RFK Jr's FDA limits use of Covid vaccine
The vaccine will now only be available to high-risk individuals and will not be administered to those who may need it to protect others.
Kennedy's FDA approved the use of the Novavax Covid-19 vaccine, but with strict conditions. It will only be made available to older people and those over the age of 12 with at least one medical condition that leaves them at high risk from Covid, The New York Times reported.
Centers for Disease Control and Prevention advisers have been discussing whether to recommend the vaccine only for those most at risk. The new restrictions mean that healthy people over the age of 65 won't be able to get the Novavax vaccine, even if they have an immunocompromised friend or family member.
Critics have slammed the restrictions for being in line with Kennedy's vaccine skepticism. The secretary has ordered an investigation into the debunked claim that vaccines cause autism.
The Novavax vaccine was previously only allowed to be used in emergencies. Meanwhile, the FDA gave full approval to vaccines by Pfizer-BioNTech and Moderna in 2022 under the Biden administration. Both companies are producing updated versions of their vaccines for the fall.
Former CDC adviser and Massachusetts General Hospital infectious disease physician Dr Camille Kotton told The Times that the new restrictions were 'incredibly disappointing.'
'I don't know why they would make this restriction; I don't know of any indication to make this change,' she added. She noted that many people are still sent to hospital and dying because of Covid-19. She called it 'a dark day in American medicine.'
The vaccine's approval requires the company to finish studies into whether it is connected to several heart conditions. However, some of the necessary research can be done with existing data.
However, The Times reported that one of the new studies would force the company to follow thousands of people between the ages of 50 and 65, a study that may cost tens of millions of dollars.
Dr. Ofer Levy of Boston Children's Hospital, where he directs the precision vaccine program, is a vaccine adviser to the FDA.
'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' Levy noted. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?'
'I don't pretend to know the answer,' Levy added.
Dr. Paul Offit is a vaccine expert at the Children's Hospital of Philadelphia.
'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive, and more feared,' he told the paper. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.'
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNN
2 minutes ago
- CNN
The Manhattan shooter had a previous arrest and 2 psychiatric holds, sources say. How was he able to own a gun?
Crime Gun violence Gun control Mental healthFacebookTweetLink Follow New York City's deadliest shooting in 25 years – in a state with some of the toughest gun laws in the nation – is raising questions about how a gunman with a history of mental health issues was able to obtain multiple firearms and drive undetected across several states to carry out the attack. The gunman who walked into a Midtown Manhattan office building on Monday, M4 assault-style rifle in hand, and sprayed it with gunfire, had a license to carry a concealed weapon in his home state of Nevada, officials said. He also had been placed on psychiatric hold in 2022 and 2024, law enforcement sources told CNN. But that may not have necessarily prohibited him from obtaining his license in 2022 or buying firearms – depending on the circumstances of the holds, according to gun law experts. Shane Devon Tamura, 27, of Las Vegas, killed four people at the 345 Park Avenue office building and injured another before he died by suicide, police said. While public health experts continue to stress that the vast majority of people experiencing mental health challenges are not violent, questions remain about the details of Tamura's psychiatric holds and if they would have shown up in a background check. The case underscores the wide gap in sharing mental health data with the federal government – an issue that can be attributed to inadequate funding to manage or require the data, as well as privacy issues, according to Thomas Chittum, former associate deputy director of the Bureau of Alcohol, Tobacco, Firearms and Explosives. Tamura had 'a documented mental health history,' according to New York Police Department Commissioner Jessica Tisch, and a previous run-in with law enforcement. Tamura was arrested and charged with misdemeanor trespassing in 2023 in Clark County, Nevada, after he refused to leave a Las Vegas casino after attempting to cash out about $5,000, according to a police incident report. A court database suggests a district attorney declined to pursue the case, meaning the incident wouldn't have prevented him from obtaining a gun. The case also throws private gun sales under the microscope. The AR-15 style weapon used in the shooting was legally purchased last year by the gunman's supervisor at the Vegas casino where he worked, two law enforcement officials told CNN. The supervisor then assembled it and sold it to Tamura for $1,400, the officials said, citing an interview with the supervisor who is cooperating with authorities. It's not yet clear whether the private sale between Tamura and the supervisor involved a background check. But the supervisor, who has not been named by authorities, could face legal jeopardy if the investigation reveals the firearm transfer took place in Nevada and the private sale didn't follow a state law requiring background checks for private sales, according to Warren Eller, gun violence expert and associate professor at John Jay College of Criminal Justice. As police work to uncover a motive behind the shooting, investigators are digging into Tamura's history and examining are how he obtained multiple firearms and made his way from Las Vegas to New York City with the assault rifle. A search of the gunman's car turned up a host of items, including additional ammunition, another loaded weapon, headphones potentially used for target practice, two cell phones, the antidepressant Zoloft and cannabis, a law enforcement source told CNN. A note found in the gunman's pocket claimed he had CTE, a disease linked to head trauma, one that's often associated with football players, a source told CNN. New York City's chief medical examiner's office will test Tamura's remains for CTE, an office spokesperson told CNN Tuesday. The only way to diagnose the disease is through an autopsy of the brain. As for the psychiatric holds, it's difficult to say without knowing the details whether they would have shown up in a background check or prevented Tamura from purchasing weapons, experts say. 'If you were on a 48-hour hold, if you were released at the end of that, it would not affect your ability to possess firearms under federal law,' Chittum said. Most states barely touch on the area of mental health when a person applies for a gun license due to concerns over privacy issues and stigmatizing people who have mental health issues, according to Eller. One concern, for example, is soldiers who struggle with post-traumatic stress disorder, or PTSD, might be reluctant to seek help because they fear their treatment history would deprive them of possessing firearms. 'Between the lack of funding to make sure the background check system is effective for those problems and the legal hang ups with advocacy groups who will challenge this, that's a long road ahead,' Eller said. There's a concerted effort by veterans' groups and advocacy organizations like the American Civil Liberties Union to fight against the sharing of mental health records with the National Crime Information Center and local law enforcement, which most states rely on for background checks, according to Eller. 'Groups have been combating that because simply being mentally ill doesn't mean you're mentally incompetent, nor does it mean you're a danger,' he added. However, in cases where a person was declared incompetent by a court, faced a restraining order, involuntarily committed or deemed a danger to themselves or others due to a mental illness, the federal government restricts firearm ownership and states largely follow federal law with some variations, according to Chittum. 'Even when we have someone who has a mental health issue that prohibits them under the law, the next question is whether the background check identifies that. Historically, mental health records have been some of the hardest for FBI to obtain when doing background checks,' Chittum said, adding there have been efforts to improve the availability of those records in some legislation. As New York homicide detectives work to piece together a timeline of events leading up to the deadly Manhattan attack, the way Tamura obtained the high-powered M4 rifle from an associate and whether Nevada's background check laws were violated will likely come under scrutiny. In Nevada, the private sale of a firearm between two parties requires a federal background check before the transfer is complete. Both individuals must go to a federally licensed firearm dealer, which conducts the background check on their behalf. There are limited exceptions, including firearm transfers between immediate family members, which do not require this process. If the private sale between Tamura and the supervisor did abide by the law and the facts can't prove the supervisor had any knowledge of possible disqualifiers in Tamura's history, including intended use of the firearm, then the seller likely won't be prosecuted, according to Eller and Chittum. Federal law doesn't impose any obligation on private gun sellers to identify the buyer, conduct a background check or keep any record of the sale, Chittum said. The Nevada law enforcing background checks for private sales was implemented in January 2020, closing the so-called 'gun show loophole' that gun safety advocates have long criticized as a means for bypassing records checks that can flag past criminal history. Most states conduct background checks through federally licensed dealers relying on the FBI's National Instant Criminal Background Check System (NICS), while some states like Nevada have a designated 'point of contact' system that offers access to state criminal history records. Under federal law, an unlicensed person buying a firearm directly from a gun dealer must also undergo a background check, however, those who already have a concealed carry permit – like Tamura had – may be exempt because they would have already undergone a background check to get the permit. Hours after the shooting in Manhattan, Las Vegas Police Crimestoppers received a tip from a licensed firearms dealer saying he remembered Tamura sought to buy an aftermarket trigger assembly for an M4 rifle at a Las Vegas gun show in June, a senior law enforcement official told CNN. Tamura returned the trigger assembly the next day, saying he needed the money back to buy 500 rounds of .223 ammunition – the same kind of ammunition used in the New York shooting, according to the official. The gun dealer told police Tamura came back the next day with additional funds and re-purchased the trigger assembly, the official said. Tamura's case calls attention to the 'gray area' in the federal regulation and enforcement of private sales that exists when people buy firearms for cash in a private sale, according to Eller. Because a concealed carry permit would exempt an individual for five years from a background check when buying a firearm from a licensed dealer, it creates a 'nuanced area' where a person could obtain a license to carry and then subsequently be convicted or have a mental health prohibitor and might still be able to use their card to purchase a firearm and avoid the background check, Chittum said. Some states recognize this issue and routinely run background checks on licensed holders to determine if their license is still valid, Chittum said. Red flag laws, including the one in Nevada, aim to keep guns out of the hands of those who pose a threat to themselves or others. But such laws are only effective if the individual demonstrated warning signs so that others can alert law enforcement and initiate the process of revoking the person's firearm, Chittum said. It's not clear if Tamura demonstrated any warning signs that would trigger the state's red flag law. The style of weapon Tamura used to slaughter four people has commonly been seen in some of the nation's deadliest mass shootings and has prompted renewed calls by progressive lawmakers for increased regulation. 'In the State of New York, you cannot buy one of these,' Gov. Kathy Hochul told CNN on Tuesday, criticizing what she said were 'much looser laws in the State of Nevada than we have here.' Hochul called on federal lawmakers to pass a national assault weapon ban that would limit access to high-powered guns like the AR-15 style rifle used in Monday's massacre and slammed GOP counterparts whom she accused of being 'intimidated by the gun lobby.' 'We need a national awakening here, people need to be talked about this once again and it shouldn't just happen in the wake of a tragedy like this,' said Hochul. CNN's Mark Morales contributed to this report.
Washington Post
2 minutes ago
- Washington Post
States sue Trump administration over access to care for transgender youths
A coalition of more than a dozen states sued the Trump administration on Friday over health care for transgender young people, claiming the White House has 'relentlessly, cruelly, and unlawfully targeted transgender individuals' since President Donald Trump took office. The lawsuit, filed in federal court in Massachusetts, seeks to have part of one executive order issued in January declared unconstitutional. The order targets gender-affirming care provided to people under the age of 19, such as puberty blockers, hormone therapy and surgical procedures, which it refers to as 'mutilation.' The lawsuit also asks the court to declare unlawful the Justice Department's targeting of providers of gender-affirming care. The section of the order that is being challenged directs the Justice Department to use laws such as the Food, Drug and Cosmetic Act, those against female genital mutilation, and child custody legislation to carry out the administration's aims. 'It is the policy of the United States that it will not fund, sponsor, promote, assist, or support the so-called 'transition' of a child from one sex to another,' Trump's order says, calling the treatments 'a stain on our Nation's history.' The states of Massachusetts, California, New York, Connecticut, Illinois, Delaware, Hawaii, Maine, Maryland, Michigan, Nevada, New Jersey, New Mexico, Rhode Island and Wisconsin, as well as the District of Columbia and Josh Shapiro in his capacity as Pennsylvania governor, filed suit. The lawsuit, filed against Trump, the Justice Department and Attorney General Pam Bondi, argues that the executive order conflicts with states' remit to regulate and police medicine and violates the 10th Amendment, which protects states' powers, and is in conflict with many state antidiscrimination laws. Nearly every major medical association endorses the availability of gender-affirming care for transgender young people, citing reductions in depression, substance abuse and suicide attempts. 'Empirical evidence has demonstrated that trans and nonbinary gender identities are normal variations of human identity and expression,' the American Medical Association has said. But the issue, and others related to transgender people, has animated conservatives. Trump has said he wants the 'official policy of the United States' to be that there are only two genders and has referred to being transgender as a 'falsehood.' The administration has moved to ban transgender service members from the military, relocate incarcerated transgender women into men's prisons and bar transgender people from using restrooms that align with their gender identity in federal buildings, among a slew of anti-trans measures, many of which have been challenged in court. After the January order, the lawsuit says, the Justice Department began 'intimidating providers into ceasing care through threats of civil and criminal prosecution.' 'These threats have no basis in law,' the complaint says. 'No federal law prohibits, much less criminalizes, the provision or receipt of gender-affirming care for transgender adolescents.' Puberty blockers temporarily inhibit sex hormones, such as estrogen and testosterone, and other hormone therapies introduce them to the body. Gender-affirming surgeries, such as breast reductions for transgender men, are rarely performed on minors. White House spokesperson Taylor Rogers said in an email that 'everyday Americans resoundingly support' the administration's actions. 'The President has the lawful authority to protect America's vulnerable children through executive action, and the Administration looks forward to ultimate victory on this issue,' she added. In June, the Supreme Court upheld a ban on gender-affirming care for minors in Tennessee.
Forbes
an hour ago
- Forbes
Novel Access Model For Sickle Cell Disease Gene Therapy Could Be Template
The Centers for Medicare and Medicaid Services announced in July that 33 states, the District of Columbia and Puerto Rico will join a new voluntary program intended to improve patient access to and lower costs for gene therapies targeting sickle cell disease. This was a Biden administration initiative, which the Trump administration decided to continue to implement. It ties payment for two novel gene therapies to positive clinical outcomes. This could make such treatments that cost millions be more widely accessible for patients. And if successful, it may serve as a template for future cell and gene therapy agreements. Medicaid, the joint federal and state program that provides health coverage to low-income individuals, is the main insurer for SCD patients. The Biden administration announced last year that the manufacturers of Lyfgenia and Casgevy had entered into agreements with CMS to participate in the Cell and Gene Therapy Access Model, which allows CMS to negotiate outcomes-based agreements on behalf of state Medicaid programs for cell and gene therapies, beginning with sickle cell disease treatments. Essentially this means that CMS will reimburse based on whether certain agreed-upon clinical thresholds are reached in patients. According to CMS, the participating states in the newly established access initiative represent about 84% of Medicaid beneficiaries with SCD. The program could contribute towards a sizable expansion of access to potentially transformative care in the form of two extraordinarily expensive gene therapies. The launch prices for Casgevy (exagamglogene autotemcel) and Lyfgenia (lovotibeglogene autotemcel) were $2.2 million and $3.1 million, respectively. SCD is a group of congenital red blood cell disorders, named sickle cell for their crescent shape. The condition affects millions of people worldwide. In the United States, approximately 100,000 individuals are living with the disease, which predominantly impacts people of sub-Saharan African descent. The disease alters the structure of hemoglobin, the molecule in red blood cells that delivers oxygen to organs and tissue throughout the body. As a consequence, this causes severe pain, anemia, organ damage and infections. Individuals with the disease have a shorter life expectancy, by more than 20 years on average. The most common sickle cell disorder type is sickle cell anemia. Besides pain medications to relieve symptoms as well as antibiotics to treat infections, hydroxyurea—a bone marrow suppressive agent that decreases red blood cell production—can be used to reduce the frequency of painful episodes. It has been in use since the 1980s. The Food and Drug Administration has approved several new therapeutics in the past ten years, but none are as promising as Lyfgenia and Casgevy. These two novel therapies can decrease or potentially eliminate pain crises in patients. Gene therapies such as Lyfgenia and Casgevy are administered in an inpatient hospital setting but are considered covered outpatient drugs because they're directly reimbursed and subject to standard, federally mandated Medicaid rebates. Manufacturers of the two treatments must also provide states with supplemental rebates (post-hoc discounts off of the list price) reflecting model-negotiated terms. In turn, states are obligated to implement an agreed-upon access policy for patients. According to CMS, there is also optional federal support of up to $9.55 million per state available to help with implementation of the arrangements, outreach and data tracking. In the cell and gene therapy space, science has generally outpaced commercialization. Access to very costly treatments is a challenge. Whether in the public or commercial sector, payers must find novel ways of paying for cell and gene therapies while generating evidence with respect to their real-world effectiveness and safety. Questions insurers must find answers to include: What are the health outcomes for patients in real-world settings? Do treatments fulfill the promise of a one-time cure for certain serious illnesses or disorders? Are there particular safety concerns that appear in real-world settings? Are side effects manageable? Coordinating evidence gathering as well as contracts across state Medicaid agencies is likely to yield a more efficient process while improving access for a substantial majority of SCD sufferers nationwide. It's not just SCD gene therapies that confront a formidable set of barriers to access. All cell and gene therapy manufacturers face a challenging environment. The regulatory hurdles are enormous to begin with, but manufacturing challenges following approval are considerable, too. Furthermore, patient preparation, side effect and adverse event profiles can be intolerable. This can deter patients from signing up to initiate treatment. On top of all of this, payers concerned about the high per unit costs often impose coverage restrictions, as the Tufts Center for the Evaluation of Value and Risk in Health describes. Nonetheless, gene therapies in particular hold the promise of delivering groundbreaking improvements in health outcomes across multiple disease areas. Therefore, overcoming obstacles to optimal patient access is crucial. If successful, the SCD model being experimented with could serve as a blueprint for other cell and gene therapies that have faced considerable barriers with respect to patient access.
