The FDA did a very unusual thing this week: It included photos from a recent unannounced inspection of an Indian drug manufacturer in its Warning Letter to the company - the first time I believe it's ever done so. Would you believe this is from a drug manufacturer?

Here is a link to slides I will present today at Options XIII Conference for Control of Influenza meeting: slides.com/jbloom/options202… Slides describe using sequencing-based neutralization assays to characterize human neutralizing antibody landscape to seasonal influenza virus in near real time. Measurements are informative for vaccine strain choice. Our latest data from last few weeks identifies emerging variants of seasonal H3N2 & H1N1 to which current human sera has reduced titers. These include H3N2 subclade K variants w V223I, and H1N1 subclade D.3.1.1 variants including w G155E. All raw data along with interactive visualizations are available at links in the slides. The section on our latest unpublished data starts on slide 19.

“Don’t be such a chicken squat. Get out there and get your shot.” -- Dolly Parton Dolly Parton didn't just use her voice to encourage vaccination, she helped support the science behind it. In April 2020, Dolly donated US$1 million to Vanderbilt University Medical Center for COVID-19 research, creating the Dolly Parton COVID-19 Research Fund. The fund supported researchers involved in the early testing of Moderna’s mRNA vaccine. Then, in March 2021, she rolled up her own sleeve at Vanderbilt to receive the Moderna vaccine herself, using the moment to encourage others to get vaccinated too. Today we remember Dolly not only for the joy she brought to millions, but for the role she played in advancing vaccine research and encouraging others to get protected.

#H5N1 ➡️ Live H5N1 Was Isolated from Fetal Bovine Serum in a Finding That Puts Laboratory Biosafety Under New Scrutiny - Researchers at Cornell University ➡️ isolated live, infectious H5N1 avian influenza virus from ➡️ a commercial lot of fetal bovine serum, ➡️ the growth supplement used in cell culture laboratories worldwide, in a report published in the August issue of the CDC journal Emerging Infectious Diseases. - The finding matters to a specific audience, and it is worth stating plainly who that is. This is a laboratory biosafety and manufacturing quality-control story, not a consumer exposure story. No pasteurized dairy product, retail meat item, or medical treatment is implicated. The people whose practices may change are diagnosticians, cell culture technicians, biomanufacturing staff, and the institutional biosafety committees that write their protocols. - The detection also carries one immediately reassuring result. Heating the serum to 56 degrees Celsius for 30 minutes, a step already built into many commercial serum products and lab protocols, inactivated the virus in the authors' experiments. - Routine Screening at Cornell Caught the Contaminated Lot - The lot arrived at the Virology Laboratory of the Cornell Animal Health Diagnostic Center in February 2025 for routine extraneous agents testing, a screening requirement under federal regulations governing biological products of animal origin. It was not submitted because anyone suspected contamination. - ➡️ Sequencing identified the virus as highly pathogenic avian influenza A(H5N1) clade 2.3.4.4b, genotype B3.13, the lineage that has been circulating in U.S. dairy cattle since March 2024. As of mid-December 2025, more than 1,084 herds in 19 states had been affected, with most concentrated in California. - The ➡️ tested lot was a pool of samples collected in five states: Pennsylvania, Kansas, Nebraska, South Carolina, and California. That detail is the load-bearing one for anyone assessing risk in their own supply chain, and it is addressed below. - Serum Is a Pooled Product, and That Matters - Fetal bovine serum is collected from bovine fetuses at slaughterhouses and is, in the paper's own framing, the most frequently used growth supplement in cell culture media. It is commonly added to basal media at concentrations of about 5-10% and supports a wide range of cell types in academic research, pharmaceutical development, and biomanufacturing. - Because it is pooled from many animals, a single infected donor can contribute a large amount that is subsequently widely distributed. ➡️ The Cornell team followed the positive lot with broader testing, screening individual serum samples collected at slaughterhouses in California and Texas, 384 from each state. ➡️ Of those 768 samples, one tested positive by real-time reverse transcription PCR, at a cycle threshold of 35, indicating a low viral load. - ➡️ The authors interpret that pattern as consistent with sporadic viremia in infected lactating dairy cattle, allowing the virus to reach tissues beyond the udder, including, on rare occasions, the fetus. Follow-up testing of 13 additional bottles from the same original lot, eight of them not heat-inactivated and five heat-inactivated, is documented in a summary table accompanying the paper, using virus isolation in two cell lines, embryonated eggs, and PCR. Detection was infrequent even by PCR, and attempts to confirm virus isolation at USDA's National Veterinary Services Laboratories were not successful, which the authors take as evidence of very low viral loads in the pooled lot. - Heat Treatment Cleared the Virus in Laboratory Tests - The inactivation experiment is the part with an actionable conclusion. Serum aliquots were spiked with bovine H5N1 at high titer and heated. The authors report that ➡️ heating at 56 degrees Celsius for 30 minutes inactivated the virus, and they conclude that although finding a zoonotic virus in serum raises biosafety concerns for diagnostic testing of bovine serum and for laboratory procedures using it, ➡️ "heat treatment of FBS seems to be efficient in inactivating the virus" and could serve as a safety precaution. - That temperature and duration are not novel. Commercial suppliers, including ATCC, publish 56 degrees for 30 minutes as the standard heat-inactivation protocol, and heat-inactivated serum is sold as a distinct product line. The complication is that ➡️ heat inactivation is not a universal practice because suppliers caution that it is unnecessary for many cell lines and can degrade heat-labile growth factors that some cells require. - The result also aligns with earlier work. Heat inactivation of H5N1 in raw cow's milk was examined in a report in the New England Journal of Medicine, part of a broader body of research into how thermal treatment affects this virus in bovine-origin material. = Consumers Are Not the Audience for This Finding - Several limitations go hand in hand with the headline result. This is a single documented lot, identified through routine surveillance rather than through any adverse event. No laboratory-acquired infection has been reported in connection with it. The authors note that their findings and conclusions do not necessarily reflect the official positions of the agencies involved, and that one co-author is affiliated with USDA's Animal and Plant Health Inspection Service. - The paper does not establish how often serum lots are contaminated because it was not designed to. Nor does it demonstrate that anyone has been infected through this route. It documents that a live virus survived in a commercial biological product and that a widely available treatment step neutralized it under laboratory conditions. - What laboratories and biomanufacturers may reasonably reconsider is whether their current serum sourcing, screening, and heat-treatment decisions account for a pathogen that was not circulating in U.S. cattle three years ago. Institutional biosafety committees, not individual bench scientists, are typically the right level for that review. ➡️ Facilities working with bovine-origin material should confirm what their supplier tests for and whether their lots are heat-inactivated. = The broader surveillance question remains open. Continued monitoring of H5N1 in dairy cattle and of the animal-origin products the herds feed into is tracked through the CDC journal's influenza research collection. ➡️ Whether contamination of serum proves to be rare or more common than a single lot suggests will depend on testing that has not yet been reported. By Cole Mercer medicaldaily.com/h5n1-fetal-…

Bird flu puts one in five Australian bird & mammal species at risk "“..the sheer scale of disaster, even the pelican & ibis are at very high risk, all but one species of penguin is at high risk. Even the cassowary. It is hard to grasp the scale of this tragedy...This will hit all over the continent.” #H5N1 smh.com.au/environment/conse…

On @CNNSOTU with @DanaBashCNN this morning. I said three things: 1. Political leaders are accountable for public health decisions, not the scientists who advise them 2. The vaccine-autism question has been studied for 25 years. The answer hasn't changed: there is no link 3. Right now too many kids are getting measles that vaccinations prevent, too many people are getting cyclospora that better tracking prevents, and ranchers are losing cattle to a pest we eliminated from this country in 1966. Three outbreaks at levels we haven't seen in years. None of them are coincidence. Stick around for the end — my view on COVID origins.

I’ve spent a few years raising awareness and helping others with their own personal advocacy.   Almost 2 years fundraising to help supplement income, and to pay for billboard campaigns etc.   I have pestered governments, healthcare leaders, and education officials for years, I’ve sang parody songs, made videos, did stunts, appeared on the news, on the radio, in newspapers, and have helped people as best I can when they need it.   I have been fundraising to continue my efforts until I can get full time work again, but there are barriers to finding employment when you are as loud as I am and when the topic is Covid.   Plenty of reasons to give up and shut up, but even with constant attacks, financial ruin, daily ridicule, and even death threats I will try to keep going as long as I can to raise awareness and help others.  I think being a noisemaking advocacy assistant is a good idea, and if you do too and want to help a share goes a long way, and no amount is too small. YerAweSum   gofund.me/f7437a4d9 Paypal: 80ssummercamp@gmail.com Highlight Reel.