FDA chief wary of federal recommendations for Covid-19 vaccines
Dr. Marty Makary, commissioner of the FDA, on Sunday made it clear he was dubious of previous federal recommendations on Covid-19 vaccinations and the agencies who made them.
In an interview with host Margaret Brennan of CBS' "Face the Nation," Makary responded to repeated requests from Brennan to clarify federal guidance (or the lack thereof) with variations on the same answer. "We believe the recommendation should be with a patient and their doctor," he said at one point, declining to give specific advice — or specifying how doctors might be able to offer guidance in the absence from direction from the federal government.
Brennan was seeking clarity from Makary in the aftermath of Health and Human Services Secretary Robert F. Kennedy Jr.'s announcement that Covid-19 vaccines would no longer be recommended for healthy children and pregnant women. The CDC subsequently offered updated advice that somewhat countered what Kennedy said but also left room for interpretation.
Makary there needed to be more controlled studies, so that decisions to approve vaccines would be more authoritative.
The CBS host tried to get Makary to say what was lacking in the current data for such vaccines, and when that information might be available to the agency, as well as the general public.
In his answers Sunday, Makary was not supportive of past guidance, criticizing the methodology of the CDC.
"We know the CDC data is contaminated with a lot of false positives from incidental positive Covid tests with routine testing of every kid that walks in the hospital," he told Brennan.
Makary also cast doubt on the CDC's Advisory Committee on Immunization Practices. "That panel has been a kangaroo court where they just rubber-stamp every single vaccine put in front of them," he said.
At the time he was nominated in November, Makary was a Johns Hopkins surgeon who was best known for his criticism of the Biden administration's response to Covid, something for which Kennedy was also known. Trump said Makary was needed because "the FDA has lost the trust of Americans." Makary, he said, would "course-correct" the agency.
On Sunday, when it came to discussing the shots and pregnant women, Makary was a model of consistency in his contention that the decision was a personal matter between a patient and her doctor. Brennan and Makary had this exchange:
Brennan: "It is still unclear what pregnant women now should do until they get the data that you say."
Makary: "I'd say talk to their doctor."
Brennan: "When do they get the data you're promising? All these controlled studies."
Makary: "In the absence of data, they should talk to their doctor ..."
Brennan: "So no date?"
Makary: "... and their doctor will use their best wisdom and judgment."
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Medscape
28 minutes ago
- Medscape
Wildfire Smoke Linked to Respiratory Admissions in Seniors
Among older adults in the western United States, exposure to high concentrations of smoke-related fine particulate matter (PM2.5) was associated with increased rates of hospitalizations for respiratory diseases, with weaker but suggestive ties to cardiovascular hospitalizations. METHODOLOGY: Researchers carried out a retrospective cohort study to analyze the association between exposure to smoke-specific PM2.5 and cause-specific hospitalizations in older adults in the United States. They used inpatient claims data of 10,369,361 Medicare beneficiaries (mean age, 74.7 years; 53.1% women) across 11 western United States during wildfire seasons from 2006 to 2016, with 57,974,120 person-months of follow-up. The causes of unscheduled hospitalizations were inferred from International Classification of Diseases, Ninth Revision, Clinical Modification codes and classified into various disease categories. codes and classified into various disease categories. Daily concentrations of surface-level smoke-specific PM2.5 were estimated through machine learning models that utilized ground measurements, satellite data, and reanalysis data sources. The associations between causes of hospitalization and smoke-specific PM2.5 were characterized by examining daily county-level rates of unscheduled hospitalization by disease category, modeling hospitalization rates according to same-day and prior-week smoke-specific PM2.5 exposure. TAKEAWAY: The leading cause of unscheduled hospitalizations was cardiovascular disease, with a mean daily rate of 7.92 per 100,000 persons, followed by digestive system disease at 3.62 and respiratory disease at 3.53 per 100,000 persons. Respiratory hospitalizations increased as smoke-specific PM2.5 exceeded 25 μg/m 3 , with average daily rates increasing by 2.40 (95% CI, 0.17-4.63) per 100,000 persons when PM2.5 levels rose from 0 to 40 μg/m 3 over a week. , with average daily rates increasing by 2.40 (95% CI, 0.17-4.63) per 100,000 persons when PM2.5 levels rose from 0 to 40 μg/m over a week. Hospitalizations due to cardiovascular diseases were unrelated to smoke-specific PM2.5 at exposure levels < 20 μg/m 3 but showed an increasing trend at higher concentrations. but showed an increasing trend at higher concentrations. No significant associations were seen for hospitalizations related to injuries, digestive issues, neuropsychiatric conditions, or endocrine disorders. IN PRACTICE: 'This information can be used by both policymakers and clinicians to design policies and guidelines to protect vulnerable older adults from the escalating health threats posed by wildfire smoke,' the authors wrote. SOURCE: This study was led by Sofia L. Vega, Harvard T.H. Chan School of Public Health, Boston. It was published online on April 30, 2025, in JAMA Network Open . LIMITATIONS: Estimating concentrations of smoke-specific PM2.5 proved challenging due to the lack of direct measurements. County-level exposure measures may not have accurately reflected the exposures experienced by individual residents. This study did not include information on wildfires from recent years when their intensity increased. DISCLOSURES: This study was supported by the Harvard Climate Change Solutions Fund and grants from the National Institutes of Health. One author reported receiving support through an environmental fellowship at the Harvard University Center. The authors reported having no conflicts of interest.
Yahoo
29 minutes ago
- Yahoo
Texas woman died after rinsing sinuses with infected tap water — here's how to keep yourself safe
A 71-year-old woman reportedly contracted a brain infection from using tap water — and died from it. Regardless of whether tap water is safe to consume where you live, experts advise against letting it go into your sinuses — or you risk being exposed to a brain-eating condition, like this unidentified woman. According to the CDC, if water contains amoeba — single-celled organisms — and it gets into a person's nose, it can travel to the brain and cause the fatal infection, commonly known as 'brain-eating amoeba' but the technical term for it is Naegleria fowleri, which is what most likely happened to this woman. Although the Texas Department of State Health Services claims that the sink water in the area is safe to consume, they believe the woman rinsed her sinuses from an RV's water system at a campground and was infected by Naegleria fowleri, as explained by the Daily Mail. The condition — typically found in warm water lakes and rivers — is rare, but it's deadly — killing almost 97% of people who contract it. The CDC reported 157 confirmed cases in the nation between 1962 and 2022. And reportedly, Texas is one of the few US states that has the largest number of amoeba cases. In addition to Texas, Florida has also fallen victim to this terrifying infection. In 2023, a Florida woman contracted the brain-eating infection the same way the Texas woman did — and died from it. 'The adult patient reportedly performed nasal rinsing daily with unboiled tap water, which is thought to be the source of the infection,' the CDC said in a statement to Fox 4. Symptoms of Naegleria fowleri start to show up about 15 days after a person has been exposed. They can range from a mild fever, headache, nausea and vomiting — to more severe ones like a stiff neck, confusion, lack of attention, loss of balance and seizures. Unfortunately, once a person has been exposed and severely infected — even with treatment, most will die from it. Regardless of where someone lives and the quality of their area's tap water — to avoid any potential exposure to this serious condition, experts recommend boiling water before rinsing sinuses with it or using distilled water, avoid going underwater in a bathtub or freshwater. It's also recommended to supervise children playing with sprinklers, and if you haven't been home in a few days, let water run for several minutes in sinks or showers to flush out stagnant water.


New York Times
32 minutes ago
- New York Times
Mets' Paul Blackburn returns looking better than ever in win over Dodgers
For the final time Monday night, New York Mets starting pitcher Paul Blackburn pulled from his scouting report on Shohei Ohtani, memories of first-hand experience from their shared time in the same division. Judging from how Blackburn pitched to Ohtani, it's likely the prep work strongly suggested to locate cutters up and in, offer changeups low and out of the strike zone. For the third time using that formula, Blackburn retired Ohtani, who hit a routine grounder with two runners on base to end the fifth inning. Advertisement Blackburn is typically reserved and soft-spoken. But after recording the final out of the fifth inning, which concluded his outing, he slapped his glove in triumph. While walking to the dugout with his head down, he briefly shouted to himself. Given Blackburn's path, some show of emotion, even for a 31-year-old veteran, seemed only natural. After waiting nine months since his last appearance in the major leagues, Blackburn blanked the Los Angeles Dodgers for five innings in the Mets' 4-3 win. Blackburn last pitched in a major-league game on Aug. 23, 2024. In that game, he was struck by a comebacker and landed on the injured list. From there, he missed the rest of the 2024 season due to a spinal leak in his back. He did not know if he would pitch again. After surgery, however, he entered spring training as a healthy player. Then came what he said was the worst part: right knee inflammation in late March resulting in a trip to the injured list, where he stayed until Monday (along the way, he also got sick, delaying an earlier return). 'For him to be out there after so much time that he missed, unbelievable job there,' Mets manager Carlos Mendoza said. Welcome back, Blackburn!@moomooApp | #LGM — New York Mets (@Mets) June 3, 2025 In line with the overall upswing of the Mets' pitching staff this season, Blackburn returned looking better than before. Despite being sidelined, Blackburn gained movement on all of his pitches. Also, he pitched smarter, and not just against Ohtani, who struck out twice against him. Blackburn leaned on his cutter, curveball and changeup. He did not throw a single four-seam fastball, a pitch he used to throw about 20 percent of the time. He didn't throw a four-seamer in his final rehab appearance, either. That is not a coincidence. The thinking for Blackburn and the Mets is, why should he mess with throwing a four-seamer, a pitch batters slugged .694 in plate appearances that ended against it last season, when his cutter is good? Advertisement Under pitching coach Jeremy Hefner's guidance, the Mets' pitching staff owns the best ERA (2.88) in MLB. They are rolling to such an extent that they didn't merely survive by plugging in a sixth starter making his season debut against the defending World Series champion — they succeeded. Blackburn, who attacked the strike zone and pitched efficiently, allowed just three hits and a walk with three strikeouts. The Mets called on Blackburn to give their starters, notably Kodai Senga, an extra day of rest while in a stretch of 10 straight games. His stay in the rotation is not expected to last longer than Monday. He is likely to slide into a long relief role. 'There's a good chance he goes back to the bullpen for now, and we'll go from there,' Mendoza said. Even after a strong first start back, the Mets don't need Blackburn in the rotation. New York Mets president of baseball operations David Stearns' pitching plan is working. Stearns went into last offseason with a preference on adding to his starting pitching depth. He steered away from long-term contracts, didn't last long in the most expensive aisle for pitchers during free agency. The Mets (38-22) have played all season without Sean Manaea and Frankie Montas, their two top pitching acquisitions from the winter. Montas, who has made two rehab starts, may return by the end of June and Manaea is behind him after just recently starting to face batters. Blackburn said he is willing and ready to pitch in whatever role the club needs. 'I'm not blind to the guys who are coming off the IL here soon,' Blackburn said. The downside of relying on depth in the way the Mets do is they will likely need to make roster moves for their bullpen. With six starters, even temporarily, the bullpen is down a pitcher until Blackburn is rested enough to appear in relief. After a 10-inning game on Monday, it would likely be challenging to get through the next six games before the next off day without fresh arms. The Mets are proving that the upside, at least right now, is hard to argue against. (Jason Parkhurst/Imagn Images)