FDA approves Novavax COVID-19 vaccine with restrictions
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NBC News
39 minutes ago
- NBC News
For some, fall Covid shots may come with copays — or no coverage at all
If you're in good health and plan to get a Covid shot this fall, you might end up with an unwelcome surprise: a bill. The Food and Drug Administration is expected to approve the next round of Covid shots soon, but only for a smaller, high-risk group — adults 65 and older and people with underlying health conditions. The Centers for Disease Control and Prevention is likely to follow suit, limiting its recommendation on who should get the shots to the same groups. (The CDC currently recommends Covid vaccination for everyone 6 months and older.) The change, experts say, could affect what insurers are willing to cover for everyone else who doesn't fall under a high-risk group. By law, most health insurance plans are required to fully cover vaccines recommended by the CDC and its outside advisory committee, the Advisory Committee on Immunization Practices (ACIP). For those who don't fall under the CDC's new recommendations, experts say coverage would depend entirely on their insurance — with some deciding to fully cover the shot, others requiring a copay and some not covering it at all. Without insurance, a Covid shot can cost up to $140, according to the CDC's vaccine price list. 'It could very well get confusing,' said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee, and an adviser to ACIP. Whether you're able to get a free shot 'may greatly depend on which company with which you have your insurance.' Who can get a Covid vaccine? Under the expected recommendations from the CDC, healthy children and adults won't be barred from getting the Covid vaccine, said Dorit Reiss, a vaccine policy expert at UC Law San Francisco. 'It's legal to give a vaccine off-label,' Reiss said, referring to when a doctor prescribes a drug for something different than what the FDA approved it for, 'and insurance companies can choose to cover them.' A spokesperson for AHIP, a health insurance industry trade group, said that every individual insurer will come up with its own policy following the CDC's final guidance. The CDC's list of conditions that put a person at high risk for severe illness from Covid is extensive, and includes cancer, heart disease and lung conditions as well as physical inactivity and depression. Insurers also take into account clinical recommendations from outside medical organizations, like the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics, the spokesperson said. On Tuesday, the AAP, which has expressed its disapproval for Health Secretary Robert F. Kennedy Jr.'s vaccine decisions, released its own recommendations supporting Covid vaccinations for children. Most people are also unlikely to notice changes to their insurance coverage overnight — if there are any, according to the AHIP spokesperson. For private plans — including Obamacare plans — any changes stemming from ACIP meetings could likely only be implemented in the next benefit year, typically Jan. 1, the spokesperson said. That means it's possible that people who get a shot before then might be covered. Medicare and Medicaid plans are required to follow ACIP recommendations immediately upon the CDC director's signature. Covid vaccines have also already been factored into insurers' plans for this year. In an emailed statement, a spokesperson for Blue Cross and Blue Shield said that 'each independent Blue Cross and Blue Shield plan will make their own coverage decisions.' Covid and flu shots The changes could affect people planning to get their Covid and flu vaccines at the same time. Schaffner, of Vanderbilt, said some people choose to get their Covid and flu shots at the same time, but there are concerns that some could be turned away due to the anticpated change in recommendations. He added that misinformation about who is able to get the Covid shots may also discourage people from getting either vaccine. 'I think we have to reassure people, particularly those at high risk, that the vaccine will be available to them,' he said. Rick Gates, Walgreens' chief pharmacy officer, said its pharmacists usually determine whether a patient has coverage before a vaccine is administered. Because of this, it's unlikely anyone would be hit with a surprise bill due to new CDC recommendations, he said, adding that the patient would first be told whether the vaccine is fully covered, a copay is required or the patient must pay entirely out of pocket. Gates said that people are already coming in for their flu shot, but many seem to be holding off on the Covid shot until the updated version is available. During last year's respiratory virus season peak, he said, more than 50% of patients got both shots at once — a number that has grown over the past two to three years.
Fox News
an hour ago
- Fox News
Operation Warp Speed was miraculous. Trump admin should not abandon technology that made it possible
"From the instant the coronavirus invaded our shores, we raced into action to develop a safe and effective vaccine at breakneck speed… We harnessed the full power of government, the genius of American scientists, and the might of American industry to save millions and millions of lives all over the world… The gold standard vaccine has been done in less than nine months." That's not a pharmaceutical company executive, scientist or public health official talking. It's President Donald Trump. President Trump made those remarks in 2020 at a White House summit celebrating his administration's Operation Warp Speed initiative. Traditional vaccines often take years to develop. But thanks to a groundbreaking technology called mRNA and tremendous partnerships between government agencies and private companies, a powerful vaccine for COVID-19 was developed less than a year after the virus was sequenced. His prediction that those vaccines would be a game-changer turned out to be correct. COVID-19 vaccines saved at least 3.2 million lives in the United States and millions more around the world. During a very dark time, it was an incredible achievement for our country. Yet Secretary of Health and Human Services Robert F. Kennedy Jr. is undermining that achievement by canceling substantial federal research investments in mRNA – the technology that has already led to approved vaccines for COVID-19 and RSV, and holds tremendous potential for future treatments and cures for many diseases. Instead of supporting researchers on the verge of revolutionizing vaccine science and saving countless lives, Secretary Kennedy has chosen to tie their hands. This decision will slow our progress, leave our nation underprepared for the next major public health emergency, and significantly damage America's leadership in the scientific and medical fields. President Trump should direct Secretary Kennedy to immediately reverse this shortsighted decision. As a pediatrician for more than 30 years, I cared for children from all walks of life. Some had great health insurance; others had none. Some lived in wealthy neighborhoods; others grew up in poverty. But regardless of their circumstances, I strived to give every one of my patients the best possible care. That's how every doctor should approach medicine, and it's also how policymakers should approach their jobs. Health is too important to be politicized. Scientists have been studying mRNA technology for decades, and the more than 13 billion doses of COVID-19 vaccines that have been administered worldwide since 2020 have allowed researchers to assess their impact. The results are clear. mRNA technology has already saved millions of lives. It is also incredibly safe; the vast majority of side effects associated with mRNA COVID-19 vaccines are minor and do not require medical intervention. The beauty of this particular technology is that scientists can quickly update and adapt those vaccines to keep up with changes in the viruses they are targeting without sacrificing quality or safety. But the potential benefits of mRNA technology go well beyond a single virus. Scientists are working on mRNA vaccines and treatments that can target multiple types of cancer, genetic disorders, several other respiratory viruses and all kinds of rare diseases. Funding mRNA research now is also critical to helping us get ahead of the next big public health emergency, whenever and wherever it arrives. That is why Secretary Kennedy's decision to terminate federal mRNA research investments and instead rely on older and slower vaccine technology is deeply flawed. Health secretaries should not be denying Americans proven medical care. Stopping medical innovation in its tracks purely for ideological purposes is just wrong. When it comes to your health, listen to the people you trust the most – your doctor or nurse – rather than politicians. As President Trump has said, COVID-19 vaccines are a "medical miracle," and mRNA holds so much promise for more Operation Warp Speed-type victories in the years ahead. But for that to happen, politicians need to unleash American innovation and let our scientists and researchers do what they do best.
Business Insider
2 hours ago
- Business Insider
Why Is EnVVeno Medical Stock (NVNO) Down 70% Today?
EnVVeno Medical (NVNO) stock took a beating after the medical device company's VenoValve surgical replacement venous valve for severe deep chronic venous insufficiency was rejected by the U.S. Food and Drug Administration (FDA). The FDA sent a non-approvable letter to EnVVeno Medical, stating it couldn't approve the Premarket Approval application for the product in its current form. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. According to EnVVeno Medical, the FDA wouldn't approve the medical device because 'the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve.' EnVVeno Medical noted its disappointment with the FDA's decision and is weighing options, including a potential resubmission or appeal. The company also said that it will take into account what it has learned from this letter in its development of enVVe a non-surgical replacement venous valve that it plans to submit an IDE application for. EnVVeno Medical Stock Movement Today EnVVeno Medical stock was down 71.84% in pre-market trading, following a 16.12% drop yesterday. The shares were still up 38.74% year-to-date but were down 20.94% over the past 12 months. Today's news came with heavy trading, as some 3.6 million shares changed hands, compared to a three-month daily average of about 148,000 units. Is EnVVeno Medical Stock a Buy, Sell, or Hold? Turning to Wall Street, coverage of EnVVeno Medical is thin. Fortunately, TipRanks' AI analyst Spark has it covered. Spark rates NVNO stock a Neutral (58) with no price target. It cites 'robust technical performance, which is somewhat overshadowed by challenging financial metrics' as reasons for this stance.
