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RSV Vaccine: Moderna, Pfizer Start a New FDA Approval Race
The COVID vaccine is here to stay after a development process that broke the record books at both Moderna and Pfizer, but a new golden age of vaccines may only be at its beginning.
Both companies have released results from Respiratory Syncytial Virus (RSV) vaccine trials with efficacy results strong enough to expect expedited approval from the FDA. The latest was Moderna, which on Tuesday night shared results from its RSV vaccine trial of over 37,000 individuals in 22 countries, effective at preventing lower respiratory tract disease.
Pfizer, whose RSV vaccine is focused on pregnant women able to transfer the antibodies to the fetus and offer protection for the first six months of life, previously released efficacy results of approximately 82% for the first 90 days of a child’s life.
The companies — which have been involved in litigation brought by Moderna alleging mRNA patent infringement, a claim Pfizer disputes — are both expecting to be in the FDA approval process for their RSV vaccines relatively quickly.
A Celebrated ‘Vaccine Against Cancer’ Faces Lawsuits, Safety Concerns
On any given day at any given pediatrician’s or family physician’s office, you’re likely to find several young adults — tweens and teens — popping in for a Gardasil vaccine, which is intended to prevent infections from four strains of the human papillomavirus (HPV). These visits take just a few minutes of a nurse’s time. Then, since fainting is a common side effect of the vaccine, the patient is supposed to sit or lie down for 15 minutes to avoid injuries. Whether a practice follows this U.S. Centers for Disease Control and Prevention (CDC) observation guideline or not is usually up to the provider.
But now, a dozen lawsuits that have been filed in federal court allege that Merck, the vaccine’s manufacturer, failed to warn patients of the risks of the Gardasil vaccine adequately. These risks, according to the lawsuits, include autoimmune problems and neurological injuries.
The plaintiffs contend that Merck was negligent in the way it conducted its clinical trials to get the vaccine approved in the first place and then deliberately downplayed the vaccine side effects and ignored postmarket safety signals.
Among the highly troubling — and sometimes lethal — side effects that Merck has ignored are chronic fatigue syndrome, fibromyalgia, premature ovarian failure and postural orthostatic tachycardia syndrome.
Another Major HIV Vaccine Trial Fails
The only HIV vaccine in a late-stage trial has failed, researchers announced Wednesday, dealing a significant blow to the effort to control the global HIV epidemic and adding to a decadeslong roster of failed attempts.
Known as Mosaico, the trial was the product of a public-private partnership including the U.S. government and the pharmaceutical giant Janssen. It was run out of eight nations in Europe and the Americas, including the U.S., starting in 2019. Researchers enrolled nearly 3,900 men who have sex with men and transgender people, all deemed at substantial risk of HIV.
The leaders of the study decided to discontinue the mammoth research effort after an independent data and safety monitoring board reviewed the trial’s findings and saw no evidence the vaccine lowered participants’ rate of HIV acquisition.
“It’s obviously disappointing,” Dr. Anthony Fauci, who as the long-time head of the National Institute of Allergy and Infectious Diseases (NIAID) was an integral partner in the trial, said of the vaccine’s failure. However, he said, “there are a lot of other approaches” early in the HIV-vaccine research pipeline that he finds promising.
‘Not Right’ for Us to Be Key Global Health Funder — Gates CEO
It is not right for the Bill & Melinda Gates Foundation to play such a big role in global health funding, but the group will not back away until others step up, its chief executive said. The Gates Foundation has faced criticism that it has too much power and influence in the global health realm, including within the World Health Organization, without the requisite accountability.
In his annual letter released on Tuesday, chief executive Mark Suzman hit back at the criticism as he revealed that the foundation would spend $8.3 billion this year, its highest-ever annual budget.
Bill and Melinda Gates, the tech billionaires-turned-philanthropists who set up the foundation, have long defended their efforts amid questions over whether their vast payouts give them undue influence and impact on global development.
Alongside funding efforts to eradicate diseases like malaria and polio, the Gates Foundation is also the second biggest donor to the WHO, one of the issues that critics have regularly raised about its role, particularly during the COVID-19 pandemic.
Gene Drives Could Fight Malaria and Other Global Killers but Might Have Unintended Consequences
Every year more than 600,000 people die from mosquito-transmitted malaria, most of them children under age five. Some insects that are disease vectors, such as mosquitoes, are currently expanding their range around the world, bringing new threats. Genetic engineering can fix this by permanently altering insect genes through what is known as a gene drive.
This technology allows a chosen set of genes to alter an animal’s biology in some way, such as making them produce sterile offspring. The inability to reproduce then sweeps through a population, upending the laws of inheritance. The genes copy themselves exponentially from generation to generation, rapidly coming to dominate the whole population.
Potentially, their careful use might save millions of lives by making mosquitoes unable to transmit malaria or by eliminating the insects entirely. The possibility of a definitive solution to major infectious diseases makes a compelling case for such a techno-fix.
Animal Testing No Longer Required for Drug Approval. But High-Tech Substitutes Aren’t Ready.
For generations, people have associated the terms “lab rat” and “guinea pig” with scientific research. Animal testing remains a standard and has been required for drug approval. Just before Christmas, though, Congress ended the requirement that all new drugs must be tested in two species — usually mice and “higher order” mammals like rabbits or primates — before being tried in people.
The change won’t stop animal testing overnight. Research tools and computer algorithms developed over the last 10 to 15 years still have gaps. And regulators won’t immediately change their decadeslong approach to proving safety and effectiveness.
But the law officially called the FDA Modernization Act 2.0, marks a triumph in scientific research on human cells and technology and the culmination of 40 years of lobbying by animal rights activists.
Animal studies help provide a measure of security that a drug could be effective and probably isn’t extremely dangerous — but they’re not foolproof. Roughly 90% of drugs that are shown safe and effective in animals turn out not to work as planned in people. Occasionally, drugs that seem safe in animal testing turn out not to be.
AbbVie, Novartis and More Win National Coverage in China Even as Pfizer’s Paxlovid Gets Left Out
Once again, biopharma companies offered hefty discounts to secure national reimbursement in China in the hopes that wider coverage in a fast-growing pharmaceutical market can offset price concessions. This time around, some companies are walking away with more deals than others.
AbbVie’s inflammatory disease drug Rinvoq, Bristol Myers Squibb’s anemia therapy Reblozyl, multiple sclerosis meds from Biogen and Novartis, Roche’s oral spinal muscular atrophy treatment Evrysdi and Takeda’s next-generation hereditary angioedema treatment Takhzyro are among those 111 new entrants.
But some other closely watched products, including Pfizer’s COVID-19 oral antiviral Paxlovid, walked away without a deal with the Chinese government.
Pfizer to Sell All Its Drugs in Low-Income Countries at Non-Profit Price
U.S. drugmaker Pfizer Inc. (PFE.N) said on Tuesday it will offer its full portfolio of drugs, including off-patent medicines such as chemotherapies and oral cancer treatments, on a not-for-profit basis to 45 low-income countries in the world.
In an expansion of the company’s “An Accord for a Healthier World” program, which is aimed at increasing access to innovative treatments in some of the world’s poorest countries, Pfizer said it will now offer a total of 500 products.
When the drugmaker launched the program in May 2022, it offered only its patented medicines including COVID-19 treatment Paxlovid and its big-selling breast cancer drug, Ibrance, at a not-for-profit price.
