pathogenic bird flu that began spreading globally in 2020. Almost 59 million commercial birds have already been culled in the United States. It’s the broadest outbreak of this type of avian flu, known as H5N1, since it was first identified in China in 1996.
The virus’s proliferation and high fatality rate have prompted questions about two types of possible vaccines: those for birds and those for humans. H5N1 kills almost all the birds it infects; among reported cases in people since 2003, the death rate has been 56%.
Vaccines for people, meanwhile, would only be considered if the virus eventually undergoes a complicated string of mutations that allow it to spread from person to person. There’s no evidence of that yet. The U.S. recorded its only human case of H5N1 last April — the person was involved in culling poultry with presumed infections in Colorado. The United Kingdom reported two cases Tuesday, both poultry workers with asymptomatic infections detected via routine testing. Chile reported one infection in March and Ecuador had one case in January.
Vaccine researchers are preparing. Moderna said that later this year, it expects to begin clinical testing of an mRNA vaccine specific to the strain now circulating in birds, called 2.3.4.4b. mRNA technology offers an advantage because it allows vaccines to be produced and updated quickly. Given that experts think a future bird flu pandemic would be caused by a strain of H5N1 that hasn’t evolved yet, the ideal vaccines could be easily tweaked to target it.
CureVac Files Expanded Patent Lawsuit Against Pfizer/BioNTech Over mRNA Technology
CureVac NV said on Friday it had filed an expanded patent infringement claim against Pfizer Inc (PFE.N) and BioNTech over the use of mRNA technology and that a U.S. court had granted its request to transfer the trial.
The company said it filed a counterclaim alleging that Pfizer and its German partner BioNTech infringed on nine of its patents, broader than its original claim of three patents.
In July 2022, CureVac filed a patent lawsuit against BioNTech over the use of mRNA technology in the company’s COVID-19 vaccine.
The transfer of the trial to the Eastern District of Virginia from the Federal District Court of Massachusetts is expected to accelerate the progress of the case and allow for a likely 2024 trial date, CureVac said on Friday.
Moderna, Looking Beyond Vaccines, Guides First mRNA Protein Replacement Therapy Past Early Clinical Test
Massachusetts-based Moderna became a household name because of vaccines but, from its early days, has harbored the goal of turning human cells into drug production factories. By hijacking cellular machinery and getting the body to produce therapeutic molecules, Moderna wants to get proteins to intracellular targets and unlock new ways to treat disease.
The phase 1/2 trial marks the first time a biotech has reported clinical data on an mRNA therapeutic for intracellular protein replacement. In the study, children with propionic acidemia (PA), a rare inherited metabolic disorder, received multiple doses of a lipid nanoparticle-encapsulated dual mRNA therapy.
Across the five dose cohorts covered by the data drop, Moderna saw no dose-limiting toxicities and three drug-related serious adverse events (SAEs). The most severe SAE was grade 3 pancreatitis in one patient. Moderna has now given more than 280 doses of mRNA-3927, with five patients taking the therapy for more than one year, and is forging ahead with the program.
Artificial Intelligence, the Pharmaceutical Industry, and Their Future
AI has been a hot topic in the pharmaceutical industry, and the latest ChatGPT hype is fueling even more conversations. Right now, there’s a bifurcation of attitudes, with some scientists excited about the prospects of AI and others generally wary of it — which isn’t surprising. Researchers and chemists are highly educated experts who have been the heroes of making cures in the last several decades with the help of computers.
One of the reasons pharmaceutical companies consider using AI is because they’re looking for ways to get to market faster with new discoveries. Still, some can’t trust “black boxes” and there’s a good reason for that.
Over the last several months, the hype about ChatGPT has even skeptics feeling like perhaps they should understand AI’s potential impact. In fact, some are now even trying adventurous things, such as diagnosing disease in patients with rare disorders, predicting viral mutations for new vaccine creation and replacing animal trials when testing new drugs.
Smallpox Vaccine Recipients Died From Heart Inflammation, Autopsies Find
Several U.S. military personnel who received a smallpox vaccination died from heart inflammation while others had not recovered from the same inflammation years after first experiencing the condition, an in-depth review of medical records has found.
Autopsies of two male military members in their 20s who suddenly died uncovered heart inflammation, or myocarditis. There were also signs that heart inflammation contributed to two additional deaths, one an 18-year-old male and the other a 23-year-old female.
Some 2.5 million service members received a smallpox vaccine between Dec. 1, 2002, and Dec. 31, 2016, the time period covered in the study.
The lead researcher of the study, which was published by PLOS One in May 2023, declined to comment. Nearly all of the researchers are employed by the Defense Health Agency (DHA). They wrote in the paper that the findings “draw attention to potential long-term morbidity and possible chronic (>3 months) or recurrent (return after a quiescent interval of 4–6 weeks) symptoms in pericarditis and myocarditis.”
Dengue Too High in Puerto Rico, Other U.S. Territories, CDC Says
Dengue, a virus transmitted by infected mosquitoes that causes illness in about 1 in 4 infected people, can lead to symptoms ranging from mild fever to shock or death. In an article this month in JAMA, Centers for Disease Control and Prevention researchers in Puerto Rico say the virus must be better controlled in U.S. territories.
Between 2010 and 2020, the CDC logged nearly 31,000 dengue cases in U.S. territories. Over 96% of these occurred in Puerto Rico, followed by American Samoa, the U.S. Virgin Islands and Guam. Approximately half were among people under age 20.
A dengue vaccine is available but not recommended for children who have not had a prior infection. Despite barriers that include screening and making sure children complete the entire three-dose course of the vaccine, the researchers write, vaccination in Puerto Rico alone could prevent 3,000 hospitalizations in 10 years, and dengue vaccinations in development could help a wider age range or people without previous infection.
Another potential solution is on the horizon: modifying mosquitoes to prevent dengue transmission. The CDC has authorized the use of genetically modified mosquitoes in some Florida and Texas counties. Elsewhere in the world, researchers have released mosquitoes infected with the Wolbachia bacterium, which reduces transmission of dengue and similar viruses. The United States is also helping to fund a World Health Organization research project in French Polynesia that sterilizes dengue-transmitting mosquitoes with radiation so they cannot produce offspring.
Cholera Vaccine Shortage to Last Until 2025 as Cases Surge, Gavi Says
A shortage of cholera vaccines is likely to last until 2025 as outbreaks surge worldwide, a global vaccine alliance said on Monday, days after the World Health Organization warned that the short-term outlook for controlling the disease was bleak.
Cholera cases and deaths jumped last year as the deadly disease spread to new regions, particularly conflict zones and areas with high levels of poverty.
In response, the World Health Organization and partners temporarily switched to using one dose of a vaccine that is normally given as two doses. But they still ran out last December. Gavi said 48 million vaccine doses had been used in the last two years, 10 million more than in the entire previous decade.
America’s Drug Shortages Reach New Heights
Shortages of cancer drugs and other life-saving medications are reaching their worst point in a decade, forcing physicians to develop workarounds and the Biden administration to mount an all-of-government response.
Why it matters: The shortfalls are surfacing deeply entrenched problems in America’s drug supply chain, particularly around commonly-used generic drugs. A recent House hearing examined a “race to the bottom” in price that chills investment in manufacturing and can leave just one or two companies actively producing a drug in shortage.
What they’re saying: “This generic business, particularly for these complex drugs, these complex formulations, is not a healthy business right now,” Scott Gottlieb, former FDA commissioner and a Pfizer board member told CBS News on Sunday.
Driving the news: There are more than 300 drugs in shortage, the highest since 2014, per the American Society for Health-System Pharmacists.
With Dupixent Leading the Way, Sanofi’s Taking On the ‘Big Players’ in Respiratory Diseases: Exec
Sanofi and Regeneron made waves when they presented data from a phase 3 trial that showed that blockbuster Dupixent could become the first biologic to treat chronic obstructive pulmonary disease (COPD) and the first new therapy for the condition in more than a decade.
Two months later, Sanofi is again touting the advantages of Dupixent in COPD, along with the prospects of its other pipeline treatments for respiratory disorders.
An approval to treat COPD — the world’s third-leading cause of death — would bring a massive market, estimated at 300,000 in the United States alone. Analysts with Evercore ISI have estimated a nod would open up a $3.5 billion sales opportunity, perhaps pushing Dupixent to more than $20 billion in sales by 2030.
