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Vox
10-07-2025
- Health
- Vox
What if IUD insertion didn't have to be so painful?
The appointment before she got her first intrauterine device, or IUD, Ana Ni's doctor asked about her pain tolerance. Low, she said; medium, if she's being generous. The clinic had just begun offering nitrous oxide, or laughing gas, to patients to help manage pain during IUD placements and, given the alternative — to undergo the procedure sans anesthetics — she gladly accepted. Before the insertion late last year, Ni, a 26-year-old health care consultant, took deep breaths of the nitrous oxide. She started to feel woozy. 'Initially you just feel relaxed,' she says, 'and then suddenly you get a bit of a head high, similar to when you would hit a vape. That kind of feeling, but intensify it more.' During the procedure, she continued to breathe the gas through cramping. Without the laughing gas, she suspects the pain would have been more acute. 'I know it's a short procedure,' Ni says, 'but I honestly cannot imagine it without the laughing gas.' Vox Culture Culture reflects society. Get our best explainers on everything from money to entertainment to what everyone is talking about online. Email (required) Sign Up By submitting your email, you agree to our Terms and Privacy Notice . This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. The reality is more complicated. Many patients felt they were lied to by their doctors whose only option for pain management was over-the-counter painkillers. Studies analyzing social media posts about IUD insertion found that almost all of them mentioned pain and discussed how this pain was minimized. Part warning, part public service announcement, these viral videos not only helped bring to light the real suffering patients were experiencing, but also shaped professional guidance regarding what pain management doctors should offer them. Within the past year, the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists (ACOG) released updated recommendations for pain management during IUD placement. Both suggest clinicians offer local anesthetics like lidocaine spray, lidocaine-prilocaine cream, and paracervical block — an injection of anesthetic around the cervix. Other providers are going further, offering anti-anxiety medications or general anesthesia. The most effective way to address pain is perhaps the most straightforward, and the most novel: talking to patients and hearing their concerns. While the ACOG guidance found insufficient evidence to support nitrous oxide use, Ni remembers her doctor telling her how it helped other patients. She had a similarly positive review; she says she'll request it again when she needs to replace her IUD. 'Unless there's some other medication then,' she says. 'But I feel like the laughing gas will suffice.' Over 6 million people in the United States currently use IUDs as contraception, and the evolving pain management standards around them show the medical establishment has moved to address women's pain — and how much more work is left to be done. Aside from having a slate of pain management options on offer, the most effective way to address pain is perhaps the most straightforward, and the most novel: talking to patients and hearing their concerns. The shifting standards around IUD procedures point to the ways doctors are only beginning to see patients as experts of their own bodies, and to take women's concerns seriously. 'This fits right into a movement that has really picked up steam, but I doubt is the norm across medical disciplines,' says Eve Espey, a professor and chair of the department of OB-GYN and family planning at the University of New Mexico. 'But if you approach patient care in that way — in thinking about what a patient might experience with a painful outpatient procedure — [it] would dovetail very nicely into that much more patient-centered approach.' A history of pain in gynecology Intrauterine devices are a form of long-acting birth control that have grown in popularity over the last 30 years, especially among those between the ages of 25 and 34. There are two categories of IUDs: copper and hormonal, both of which prevent sperm from fertilizing eggs. Part of the allure of IUDs is that, unlike the pill, which must be taken daily, an IUD is effective for anywhere from three to 10 years, depending on type. No upkeep, no prescription refills. Some users report less cramping and bleeding during periods and less endometrial pain; others stop getting their periods altogether. 'There's also some literature that says if you tell people that something's going to hurt, that it hurts more, which is true.' Although the insertion itself only takes a few minutes, there are multiple points of pain throughout the procedure. First, the medical professional inserts the speculum, an instrument that opens the vaginal walls, which can be painful for some patients. Then, using a device called the tenaculum, the provider will grasp the cervix to straighten and hold it in place. The depth of the uterus is then measured, which can cause cramping, and finally, the IUD itself is inserted. Espey has placed countless IUDs during her 37-year career as an OB-GYN. For a while, she'd outline the risks and benefits and answer any patient questions. But she wouldn't necessarily emphasize the potential for pain in order to avoid scaring patients. 'We just assumed that if somebody came in for an IUD, that they wanted it,' Espey says. 'It's not that we wouldn't describe the fact that it was painful — I did — but it's also a little tough, because there's also some literature out there that says if you tell people that something's going to hurt, that it hurts more, which is true.' The concern was IUDs would be too difficult and painful to place for anyone else. 'On average,' Epsey says, 'women who have had vaginal births, particularly recent vaginal births, have far less pain with IUD placement than women who have not or who have only had C-sections.' Birth control pills were the go-to contraceptive method for decades, Espey says. But as more evidence emerged about the safety and efficacy of IUDs for people of all ages with uteruses, guidance about who should get an IUD began to change in the 2010s. But even as more people — particularly those who had never given birth — began to get them, the perception that the procedure was only mildly uncomfortable persisted. Indeed, medical providers often rated their patients' pain during IUD placement as significantly lower than what the patients experienced. Women and gender-nonconforming people's experiences in medical settings have long been dismissed. In a 2018 review of scientific literature about gender biases in health care, men were seen as 'stoic' when it came to pain, while women were perceived as being more sensitive to pain and 'hysterical.' Hysteria was a popular medical diagnosis for centuries, almost exclusively used to refer to women. The diagnosis was used to classify women as having a mental disorder associated with sexual and social repression and weak character. Women and gender nonconforming people's experiences in medical settings have long been dismissed. The field of gynecology has similarly nefarious origins. The 'father of modern gynecology,' James Marion Sims, developed gynecological practices by experimenting on enslaved women without anesthesia based on the false stereotype that Black people have higher pain thresholds. Amid the eugenics movement of the 1900s, those with low incomes, people of color, and people with disabilities underwent forced sterilizations. Even as late as the 1990s, contraceptive implants were marketed toward low-income Black communities as a means of controlling reproduction of those deemed unfit or unworthy of parenthood. 'I'm an OB-GYN,' says Ashley Jeanlus, a board-certified OB-GYN in Washington, DC, 'but I'm also not very naive that historically and to modern times, how we take care of patients isn't always patient-centered.' The recent CDC and ACOG pain management guidelines are a welcome change, Jeanlus says. 'We're showing that there is improvement, that we're taking important steps to making sure that we are standardizing care, ensuring that patients are receiving these procedures with compassion and dignity, and we're not telling them to just tough it out anymore,' she says. Better evidence ACOG's pain recommendations, released in May, were almost two years in the making. Between the uproar on social media and a greater availability of research showing the efficacy of local anesthetic during IUD placement and other in-office procedures, clinicians felt it appropriate to make a statement, says Kristin Riley, an OB-GYN and minimally invasive gynecologic surgeon at Penn State Health and one of the co-authors of the ACOG committee opinion on pain management. 'There's a lot more studies about this overall topic,' she says, 'and we wanted to pull it all together in one place where clinicians and potentially patients could see it all together and really give people options.' Both the ACOG and CDC guidelines are just that: recommendations for practitioners. They urge doctors to better understand what pain management options are available and supported by research, and to inform their patients of these options, risks, and benefits. CDC guidelines simply mention topical lidocaine 'might be useful for reducing patient pain.' ACOG goes a step further, saying pain management options 'should be discussed with and offered to all patients seeking in-office gynecologic procedures.' But whether doctors follow the guidelines is completely voluntary. Getting an IUD? Here's how to advocate for yourself. Learn about the different options for pain management. What might be best for you? Discuss your concerns, fears, and preferences with your doctor ahead of time. Don't wait until the day of your appointment to ask about anesthetics or anti-anxiety medication. Ask as many questions as you want until you feel comfortable. Make sure your doctor explains all of your options, which may include referring you to another clinic with more resources. Develop a plan. What medications will you take pre-appointment? What form of anesthetic will your provider use during the procedure? If your doctor isn't taking your concerns seriously or doesn't offer pain management that you want, find a new one. Ask if your doctor has a referral list. Or you could reach out to a hospital affiliated with a university. There might be a higher chance of finding a provider that offers additional pain management there, Jeanlus notes. You can also try searching for a provider who is fellowship trained in complex family planning , which means they have received additional training in abortion and contraceptive care. Pain is complex and subjective, which makes studying it difficult. Patients who have a history of sexual abuse and trauma or prior negative gynecological experiences can also experience greater pain during IUD placement. The number of different pain medicines — injected lidocaine, sprays and gel-based lidocaine anesthetics, over-the-counter painkillers — and the various combinations in which researchers use them in studies make it difficult to reach conclusive results, Riley says. Danielle Tsevat, an OB-GYN at the University of North Carolina at Chapel Hill who studies gynecological pain, says the most conclusive evidence for pain relief during IUD insertion points to a lidocaine paracervical block, especially among patients who have never given birth. During her medical residency a few years ago, Tsevat had a mentor who utilized the anesthetic during IUD placements. She'd seen it used for other procedures, like abortion or miscarriage evacuations, but the shot wasn't commonly used for IUD placements. Other studies have found topical lidocaine gel or creams to be effective at minimizing pain from the tenaculum (the device that holds the cervix in place during the procedure), Tsevat says. Other methods aren't as definitive. Ibuprofen hasn't been shown to help during the insertion, but can ease cramping afterward. Some clinicians will offer anti-anxiety medications since anxiety can put a patient at higher risk for pain, Tsevat says. 'They report improved outcomes after that too,' she says. 'That one also doesn't really have much evidence behind it yet…but it's something that we've seen offered.' Nitrous oxide, what Ana Ni used during her procedure, has also shown promise in studies, Espey says. Meanwhile, misoprostol, one of the pills used in medical abortions, was found by ACOG to cause more abdominal pain during IUD placement. No one option provides a panacea because there is no one source of pain during IUD placement, and the pain itself is relatively short-lived, lasting all but a few seconds. Additionally, a shot itself can be uncomfortable. Perhaps the paracervical block — administered after the speculum is inserted — would be more effective if clinicians waited a few minutes after giving the shot. 'But that also prolongs the procedure too,' Tsevat says. 'A lot of patients just say, 'I want to get this over with and done,' and not be in the speculum for that long.' Related How to get the sexual health care you deserve During her medical training, Fran Haydanek, a board-certified OB-GYN in Rochester, New York, says she was never taught about pain management during IUD placement. After hearing from her patients, and others' horror stories on social media, she began counseling patients on pain management options and offering paracervical blocks in 2021. She estimates 80 percent of her patients opt for the injection, and her practice eats the cost because insurance won't reimburse for the medication, she says. 'There's clear guidelines from medical organizations that are saying this [medication] should be offered,' Haydanek says. 'Doctors should be reimbursed for that.' However, across the board, few providers seem to be offering these medications. In a small recent study, only 28 percent of clinics offered lidocaine, including paracervical blocks, for pain management; 85 percent recommended ibuprofen. Another study that looked at pain medications for IUD placement within the Veterans Affairs Health Care System found that lidocaine was used only 0.2 percent of the time, while nonsteroidal anti-inflammatory drugs were used during 8 percent of IUD placements. Whose pain matters? Perhaps the most effective pain management option is IV sedation or general anesthesia, which ACOG notes requires additional research to determine risks, benefits, cost, and accessibility. It's an even more resource-intensive option. 'I would bet a million dollars that if we studied IV sedation and IUD pain that we would find that it significantly reduces pain,' Espey says. But clinics would need a pharmacy, nursing staff, advanced monitoring equipment, a recovery room — all of which could drive up costs for patients. The many years that passed before women's pain was taken seriously for IUD insertions, as well as the continued lack of research into the cost and accessibility of general anaesthesia, lead to a logical question: Whose pain does the medical establishment take seriously? Men have long been offered pain medication for below the belt treatments. Aside from medications, innovations to the devices used during IUD placement could make the procedure more comfortable. The tenaculum, for instance, the tool that grasps the cervix and is a major source of pain, dates back to the 1800s. A Swiss company, Aspivix, has developed an alternative tool, called Carevix, that uses suction to secure the cervix. The device is FDA-cleared in the US and is used in 21 health care centers worldwide, including at the Indiana University School of Medicine and Columbia University, according to the company's chief marketing officer, Ikram Guerd. Given the absence of a silver-bullet solution, the most consequential change when it comes to addressing pain is far more understated. 'The most important thing that we've done, ironically, is stressed how important it is to talk to your patient,' Espey says. Trauma-informed care — in which doctors take a patient's past into account — puts the patient at the center of treatment. When patients feel safe to discuss prior challenging IUD placements or past sexual assault, the provider can better individualize pain control. Giving survivors of sexual assault control over their medical appointments can help avoid retraumatizing them. But how much control, how much information, is appropriate to share with patients? Doctors walk the fine line between disclosing how much discomfort to expect from a procedure (and potentially causing increased anxiety) and downplaying their concerns. Research shows that the more people expect pain, the more painful the experience actually is. But to say IUD insertion is entirely pain-free might come across as gaslighting. 'Do you minimize pain to reduce that anticipatory anxiety at the expense of potentially looking like you're lying to your patient about something quite painful?' Espey says. For Espey, the sweet spot is offering patients plenty of options, from prescribing anti-anxiety medications prior to the procedure or rescheduling them at a clinic with more resources. 'Just giving patients options really helps people feel like they can make a decision,' she says. In a current study, Tsevat, the UNC OB-GYN, is surveying patients post-IUD placement. The feedback has been interesting, she says. Some patients report low pain, while others have compared the experience to razor blades in their uterus. Some were offered pain management, others were not. One participant, who was getting her IUD replaced after eight years, was delighted when her doctor explained the pain management options available. 'She said it was still painful,' Tsevat says, 'but she was just happy that she had gotten something and [it] helped her experience a little bit.' Most notably, patients hardly ever discussed their experience with their doctors afterward; it wasn't something they thought was appropriate to mention. When patients don't feel seen or taken seriously, it can have lasting impacts and may result in their avoiding future health care. While one aspect of women's pain in medicine is finally being discussed, others with painful periods or endometriosis may still feel dismissed. There's still room for more conversations, more transparency.
Medscape
10-07-2025
- Health
- Medscape
First-Trimester TMP-SMX Antibiotics and Birth Defects
Infants of mothers treated in the first trimester of pregnancy with trimethoprim/sulfamethoxazole (TMP-SMX) antibiotics for urinary tract infection (UTI) appeared to have a higher risk for any malformation, severe cardiac malformation, and cleft lip and palate than those exposed to beta-lactam antibiotics, a large cohort study of commercially insured pharmaceutical claims found. Recommended routine screening for asymptomatic bacteriuria at the initial prenatal visit often leads to antibiotics being given in the first trimester when the fetus is most susceptible to teratogenic medications and adverse effects from infections. The study, published in JAMA Network Open found no elevated malformation risk for nitrofurantoin, however, although current American College of Obstetricians and Gynecologists (ACOG) guidance recommends that it be avoided in the first trimester unless there is no other appropriate alternative. Anne M. Butler, PhD, MS By type of defect, TMP-SMX was associated with an increased risk for severe cardiac malformations (relative risk [RR], 2.09; 95% CI, 1.09-3.99), other cardiac malformations (RR,1.52; 95% CI, 1.02-2.25), and cleft lip and palate (RR, 3.23; 95% CI,1.44-7.22) compared with beta-lactam antibiotics, according to Anne M. Butler, PhD, MS, a pharmacoepidemiologist at Washington University in St. Louis, and colleagues. The findings emerged from an examination of 71,604 pregnancies in women aged 15-49 years with a median age of 30. Common in pregnancy, UTIs include asymptomatic bacteriuria and acute cystitis; both are associated with adverse perinatal outcomes, including preterm birth, low birth weight, pyelonephritis, and maternal sepsis. 'There is limited guidance on antibiotic selection for UTI treatment in the first trimester due to the potential risk of congenital malformations associated with some antibiotics commonly used to treat UTIs,' Butler told Medscape Medical News. 'But outside of the first trimester of pregnancy, nitrofurantoin and TMP-SMX are considered first-line agents for UTI treatment.' Median gestational age at exposure differed by antibiotic with TMP-SMX prescribed significantly earlier in pregnancy than others: TMP-SMX, 26 (13-59) days; nitrofurantoin, 62 (45-77) days; fluoroquinolones, 18 (9-27) days; and beta-lactams, 63 (48-77) days. Very little TMP-SMX use occurred at 10-13 weeks, when asymptomatic bacteriuria screening typically occurs. The authors conjectured that TMP-SMX-exposed individuals may have had more unrecognized or unplanned pregnancies than their beta-lactam-exposed counterparts. That could result in residual confounding because such pregnancies may be more exposed to teratogenic prescription medications, tobacco, alcohol, or illicit drugs. Malformation Risks Per 1000 infants, the absolute risk for any malformation was 19.8 (95% CI, 18.0-21.8) for beta-lactams; 21.2 (95% CI,19.9-22.7) for nitrofurantoin; 23.5 (95% CI, 18.8-28.9) for fluoroquinolones; and 26.9 (95% CI, 21.8-32.8) for TMP-SMX. After accounting for confounding, the relative risk for any congenital malformation was highest for TMP-SMX (RR, 1.35; 95% CI, 1.04-1.75). Risk was similar for nitrofurantoin (RR, 1.12; 95% CI, 1.00-1.26) and fluoroquinolones (RR, 1.18; 95% CI, 0.87-1.60) compared with beta-lactams. Nitrofurantoin and TMP-SMX are more effective for UTIs than beta-lactams. 'TMP-SMX resistance can be high in some geographical areas such that it shouldn't be used in the absence of culture results,' Butler said. She added that nitrofurantoin works well for lower UTIs such as acute cystitis and asymptomatic bacteriuria but is not recommended for suspected upper UTIs such as pyelonephritis. Butler said that their results support the current ACOG recommendation for caution in using TMP-SMX during the first trimester but do not support current recommendations to limit nitrofurantoin use. Rachel Newman, MD Commenting on the research but not involved in it, Rachel Newman, MD, an assistant professor and maternal-fetal medicine specialist at UTHealth Houston, called it a well-done study that removes the confounding of previous studies. It used an active comparator design and restricted the cohort to individuals treated for UTI rather than for any indication. 'It should be generalizable with the caveat that different practice communities have different degrees of resistance to individual antibiotics,' Newman said. However, the commercial database findings may not be applicable to government-insured and uninsured patients, she noted. Newman stressed that any antibiotic use in pregnancy should be a thoughtful weighing of risks and benefits, but abundant data have demonstrated the safety of all the antibiotics in this study for pregnant women. 'It is reassuring to me that we may be able to use more nitrofurantoin than we've been since there is less resistance to this than to beta-lactams,' she said, which provides another option making UTIs easier to treat before they progress to greater morbidity. 'But the study points out that antibiotics, though safe in general, should not be used lightly in pregnancy.'
Business Insider
02-07-2025
- Health
- Business Insider
Alpha Cognition shares preclinical data for TBI drug ALPHA-1062
Alpha Cognition (ACOG) announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury, or mTBI. The study, supported by the U.S. Department of Defense and conducted with VA investigators, demonstrated that ALPHA-1062 administration following blast-induced mTBI resulted in a notable reduction in indices of TBI-associated neuropathology, including toxic forms of brain protein Tau. These changes suggest a potential role for ALPHA-1062 in treating TBI and possibly reducing the risk of later Alzheimer's disease. Next steps include formulation for sublingual administration and a bridging pharmacokinetic study. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Yahoo
01-07-2025
- Business
- Yahoo
Is Alpha Cognition Inc. (ACOG) Outperforming Other Medical Stocks This Year?
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Alpha Cognition Inc. (ACOG) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question. Alpha Cognition Inc. is a member of our Medical group, which includes 989 different companies and currently sits at #7 in the Zacks Sector Rank. The Zacks Sector Rank gauges the strength of our 16 individual sector groups by measuring the average Zacks Rank of the individual stocks within the groups. The Zacks Rank is a successful stock-picking model that emphasizes earnings estimates and estimate revisions. The system highlights a number of different stocks that could be poised to outperform the broader market over the next one to three months. Alpha Cognition Inc. is currently sporting a Zacks Rank of #1 (Strong Buy). Over the past three months, the Zacks Consensus Estimate for ACOG's full-year earnings has moved 49.3% higher. This signals that analyst sentiment is improving and the stock's earnings outlook is more positive. According to our latest data, ACOG has moved about 58.4% on a year-to-date basis. Meanwhile, stocks in the Medical group have lost about 3.7% on average. This shows that Alpha Cognition Inc. is outperforming its peers so far this year. Another stock in the Medical sector, Astellas Pharma Inc. (ALPMY), has outperformed the sector so far this year. The stock's year-to-date return is 0.9%. The consensus estimate for Astellas Pharma Inc.'s current year EPS has increased 15.2% over the past three months. The stock currently has a Zacks Rank #1 (Strong Buy). To break things down more, Alpha Cognition Inc. belongs to the Medical - Biomedical and Genetics industry, a group that includes 497 individual companies and currently sits at #85 in the Zacks Industry Rank. This group has lost an average of 3.4% so far this year, so ACOG is performing better in this area. Astellas Pharma Inc., however, belongs to the Medical - Drugs industry. Currently, this 155-stock industry is ranked #90. The industry has moved +1.2% so far this year. Investors with an interest in Medical stocks should continue to track Alpha Cognition Inc. and Astellas Pharma Inc.. These stocks will be looking to continue their solid performance. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alpha Cognition Inc. (ACOG) : Free Stock Analysis Report Astellas Pharma Inc. (ALPMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
USA Today
29-06-2025
- Health
- USA Today
As new variant spreads, what's the latest COVID-19 vaccine guidance? It's complicated.
As a new COVID-19 variant takes over in the U.S., guidance surrounding vaccines has become increasingly confusing. Changes in vaccination guidelines, ever-evolving variants and strains, along with threats to health insurance, have sent average Americans looking for the latest recommendations as members of the federal government often conflict with independent medical agencies and healthcare professionals. In the two weeks leading up to June 21, the Centers for Disease Control and Prevention (CDC) reported just shy of 14,500 positive COVID tests, and while hospitalizations and deaths are fortunately down significantly since the pandemic's peak, vulnerable people are still grappling with limiting their risk amid changing practices. Having trouble keeping track of variants and vaccines? Here's what we know. What is the new NB.1.8.1 COVID variant? NB.1.8.1 is one of the latest variants of COVID-19, a "slightly upgraded version" of the LP.8.1 variant that is prominent right now, Subhash Verma, microbiology and immunology professor at the University of Nevada, Reno, previously told USA TODAY in May. Verma previously stated that NB.1.8.1 may be transferred more easily than LP.8.1. Additionally, he noted that NB.1.8.1 can evade antibodies created by vaccines or past infections more easily than LP.8.1. In early April, NB.1.8.1 accounted for 0% of COVID cases in the U.S. In the two weeks ending June 21, it accounted for the majority of cases at 43%, according to the CDC. The variant has similar symptoms to other strains, including fever or chills, cough, shortness of breath or difficulty breathing, sore throat, congestion or a runny nose, new loss of taste or smell, fatigue, muscle or body aches, headache, nausea or vomiting. One of its more unique features is "razor blade throat," reported by patients as an exceptionally sore throat. RFK and HHS change COVID vaccine guidance Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said on May 27 that the COVID-19 vaccine would no longer be included in the CDC's recommended immunization schedule for healthy children and pregnant women, a move that broke with previous expert guidance and bypassed the normal scientific review process. Under the changes, the only people who will be recommended for COVID-19 vaccines are those over 65 and people with existing health problems. This could make it harder for others who want the COVID-19 vaccine to get it, including health care workers and healthy people under 65 with a vulnerable family member or those who want to reduce their short-term risk of infection. The American College of Obstetricians and Gynecologists (ACOG) and American Academy of Pediatrics (AAP), among other organizations, issued statements condemning the change, with the ACOG saying it was "...concerned about and extremely disappointed by the announcement that HHS will no longer recommend COVID-19 vaccination during pregnancy." "It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth," President Steven J. Fleischman said in a statement. Insurance coverage typically follows federal recommendations, so anyone who is healthy and under 65 is likely to have to pay out of pocket to get the shot, which runs about $200, if they can get it. It's not clear what insurance companies will do about the new recommendations. AMA, AAP other organizations break from RFK and HHS on vaccines The American Medical Association (AMA) and American Academy of Pediatrics (AAP), in partnership with other professional medical organizations, broke from RFK and HHS after this announcement, sharing plans to develop their own guidelines independent of the government organization. In an open letter signed by 80 medical organizations across the country and published on June 25, the AMA called for physicians, healthcare networks and insurance companies to continue supporting "evidence-based immunizations to help prevent severe disease and protect public health." "Vaccines for influenza, RSV, and COVID-19 remain among the best tools to protect the public against these illnesses and their potentially serious complications—and physicians are among the most trusted voices to recommend them. We come together as physicians from every corner of medicine to reaffirm our commitment to these lifesaving vaccines," the letter said. "Recent changes to federal immunization review processes raised concerns across the medical and public health community. In this moment of uncertainty, physicians must align around clear, evidence-based guidance for patients." The AAP likewise said in a June 26 statement that it will "continue to publish its own evidence-based recommendations and schedules." AAP President Susan J. Kressly said the creation of federal immunization policy is 'no longer a credible process," adding, "...we're not stepping back, we're stepping up. The AAP will continue to publish our own immunization schedule just as we always have, developed by experts, guided by science, trusted by pediatricians and families across the country.' These latest independent guidelines have yet to be released. Vaccine committee adjourns without fresh recommendations Meanwhile, the new Advisory Committee on Immunization Practices (ACIP) gathered for the first time on June 25 in a meeting that drew criticism from some experts. RFK fired all 17 original members of the committee on June 9, replacing them with members that critics have called unqualified. Some of the members, like Kennedy, have a history of anti-vaccine advocacy, prompting backlash that had doctors and organizations calling for a delay in the meeting. Anti-vaccine sentiments were repeated by ACIP Chair Martin Kulldorf at the meeting, who said the panel will be "investigating" MMR and childhood vaccines. The CDC panel also reviewed data about COVID-19 vaccines, questioning their safety and effectiveness. They also raised questions about the study design, methodologies and surveillance monitoring systems behind the data, which Dr. Pamela Rockwell, clinical professor of family medicine at the University of Michigan Medical School, addressed as a standard of medical research. "Our efforts, through a very robust system of checks and balances, are to create vaccines and vaccination programs that result in the most benefit with the least harm," said Dr. Gretchen LaSalle, a family physician in Spokane, Washington, who represented the American Academy of Family Physicians. Despite this, the committee didn't vote on COVID-19 vaccine recommendations for the fall and isn't expected to reconvene until 'September/October,' according to the CDC website. ACIP commitee: Inside the unusual, RFK-appointed panel that's deciding on childhood vaccines FDA updates warning label for COVID vaccines The FDA likewise announced updated requirements for mRNA COVID-19 vaccine warning labels on June 25, which apply to Comirnaty by Pfizer Inc. and Spikevax by ModernaTX Inc. Prescribing information will now include warnings of the connection between the vaccines and a rare side effect that causes inflammation of the heart muscle and lining. The new warning label discloses the risk of myocarditis, which appeared in 8 cases per 1 million people who got the 2023-2024 COVID shots between the ages of 6 months and 64 years old, mostly commonly among males aged 12 to 24. The previous label, which also disclosed the risk, said the problem mostly occurred in minors aged 12-17. So, how do you protect yourself from NB.1.8.1 and other variants? Despite the back-and-forth in the U.S., the World Health Organization (WHO) has kept its recommendation consistent. Currently approved COVID-19 vaccines are expected to remain effective against the NB.1.8.1 variant, it said. In a webpage dated Jan. 7, the CDC advised that everyone over the age of six months get the 2024-2025 COVID-19 vaccine, specifically the 2024-2025 Moderna COVID-19 Vaccine. The page has since been updated with a banner, reading "COVID-19 vaccine recommendations have recently been updated for some populations. This page will be updated to align with the updated immunization schedule." The original recommendations align with the WHO's current guidelines. WHO, AMA, AAP and existing standards recommend that people who have never received a COVID-19 vaccine, are age 65 and older, are immunocompromised, live at a long-term care facility, are pregnant, breastfeeding, trying to get pregnant, and/or want to avoid getting long COVID, should get the vaccine, especially. Contributing: Greta Cross, Adrianna Rodriguez, USA TODAY
