Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
Moderna Embarks on New Vax Push in Long COVID Prevention Campaign
The COVID-19 virus has been widely studied for four years, but much less is known about long COVID, in which symptoms of the virus stick around for months or even years for some patients. Until more is known — and until any treatments have been approved specifically for long COVID — according to a new campaign from Moderna, the best offense is a good defense, in the form of regular coronavirus vaccines.
The campaign launched on March 15, which also marked the second annual Long COVID Awareness Day. It includes a blog post encouraging readers to stay up to date on their COVID shots, plus a Moderna-branded video in which a patient named Rachel shares her story of living with long COVID since 2021.
The post ends with the declaration that the best protection against long COVID is prevention, as “research suggests there is a strong association between receiving the COVID-19 primary vaccination series and a reduced risk of receiving a diagnosis of long COVID.” Both the video and post stop short of pushing Moderna’s own Spikevax vaccine, instead encouraging those eligible to simply “receive their updated COVID-19 vaccine” and to talk to their doctor about any questions or concerns.
The vax push comes in the wake of plummeting revenues from both Moderna and Pfizer’s COVID vaccines — which brought in $6.7 billion and $11.2 billion in total 2023 sales, respectively. Both companies are expecting to take in even less from their vaccines this year, though Moderna’s projected drop-off is much less steep: It’s expecting Spikevax to bring in at least $4 billion in 2024, compared to Pfizer’s $5 billion forecast for its Comirnaty shot.
Big Pharma Sent Massive Payments to NIH During COVID Pandemic, Watchdog Finds
Scientists and Doctors who worked for the federal government received hundreds of millions of dollars from big Pharma during the COVID-19 pandemic.
The watchdog group Open the Books filed two federal lawsuits to uncover the details of who received the money and who paid the money.
“These have been very successful federal lawsuits with our legal partner Judicial Watch. For example, during the pandemic, we got the feeling that big government was very close to big Pharma,” Open the Books CEO Adam Andrzejewski said. “The third-party royalty database shows just how close they are. There are 3,000 companies since 2010 that paid 2,600 scientists over at the NIH 64,000 payments.”
The report from Open the Books reveals hundreds of millions paid in third-party royalties to government scientists with close attention to those payments and transactions during the COVID pandemic.
Massive Public Health Experiment Sends Vaccination Rates Soaring
Deploying mobile COVID-19 vaccination clinics in rural areas of Sierra Leone increased vaccination rates sharply, according to an ambitious experiment involving 150 villages. The effort is an outlier: many more studies examine vaccine hesitancy and misinformation than focus on vaccine access.
The results, published on March 13 in Nature, highlight the importance of delivering vaccines, as well as other essential medical treatments and supplies, to rural, less affluent areas, says study co-author Ahmed Mushfiq Mobarak, an economist at Yale University in New Haven, Connecticut.
The researchers found that the clinics’ success varied by region; after the clinics were held, the vaccination rate was at least 65% in some communities and as low as 0% in others. Mobarak says that future research will need to identify the source of this variation and the extent to which vaccine hesitancy might have played a part.
Hesitancy is important to understand, but it shouldn’t preclude vaccination campaigns or more research on vaccine supply and access, Mobarak says. “When you’re starting with a baseline vaccination rate of essentially zero, our research shows that the most cost-effective thing to do is just to show up,” he says.
COVID Paved the Way for a New Vaccine Era
The unprecedented success of the COVID-19 vaccines has elevated the mRNA platform and raised expectations the technology could soon be wielded against other infectious diseases. The big picture: COVID is still the only disease for which any mRNA vaccines are approved, but dozens more are being developed and tested against the flu, RSV, HIV and even cancer.
Between the lines: Scientists had been working on mRNA vaccines for decades, but the technology, which essentially provides instructions to the immune system, got a significant boost when Pfizer‘s and Moderna‘s COVID vaccines were developed and brought to market at a record pace.
State of play: By next year, it’s possible Pfizer and Moderna will both have approved combination flu-COVID vaccines that would make it easier to provide protection against respiratory threats.
Friction point: Remarkable advances are also coming at a time of heightened vaccine skepticism, potentially tempering the impact of any future breakthroughs.
Global Eradication of Polio ‘ Tantalizingly Close’ With UK Urged to Keep Up Funding
The world is “tantalizingly close” to eradicating polio — with no confirmed cases of wild polio anywhere so far this year. But experts warn that vaccination efforts — and funding — must not falter if the world is to rid itself of a human infectious disease for the second time in history, after smallpox.
There have been no reported cases of wild polio infection in people for the last 19 weeks. Figures from the World Health Organization reveal that the last confirmed cases were on the borders of Pakistan and Afghanistan in October and September 2023 respectively; these are the last nations on Earth where polio is endemic.
Still, said Gordon McInally, president of Rotary International, a founding partner in the Global Polio Eradication Initiative (GPEI), if they can get through another 33 weeks (one full year after the last case), they will be “celebrating cautiously,” and if the world stays two years disease-free they can officially declare the global eradication of polio.
Reckitt Unit Hit With $60 Million Verdict in Enfamil Baby Formula Case in Illinois
An Illinois jury has ordered Reckitt Benckiser (RKT.L) unit Mead Johnson to pay $60 million to the mother of a premature baby who died of an intestinal disease after being fed the company’s Enfamil baby formula.
The jury in an Illinois state court in St. Clair County on Wednesday found that Mead Johnson was negligent and that it failed to warn of the risk of necrotizing enterocolitis (NEC). The disease, which causes the death of bowel tissue, mostly affects premature newborns and has a fatality rate of about 15% to 40%.
The $60 million verdict includes compensation for plaintiff Jasmine Watson’s loss and grief, and for the pain and suffering of her baby, Chance Dean. The verdict comes in the first trial out of hundreds of lawsuits claiming that various Enfamil and Abbott Laboratories’ (ABT.N) Similac formulas caused NEC.
“This verdict confirms what Mead Johnson has known for years: cow’s-milk-based baby formula causes NEC in preterm infants, often with fatal consequences,” Ben Whiting, a lawyer for Watson, said in a statement.
More than 400 NEC lawsuits against Mead Johnson and Abbott are pending in federal court in Chicago, and others, like Watson’s, are in state courts. The NEC lawsuits are separate from ongoing litigation against Abbott over the shutdown of its Sturgis, Michigan, plant and subsequent recall of batches of baby formula for possible contamination, which contributed to a nationwide formula shortage in 2022.
With Pfizer Struggling in 2023, CEO Bourla Hit With 35% Pay Cut to $21.6M
Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. When the year was over, the company’s revenue was down 41% and its shares had plunged by 44%.
So, it’s no surprise that Pfizer’s execs felt the pinch in their 2023 compensation. CEO Albert Bourla took a 35% hit in his pay as it fell from $33 million in 2022 to $21.6 million last year, according to a regulatory filing.
With the company raking in huge profits during the pandemic years, Bourla ranked No. 2 among industry CEOs in 2021 at $24.3 million and No. 3 in 2022 as he made $33 million. But his compensation last year will likely knock him out of the top 10. Just this week, Johnson & Johnson reported that its CEO Joaquin Duato’s 2023 pay has hit $28.4 million.
Bayer Exec: U.S. Is Key in Reviving Beleaguered Pharma’s Drug Pipeline
German pharmaceutical company Bayer is expanding its U.S. pharma business significantly, despite corporate turmoil and pricing pressures that have led many in the drug industry to bemoan the potential end of the American biotech innovation boom.
Bayer’s C-suite has been on a soul-searching mission for the last year, spurred by new leadership and the realization that the company is, as new CEO Bill Anderson said earlier this month, “badly broken.”
The biggest fissure is the debt and litigation costs stemming from Bayers’s 2018 acquisition of agriculture firm Monsanto, but the aspirin-maker’s pharmaceutical portfolio is also facing strain. Some of Bayer’s top products, including the anticoagulant drug Xarelto and the eye medication Eylea, are under patent pressure. Xarelto is also one of the first drugs to be subject to Medicare price negotiations under the Inflation Reduction Act, though Johnson & Johnson owns U.S. rights to the drug.
GSK, Facing Shingrix Penetration Plateau, Doubles Funding for Adult Vaccine Uptake Programs
GSK is stepping up its push to get vaccines in arms. With adult vaccination rates now rebounding from a pandemic-era slump, the Big Pharma is doubling its financial support for an uptake initiative and giving physicians and patients new tools to manage the vaccine process.
The vaccine space is central to GSK’s business, accounting for almost one-third of total revenues last year. Within the vaccine segment, products aimed at adults, such as GSK’s shots for shingles and respiratory syncytial virus, are key contributors. The fallout from the pandemic has held back efforts to grow sales of those products, with the vaccination rate falling as much as 47% between 2019 and 2023 in U.S. states.
Moderna Won’t Advance U.S.-Backed Zika Vaccine Without More Outside Funding
Moderna does not plan to advance a midstage Zika vaccine without additional outside cash, despite receiving U.S. funding thus far, according to a regulatory disclosure.
The news, tucked into Moderna’s annual report released Friday, throws cold water on the most mature vaccine in Moderna’s public health pipeline. The company is also working on vaccines for mpox and Niphah under the public health umbrella, both of which are in phase 1 studies.
The Flagship biotech’s Zika vaccine, mRNA-1893, is currently in a phase 2 study that’s fully enrolled some 800 patients in the mainland U.S. and Puerto Rico. The primary completion date is late July 2024, according to the study’s clinical trial record.
FDA Approves First Drug for Common, Serious Liver Disease
U.S. News & World Report reported:
Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday.
The condition is called non-cirrhotic non-alcoholic steatohepatitis (NASH). NASH with liver scarring is thought to affect up to 8 million Americans. It’s often tied to high blood pressure and type 2 diabetes, the FDA explained in a statement.
The agency said that the drug was approved under an “accelerated” pathway because it addressed “an unmet medical need.” Rezdiffra is made by Madrigal Pharmaceuticals and was approved based on data collected after a year as part of an ongoing 54-month trial. That data assessed improvement in levels of liver scarring compared to patients who were taking a placebo.
Rezdiffra did come with side effects, including diarrhea and nausea, and its label includes warnings regarding the risk for drug-induced liver toxicity and gallbladder issues.
