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COVID Rebound Occurs in 1 in 5 People Taking Paxlovid
U.S. News & World Report reported:
Paxlovid helps prevent severe COVID-19, but it also might significantly increase a person’s risk of a rebound case, a new study confirms. About 1 in 5 people taking Paxlovid recovered and tested negative for COVID, but later experienced a positive test result and started shedding live and potentially contagious virus.
That’s called “virologic rebound.” It only happened about 2% of the time in people not taking Paxlovid, according to results published Nov. 13 in the Annals of Internal Medicine.
“We found that the virologic rebound phenomenon was much more common than expected — in over 20% of people taking Paxlovid — and that individuals shed live virus when experiencing a rebound, implying the potential for transmission after initially recovering from the virus,” researcher Dr. Mark Siedner, an infectious disease clinician at Massachusetts General Hospital in Boston, said in a news release from Mass General Brigham.
The study runs counter to clinical trials that found only 1% to 2% of patients taking Paxlovid experienced virologic rebound, the researchers noted.
Surge in Vaccine Lawsuits Forces Biden Admin to Hire More Attorneys
The administration of President Joe Biden is hiring additional attorneys to help handle the workload from vaccine lawsuits after seeing a spike in people filing claims.
The COVID-19 pandemic thrust the potential side effects of vaccines into the spotlight, prompting fierce debate about whether the benefits outweigh the potential negative outcomes. While COVID vaccine side effects have been limited, several lawsuits from plaintiffs who have experienced adverse effects have attempted to hold pharmaceutical companies accountable.
It’s unclear if the attorneys the Biden administration is hiring will be responsible for COVID-19 vaccine claims. COVID-19 vaccines are covered under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), according to the Health Resources and Services Administration. Vaccines covered under the VICP include tetanus, measles, mumps and rubella, and polio.
The position posted online advised applicants that they would have to handle heavy caseloads and work on cases that involve complex scientific issues that require expert witnesses. Since most cases are resolved without a trial, attorneys should be prepared to engage in settlement and damage negotiations, according to the posting.
Frustrations with vaccine injury compensation suits aren’t something unique to COVID claims. Attorneys and activists for years have been pushing for reform, pressing for the hiring of additional staff to handle the VICP cases. As of October, there was a backlog of nearly 4,000 claims, according to Bloomberg. Lawyers working on the cases hope Congress will pass legislation to reform how vaccine injuries are handled and for people to take action against pharmaceutical companies, not just the government.
Australian Government Will Apologize to People Affected by Thalidomide Tragedy
The Australian government will issue a formal apology to people affected by thalidomide, the morning sickness drug that caused significant birth defects in babies during the 1950s and 1960s.
The government announced on Monday it would also unveil a national memorial site, with the prime minister, Anthony Albanese, describing the “thalidomide tragedy” as a “dark chapter” in history for Australia and the world and saying the apology was well overdue.
Thalidomide was marketed as a sedative and anti-nausea drug for pregnant women in the 1950s, but caused birth defects including “shortened or absent limbs, blindness, deafness or malformed internal organs”, according to Australia’s Department of Health.
The drug was not tested on pregnant women before being approved, and the birth defect crisis led to greater medical oversight worldwide, including the creation of Australia’s Therapeutic Goods Administration.
Pfizer Wants in on the Weight Loss Drug Market — and Upcoming Data Will Be Crucial for Its Success
As its COVID gains evaporate, Pfizer wants a chunk of the budding weight loss drug market. Analysts say upcoming data on Pfizer’s experimental obesity pill, danuglipron, will be crucial in determining how competitive the company can be against the space’s dominant players Eli Lilly and Novo Nordisk.
Those companies helped spark the weight loss drug industry gold rush over the last year with their weekly obesity and diabetes injections, such as Novo Nordisk’s Wegovy and Ozempic and Eli Lilly’s Mounjaro. They are now racing to develop their own pills for obesity and diabetes.
Investors are waiting for Pfizer to release phase two trial data on its twice-daily pill, in obese patients without diabetes, by the end of the year. They want to see the drug cause a similar level of weight loss as a once-daily pill from Eli Lilly. Investors are also eager for Pfizer to release trial data early next year on a once-daily version of danuglipron, which is seen as the more competitive form of the drug.
Pfizer sees a major opportunity in the segment, as it looks to rebound from plummeting demand for its COVID products and reverse a roughly 40% share price drop this year.
FDA Approves First Vaccine for Mosquito-Born Viral Disease
The Food and Drug Administration (FDA) approved the first vaccine for the mosquito-born illness chikungunya on Thursday, a key step in fighting the dangerous virus.
Chikungunya virus infects more than 300,000 people per year globally, the FDA said, mostly in the global south. The virus has recently become more prevalent in the north, however, leading to FDA approval of the new vaccine.
The new vaccine, Ixchiq, will be available for vulnerable populations of adults like those who have recently traveled to places with infected mosquito populations and those with predisposed risks.
The Long Quest for a Universal Flu Vaccine Finally Takes Its First Steps
Every summer, as the northern hemisphere’s flu season approaches, public health people fretfully anticipate the data. Will manufacturers deliver the shot in time? Will enough people take it? How effective will it be? And every year, as they watch the numbers settle, at least some of them long for something that could short-circuit the waiting: a vaccine that works no matter how the virus changes and that could be produced far enough in advance to prevent a fall vaccination crunch.
That goal is known as a universal influenza vaccine. For immunologists, it has been an end-of-the-rainbow phantasm for more than a decade, a deeply desired treasure that manages to stay just out of reach. Recently, though, the pursuit of a better flu shot has notched promising achievements.
A vaccine candidate developed by the National Institutes of Health has entered its second Phase 1 clinical trial (which tests whether a compound is safe for humans). Other candidates developed by Moderna, based on the mRNA technology that allowed rapid development of COVID vaccines, are in Phase 1/2 and also Phase 3 trials (which test for efficacy). And novel constructs developed by teams at Mount Sinai School of Medicine and the University of Pennsylvania have delivered promising results in mice. They are all feats of engineering and imagination, deploying the latest virological tools against an ancient foe.
Brain Games?
In 2022, the U.S. National Institutes of Health (NIH) placed a large bet on an experimental drug developed to limit brain damage after strokes. The agency committed up to $30 million to administer a compound called 3K3A-APC in a study of 1400 people shortly after they experienced an acute ischemic stroke, a perilous condition in which a clot blocks blood flow to part of the brain.
The gamble seemed warranted. Lab studies, most by a longtime grantee, prominent University of Southern California (USC) neuroscientist Berislav Zlokovic, had generated promising data. A small safety study of the drug, sponsored by a company Zlokovic co-founded called ZZ Biotech, was also encouraging. Analyses of data from the phase 2 trial hinted that the treatment reduced the number of tiny, asymptomatic brain hemorrhages after stroke patients received either surgery to remove the clot, the clot-busting drug tissue plasminogen activator (tPA), or both.
A 113-page dossier obtained by Science from a small group of whistleblowers paints a less encouraging picture. The dossier, which they submitted to NIH, highlights evidence from the phase 2 trial that the experimental remedy might have actually increased deaths in the first week after treatment: Six of the 66 stroke patients who received 3K3A-APC died within this period, compared with one among 44 in the placebo group, although the death rate evened out after a month. Patients who received the drug also trended toward greater disability and dependency at the end of the trial, 90 days after treatment.
Deepening the concern, the dossier also highlights evidence that dozens of papers from Zlokovic’s lab — including many supporting the idea that the compound was ready for human testing — contain seemingly doctored data that suggest scientific misconduct. The whistleblowers say apparent changes to images used for protein identification and other purposes seem to skew results in favor of the scientist’s hypotheses, which include influential ideas about the blood-brain barrier and its role in stroke and Alzheimer’s disease, as well as how 3K3A-APC supposedly affects it.
Michigan Bill That Would Pare Back Pharma Liability Shield Law Moves Closer to Enactment
A one-of-a-kind law in Michigan that prevents the state government and residents from suing pharmaceutical companies over injuries caused by their medicines is poised to be pared back.
A bill designed to allow product liability lawsuits to be filed against drug companies passed the Michigan Senate last month and then passed the House last week. The legislation, which won overwhelming majorities in both chambers but was opposed by the Michigan Chamber of Commerce and a pharmaceutical industry trade group, now goes to Gov. Gretchen Whitmer.
The move comes after years of efforts to roll back a law the state adopted in 1995 to keep a large manufacturer, Upjohn, in Kalamazoo, Mich. The company, which was later purchased by Pfizer, has been a key employer in the state, but the law meant Michigan stood apart from other states, where companies can face product liability lawsuits by state and local governments, and residents.
U.K. Experts Recommend Chickenpox Shot for Kids for the First Time, Decades After Other Countries
An expert scientific committee advising the British government recommended for the first time Tuesday that children should be immunized with the chickenpox vaccine — decades after the shots were made widely available in other countries, including the U.S., Canada and Australia.
In Britain, those who want to be immunized against the disease have to pay about £150 (US $184). In a statement, Britain’s Joint Committee on Vaccination and Immunisation said that children between 1 year and 18 months should be offered two doses of the vaccine, in a shot that also combines protection against measles, mumps and rubella.
The chickenpox vaccine recommendation will next be considered by the government.
Britain’s National Health Service has long said that introducing the chickenpox vaccine might leave some adults vulnerable to shingles if unvaccinated children catch the virus as adults, which can be more severe than chickenpox.
Experts noted, however, that Britain’s government offers the shingles vaccine to adults at risk of the disease.
