Guillain-Barré Syndrome ‘More Common Than Expected’ With RSV Vaccine in Older People, CDC Reiterates + More
The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.
The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.
Reports of a rare nervous system disorder were “more common than expected” in older U.S. adults who got the new RSV vaccines, according to a Centers for Disease Control and Prevention report released Thursday that’s similar to what the organization said earlier this year.
The CDC and the U.S. Food and Drug Administration say they’re evaluating any risks, but do not plan to change their recommendation for the RSV shots, which is that patients 60 and older should talk to their doctor and then decide whether to be vaccinated.
More than 10 million older adults have gotten either Pfizer or GSK single-dose shots since early August to protect against respiratory syncytial virus, which is a common cause of cold-like symptoms and can be dangerous for infants and older people.
An estimated 3,000 to 6,000 people develop Guillain-Barré syndrome in the U.S. each year — either after being infected by a virus or linked to a vaccination — and it’s more common in older people, according to the CDC. Most people fully recover, but some have permanent nerve damage.
U.S. Close to Deal to Bankroll Moderna Bird Flu Vaccine Trial
The U.S. government is nearing an agreement to bankroll a late-stage trial of Moderna’s mRNA pandemic bird flu vaccine, hoping to bolster its pandemic jab stockpile as an H5N1 outbreak spreads through egg farms and among cattle herds. The federal funding from the government’s Biomedical Advanced Research and Development Authority, known as Barda, could come as early as next month, according to people close to the discussions.
It is expected to total several tens of millions of dollars, and could be accompanied by a commitment to procure doses if the phase-three trials are successful, they said.
Talks between the government and Pfizer over supporting the development of its mRNA vaccine targeting the H5 family of viruses are also ongoing. Pfizer, like Moderna, played a pivotal role in supplying mRNA vaccines for Washington’s jab rollout during the COVID-19pandemic.
The possibility of contributing to the U.S. pandemic vaccine stockpile also represents a commercial opportunity for the mRNA vaccine makers, whose market valuations have fallen significantly from pandemic highs. Moderna’s share price is up nearly 37% since the start of April. Moderna has completed dosing of a mid-stage trial of its H5 pandemic flu vaccine, with interim data expected soon.
Pfizer said in a statement on Wednesday that it “would be prepared to deploy the company’s capabilities to develop a vaccine for strategic stockpiles”, confirming that it had launched a phase-one trial for a pandemic flu vaccine last December.
With Ruling, Pfizer Can Escape Some Claims in Legal Battle Over Chantix Carcinogen Allegations
Pfizer chalked up a key win in its legal battle surrounding the now-recalled smoking cessation drug Chantix after a New York judge narrowed the scope of the arguments in play.
The consolidated class action lawsuit was brought by Chantix users and payers and levies a number of accusations at Pfizer, including arguments of negligence and unjust enrichment tied to the company’s representation of the drug as being free of nitrosamines.
While Pfizer’s efforts to get the complaint dismissed entirely didn’t pass muster, the court did deny several of the plaintiff’s claims. In a ruling this week, the U.S. District Court for the Southern District of New York threw out claims that the company fraudulently misstated or omitted information about the medicine’s risk.
Chantix, which the FDA first approved in 2006, had been at the center of a legal battle even before the carcinogen concerns.
Back in 2013, Pfizer forked over $273 million and settled more than 2,000 lawsuits surrounding Chantix’s alleged links to suicide attempts and other psychiatric disturbances. That led to the FDA slapping a boxed warning on the med alerting patients to psychiatric side effects.
Bird Flu: Diverse Range of Vaccines Platforms ‘Crucial’ for Enhancing Human Pandemic Preparedness
Vaccination remains the most effective strategy for avian influenza prevention and control in humans, despite varying vaccine efficacy across strains. That’s according to the authors of a new review which delves into existing research into bird flu vaccines for humans.
Published in the peer-reviewed journal Human Vaccines & Immunotherapeutics, the results of the paper are particularly timely following news last week (Wednesday, May 22) that the bird flu strain H5N1 had once again, for a second time, jumped from cattle in America to a human — prompting fears of subsequent human-to-human infection, with possible critical consequences.
The concern now, though, is that if H5N1 continues to be given the environment in which to mutate (such as in close quarter cattle farms) — and this continues long enough — it has the potential to find a combination that will easily spread to humans.
Overall, the team suggests “exploring and employing a diverse range of vaccine platforms,” will be “crucial for enhancing pandemic preparedness and mitigating the threat of avian influenza viruses.”
COVID Shots Could Use Another Update, Study Suggests — Latest Vaccines Mostly Kept up With Circulating Strains, but Dipped Against JN.1
The three vaccines updated to target the SARS-CoV-2 XBB.1.5 subvariant — Moderna‘s and Pfizer-BioNTech’s mRNA vaccines and the Novavax vaccine — were 66.8% effective against hospitalization at 4 weeks, decreasing to 57.1% after 10 weeks, wrote Dan-Yu Lin, Ph.D., of the UNC Gillings School of Global Public Health in Chapel Hill, North Carolina, and colleagues.
Vaccine effectiveness against infection was about 52% after 4 weeks, decreasing to 33% after 10 weeks, and to 20% after 20 weeks, the New England Journal of Medicinecorrespondence showed.
Data appeared to point to lower effectiveness against infection, hospitalization, and death after the arrival of the JN.1 subvariant, the dominant strain in the U.S. through the end of March of this year.
The FDA‘s Vaccines and Related Biological Products Advisory Committee is set to meet on June 5 to discuss and make recommendationson the selection of the formula for the 2024-2025 season. Signs point to the selection of JN.1 or one of its newer descendants such as KP.2, which currently accounts for an estimated 29% of U.S. cases.
Jacksonville Research Group Seeks Participants for New COVID Vaccine Trial
Researchers at the Jacksonville Center for Clinical Research (JCCR) are recruiting people to participate in an upcoming trial for a new COVID-19 vaccine. The FLirt-variant is the latest subvariant of the Omicron version of COVID-19.
The new vaccination, which doesn’t have a name yet, would no longer require needles because it is administered as a pill. Vaxart pharmaceutical company, out of San Francisco, California, is making the vaccine and started developing it in 2020.
Unlike the current COVID-19 Messenger RNA vaccines that are required to be stored in special freezers to maintain their effectiveness before being injected, the new oral vaccine is room-temperature stable.
According to researchers, the new oral vaccine inhibits airborne transmission of COVID-19 by reducing shedding. Viral shedding is when an infected person releases copies of the virus from their body by sneezing or coughing. People with COVID-19 shed the virus for about 10 days.
Who Will the Next ‘Big Pharma’ Players Be?
The top 20 biopharma companies by revenue all bring in well over $10 billion dollars annually. Topping the list in 2023 was Johnson & Johnson, with a grand total just north of $85 billion in sales. Last week, AstraZeneca — which ranked in the top 10 last year with nearly $46 billion in revenue — announced that it is targeting the $80 billion mark by 2030.
While there is no official definition of Big Pharma, these companies are no doubt it. So are Pfizer and Eli Lilly and Merck and Roche, among others. And it’s not just because of their revenue. A firm’s global presence is also important, Hartaj Singh, managing director and biotechnology analyst at Oppenheimer Holdings, told BioSpace.
“Most pharma companies are what you call a multinational company,” Singh said. “Pfizer is presently [in] 150 countries; J&J, 175-plus.”
However you consider Big Pharma, there are smaller biopharma firms that are jostling for a position among those ranks. Nicholas Schmitz, senior analyst at KBI Biopharma, identified several companies as emerging big pharma, including Regeneron and Vertex, plus big COVID-19 players BioNTech and Moderna. Similarly, Singh pointed to Vertex and Moderna.
All of these companies bring in billions of dollars every year, and most have cracked GlobalData’s list of top 20 biopharma companies by market cap in Q1 2024. Gilead, Regeneron and Vertex all push or exceed $100 billion in this statistic, on par with GSK and Bristol Myers Squibb and not far behind Amgen, Sanofi and Pfizer.
Do Kids Still Need the COVID Vaccine in Australia?
So what are the current recommendations for children and the COVID-19 vaccine, and how should you stay across any changes? The COVID-19 vaccine is not currently recommended for “healthy children”, explains Daryl Cheng, an associate professor and immunization consultant at Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC).
“But if they have other medical comorbidities, such as immunocompromised, it should be considered.”
We better understand the risk-benefit assessment for different age groups in the population than we did at the start of the pandemic. This includes understanding transmission as well as latest understanding that the risk of severe disease in infants is different to that of older children — and that overall, childhood risk is much lower than that of older adults — hence this influences recommendations for a vaccine that is primarily designed not to prevent the illness, but to reduce chance of severe disease.
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