RSV Vaccines From Pfizer, GSK Take Another Hit With New FDA Warning Mandate
The U.S. Food and Drug Administration will require GSK and Pfizer to include on the label of their respiratory syncytial virus, or RSV, vaccines a warning about the risk of developing Guillain-Barré syndrome, a rare neurological condition that can cause paralysis. The ruling will affect GSK’s Arexvy and Pfizer’s Abrysvo, both of which were approved by the agency in May of 2023 for adults 60 years or older and realized booming sales in their first year on the market.
Seven months ago, however, the sales potential for both shots declined significantly when the Centers for Disease Control and Prevention recommended that they only be used by adults aged 75 and older and those 60 and older who have a high risk of severe disease due to underlying medical conditions.
Ozempic May Be Linked To Cause of Sudden Blindness, Another Study Shows
A new study has found that semaglutide, the active ingredient in the popular weight loss drugs Ozempic and Wegovy, may be linked to a type of sudden vision loss called non-arteritic anterior ischemic optic neuropathy. The study, which hasn’t been published in a peer-reviewed journal, is the second to suggest a link between semaglutide and the condition, a small vessel “stroke” of the optic nerve that usually leads to permanent blindness.
There are about 6,000 new cases every year. Experts said, however, that the new research shouldn’t necessarily dissuade people from trying semaglutide or other glucagon-like peptide-1 (GLP-1) agonists, a class of medications that also includes the diabetes and weight loss drugs Zepbound and Mounjaro.
Merck’s GARDASIL Receives Expanded Approval for Males in China
Merck, known as MSD outside of the U.S. and Canada, today announced that the National Medical Products Administration (NMPA) of China approved GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases.
The approval makes GARDASIL the first HPV vaccine approved for use in males in China. GARDASIL is now indicated in China to prevent anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11 and the following precancerous or dysplastic lesions caused by HPV Types 6, 11, 16 and 18: grade 1, grade 2 and grade 3 anal intraepithelial neoplasia.
“The approval of GARDASIL for use in males 9-26 years old in China is a significant step forward in advancing public health,” said Joseph Romanelli, president, Human Health International, Merck. “Since first approval, our HPV vaccines have helped protect over 50 million females in China from certain HPV-related cancers and diseases. With this expanded approval, we look forward to helping protect this new population of Chinese males from certain HPV-related cancers and diseases.”
More Minnesota Kids Get Exempted From Required Vaccinations. Here’s What’s Happening
Vaccination rates for school-aged children have declined in Minnesota and across the nation as more families seek to exempt their kids from required vaccinations. Medical professionals say those exemption counts are near the point where Minnesotans should be extremely concerned, especially when it comes to schools. In 2024, Minnesota cases of pertussis, a highly contagious disease also known as whooping cough, hit an eight-year high. The Twin Cities last year also saw a measles outbreak as the immunization rate for the MMR — measles, mumps and rubella — vaccine continues to drop. Without a critical mass of immunized kids, children at schools and childcare operations can be more vulnerable to diseases, including measles and chickenpox, that are preventable.
Over the last decade, medical exemptions for required vaccinations have stayed relatively the same. These are exemptions that have been confirmed by a doctor.
Nonmedical exemptions — which anyone can seek on religious, moral, ethical or philosophical grounds — have been on a steady increase with a noticeable spike in 2020 during the COVID-19 pandemic. Overall, these exemptions have gone up a few percentage points with the MMR vaccines seeing the most exemptions.
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A Vaccine To Prevent Weight Gain? It’s on the Horizon
This time of year, millions of people turn to diets, exercise and medication to help them get their weight in check. New University of Colorado Boulder research suggests another surprising tool that could help them achieve their resolution: Exposure to beneficial bacteria. The study, published in the journal Brain, Behavior, and Immunity, shows that animals injected weekly with a microorganism found in cow’s milk and soil were essentially immune to weight gain from a high-fat, high-sugar diet.
“What is so striking about this study is that we saw a complete prevention of diet-related weight gain in these animals,” said senior author Christopher Lowry, professor of integrative physiology. “This suggests that exposure to beneficial bacteria can protect us against some of the negative health outcomes of the typical Western diet.”
Pfizer, PhRMA Rank Among Groups Pledging Funding for Trump’s Inauguration: NYT
From condemning the Jan. 6 Capitol riots to helping fund the president-elect’s impending inauguration, recent years have seen biopharma leaders learn to embrace a “live and let live” mentality when it comes to Donald Trump. Now, Pfizer and the trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, rank among the organizations that have helped Trump raise a record-setting $150 million in pledges to fuel this month’s inauguration festivities, The New York Times reported over the weekend, citing sources tied to the fundraising efforts.
All told Trump’s allies have raised more than $200 million in pledges since the November election in a bid to help fund not only the inauguration but also Trump’s broader political operation and, eventually, his presidential library, the NYT explained. The zeal behind the pledged donations signals an attempt by allies and corporate interests to win favor with Trump ahead of his second term, the newspaper points out.
Last Year’s Flu Vaccine 41% Effective in Preventing Medically Attended Influenza, Data Show
Last year’s seasonal flu vaccine was 41% effective in preventing medically attended flu but offered significantly more protection against infections caused by influenza B compared to those caused by either influenza A (H1N1) or A (H3N2). The findings were published yesterday in Clinical Infectious Diseases, and are based on outcomes seen among outpatients ages 8 months and with acute respiratory illness in seven states: Arizona, Michigan, Missouri, Ohio, Pennsylvania, Texas and Washington. Polymerase chain reaction testing was used to determine influenza positivity and which type of strain was causing infections.
Patients were tested for flu if they reported worsening cough over the past seven days, among other symptoms. Vaccine effectiveness was estimated with a test-negative design comparing odds of testing positive for influenza among vaccinated versus unvaccinated participants, the authors said.
Costs for US Adult, Kids’ Vaccines Rose at Different Rates in Recent Decades
Each year from 2001 to 2023, average inflation-adjusted private-sector vaccine costs in the U.S. climbed 0.9% for children and 1.4% for adults, while costs of vaccines contracted through the Centers for Disease Control and Prevention (CDC) increased 0.9% and 1.0%, respectively.
These findings, from a CDC study published late last week in Vaccine, call into question the common assumption that inflation-adjusted vaccine costs over time are constant, the authors say.
The team analyzed private-sector and CDC-contracted vaccine cost data using the CDC Vaccine Price List converted to 2023 dollars to adjust for inflation. They also calculated the annual percentage changes in costs for each vaccine.
After Tough Year, Moderna CEO Confronts Challenges for RSV, COVID Businesses in Shareholder Letter
With COVID-19 vaccine sales in the doldrums and a respiratory syncytial virus (RSV) vaccine market in “contraction,” Moderna CEO Stéphane Bancel had the unenviable task of trying to put a positive spin on a sharp stock decline in his annual shareholder letter. After an unexpectedly limited RSV vaccination recommendation from the Centers for Disease Control and Prevention resulted in a “contraction” in the U.S. market, Moderna will adjust its financial reporting traditions to exclude products in their launch year, Bancel said Monday in his annual letter to shareholders.
The company was “too optimistic about our ability to break into the market given the headwinds from a midyear approval and launch,” the Moderna CEO wrote about the RSV launch. “We are taking those learnings to heart and going forward, we will not include revenue from products in their launch year in our financial framework,“ he added.
Stat+: Scribe Therapeutics Becomes Latest CRISPR Company To Announce Layoffs
Scribe Therapeutics has laid off just under 20% of its staff, the company confirmed to STAT on Wednesday, joining a slate of CRISPR gene editing companies to cut staff amid a prolonged downturn for the field.
Co-founded by CRISPR pioneer and Nobel laureate Jennifer Doudna, Scribe was among a second generation of gene editing companies to emerge in the late 2010s. It promised to use engineering principles and a new CRISPR enzyme, called CasX, to create better and safer gene editors than those of other companies. The company’s work on CasX attracted partnerships from Sanofi, Eli Lilly and Biogen at a time when few large companies were investing heavily in gene editing.
