Food
FDA approves Moderna flu shot made with mRNA : NPR
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Moderna announced late on Wednesday that the Food and Drug Administration had approved its mRNA vaccine for seasonal flu in people aged 50 and over.
This is the first flu vaccine approved that utilizes the same COVID-19 technology.
Moderna claims that the vaccine, called mFLUSIVA will be ready “within the next few weeks”, just in time for respiratory virus season 2026-2027 in the U.S.
In a press release, Moderna CEO Stephane Bancel said, “The FDA’s approval of mFLUSIVA… shows the strength and versatility our mRNA platforms continue to offer.” Flu remains an important public health problem, and mFLUSIVA offers a new treatment option to America’s senior citizens. The approval also shows the potential for our mRNA technology to address public health issues through scientific innovation.
mFLUSIVA was found to be safe by a company study involving over 40,000 participants. It also appears that it provides a stronger level of protection than the traditional influenza vaccine.
Due to the Trump administration’s opposition towards mRNA, FDA’s decisions was closely watched.
During his first term, President Trump adopted mRNA to create the COVID vaccinations. This achievement was widely praised for being a medical success that has saved millions of life.
The backlash to pandemic response, such as vaccine mandates led some to vilify vaccines and the mRNA technologies, and they became the subject of misinformation.
Robert F. Kennedy Jr. has been a critic of vaccines for a very long time. He has condemned them repeatedly.
The government also cut funding for research on mRNA vaccines and restricted access to COVID vaccines.
Moderna’s mRNA influenza shot was initially rejected by the FDA. The FDA eventually relented after receiving backlash from both the pharmaceutical industry as well as public health experts.
In June, the agency called a meeting with independent external advisers to discuss the new vaccine. The panel unanimously voted to approve the vaccine.
There are other benefits to the mRNA influenza vaccine, according to many public health officials.
For example, mRNA vaccinations can be produced and updated much faster than standard vaccines.
This could help the vaccine be more effective when an unexpected new strain of flu emerges, as happened last season. This could be crucial, especially if an entirely new strain of flu emerges and triggers a pandemic.
Michael Osterholm is an infectious diseases expert from the University of Minnesota.
Other people agree.
The FDA has signaled openness towards this platform which was a controversial and a problem, says Jeanne Marrazzo. She is the chief executive of the Infectious disease Society of America.
It’s an incredibly promising product, which could help us not only to better respond to the bad flu season this year but to also improve our response to biological threats.
Critics are not happy with the outcome.
Food
New flu vaccine mFlusiva is approved for older people
WASHINGTON, D.C. (AP) – The Food and Drug Administration approved a new type of influenza vaccine for elderly people. It is the first flu shot made using the same mRNA techniqe that helped end the COVID-19 Pandemic.
The shot is for those aged 50 and older. Moderna announced late Wednesday it expected to have some of the new version of its flu shot available at selected retailers soon.
There are several flu vaccines available in the U.S. including three that are specifically for those over 65. However, older Americans are the ones most at risk.
Flu vaccines need to be updated every year in order to match the circulating virus strains. The Nobel Prize-winning technology of mRNA allows for faster manufacturing than any other type. Experts say that this option could be useful if the flu virus changes shape and requires the production of new vaccines.
Moderna of Cambridge, Massachusetts said that the FDA approved the use of mFlusiva in the 50-64 age group. The FDA’s approval was based on a 40,000 person study which showed the shot to reduce flu cases by 27% compared to another flu vaccine. The FDA has granted accelerated approval to people aged 65 and older based on the results of a small study that showed a stronger immune response than an existing high dose vaccine.
Moderna data revealed no safety concerns, although some minor reactions were reported, including temporary injection site discomfort, fever, headaches, fatigue and aches. These symptoms occurred more frequently than today’s influenza shots.
This FDA decision comes following a very unusual and public debate over mFlusiva that took place earlier in the year. The FDA’s action comes after a highly unusual public dispute over mFlusiva earlier this year.
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Follow the AP’s coverage of the U.S. Food and Drug Administration at https://apnews.com/hub/us-food-and-drug-administration.
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Robert Wood Johnson Foundation and Howard Hughes Medical Institute Department of Science Education provide support to the Associated Press Health and Science Department. All content is the sole responsibility of The Associated Press.
Food
Anthony Fauci; Abdul El-Sayed; Trump’s economy : NPR
Hello. Your reading the Up First Newsletter. You can subscribe here and get the newsletter delivered straight to your email. Listen to the Up First Podcast for the latest news to kick off your day.
Top stories of the day
Abdul El-Sayed, a Democratic candidate who defeated Rep. Haley Stevens during Michigan’s primaries is set to take on Republican congressman Mike Rogers at the midterm elections in November. Both candidates will vie for the vacant Senate seat left by Democratic Senator Gary Peters. Democrats expect the Senate race to be an intense battle. They see it as a fight they must win to take back control from Republicans.
According to Colin Jackson of Michigan Public Radio, a Republican hasn’t won an U.S. Senate election in Michigan since 1990. El-Sayed cultivated a coalition of younger voters by campaigning with Bernie Sanders and AOC. Jackson claims he will now need to appeal to Stevens’ traditional coalition, including Black, Working-Class and Jewish voters. El-Sayed faces a major fundraising deficit, since Republican groups have committed $45 million to him. Rogers is an established Republican who appeals to Make America Great Again supporters and labels El-Sayed a radical and communist. The Egyptian-American denies these accusations. Rogers must attract MAGA Republicans to win this race without alienating the independents that oppose Trump.
Today, a Senate committee will vote on whether or not to find Dr. Anthony Fauci guilty of contempt before Congress. Last week, the retired official in charge of U.S. coronavirus responses invoked his Fifth Amendment rights against self-incrimination during an hearing and refused to answer questions from lawmakers. Fauci and Sen. Rand Paul (R-Ky.) have often disagreed over the COVID-19 Pandemic’s origins. Paul, in the days leading up to the hearing, released over 1,000 pages from Fauci’s diary, accusing Fauci of concealing his doubts about the origin of the COVID-19 pandemic. Fauci’s vote comes just a day after Dr. Erica Schwartz was confirmed as director of the Centers for Disease Control and Prevention (CDC), an agency that Fauci worked closely with during the pandemic.
Trump made a pitch to voters yesterday at an event held in Las Vegas. He has struggled to convince them of his economic agenda as the price of goods have increased due U.S.-Israeli war against Iran. Las Vegas is heavily dependent on tourism and the policies of President Trump are not helping. In a new Reuters/Ipsos survey, more Americans now favor Democrats on economic matters than Republicans for the first in almost ten years. Trump says that the U.S. is flourishing under his policies. This includes no tax on tips. He blames high prices for inherited conditions by Democrats.
Deepa Shivaram of NPR speaks with tip workers from Vegas who tell her that although they have received a higher refund this year they still face other challenges. According to Las Vegas Convention and Visitors Authority, tourism in the city will decline by more than 7 percent in 2025. Shivaram reports a drop in Canadian tourists after Trump soured the relationship with Canada over tariffs. Residents claim that Trump’s tax-free policy on tipping is not enough. This is especially true as Vegas struggles with a declining tourist industry and rising prices.
Amit Mehta, U.S. district judge, dismissed with reluctance the conspiracy case brought against Stewart Rhodes and other members of Oath Keepers. Rhodes, along with five other defendants, were convicted by juries of trying to overthrow government using force and contributing to violence and chaos when rioters broke into the U.S. Capitol building on January 6, 2021. Under the Trump administration, the Department of Justice moved to vacate and dismiss the convictions. The dismissal of Judge Mehta marks the end of efforts by prosecutors to bring Trump supporters responsible for the violent siege on the Capitol.
Live better
Living Better, a series of specials about how to remain healthy in America.
The snacking culture is forever altered by the ultra-processed food, designed to be convenient and easy-to-eat on-the-go. These foods are available in vending machine across all communities. Most pediatricians suggest that children from toddlers through tweens consume three meals and at least two snacks per day. This advice is based on studies which did not take into account the growth of processed food. They can also increase the amount of sugar and sodium in children, as well as their saturated fat intake. Researchers suggest the following new guidelines to ensure children receive the nutrition they require:
Preferably, avoid snacks that are high in carbohydrates. This includes crackers, puffs, and pretzels. They contain refined starches that can cause blood sugar to spike, causing crashes and making kids want more of these high-carb foods.
Children should be weaned off of processed foods and on to whole food. Kids can be tempted to consume ultraprocessed foods even if they are not hungry.
Prioritize the quality over quantity of your snacks. Jennifer Orlet Fisher, a behavioral nutritionist, says that foods like nuts, fruits, dairy, and beans can help kids improve their diets, increasing the amount of fiber and vitamins they consume.
Avoid carrying processed foods in your bag or purse. Children will no longer associate your bag or purse with snacking and eventually stop expecting them.
Picture Show
Deadheads are out in force as the temperatures rise and the sun shines. The Grateful Dead fans gather to dance and spread the positive vibes, even when the original members of the band are not on tour. Fans spent the summer proving the Grateful Dead’s power never ceases. From themed hangouts in Chicago’s Garcia’s venue, which is dedicated to their lead singer, to All Good Now, a festival held at Maryland’s iconic Merriweather Pavilion. View photos of Deadhead events across the United States.
Before you travel, here are 3 important things to consider
The heatwave in Europe has drained the water from Serbia’s River, revealing Nazi-era German ships that were lost during 1944’s retreat.
Last week, the Dallas Zoo welcomed an elephant calves weighing 230 pounds. (via KERA News).
Todd Miller, a researcher at the University of Wisconsin-Milwaukee in Milwaukee deployed a solar-powered buoy into Lake Michigan ahead of the USA Triathlon this weekend in Milwaukee. This device tracks the water temperature in real time at various depths to help thousands of athletes get ready for the race before taking the plunge. (via WUWM)
Food
FDA Approves Moderna’s mRNA Flu Vaccine After Initially Refusing To Review It
In a recent press release, Moderna announced that the US Food and Drug Administration has finally approved its mRNA flu vaccine. Initially, they refused to review the product. The immunization, known as mFlusiva or mRNA-1010, is effective against four of the most common influenza strains and has been tested in humans since 2021. The World Health Organization reported in 2017 that these variants can cause as many as 5 million cases of severe influenza every year, and as much as 650,000 respiratory death.
Adults aged 50 years and older are eligible to receive the vaccine. Moderna announced that it had received approval to treat adults aged 50-64 after participating in a phase 3 clinical study which enrolled 40 805 adults from 11 different countries. The approval was also accelerated for those 65 years and older. It was the trial’s objective to compare the relative effectiveness of mFlusiva to a non-mRNA approved vaccine.
Researchers at Moderna concluded in their study that “mRNA-1010 is superior to licensed standard dose vaccines as a preventative measure for influenza-like illnesses among adults aged 50 and older.” It did add that “solicited side effects” such as injection site pain, fatigue and headaches were more common with mRNA-1010 compared to current flu vaccines. The study found that most adverse reactions are “mild, moderate or transient”.
Moderna’s flu vaccine approval had a rough start when the FDA declined to review Moderna’s application. US regulators initially claimed that Moderna’s comparator vaccine did not represent “the best available standard of treatment” at the time the study was conducted in the US, but that they preferred an older adult higher dose vaccine as a comparison.
After the FDA director overruled the career scientist, critics dubbed the decision political. Richard Hughes IV, a law professor at The Guardian said that the FDA’s refusal to review the vaccine was based on the director of drug approval overruling career scientists. Critics called the move political.
In less than one week, however the FDA changed its mind and accepted to review Moderna’s application. This was likely due to it having previously informed Moderna that their selected comparator vaccination was perfectly fine. The FDA had told Moderna that they agreed it was acceptable to use an approved standard dose of influenza vaccine in their Phase 3 study.
Moderna’s mRNA-based vaccines and those of others, have passed trials with flying colors due to their inherent qualities that make them more efficient and safer than conventional vaccines. These include rapid development, high effectiveness in preventing serious illness, the adaptability of new strains and manufacturing without living viruses. They also have fewer side-effects for people with immunocompromised immune systems, as well as the ability to activate a powerful immune response.
Food
FDA Approves First mRNA Flu Vaccine For Older Adults
Topline
After facing criticism from scientists and medical professionals, the U.S. Food and Drug Administration has approved the first flu shot based on mRNA for older adults. This comes after the FDA refused to examine the vaccine as part of a larger effort led by Robert F. Kennedy Jr. to clamp down on mRNA injections.
The Key Facts
Important Quote
The flu remains an enormous public health problem, and mFLUSIVA offers a new treatment option to America’s senior citizens. The approval also shows the potential that our mRNA technology has to offer, said Moderna’s CEO Stephane Bancel.
What do we know about the FDA’s earlier stance?
Moderna reported in February that the FDA rejected their request for a review of its mRNA influenza vaccine. Moderna noted that FDA’s top regulator for vaccines, Dr. Vinayprasad dismissed its application because it did not consider their choice of control vaccine against which the mRNA flu shot was compared to be the best vaccine available. Prasad has long been an advocate of Kennedy’s and a critic for the COVID-19 vaccination. The FDA commissioner Marty Makary reversed his decision after the backlash. He said that the original refusal “was part of a discussion with all drug manufacturers.”
Key Background
Kennedy, a noted vaccine skeptic who has attacked mRNA COVID-19 vaccines despite pushback from medical professionals and scientists, announced last year that he was canceling grants and contracts worth almost $500 million intended to develop mRNA vaccinations. Health and Human Services described this decision as “a coordinated wind-down” of the mRNA development activities within the Biomedical Advance Research and Development Authority. Kennedy is a vaccine skeptic and has criticized mRNA COVID-19 vaccinations, even though medical professionals and researchers have pushed back. Kennedy claimed data shows that 22 mRNA COVID-19 vaccinations “fail[ed] to protect against upper respiratory infection like COVID and influenza,” despite the pushback by scientists and doctors. Rick Bright, an immunologist and former BARDA director, criticised the decision. He said: “BARDA had invested in mRNA because of its ability to deliver safe, scaleable vaccines within record times, as demonstrated during the COVID outbreak.” We cripple our first-line defence by dismantling this platform. This is just in time for unknown biological threats.
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Food
Russian missile barrage kills 17 in Ukraine’s capital region
Kyiv, Ukraine, (AP) — Russian missiles fired overnight at Ukraine failed to be stopped by Ukraine’s weakened air defense system. The attacks killed and injured 17 civilians and left dozens more wounded, according to President Volodymyr Zelenskyy.
This barrage lasted for about two hours and was part of a string of Russian large-scale missile attacks that has become routine in the summer. Moscow exploits Ukraine’s shortage of Patriot interceptors, which are the only air defense weapons in Moscow’s arsenal that can shoot down missiles.
Zelenskyy pleaded to other countries and especially the U.S. for more ammunition, which has become scarcer due to the Iran War. In the event that this fails, Zelenskyy wants to manufacture Patriot ammunition in Ukraine. He also hopes to get permission from Elon Musk for him to use Starlink’s satellite communication system to direct strikes against Russia missile launchers.
Uncertainty surrounds the number of interceptors Ukraine still has. Zelenskyy claimed that after the Russian air attack on Friday, the air defenses only shot down one missile. “Only because of the Patriots.” Zelenskyy stated.
Zelenskyy posted on Wednesday that ballistic interceptors could have prevented the deaths of many people. It is important that our partners understand the impact of delays or refusals to provide anti-ballistic system.
Zelenskyy stated that the targets of the barrage were a brewery and warehouses for building materials, as well as a sorting office. These had no connection to the war. The Russian Defense Ministry claimed that the companies had military links.
Tymur Tkachenko of the regional military administration of Kyiv announced that Thursday would be an official mourning day for 17 victims. At least 44 other people have been injured in addition to those who died.
Ukraine responds with drones that can fly long distances
Ukraine’s deep-strikes on Russian oil refineries and other key targets have increased as U.S. peace efforts appear to be stalling. The aim is to force Russian President Vladimir Putin into negotiations. Zelenskyy accepted the unconditional ceasefire requested by U.S. president Donald Trump, but Putin refused.
Ukrainian drones have attacked a warehouse south of Moscow in Tula, according to the governor and company. The attack was the latest on the largest online retailer for Russia, Wildberries.
Ukraine struck more than a dozen Wildberries sites in less than three weeks. The company is said to provide goods which can be used for military purposes. Kyiv also wants to unnerve the Russian people with attacks of high profile.
According to the Russian Defense Ministry, its forces shot down 475 Ukrainian drones over the course of one night in 16 Russian regions as well as the illegally annexed Crimea as well as the Sea of Azov or Black Sea.
Russia claims it has struck targets related to war
Ukraine’s authorities reported that Russia had fired 24 ballistic rockets and four hypersonic Zircon and supersonic Onik missiles. They also said they launched 115 drones – many jet powered and difficult to stop because of their speed.
According to the Russian Defense Ministry, it has struck four transport, logistic and distribution centres involved in military-related activities, including those in Kyiv.
Serhii Beksrestnov, a Zelenskyy advisor, stated on Facebook that “the enemy attacks everything without discrimination — retail stores, food storage, logistic hubs, businesses, and building material warehouses.”
The different Russian and Ukrainian assessments of the target’s military worth could not be independently reconciled.
Mykhailo Hukov, a warehouse worker in Kyiv, said that an air raid alert with a missile warning sounded shortly after midnight.
He told The Associated Press that “everyone started running”. I turned them all around to make sure they didn’t return inside and get their bags.
Minutes later they heard “very large explosions” in an underground shelter.
Nova Poshta Ukraine’s largest private post operator said that a Russian cluster munition had destroyed one of their sorting centres in Kyiv.
According to the Russian Defense Ministry, the facility was used for “storing and disseminating dual-use products, such as those that are needed in the manufacture of unmanned long- and mid-range aerial vehicles as well as robot systems and electronic war systems” and claimed two other logistic centers were located in Kyiv.
Russia also claimed that its forces had attacked three bulk carriers in the Black Sea, south of Odesa. It said they were carrying Ukrainian military and weapons equipment. Officials from Ukraine have not commented on this claim.
The narrow escape of truck drivers
Ivan Braga (46), a truck driver who is from Moldova and was in Kyiv at the time of the attack, told reporters that he, along with a co-worker, fled from their car when shrapnel was thrown in by a wave of explosions.
Braga, a spokesperson for AP, said: “We did not have enough time to get our documents and anything else.” I couldn’t believe what happened. “I’d been to Kyiv before and heard some explosions, but not like this.”
Epicentr was one of Ukraine’s biggest retail and construction companies. In a Facebook statement, it said that Russian missiles “in minutes” destroyed the work of decades. One employee died and three other were injured.
The Russian Defense Ministry reported that the Epicenter Logistics Center handled the processing of orders, sorting and storing dual-use products and drone components, as well as the delivery.
The Russian factory boss of drones is seriously injured in an explosion that occurred during a car accident
News reports on Wednesday said that the director of an Ural Mountains-based factory which makes drones and other military equipment for Russia was severely injured in his car when it exploded.
The state-run Tass agency and RIA Novosti reported that Vladimir Tkachuk had been hospitalized following the blast late on Tuesday, just east of the city located 1,400 km (about 870 mi) from Moscow.
Uraldronzavod is the factory that produced the Upyr. It was a simple and cheap drone, which proved popular among troops because of its ability to protect them from jamming.
Russian officials did not comment. However, authorities have previously blamed Ukraine in a series of attacks and bombings that targeted military officials.
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Illia Novikov, Volodymyr Yurchuk, and Dan Bashakov from AP contributed in Kyiv.
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