What you need to know about Moderna's new COVID vaccine, just approved by the FDA
Moderna's COVID shot had previously been approved for everyone 12 and older.
The narrower approval follows the FDA announcing it was likely to limit access to immunizations among healthy children and adults under 65 this fall—as well as an announcement by Health Secretary Robert F. Kennedy Jr. (who, in 2021, called mRNA shots the 'deadliest vaccine ever made') about how COVID shots would be removed from the federal vaccine schedule for children and pregnant women. Still, days later, the CDC issued its own updated advice, going against Kennedy's announcement by keeping the shots on the schedule for healthy children 6 months and older.
The mNEXSPIKE vaccine, which is meant to be a booster but will not immediately replace the Moderna's original COVID shot, was found through a Phase 3 clinical trial of 11,400 participants to be superior to the original; it showed a 9.3% higher relative vaccine efficacy (rVE) in individuals 12 and older and a 13.5% higher rVE in adults 65 and older.
It will be available to those in the eligible populations—including those with risk factors such as asthma, chronic lung or kidney disease, or diabetes, according to the CDC—in the 2025–2026 respiratory virus season.
The limits worry some physicians, including Dr. Jennifer Nayak, associate professor of pediatrics, microbiotics, and immunology at the University of Rochester, who told Rochester First, 'We know that [of] children who are hospitalized with COVID-19, about 41% of them don't have a known preexisting condition,' Nayak said. 'When you limit vaccination to only children who have preexisting conditions, you're going to miss some of the children who will get more seriously ill with this virus.'
This updated mRNA shot still works by teaching the body to make a specific protein that helps your immune system ward off certain diseases.
But instead of targeting the entire spike protein on the virus's surface, reports Medical Xpress, the new vaccine focuses on just two segments. This helps it last longer when refrigerated, making it easier to distribute in certain parts of the world, and more effective at lower doses.
In the clinical trial, the new vaccine was found 'to have a similar safety profile' to the original, with 'fewer local reactions and comparable systemic reactions,' the most common being injection site pain, fatigue, headache, and myalgia.
Still, other possible risks listed by Moderna, which 'may not be all the possible side effects,' include:
Severe allergic reaction (which would occur within one hour) that could cause trouble breathing, face or throat swelling, body rash, fast heartbeat, or dizziness
Myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the heart's outside lining, especially in males age 12–24; symptoms include chest pain, shortness of breath, and feelings of a fluttering or pounding heart)
Such reactions, Moderna suggests, can be reported to the Vaccine Adverse Event Reporting System (VAERS).
'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' said Stéphane Bancel, chief executive officer of Moderna, in a company news release. 'COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.'
More on vaccines:
The new COVID strain, NB 1.8.1, is an Omicron variant. Here's all you need to know
Researchers uncover a link to autism—and it isn't vaccines
The shingles vaccine could be the next best tool to prevent dementia, new study finds
This story was originally featured on Fortune.com
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Atlantic
23 minutes ago
- Atlantic
COVID Revenge Is Supercharging the Anti-Vaccine Agenda
Four and a half years ago, fresh off the success of Operation Warp Speed, mRNA vaccines were widely considered—as President Donald Trump said in December 2020 —a 'medical miracle.' Last week, the United States government decidedly reversed that stance when Secretary of Health and Human Services Robert F. Kennedy Jr. canceled nearly half a billion dollars' worth of grants and contracts for mRNA-vaccine research. With Kennedy leading HHS, this about-face is easy to parse as yet another anti-vaccine move. But the assault on mRNA is also proof of another kind of animus: the COVID-revenge campaign that top officials in this administration have been pursuing for months, attacking the policies, technologies, and people that defined the U.S.'s pandemic response. As the immediacy of the COVID crisis receded, public anger about the American response to it took deeper root—perhaps most prominently among some critics who are now Trump appointees. That acrimony has become an essential tool in Kennedy's efforts to undermine vaccines. 'It is leverage,' Dorit Reiss, a vaccine-law expert at UC Law San Francisco, told me. 'It is a way to justify doing things that he wouldn't be able to get away with otherwise.' COVID revenge has defined the second Trump administration's health policy from the beginning. Kennedy and his allies have ousted prominent HHS officials who played key roles in the development of COVID policy, as well as scientists at the National Institutes of Health, including close colleagues of Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases (and, according to Trump, an idiot and a 'disaster'). In June, Kennedy dismissed every member of the CDC Advisory Committee on Immunization Practices (ACIP), which has helped shape COVID-vaccine recommendations, and handpicked replacements for them. HHS and ACIP are now stacked with COVID contrarians who have repeatedly criticized COVID policies and minimized the benefits of vaccines. Under pressure from Trump officials, the NIH has terminated funding for hundreds of COVID-related grants. The president and his appointees have espoused the highly disputed notion that COVID began as a leak from 'an unsafe lab in Wuhan, China'—and cited the NIH's funding of related research as a reason to restrict federal agencies' independent grant-awarding powers. This administration is rapidly rewriting the narrative of COVID vaccines as well. In an early executive order, Trump called for an end to COVID-19-vaccine mandates in schools, even though few remained; earlier this month, HHS rolled back a Biden-era policy that financially rewarded hospitals for reporting staff-vaccination rates, describing the policy as ' coercive.' The FDA has made it harder for manufacturers to bring new COVID shots to market, narrowed who can get the Novavax shot, and approved the Moderna COVID-19 vaccines for only a limited group of children, over the objections of agency experts. For its part, the CDC softened its COVID-shot guidance for pregnant people and children, after Kennedy—who has described the shots as 'the deadliest vaccine ever made'—tried to unilaterally remove it. Experts told me they fear that what access remains to the shots for children and adults could still be abolished; so could COVID-vaccine manufacturers' current protection from liability. (Andrew Nixon, an HHS spokesperson, said in an email that the department would not comment on potential regulatory changes.) The latest assault against mRNA vaccines, experts told me, is difficult to disentangle from the administration's pushback on COVID shots—which, because of the pandemic, the public now views as synonymous with the technology, Jennifer Nuzzo, the director of the Pandemic Center at Brown University School of Public Health, told me. Kennedy justified the mRNA cuts by suggesting—in contrast to a wealth of evidence—that the vaccines' risks outweigh their benefits, and that they 'fail to protect effectively against upper respiratory infections like COVID and flu.' And he insisted, without proof, that mRNA vaccines prolong pandemics. Meanwhile, NIH Director Jay Bhattacharya argued that the cancellations were driven by a lack of public trust in the technology itself. In May, the Trump administration also pulled more than $700 million in funds from Moderna that had initially been awarded to develop mRNA-based flu vaccines. The mRNA funding terminated so far came from HHS's Biomedical Advanced Research and Development Authority; multiple NIH officials told me that they anticipate that similar grant cuts will follow at their agency. (In an email, Kush Desai, a spokesperson for the White House, defended the administration's decision as a way to prioritize funding with 'the most untapped potential'; Nixon echoed that sentiment, casting the decision as 'a necessary pivot in how we steward public health innovations in vaccines.') COVID is a politically convenient entryway to broader anti-vaccine sentiment. COVID shots are among the U.S.'s most politicized vaccines, and many Republicans have, since the outbreak's early days, been skeptical of COVID-mitigation policies. Although most Americans remain supportive of vaccines on the whole, most Republicans—and many Democrats—say they're no longer keen on getting more COVID shots. 'People trust the COVID vaccines less,' Nuzzo told me, which makes it easy for the administration's vaccine opponents to use attacks on those vaccines as purchase for broader assaults. For all their COVID-centric hype, mRNA vaccines have long been under development for many unrelated diseases. And experts now worry that the blockades currently in place for certain types of mRNA vaccines could soon extend to other, similar technologies, including mRNA-based therapies in development for cancer and genetic disease, which might not make it through the approval process at Kennedy's FDA. (Nixon said HHS would continue to invest in mRNA research for cancer and other complex diseases.) Casting doubt on COVID shots makes other vaccines that have been vetted in the same way—and found to be safe and effective, based on high-quality data—look dubious. 'Once you establish that it's okay to override something for COVID,' Reiss told me, 'it's much easier to say, 'Well, now we're going to unrecommend MMR.'' (Kennedy's ACIP plans to review the entire childhood-immunization schedule and assess its cumulative effects.) Plenty of other avenues remain for Kennedy to play on COVID discontent—fear of the shots' side effects, distaste for mandates, declining trust in public health and medical experts —to pull back the government's support for vaccination. He has announced, for instance, his intention to reform the Vaccine Injury Compensation Program, which helps protect manufacturers from lawsuits over illegitimate claims about a vaccine's health effects, and his plans to find 'ways to enlarge that program so that COVID-vaccine-injured people can be compensated.' Some of the experts I spoke with fear that the FDA's Vaccines and Related Biological Products Advisory Committee—the agency's rough equivalent of ACIP—could be remade in Kennedy's vision. The administration has also been very willing to rescind federal funding from universities in order to forward its own ideas: Kennedy could, perhaps, threaten to withhold money from universities that require any vaccines for students. Kennedy has also insisted that 'we need to stop trusting the experts'—that Americans, for instance, shouldn't have been discouraged from doing their own research during the pandemic. He could use COVID as an excuse to make that maxim Americans' reality: Many public-health and infectious-disease-focused professional societies rely on at least some degree of federal funding, Nirav D. Shah, a former principal deputy director of the CDC, told me. Stripping those resources would be 'a way to cut their legs off'—or, at the very least, would further delegitimize those expert bodies in the public eye. Kennedy has already barred representatives from professional societies, including the American Academy of Pediatrics and the Infectious Diseases Society of America, from participating in ACIP subcommittees after those two societies and others collectively sued HHS over its shifts in COVID policy. The public fight between medicine and government is now accelerating the nation onto a path where advice diverges over not just COVID shots but vaccines generally. (When asked about how COVID resentment was guiding the administration's decisions, Desai said that the media had politicized science to push for pandemic-era mandates and that The Atlantic 'continues to fundamentally misunderstand how the Trump administration is reversing this COVID era politicization of HHS.') The coronavirus pandemic began during the first Trump presidency; now its legacy is being exploited by a second one. Had the pandemic never happened, Kennedy would likely still be attacking vaccines, maybe even from the same position of power he currently commands. But without the lightning rod of COVID, Kennedy's attacks would be less effective. Already, one clear consequence of the Trump administration's anti-COVID campaign is that it will leave the nation less knowledgeable about and less prepared against all infectious diseases, Gregory Poland, a vaccinologist and the president of Atria Research Institute, told me. That might be the Trump administration's ultimate act of revenge. No matter who is in charge when the U.S. meets its next crisis, those leaders may be forced into a corner carved out by Trump and Kennedy—one from which the country must fight disease without adequate vaccination, research, or public-health expertise. This current administration will have left the nation with few other options.
Politico
23 minutes ago
- Politico
NIAID acting director's view of ‘risky research'
THE LAB Dr. Jeffery Taubenberger, acting director of the National Institute of Allergy and Infectious Diseases, says conducting so-called gain-of-function research shouldn't be dismissed. He discussed the controversial topic with his boss, NIH Director Jay Bhattacharya, on the latter's 'Director's Desk' podcast this week. What is it? Gain-of-function involves genetically altering pathogens to make them deadlier or more transmissible to better study them. But the research is a lightning rod issue for President Donald Trump and many Republicans in Congress who believe the Covid-19 pandemic was caused by a lab leak stemming from gain-of-function research in Wuhan, China, where the virus first emerged. That thinking puts them at odds with most of the scientific community who believe the virus most likely spilled over from animals into humans. In May, Trump signed an executive order banning all 'present and all future' federal funding for gain-of-function research in countries like China,which Trump said has insufficient research oversight. He also ordered the National Institutes of Health to review and possibly halt experiments the administration believes could endanger Americans' lives. In Congress, Sen. Rand Paul's (R-Ky.) Risky Research Review Act, which hasn't yet been taken up by the full Senate, would create a panel to review funding for gain-of-function research. Not black and white: During the podcast, Bhattacharya asked Taubenberger how the institute should approach gain-of-function research. 'It's not a simple black-and-white issue,' replied Taubenberger, a senior investigator in virology who's a leading expert on the 1918 flu pandemic and sequenced the virus that caused it. He's also co-leading the effort to develop a universal flu vaccine, backed with $500 million from the Trump administration. 'Very reasonable, very well-informed people could fall on opposite sides of the line, wherever you draw the line,' he said. 'Having a wide variety of people with different levels of expertise — not just logic expertise, but safety, national security, all sorts of other questions — having them weigh in on this is really important.' Regardless of where people fall, gain-of-function work shouldn't be shut down, he said. 'Work on nasty bugs that have the potential to kill people, for which we want to develop better therapeutics, diagnostics, prognostics, treatments and preventatives, needs to happen. That's important for global health. It's important for U.S. health,' Taubenberger said. But that research has to be done very carefully, with oversight and should be evaluated on a risk-benefit basis, he warned. While the pandemic turbocharged the issue, the controversy over gain-of-function predates Covid-19. The government paused funding for the research roughly a decade ago, Taubenberger pointed out, while they put stronger oversight mechanisms in place. 'I favor this kind of work being done, where possible, in U.S. government labs, by U.S. government scientists, monitored by U.S. government safety officials and regulators — with openness and transparency.' What didn't come up in conversation: The implementation of Trump's executive order hasn't gone as smoothly as the podcast discussion might have suggested. A July post on the NIH's X account implied that staff at the NIAID had acted inappropriately by omitting certain grants while compiling a list of potentially dangerous gain-of-function research experiments in compliance with the order. Contacted by POLITICO at the time, an official at HHS described the behavior as 'malicious compliance' and said the administration wouldn't tolerate it. NIH Principal Deputy Director Matt Memoli, according to The Washington Post, overrode staff by classifying tuberculosis studies NIH reviewers deemed safe as potentially dangerous gain-of-function research. WELCOME TO FUTURE PULSE Former Texas Gov. Rick Perry and former Sen. Kyrsten Sinema (I-Ariz.) described undergoing mental health treatment with the psychedelic drug ibogaine to the New York Times. Share any thoughts, news, tips and feedback with Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Want to share a tip securely? Message us on Signal: RuthReader.02 or ErinSchumaker.01. TECH MAZE Under Gov. Gavin Newsom, California has moved faster than other states to regulate artificial intelligence, including signing a bill last year barring health insurers in the state from using AI to deny claims. Now, a prominent AI company is urging the Democratic governor to consider a less rigid regulatory approach. In a letter to Newsom, obtained by our POLITICO colleagues at California Decoded, OpenAI suggests that California should consider AI companies that sign onto national and international AI agreements as compliant with state AI rules. The letter, dated Monday, from OpenAI's Chief Global Affairs Officer Chris Lehane, comes as Sacramento continues to debate key AI legislation, including Democratic state Sen. Scott Wiener's bill SB 53, which would require large AI developers to publish safety and security protocols on their websites. Lehane recommended that 'California take the lead in harmonizing state-based AI regulation with emerging global standards' when it comes to the technology, dubbing it the California Approach. World view: OpenAI and other developers have already signed, or plan to sign, onto the EU's AI code of practice and have committed to conducting national security-related assessments of their programs. Lehane said that 'we encourage the state to consider frontier model developers compliant with its state requirements when they sign onto a parallel regulatory framework like the [European Union's] CoP or enter into a safety-oriented agreement with a relevant US federal government agency.' Newsom spokesperson Tara Gallegos said, 'We have received the letter. We don't typically comment on pending legislation.' Worth noting: The EU code is a voluntary way for companies to comply with the bloc's AI Act and is nonbinding in the U.S., which has no equivalent. Commitments to work with federal regulators don't necessarily cover all the areas, like deepfakes or chatbots, where Sacramento wants to regulate AI. But the letter offers Newsom something of an off-ramp, after he vetoed Wiener's broader AI safety bill last year that would have required programs to complete prerelease safety testing. Last week, Newsom spoke with cautious positivity about Wiener's effort this year, saying it was in the spirit of an expert report on AI regulation he commissioned. But SB 53 — which would establish whistleblower protections for AI workers and require companies to publish their own internal safety testing — still faces opposition from the tech industry. Lehane's letter puts an industry-sponsored solution on the governor's desk. He framed the simplified California Approach as a way to give 'democratic AI' an edge in the race with Chinese-built programs by removing unnecessary regulation, a key priority for the Trump administration. 'Imagine how hard it would have been during the Space Race had California's aerospace and technology industries been encumbered by regulations that impeded rapid innovation,' Lehane wrote.
Yahoo
an hour ago
- Yahoo
The hookup talk everyone wishes they'd heard earlier
Dr. Jill Grimes is the author of 'The Ultimate College Student Health Handbook: Your Guide for Everything From Hangovers to Homesickness.' With more than 30 years in private practice and academic medicine, she shares her medical wisdom as The College Doc. I know that casual sex and the hookup culture are often considered the norm in college, and many students don't consider negative consequences beyond pregnancy. Unfortunately, nearly half (48.2%) of the 2.4 million reported cases of chlamydia, gonorrhea and syphilis (all stages) in the United States in the most recent year surveyed were among adolescents and young adults ages 15 to 24 years, according to the Sexually Transmitted Infections Surveillance, 2023 from the US Centers for Disease Control and Prevention. What I've seen in my clinical experience is that teens and young adults often overlook the need for protection against infections, especially when they are using birth control pills or IUDs to prevent pregnancy. In fact, the Spring 2024 National College Health Assessment data shows that only half (50.2%) of the students who used any method of contraception reported using a male condom the last time they had vaginal intercourse. As a college health doctor, I'm aware that many college students are having sex, and that is clearly their choice. But I've seen firsthand how emotionally and physically devastating these diagnoses can be, with tears flooding the exam room from students diagnosed with herpes, chlamydia, gonorrhea, genital warts or HIV. Whether the disease is curable or chronic, the emotional toll is often greater than the physical symptoms — especially since many of these sexually transmitted infections could have been prevented. That's why I want you to know what's really going on in college and what you can do to keep yourself safe and healthy. This is the no-judgment, real-world talk that everyone deserves to hear before swiping right in college — or anywhere. Is everyone else having sex? First, don't believe everything you hear in your dorm, at the dining hall or at keg-fueled parties. While students will hear that 'everyone' is hooking up, that's not true. Nearly 52% percent of college students reported having vaginal intercourse within the last year, according to the 2024 American College Health Association National College Health Assessment. That means 48% did not. And it's not all consensual sex. True consent is clear, enthusiastic, ongoing, verbalized, freely given and able to be withdrawn at any time. Students often feel pressured to be more physically intimate to fit in. Thirteen percent of undergrads report 'nonconsensual sexual contact by physical force or inability to consent,' according to the Association of American Universities. Intoxicated or high individuals cannot give consent, yet many hookups happen under the influence. Many students have tearfully shared that they 'just wanted to get it over with' or chose oral or anal sex to stay a 'technical virgin.' Some feel guilt or regret, while others are fully comfortable with their physical intimacy but are shocked by an STI or pregnancy diagnosis. You can't tell who has an STI When a student comes in concerned about a genital rash, blisters, discharge or pain with urination, STI testing is part of the workup. Students often are selective about which STI tests they want; they're often fine with checking for chlamydia and gonorrhea but decline HIV testing, because their partner is 'not that kind of person.' While the myth persists that these diseases are passed around in other communities (not yours), sexually transmitted infections don't discriminate. Your risk of an STI comes from behavioral choices, not anyone's appearance, skin color, culture, religion, values, wealth, sexual orientation or political persuasion. Yes, some STIs are more common in certain populations. But check your bias anyway, especially with HIV. Heterosexual contact accounted for 22% of new HIV infections in the United States in 2022, and 13- to 24-year-olds made up 20% of new HIV diagnoses, according to a federal website with information and resources related to HIV/AIDS from the US government. Additionally, young adults are increasingly more fluid in their sexuality, which includes having more bisexual experiences, whether or not they identify as gay or bisexual. If you test positive for one STI, you need more testing. Sexually transmitted infections are mostly spread through body fluids, and some are simply shared through direct contact. If you've contracted one infection, you may have another, so you should be tested for them. Unfortunately, we frequently diagnose more than one at a time. Oral sex is not risk-free Did you know your partner's cold sore can become your genital herpes? Cold sores are caused by herpes simplex virus type 1, or HSV-1, which is easily transmitted by direct contact from one person's oral area to another person's genitals. While herpes is probably the most common disease we see passed via oral sex, it's not the only one. Chlamydia, gonorrhea, syphilis, human papillomavirus (HPV), herpes and less commonly, HIV, can all be spread bidirectionally from oral-genital intimacy. That means STIs can also cause throat, genital and anal infections. Barriers such as condoms or dental dams can significantly reduce your risk. (This is why flavored condoms exist.) No sign of symptoms is no guarantee Most STIs are silent, causing no, fleeting or minimal symptoms, yet capable of causing significant disease in you or your partner. Screening tests are critical to detect asymptomatic bacterial infections early while they can still be easily treated. Chlamydia is the most common bacterial STI in the world, according to the Pan American Health Organization. Chlamydia is also the most common bacterial STI in the United States, with more than 1.5 million reported cases per year, and yet chlamydia causes no obvious symptoms in most women (75% of females and 50% of males, according to Scripps Health). Left untreated, 10% to 15% of women will develop pelvic inflammatory disease, or PID, and roughly 10% of those women with PID develop infertility, according to the Cleveland Clinic. Gonorrhea is the second most common bacterial STI, with more than 600.000 cases in the United States in 2023, according to the National Overview of STIs in 2023. Although gonorrhea can also cause PID, very often there is a coinfection with chlamydia, ranging from 10% to 40% in some National Institutes of Health studies. Gonorrhea's biggest challenge is its growing resistance to antibiotics, making it increasingly difficult to treat. PID is the most common preventable cause of female infertility in the United States, affecting an estimated 100,000 women per year, the Cleveland Clinic noted. Sexually active young women should proactively get tested for chlamydia and gonorrhea each year to protect their future fertility. Human papillomavirus is the most common STI overall. Although most HPV infections will resolve spontaneously without problems, persistent infections can quickly cause genital warts or, years later, lead to cancer. Because HPV may be transmitted to a person performing oral sex, HPV also causes 60% to 70% of the roughly 60,000 oropharyngeal cancers (twice as common in men versus women) diagnosed annually in the United States, according to the American Cancer Society. The emotional burden of STIs Human papillomavirus genital warts are not lethal, but they will make you miserable. The treatment is painful, with repeated procedures and a high risk of recurrence. Patients are often scared, embarrassed and emotionally distraught, terrified that this incurable disease will make them undesirable to any future potential partners. I cannot emphasize enough how this emotional burden (which we see with herpes and HIV as well) critically affects students' self-image, confidence and mental health. Since the HPV vaccine rollout, HPV high-risk infections (including genital warts) have fallen by up to 88% among teen girls and young women, thanks to both direct immunization and herd immunity, according to the CDC. Patients with genital warts used to fill our college clinics, and now thankfully are significantly less common. The Human Papillomavirus Vaccine Impact Monitoring Project shows that cervical precancers dropped roughly 80% in women ages 20 to 24, and researchers predict HPV vaccination can prevent over 90% of all HPV-related cancers from ever developing, according to the CDC. How to reduce your risk If you're going to have sex, be prepared before you have sex. Birth control pills are extremely effective when used correctly, but college life is filled with irregular schedules, late nights, road trip weekends and, for some people — vomiting. If pills are delayed, forgotten, missed or thrown up, the efficacy plummets. Adding condoms not only decreases your risk of conception but also adds protection against STIs. Do not, however, double up on condoms. This myth is still perpetuated, but using two condoms at once can increase your risk of breakage and failure. Numbers also matter. If you never drive or ride in a car, you'll never have a car accident. The more you drive, the higher your cumulative risk. It's math, not morality. What you deserve Teens and young adults deserve more than outdated, awkward and judgmental sex talks. They need to learn how to protect their health, their future fertility and their emotional well-being while learning to live life as adults. If more students knew this information, far fewer would end up blindsided in their college medical center's exam rooms. Hookups may be part of college culture for many students, but let's normalize being open, prepared and honest about the risks. Check with your university health center to learn more about prevention, screening and treatment. Get inspired by a weekly roundup on living well, made simple. Sign up for CNN's Life, But Better newsletter for information and tools designed to improve your well-being.
