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CDC Finds No Link Between COVID Vaccines and Cardiac Death in Young People
There is no evidence to suggest COVID vaccines could cause sudden cardiac death and other heart problems in young people, the Centers for Disease Control and Prevention said Thursday, following a string of unfounded conspiracy theories in recent years linking the vaccines to cardiac arrest in young athletes.
Myocarditis after receiving a COVID vaccine is rare, the CDC said. Rates of myocarditis after vaccines are highest among males in their late teens and early 20s, according to the agency, which noted evidence indicates the benefits of receiving a COVID vaccine outweigh the risk of myocarditis. A study published last May indicated COVID vaccines are associated with a reduced risk of major adverse cardiac events, like heart failure.
Another study published in December found no evidence linking COVID vaccines to heart health problems in young athletes, while other researchers found a lack of evidence indicating an increase in sudden cardiac deaths among young people after COVID vaccines were introduced.
A study published in February found COVID vaccines from Pfizer, Moderna and AstraZeneca were linked to rare occurrences of heart, brain and blood disorders. Despite the link, experts told Forbes the risk of developing COVID-19 outweighed the risks of getting vaccinated.
With 9% Pay Hike, Merck CEO Davis Entered $20 Million Compensation Club in 2023
Merck CEO Robert Davis has cracked the $20-million mark in annual pay for the first time, putting him in an exclusive club of biopharma heavy hitters. Davis, 57, who took over as CEO in 2021 and as chairman the following year, received a 9% bump in pay in 2023 to $20.3 million, according to the company’s proxy filing.
Davis joins Johnson & Johnson’s Joaquin Duato ($28.4 million), Eli Lilly’s David Ricks ($26.6 million), AbbVie’s retiring Richard Gonzalez ($25.7 million), Pfizer’s Albert Bourla ($21.6 million), AstraZeneca‘s Pascal Soriot ($21.3 million) and Vertex’s Reshma Kewalramani ($20.6 million) in the $20-million-plus club for 2023.
The pay increase for Davis came in a year in which Merck’s market cap fell by 2% amid nervousness about the drugmaker’s reliance on Keytruda, which loses patent protection in 2028. The cancer superstar was the world’s top-selling drug last year, generating $25 billion. In the fourth quarter, Keytruda accounted for 45% of Merck’s revenue.
$10 Billion Long COVID ‘Moonshot’ Is Being Floated by Bernie Sanders
Bernie Sanders is pushing for a long COVID “moonshot.” He released a draft legislative proposal this week, a follow-up to a milestone hearing in January that sounded the alarm on long COVID as a pressing public health crisis.
The pitch calls for $10 billion in mandatory funding over the next decade to establish a new long COVID research program at the National Institutes of Health. This money — $1 billion per year — would be in addition to, and more secure than, the funding recently set aside to continue the RECOVER trial. While the proposal is still in its early stages in the Senate Committee on Health, Education, Labor and Pensions which the Vermont senator chairs, it could give long COVID researchers more runway to find much-needed therapies. Part of the plan would help fast-track treatment trials.
If adopted, the proposal would also task the NIH with setting up a new, expedited process for researchers to apply for grants to study long COVID. The new structure should make for a faster turnaround — a final decision within 120 days — for clinical trials on preventive therapies, and potential long COVID treatments, such as repurposed drugs. Researchers who have support from long COVID patient organizations would have an advantage in the new application system.
Will Biopharma Companies Shun Vaccine R&D in a New Pandemic?
While COVID-19 hasn’t gone completely away, it is in our rearview mirror. Thus, it was of interest to read Matt Herper’s terrific analysis of how those companies that developed the COVID-19 vaccines have since fared. Titled “During the pandemic, were great vaccines bad business? A company-by-company review,” Herper shows that, while the revenues that were generated from the vaccines were “staggering,” long-term success wasn’t guaranteed. In fact, the data suggest that by shifting a company’s prime focus to discovering, developing and manufacturing a COVID-19 vaccine, other parts of the company understandably suffered.
The poster child for this is Pfizer. Despite having generated sales of its COVID-19 vaccine (Comirnaty) of over $75 billion in its first two years on the market, Pfizer’s stock price has declined 32% since the start of the pandemic. As a result, Pfizer is in the midst of a $4 billion cost-cutting program.
As Herper states: “Directing an entire 83,000-person company to take on a global catastrophe may not have been without consequences to the rest of the business.” Contrast this with Merck’s experience. Despite having failed in its vaccine efforts, Merck’s stock price has risen 56% over this same period — it was able to keep focus on its existing pipeline. Herper believes that this experience will impact biopharma going forward.
When Pfizer CEO, Dr. Albert Bourla, made the decision to collaborate with BioNTech to find a COVID-19 vaccine, he wasn’t exactly doing it from a position of strength. He had only been CEO for 14 months. He was investing in mRNA technology which was totally unproven. Yet, when told the amount of money needed to do this would likely be over $2 billion, Bourla responded that “this won’t break us.” Pretty brave talk from a new CEO whose 2019 sales were only $41 billion.
U.S. Accuses Regeneron of Fraudulent Price Reporting for Eye Drug
The U.S. Justice Department on Wednesday accused Regeneron Pharmaceuticals (REGN.O) of manipulating Medicare’s drug-pricing process by inflating the average sales price for its expensive macular degeneration drug Eylea.
The department, in a complaint filed in federal court in Boston, alleged the drugmaker failed for years to report how it paid hundreds of millions of dollars to subsidize Eylea purchases by reimbursing drug distributors for credit-card processing fees.
The drug, which the Tarrytown, New York-based company began marketing in 2011, is approved by the U.S. Food and Drug Administration for treating conditions including wet age-related macular degeneration, which impairs vision.
The medication has a wholesale acquisition cost of $1,850 per vial, and the department said it was a leading expense for Medicare, the government healthcare program for people 65 and older, with more than $25 billion paid out from 2012 to 2023.
FDA Commissioner Tells Lawmakers His Agency Needs More Authority to Prevent Drug Shortages
After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s commissioner Robert Califf, M.D., on a wide range of issues at a Thursday hearing.
Committee Chairman James Comer, R-Kentucky, kicked off the nearly five-hour event by criticizing the FDA for “failing to do the bare minimum” in ensuring food and drug safety and for “a pattern of issues” that show the agency “appears consistently unprepared for crises,” the representative said in his opening remarks.
One area the congressman singled out is FDA inspections, which he noted haven’t yet returned to pre-pandemic levels overseas. Comer cited a previous investigation that found a 79% dip in foreign plant inspections in 2022 compared with 2019.
Later in the hearing, Califf agreed that “we need to pick up the pace” of inspections. To address some problems it was facing, the FDA recently “completely” reworked its inspection system in India, the FDA official said.
Moderna Halts Plans to Build Kenya Vaccine Plant as COVID Shot Demand Plunges
Moderna on Thursday said it has paused plans to build a vaccine-manufacturing site in Kenya after a steep drop in demand for its COVID vaccines.
The biotech company said it has not received any vaccine orders for Africa since 2022 and has taken more than $1 billion in losses and write-downs related to the cancellation of previous orders from the continent.
Moderna’s decision aligns with its broader effort to cut costs by resizing its COVID vaccine-manufacturing footprint. The company’s business took a major hit last year as demand for those jabs waned worldwide, with people relying less on protective vaccines and treatments against the virus.
Shares of Moderna fell 45% last year, but the stock is up around 6% this year.
The company said it is also working to develop vaccines for diseases that predominantly affect the African continent, such as HIV and malaria. Those shots are part of Moderna’s broader effort to expand access to vaccines that are out of reach in many parts of the world.
Chlamydia Vaccine Shows Promising Results in Early-Stage Trial
The Chlamydia vaccine showed promising results in an early-stage clinical trial conducted by researchers in the U.K. and Denmark.
The early phase of the research found the experimental vaccine to be safe. The study was conducted from 2020 through 2022 with individuals split between non-pregnant women and men, while none had chlamydia. The researchers examined and tested various dosages of the vaccine, they noted reported in The Lancet Infectious Diseases on Thursday.
During the trial, participants also got the vaccine through eye drops as a part of getting the shot in the arm. Phase 2 trial will look at the effectiveness of the shot.
The next phase still has to answer questions, especially with the research being in its infancy. “Does it confer the ability to hold off infection with chlamydia?” Dr. Hilary Reno, a professor of medicine at Washington University School of Medicine in St. Louis, told NBC News.
“We don’t know that and that’s what the next phase of studies would be,” Reno said.
Kenya Recalls J&J Children’s Cough Syrup Over Suspected Toxicity
Kenya’s drug regulator is recalling a batch of Johnson & Johnson (JNJ.N) children’s cough syrup, it said on Thursday, a day after Nigeria recalled the same batch of medication under the Benylin Paediatric brand.
Nigeria’s health regulator said laboratory tests on the syrup showed a high level of diethylene glycol, which has been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since 2022 in one of the world’s worst waves of poisoning from oral medication.
Kenya’s Pharmacy and Poisons Board (PPB) said in a statement it had commenced investigations and advised that sales of certain batches of the product be halted and returned to suppliers.
Pfizer Settles 12-Year-Old Lawsuit in Alleged Pay-for-Delay Scheme for $39 Million
In a case so old that it predates Pfizer’s 2009 acquisition of Wyeth, the companies and a class-action group of direct drug purchasers have agreed to settle an antitrust claim for $39 million.
The lawsuit, which was originally filed in 2011, contends that Wyeth conspired with Teva in a pay-for-delay scheme, to keep the Israeli drugmaker’s generic version of Wyeth’s antidepressant blockbuster Effexor XR off the market from June 2008 to June 2010.
At a New Jersey federal court on Wednesday, Pfizer and the buyers group — including Rochester Drug Co-Operative, Stephen L. LaFrance Holdings, SAJ Distributors and Uniondale Chemists — submitted their settlement proposal. Of the $39 million settlement figure, $13 million has been earmarked for lawyers representing the buyers.
Before it faced generic competition, Effexor XR was the top-selling antidepressant in the world. It generated $3.8 billion in revenue in 2008. As the first company to file a generic application for the product, Teva was provided a 180-day period of exclusivity that kept other generics off the market until it launched.
Pfizer acquired Wyeth for $67 billion in 2009, gaining other blockbuster products in the deal such as Enbrel and Prevnar.
