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Empathy Should Guide Responses to Reported Vaccine Injuries
As a co-leader of the team at the National Institutes of Health that developed technologies powering a number of COVID-19 vaccines, I often speak publicly about vaccine science, even though I no longer work for the government. After my talks, people often approach me, almost always thanking me for my work. There is no denying the millions of lives that COVID-19 vaccines saved. sometimes, though, they relate stories of vaccine injuries.
I still hold on to the story of one person who approached me in a crowded auditorium following one of my talks, asserting that the COVID-19 vaccine harmed her. She asked me what I was doing to investigate vaccine injury. I replied that the side effects of vaccines, as they emerge in clinical trials, are investigated, and there is continuous monitoring of vaccinated people by the Food and Drug Administration and the federal Centers for Disease Control and Prevention.
But I wonder: Is that enough? Has my own science contributed to ignoring people who feel they have been harmed and not heard? At that moment, did I really hear this woman, who believed a COVID-19 vaccine had harmed her?
For starters, they deserve empathy from their doctors and other healthcare providers, as well as from those who set and drive vaccine policy. Science owes them — and ultimately all of us — far more investment in research to validate or invalidate claims of vaccine-related harm. They must be fully investigated to prevent further vaccine-related injuries.
Is Pfizer Working on a Vaccine for the Bird Flu?
Pfizer has been working on a vaccine for the H5N1 influenza virus since 2023 as part of the company’s “broader pandemic preparedness efforts.” The company said on May 28 that a vaccine candidate has been shown to provide “notable increases in antibody responses” against the virus commonly called bird flu.
Transmission to humans has been rare in the United States but it occurred in a single case in 2022 in Colorado and twice in the past two months in Texas and Michigan. Last month, dairy workers were monitored for the disease after bird flu was detected in dairy cows in northeastern Colorado.
Between 2022 and June 4, 2024, at least 29 people contracted bird flu in nine countries. Seven died, 15 became severely ill, six had mild symptoms and eight were asymptomatic. The CDC said the human health risk from the disease remains low.
Baltimore Reaches $45 Million Opioid Settlement With Allergan
The city of Baltimore has reached a $45 million settlement with Allergan Financet to resolve the city’s claims in ongoing litigation against opioid distributors and manufacturers related to the nation’s opioid epidemic.
The settlement comes after the city opted out of a proposed global settlement with other municipalities and states under which Baltimore would have received about $7 million spread over seven years, according to Mayor Brandon M. Scott.
The city’s settlement is larger than the settlements Allergan reached with many states, including the state of Maryland. In March, Maryland Attorney General Anthony G. Brown finalized settlements totaling $238 million with four firms: Teva, $70 million; Allergan, $38 million; Walmart, $55 million and Walgreens, $75 million.
The litigation is aimed at holding distributors and manufacturers accountable for the opioid epidemic. Allergan’s two opioid drugs, Kadian and Norco, made up less than half a percent of the opioids sent to Baltimore pharmacies.
Dozens of CVS Generic Drug Recalls Expose Link to Tainted Factories
One factory making CVS-branded pain and fever medications for children used contaminated water. Another made drugs for kids that were too potent. And a third made nasal sprays for babies on the same machines it used to produce pesticides.
The drugs were among those sold by CVS Health Corp., the largest U.S. pharmacy, under its store-brand label before being recalled.
A Tailored Vaccine Shows Promise in Treating Childhood Eczema
A multi-disciplinary team from Ireland’s Trinity College Dublin published a study today in the journal JCI Insight suggesting a “tailored vaccine” could effectively tame bacteria-driven eczema in children.
The researchers have identified new cellular targets for a vaccine after they furthered their understanding of how the immune response works in cases of eczema caused by the common staphylococcus aureus bacterium.
“There is a real need for new options to treat and prevent infected flares of eczema in children,” said Dr. Julianne Clowry, a consultant dermatologist, visiting research fellow at Trinity, and lead author of the study, in a statement. “Current strategies are limited in their success and even when they do provide relief, the effects may be short-term as symptoms often return.”
Clowry said when combined, the detrimental factors make a tailored vaccine an attractive target to possibly limit the severity of eczema, produce longer-lasting and better outcomes, and reduce the need for antibiotics “all while also reducing the risk of complications and potentially the development of other atopic diseases, such as hay fever and asthma.”
NIAID Is ‘on the Ball’ With H5N1 Research, but Gaps in Bird Flu Prevention Remain: Experts
Against a backdrop of low-volume but growing concerns about bird flu, the National Institutes of Health’s (NIH‘s) infectious disease arm has laid out its plans to study the virus that causes the illness.
In a document released publicly on June 5, the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) explained that it planned to track the H5N1 virus’s evolution, study its clinical course and come up with prevention, diagnostic and treatment strategies.
The CDC maintains that the risk to the general public is low. No one who has contracted H5N1 in the current outbreak has died, though about half of the 909 cases reported between 1997 and late April 2024 were fatal, according to the health agency. Given that all the people infected by cows were in direct contact with the animals, it doesn’t seem like the virus can be transmitted between humans — yet.
Part of NIAID’s H5N1 research agenda includes preparing for that possibility. The agency’s effort will characterize how the virus is transmitted — including whether it can be carried from host to host via infected milk products — and monitor to make sure that any cases of human-to-human transmission are caught quickly. NIAID will also attempt to develop a universal vaccine that works against not only H5N1 but most other flu strains, too, as well as broad-spectrum antivirals and antibody-based preexposure prophylaxis or treatments.
Bernie Sanders Calls Vote to Subpoena Novo Nordisk U.S. Head Over Ozempic, Wegovy Prices
Senate health committee chair Bernie Sanders has called a vote to subpoena the chief of Novo Nordisk’s U.S. division over the company’s pricing of the popular diabetes drug Ozempic and the obesity drug Wegovy, his office announced Tuesday.
The vote is scheduled for June 18. Sanders (I-Vt.) is seeking the appearance of Novo’s Doug Langa at a hearing next month. Sanders launched an investigation into Novo Nordisk’s pricing practices in April, and, he said that the committee “reached out time and time again” to schedule Novo Nordisk’s voluntary appearance at a hearing to no avail.
“Unfortunately, despite all of our efforts, they have repeatedly denied our requests,” Sanders said. “We look forward to their presence at a hearing on July 10.”
New Pharma Will Crowd Out Big Pharma
Big Pharma is under threat from tech-driven upstart rivals. The values of large, established players like $159 billion Pfizer (PFE.N), $230 billion Novartis (NOVN.S) and $216 billion Roche (ROG.S) are converging with newer players like $121 billion Vertex Pharmaceuticals (VRTX.O). As drugmakers wrestle with the need to constantly replenish their stocks of remedies via deals, big names may struggle to remain relevant.
Big Pharma companies have taken over a century to become market leaders. Swiss giant Roche was founded in 1896, while U.S. drugmaker Pfizer has been around since 1849, when typhoid and scarlet fever were among the biggest killers. Both giants came to dominate the industry by making savvy calls on common diseases, like cancer and infectious ailments. M&A is also a critical part of their growth story — witness Roche’s $47 billion takeover of Genentech in 2009, and Pfizer’s $43 billion purchase of cancer specialist Seagen in 2023.
But now a new breed of tech-savvy drugmakers, once the obvious prey of their established rivals, are threatening their dominance. Over the past five years, Amgen (AMGN.O), Regeneron (REGN.O), Genmab (GMAB.CO) and Vertex have added $270 billion to their combined market values. That compares to Big Pharma firms like Pfizer, Novartis, GSK (GSK.L), Sanofi (SASY.PA) and Roche, whose aggregate market value has declined by nearly $80 billion in the same period
GSK Asks to Appeal Delaware Ruling Allowing Zantac Cases to Go Forward
GSK (GSK.L) and other drugmakers on Monday asked a Delaware court for permission to appeal a ruling allowing more than 70,000 lawsuits claiming that heartburn drug Zantac causes cancer to go forward.
If Judge Vivian Medinilla of Delaware Superior Court grants the petition, which is also joined by Pfizer (PFE.N), Sanofi (SASY.PA) and Boehringer Ingelheim, the appeal will go directly to the Delaware Supreme Court. If she denies it, GSK said, the companies will ask the Supreme Court directly to hear the case.
The companies, which all sold Zantac at different times, argue that Medinilla should have granted their motion to block plaintiffs from presenting expert testimony that Zantac causes cancer. That would have effectively ended all of the lawsuits in Delaware, where the vast majority of Zantac lawsuits nationwide are pending.
Alzheimer’s Drug That Can Slow Disease Gets Backing From FDA Advisers
A closely watched Alzheimer’s drug from Eli Lilly won the backing of federal health advisers on Monday, setting the stage for the treatment’s expected approval for people with mild dementia caused by the brain-robbing disease.
Food and Drug Administration advisers voted unanimously that the drug’s ability to slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored.
The FDA will make the final decision on approval later this year. If the agency agrees with the panel’s recommendation, the drug, donanemab, would only be the second Alzheimer’s drug cleared in the U.S. that’s been shown to convincingly slow cognitive decline and memory problems due to Alzheimer’s. The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year.
