Latest news with #Novavax
Business Insider
2 days ago
- Business
- Business Insider
Bank of America Securities Remains a Buy on Revolution Medicines (RVMD)
Bank of America Securities analyst Alec Stranahan reiterated a Buy rating on Revolution Medicines (RVMD – Research Report) on May 30 and set a price target of $78.00. Confident Investing Starts Here: Stranahan covers the Healthcare sector, focusing on stocks such as Novavax, Y-Mabs Therapeutics, and TG Therapeutics. According to TipRanks, Stranahan has an average return of -11.2% and a 35.35% success rate on recommended stocks. Currently, the analyst consensus on Revolution Medicines is a Strong Buy with an average price target of $70.63.
Forbes
2 days ago
- Health
- Forbes
Subtle Differences Emerge Between FDA And CDC On COVID Vaccine Advice
An illustration picture shows vials with Covid-19 vaccine stickers attached and syringes with the ... More logo of the company Novavax. (Photo by JUSTIN TALLIS / AFP) (Photo by JUSTIN TALLIS/AFP via Getty Images) In a major policy shift last month, Food and Drug Administration officials proposed requiring new clinical trial research with respect to the effectiveness of COVID-19 vaccines in healthy people under 65, including pregnant women, before issuing an updated approval for a broader population. At the same time, in an update to its immunization schedule posted May 29th, the Centers for Disease Control and Prevention include the option of COVID-19 vaccines for healthy children and pregnant women. Based on the language used by CDC, it suggests the agency aims for a shared decision-making approach in which individuals consult with their doctor prior to getting a shot. We witnessed a preview of the new FDA approach when the agency made an unusual decision to limit the approval of the nation's only non-mRNA coronavirus vaccine, Novavax's nuvaxovid, for use only in adults 65 and older or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19. To be indicated for a broader population, the FDA plans to require that vaccine makers conduct booster trials to demonstrate effectiveness in people under 65 or without certain risks. These trials could take a year to complete, according to a STAT report. As such, it's not something that can be accomplished prior to the autumn, even if Novavax, Pfizer, or Moderna, wished to pursue this pathway. Similar to annual flu shots, which adapt to new strains, COVID-19 boosters update immunity to target evolving variants. Data from several years of booster campaigns show lower hospitalization and death rates for boosted individuals compared to unvaccinated people or those who haven't gotten boosters. This particularly applies to the vulnerable subpopulations, stratified by age and underlying health conditions. The COVID-19 vaccines, both mRNA and non-mRNA, are recommended for anyone who is over 65 or who has a medical condition that can increase the risk of severe illness or death. Underlying conditions include, among other things, obesity, 'physical inactivity,' diabetes, clinical depression and being immunocompromised. It's estimated that between 100 and 200 million Americans will still be eligible for vaccination due to having such health issues. Nevertheless, this raises questions for people who don't have underlying health conditions and are under 65 but would like to get a COVID-19 shot this fall. The FDA and CDC appear to differ subtly in terms of their current advice for healthy individuals under 65. Is it possible for these folks to obtain a jab at the pharmacy with no questions asked? Or will they have to go to their doctor and be granted de facto permission to get the shot? Perhaps equally important, will their insurer pay for it? As the New York Times explains, insurance companies may serve as the 'gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.' The out-of-pocket cost to patients could be as much $140 a shot. Top FDA officials Prasad and Makary advocate an 'evidence-based' approach to COVID-19 vaccination. They also write of aligning policy with Europe. Indeed, in most instances, European public health authorities have adopted a targeted approach that aims at ensuring the elderly and those with underlying health conditions get boosted. This means that outreach campaigns in European countries only target subpopulations for which the vaccine is recommended by the respective public health authority. This is unlike the universal recommendations previously issued by the CDC that didn't differentiate by age or risk factors. However, the European agencies in charge of vaccine approval, the EMA and MHRA, haven't suggested marketing authorization changes, such as narrowing the indication based on age, for any of the approved COVID-19 vaccines.
CBS News
3 days ago
- Health
- CBS News
Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose - a fifth of the dose of its current COVID-19 vaccine, Spikevax - by refining its immune target. The approval "adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective - and more by some measures - than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. It also comes as the Centers for Disease Control and Prevention changes its recommendation to children for COVID-19 vaccine under Kennedy's directive. The agency on Thursday dropped its recommendation for all children to get the vaccinated but still broadly recommends COVID-19 vaccines for moderately or severely immunocompromised children, in addition to most adults for now. Kennedy's directive cited "a review of the recommendations" of the Food and Drug Administration and National Institutes of Health, saying that the risks of the COVID-19 vaccine for healthy children "do not outweigh the purported benefits of the vaccine." The directive also cited "the lack of high-quality data demonstrating safety of the mRNA vaccines during pregnancy combined with the uncertainty of the benefits" for pregnant moms and their baby. "Truly the death of expertise. This would be like the secretary of transportation directing that all planes must fly 5,000 feet higher than current. It's vibe-based decision making," one federal health official said of the directive.
Miami Herald
3 days ago
- Health
- Miami Herald
Moderna wins narrower US approval for new COVID vaccine
Moderna Inc. gained U.S. approval for a new COVID vaccine for a narrower group of people, in the latest sign that regulators are restricting access to immunizations under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr. The company's second-generation vaccine is cleared for all adults over 65 and anyone over 12 who has at least one risk factor for severe disease, Moderna said in a statement Saturday. Moderna's COVID shot had previously been approved for people 12 years of age and older regardless of their underlying health. Vaccine makers have been on high alert to challenges under Kennedy, a longtime critic of immunizations who leads the health agency that oversees the Food and Drug Administration. The FDA's decision on Moderna's COVID vaccine was seen as a litmus test of whether Kennedy's doubts about the shots would hinder future approvals. Under Kennedy, U.S. health agencies have taken steps to limit who can get COVID vaccines, arguing there's a lack of evidence for repeat doses. In May, the FDA said it will no longer approve COVID booster shots for healthy adults and children without new studies confirming their safety and effectiveness. Kennedy also removed the COVID shot from a list of recommended vaccines for healthy children and pregnant women, which could limit insurance coverage. The FDA recently gave full approval to a COVID vaccine made by Novavax Inc., but for a narrower group of people than before - adults 65 and older and those ages 12 to 64 who have an underlying condition that puts them at high risk if they get the virus. Moderna's approval faced even greater uncertainty because, unlike Novavax, its COVID vaccine uses mRNA technology, which has faced opposition from anti-vaccine groups that support Kennedy. On Wednesday, U.S. health officials terminated a contract with Moderna worth up to $766 million to develop vaccines for bird flu. In a statement, an HHS spokesman said that "mRNA technology remains under-tested." Improved performance Moderna's next-generation COVID shot proved more effective in older adults in a key study than the version now available, called Spikevax. Instead of targeting the entire spike protein on the surface of the virus, the new shot hones in on just two segments. The change helps it last longer when refrigerated, making it easier to distribute in certain parts of the world. It's also more effective at lower doses, allowing the company to make combination shots that protect against both COVID and flu. Packaging the two immunizations together will boost protection from COVID because more people get flu shots each year, according to the company. More than five years after the start of the pandemic, the virus poses less of a threat, although the elderly and infants face higher risks than the general public. Many people no longer feel the urgency to get another COVID booster, having been infected multiple times and experienced mild symptoms. As a result, COVID vaccination rates have been in decline, with just 23% of U.S. adults getting the latest booster, according to the Centers for Disease Control and Prevention. Kennedy has long criticized COVID shots, once claiming, without evidence, that they are "the deadliest vaccine ever made." In a recent video announcing that COVID vaccines have been removed from the CDC's recommended immunizations schedule, Kennedy said, "I couldn't be more pleased." --- (With assistance from Bill Haubert.) Copyright (C) 2025, Tribune Content Agency, LLC. Portions copyrighted by the respective providers.
Yahoo
3 days ago
- Health
- Yahoo
FDA approves Moderna's new lower-dose COVID-19 vaccine
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target. The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. The Associated Press 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
