TRACKING EMERGING VIRUSES – July 2, 2025 – Covid
“The Food and Drug Administration’s top vaccine official rejected broad uses of two Covid vaccines, citing unknown risks or injuries despite assurances of safety from dozens of staff experts, newly released documents show.
The decisions by the official, Dr. Vinay Prasad, the agency’s new chief medical and scientific officer, stunned agency veterans. Records show that the F.D.A.’s vaccine staff members had signed off on approving the Novavax vaccine, an alternative to mRNA shots and weeks later on the next-generation of the mRNA Covid shot by Moderna for anyone 12 and older.”
“His decisions were part of a broader F.D.A. reversal of years of Covid vaccine policy announced in May by Dr. Prasad and Dr. Marty Makary, the agency commissioner. The changes mean that doctors will have to write so-called off-label prescriptions for younger people who want protection from the virus, which experts said could be a barrier for some patients.” (1)
“The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.
“Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue.
In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. While the FDA can mandate label changes, the process is often more of a negotiation with companies.”
“The FDA’s labeling change appears to conflict with some prior findings of scientists elsewhere in the U.S. government.
The Centers for Disease Control and Prevention previously concluded there was no increased risk of myocarditis detected in government vaccine injury databases for COVID-19 shots dating back to 2022. Officials also noted that cases tend to resolve quickly and are less severe than those associated with COVID-19 infection itself, which can also cause myocarditis.” (2)
“Moderna is preparing to test Health Secretary Robert F. Kennedy Jr.’s tougher vaccine policies with a combination flu-COVID shot.
“The question is whether it gets approved for both viruses.
Why it matters: The company this week reported positive late-stage safety and efficacy results for a flu shot called mRNA-1010 that would provide the basis for the combo jab.
That poses a quandary for regulators, who could treat it like another seasonal flu shot for the general population or apply heightened scrutiny and require additional studies, the way they’ve done for new COVID boosters.”
The intrigue: Food and Drug Administration commissioner Marty Makary and his top vaccine regulator, Vinay Prasad, have said flu shots should be widely recommended for all age groups. But they’ve limited COVID vaccine to certain age groups or high-risk individuals.”
“Makary has previously said that the flu vaccines have been tried and tested for over 80 years while the COVID vaccine has been around for four and underwent minimal testing.” (3)
Updated COVID-19 vaccines are keeping up with new coronavirus strains and remain effective for keeping people out of the hospital, a new study says.
““These findings reinforce the importance of staying up to date with recommended vaccines, particularly for our older and more vulnerable patients as the virus continues to evolve,” he said.
These findings come as government actions have placed roadblocks in the way of updated COVID vaccines.
In May, the U.S. Food and Drug Administration (FDA) announced that it won’t approve updated COVID vaccines for the general public unless they’ve been subjected to placebo-controlled trials.
Later that month, Health and Human Services Secretary Robert F. Kennedy Jr. said that the U.S. Centers for Disease Control and Prevention (CDC) would no longer recommend the COVID vaccine for healthy children or healthy pregnant women. The CDC’s website has not been updated to reflect Kennedy’s orders.” (4)
A new sub-variant of COVID-19, known as “Nimbus,” is spreading rapidly across the United States, presenting with atypical symptoms that differ from those commonly associated with the virus.
The NB.1.8.1 sub-variant of Omicron is noted for its ability to adhere to and infect cells effectively.
According to symptom trackers, the primary symptom of this variant is a hoarse voice accompanied by a severe sore throat, described as a “razor blade sensation.”
Dr. Stephen Blatt, an infectious disease specialist at Ohio’s TriHealth, emphasized the importance of recognizing these symptoms.
“Lots of us don’t associate a sore throat with this virus,” said Dr. Blatt. “For those people who are at risk, the virus hasn’t gone away, and they still have to respect it.”
In addition to respiratory symptoms, the Nimbus variant is causing gastrointestinal issues such as nausea, vomiting, diarrhea, bloating, constipation, heartburn, and stomach pain. Traditional COVID-19 symptoms like coughing, sneezing, and respiratory problems remain prevalent and are still leading to intensive care admissions, particularly among individuals with pre-existing health conditions.” (5)
“In the past, as new variants have come on the scene, there almost invariably have been questions about distinctive symptoms, and after a while, when you gather a lot of data, turns out not to be the case — all of these symptoms have occurred before,” said Dr. William Schaffner, a professor of preventive medicine in the department of health policy at Vanderbilt University Medical Center in Nashville, Tennessee.” (6)
“The percentage of US adults reporting high confidence in the Centers for Disease Control and Prevention (CDC) fell from 82% in February 2020 to 56% in June 2022, along with decreasing trust in other US health institutions, according to a study yesterday in PLOS Global Public Health.” (7)
“Keeping tabs on COVID-19 outbreaks is as easy as tracking a city’s wastewater, a new study says.
Levels of the COVID virus, SARS-CoV-2, found in wastewater samples accurately predicted by a week the rise and fall of case counts in a community, researchers reported June 23 in the The Journal of Infectious Diseases.
“We learned during 2020 that rising SARS-CoV-2 virus in wastewater provided a two-week heads up of coming COVID visits to hospitals and clinics,” senior researcher Dr. Timothy Schacker, a professor of infectious diseases at the University of Minnesota Medical School, said in a news release.
“This ongoing work demonstrates the continued importance of wastewater surveillance to public health planning for our state’s hospitals and clinics,” he added.
For the study, researchers took 215 wastewater samples from the Twin Cities Wastewater Treatment Plant between January 2022 and August 2024.” (8)
“Researchers found that when there is an increase in the levels of fungal spores in the air, there is also an increase in cases of illnesses like COVID-19. This correlation suggests that air monitoring systems could be an effective form of public health used to warn people of rising risks of respiratory viruses.
“By monitoring the air we breathe, we may be able to better forecast and prepare for seasonal outbreaks of respiratory viral infections,” said Félix E. Rivera-Mariani, presenting study author and associate professor of Biochemistry and Special Topics in Biology at Lynn University, in a press release. “These findings may help inform environmental risk alerts, particularly for vulnerable populations like the elderly or those with asthma and allergic rhinitis.”
For this study, researchers were interested in learning more about the relationship between environmental exposures and respiratory viral infections. Environmental exposures include things like fungal spores and pollen that can potentially play a role in triggering respiratory illnesses like COVID-19.” (9)
“5 years later: What went right and wrong in the COVID-19 pandemic”, https://www.9news.com/video/news/health/5-years-later-what-went-right-and-wrong-in-the-covid-19-pandemic/73-bb748bf8-834b-4e8a-a2e4-f5f42db9cf48
“After recent moves by the U.S. Department of Health and Human Services to restrict the approval and use of some vaccines — and signs that more changes might be coming — some states and private partnerships are scrambling to ensure that vaccines will still be available to those who want them.
People familiar with various efforts that are underway described them as necessary but not ideal.
“When you start splintering the message from the federal government down states and local health departments, people end up losing faith in everybody. They don’t know who to believe,” said one official familiar with several ongoing efforts who spoke on the condition they not be named because they weren’t authorized to share the details of those plans.
Several groups, for example, are working to create panels of subject matter experts who would review the latest science behind vaccines and make evidence-based recommendations for their use, much like the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, has done for the past 60 years.” (10)
“During the worst of COVID-19, our intensive care unit overflowed. Rooms weren’t enough, so we made beds in the halls. Personal protective equipment was rationed and reused. Families said goodbye over the phone. We worked through everything because we had to. And one of the hardest things I remember wasn’t the chaos. It was the patients who waited too long to believe. There wasn’t just one. There were many. Patient after patient, strapped into BiPAP machines that sealed over their faces, forcing oxygen into lungs that could no longer function on their own. Eyes wide with panic. Mouths dry from the pressure. Every breath a battle. Over and over, I would hear the same thing. They would take the mask off for just a few seconds, which was all they could spare, and ask me the same question. “Can I get the vaccine now?” Each time, I had to tell them no. I’m sorry. It’s too late. Your body won’t have time to build immunity now. And I would help them put the mask back on, because oxygen couldn’t wait for explanations. Some nodded. Some cried. Some didn’t speak again. These weren’t one-offs. This wasn’t rare. It became routine. We heard that question more times than I can count. People who had refused the shot. People who said it was political. People who didn’t think they were at risk. Now they couldn’t breathe, couldn’t eat, couldn’t rest, couldn’t survive without machines. And they realized, just in time to ask for help, that the help they needed had come too late. The BiPAPs were loud, heavy, relentless. It’s not like wearing an oxygen mask. It’s air pushed into your body at high pressure, around the clock. Your face is strapped in. You can’t talk. You can’t sleep. You panic, and there’s no way to pull away. That’s what not sick enough to be intubated yet looks like. I’m not writing this to shame anyone. I’m writing it because we were the ones in the room when it mattered. We were the last people some of these patients saw. We heard their final questions. And someone needs to carry those forward. They weren’t bad people. They were scared. They were misled. They were failed by the noise, the spin and the systems that made them doubt what could have saved them. If you still think this can’t happen to you, think again. COVID-19 isn’t gone.” (11)
(1)Top F.D.A. Official Overrode Scientists on Covid Shots, By Christina Jewett, https://www.nytimes.com/2025/07/02/health/fda-covid-vaccines.html?smid=nytcore-ios-share&referringSource=articleShare
(2) FDA requires updated warning about rare heart risk with COVID shots, By MATTHEW PERRONE, https://apnews.com/article/covid-vaccines-heart-myocarditis-warning-07103a53236cb715400aac0608e27dab
(3) Moderna’s flu-COVID combo shot will test RFK Jr.’s vaccine regulators, by Tina Reed, https://www.axios.com/2025/07/02/moderna-flu-covid-vaccine-rfk-regulations
(4) Updated COVID Vaccines Effective Against New Strains, By Dennis Thompson, https://www.cnbc.com/2025/06/30/modernas-flu-vaccine-shows-positive-trial-results-paving-way-for-combo-shot.html
(5) New COVID-19 sub-variant may cause ‘razor blade sore throat’, by Liz Bonis, https://local12.com/health/health-updates/new-covid-19-sub-variant-nimbus-spreads-unusual-symptoms-cincinnati-hoarse-sore-throat-voice-vaccine-omicron-coughing-sneezing-respiratory-issues-breathing-flu-sick-ill-allergy-allergies-cdc-mild-severe-hospitalized-infected-complications
(6)“This Alarming COVID Symptom Is Everywhere With The Latest Variant. We Asked Experts What You Need To Know.”, by Jillian Wilson, https://www.buzzfeed.com/jillianwilson/razor-sore-throat-painful-covid-symptom
(7) New data underscore rise in CDC mistrust during pandemic, Jim Wappes June 27, 2025, https://www.cidrap.umn.edu/public-health/new-data-underscore-rise-cdc-mistrust-during-pandemic
(8) Wastewater Can Accurately Predict COVID-19 Surges, By Dennis Thompson, https://www.healthday.com/health-news/infectious-disease/wastewater-can-accurately-predict-covid-19-surges
(9) Can The Air We Breathe Predict The Next COVID-19 Surge?, By Stephanie Edwards, https://www.discovermagazine.com/health/can-the-air-we-breathe-predict-the-next-covid-19-surge
(10) With federal support uncertain, states and nonprofits scramble to safeguard access to vaccines, by Brenda Goodman, https://www.wxii12.com/article/states-vaccine-policy-changes-response/65250504
(11) “When you’re in the ICU with COVID-19, it’s too late to ask for the vaccine”, By Abby Ehrhardt, https://www.theolympian.com/opinion/article308840525.html
curated by Jonathan M. Metsch, Dr.P.H.
Clinical Professor of Environmental Medicine, Icahn School of Medicine at Mount Sinai