- F.D.A. Advisers Endorse Paxlovid’s Benefits as a Covid Treatment The New York Times
- FDA advisers vote in support of Paxlovid approval for Covid-19 treatment in high-risk adults CNN
- COVID-19 treatment Paxlovid for high-risk adults close to full FDA approval WKRC TV Cincinnati
- AI-based drug interaction prediction technology analyzes the interaction between Paxlovid ingredients News-Medical.Net
- FDA advisors recommend full approval of Pfizer Covid treatment Paxlovid for adults 50 and over and other high-risk people CNBC
- View Full Coverage on Google News
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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States
CNN
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A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.
The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.
The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.
Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.
This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.
Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.
People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.
The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.
Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.
Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.
“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”
Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.
Others feel that convenience is important but also stressed that data supported the switch.
“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.
Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.
“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.
Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.
The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.
The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.
“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.
“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.
In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.
For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?
The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.
Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.
“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”
The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.
One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.
Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.
Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.
Another puzzle will be how to pick the strains that are in the vaccines.
The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.
“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”
Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.
At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.
The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.
In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.
After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.
At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.
The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.
When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.
Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.
The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.
Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.
Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.
Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.
Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.
What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.
The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.
“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.
Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.
The FDA confirmed that the agency is taking a closer look.
“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.
The FDA did not give a time frame for when these studies might have results.
Iranian advisers killed aiding Russians in Crimea, says Kyiv | Ukraine
Ukraine’s top security official has confirmed that Iranian military advisers have been killed in Crimea, and warned that any other Iranians on occupied Ukrainian territory in support of Moscow’s invasion would also be targeted.
Oleksiy Danilov, secretary of Ukraine’s national security and defence council, said Iranians were present in Crimea to help Russia pilot the Shahed-136 armed drones supplied by the Tehran government, but did not say how many Ukraine had killed.
Reports in the Israeli press in October said that 10 were killed because of Ukrainian military strikes in occupied Crimea. Danilov made it clear that any further Iranian military presence would be targeted.
“You shouldn’t be where you shouldn’t be,” Danilov said, in an interview in Kyiv. “They were on our territory. We didn’t invite them here, and if they collaborate with terrorists and participate in the destruction of our nation we must kill them.”
Wave after wave of Russian air attacks, including drone and missile strikes, have since October targeted Ukraine’s civilian energy infrastructure, plunging it into blackouts as the winter cold has begun to fall across the country. The Ukrainian president, Volodymyr Zelenskiy, told a meeting UN security council late on Wednesday that the attacks “an obvious crime against humanity” and said Kyiv would put forward a resolution condemning “any forms of energy terror”.
The Kremlin spokesperson Dmitry Peskov on Thursday sought to blame Ukraine, saying it could “end all possible suffering of the civilian population” if it met “the demands of the Russian side”.
After initially denying the presence of Iranian drones in Ukraine, the Tehran government has claimed that it had supplied a “small number” of the unmanned aircraft to Russia months before Vladimir Putin launched an all-out invasion of Ukraine in February. It denies sending Iranian trainers to help Russians fly the drones from occupied territory.
Kyiv has expressed scepticism about Iran’s version of events, and experts from both countries have met at Tehran’s request to discuss evidence collected by Ukraine.
“The Iranians keep insisting that they are not suppliers of weapons to the Russian Federation but we need confirmation. Do we have this confirmation as of today? No we don’t.” Danilov said. “We understand these things don’t fly without [people] learning how to operate them, and the Russians don’t have the brains to figure it out themselves … In the modern world you can’t hide anything. It is just a matter of time when it will be made public.”
He said it was unclear whether Iran had also delivered ballistic missiles to Russia.
“We are trying to answer this question and we’ll do everything we can to make sure it doesn’t happen,” Danilov said. “But if it does happen, it will tell us two things. First, that Russia has no capability of manufacturing their own missiles, at least in the numbers that would allow it to continue a large-scale war. Second, if a country that has been under sanctions since 1979 has a capability of producing such weapons, what kind of sanctions are we talking about? So it raises a big question about enforcement.”
The papers on the conference table in Danilov’s office were covered up with blank pages for security reasons, and sitting among them was a chess set with just a single black pawn advanced. Asked about it, Danilov said it was a metaphor for a world in which the old rules no longer applied.
“It shows that everybody is now starting with black,” he said. “Or what is black could also be white, or perhaps grey.”
Ukraine’s relations with Israel are an example of a grey area. There is a long list of Israeli military equipment the Kyiv government would like to acquire, but Israel has sought to avoid Moscow’s retribution and tried to portray itself as neutral.
Benjamin Netanyahu’s political comeback in elections this month complicates the picture further as he has a warm relationship with Vladimir Putin, but Iran’s involvement on Russia’s side will also affect Israel’s calculations.
“The stand of Israel towards this war is well known and understandable,” Danilov said. “Once again, I would point out that in the modern world you cannot hide anything, support or the absence of support. Are you pro-democratic or pro-authoritarian? What side are you on?”
Danilov was speaking after the liberation of Kherson city by Ukrainian armed forces, and rumours of raids across the Dnipro River to the southern part of Kherson region leading to Crimea. He was cagey about the state of the southern front, but pointed to previously reported operations behind Russian lines.
“Our armed forces are wherever they are required. We proved that more than once with our actions – when something has blown up in the occupied territories, or something went bang, when things break down, bridges fall, airfields burn and much else besides.”
He shrugged off suggestions that the pace of the Ukrainian counter-offensive might be slowed down by the winter weather, or the physical barrier of the Dnipro, or nervousness among western allies that the potential loss of Crimea would drive Putin to desperate, catastrophic, measures.
“We must defend our country and free it from terrorists at any time of year. The season doesn’t matter,” Danilov said, adding that the Dnipro was “just one more obstacle we will overcome”, and that “with the modern equipment and modern weapons, it’s just a task to be carried out”.
He added: “Until our entire territory is free our army cannot stop, and that includes Crimea and the other territories.”
Expert advisers urge FDA to pull pregnancy drug from market
Peter Stein, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, acknowledged in closing arguments clinicians’ arguments about the need for an effective drug to reduce the incidence of preterm birth — a leading cause of infant mortality in the United States. He said the agency agrees with clinicians who testified during three days of hearings on the urgent need for such a drug, but only if the data and science support it — and that is not the case for Makena.
“Hope is a reason to keep looking for options that are effective, whether we find them here or elsewhere,” he said. “Hope is not a reason to take a drug that is not shown to be effective. or keep it on the market.”
The recommendations of the panel of independent advisers are nonbinding, though the agency usually follows its advice. Withdrawing a drug from the market is a highly unusual step.
The three-day hearing was emotional both for members of the public, as well as the panel members of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee.
Several health groups have supported keeping Makena on the market while further study is done, worried that pulling it could deepen health inequities. “We believe that removing access will have a detrimental impact on the health of women and birthing people at risk of recurrent preterm births and will not impact all women equally,” said Martha Nolan, senior policy adviser at HealthyWomen, nonprofit women’s health group focused on helping women making informed decisions about their care.
Members of the panel, which is made up of maternal health experts, neonatologists, statisticians and other experts, related the difficulty of their decision.
“I’m so disappointed … I wish we weren’t sitting here today,” one member said. Another expressed “deep sadness” about the large trial of Makena that showed no benefit.
Esther Eisenberg, a reproductive endocrinologist, supported withdrawing the drug, “but I’m very conflicted. This is a very very difficult question.”
Cassandra Henderson, a maternal-fetal medicine specialist in New York City who was the sole panel member who argued the large clinical trial showed promise for some patient subgroups and who voted to keep the drug on the market, said she was concerned about the low representation of minority women in the trial, as “we do know race is sort of a surrogate for racism and all the structural inequities.”
Drugmaker Covis Pharma and its backers have argued that the study may have missed its benefits in high-risk populations in the United States because participants were largely Eastern Europe and only 7 percent Black. In a filing with the FDA, the drug company called the latter trial “flawed,” not only because of its racial demographics, but also because the population was low-risk and the women had access to national health-care systems that differ greatly from the complex piecemeal system in the United States.
Raghav Chari, chief innovation officer for Covis, had testified the company was willing to work with the agency to limit Makena’s use to “a higher-risk target population” only and would also agree to stop active promotion of the drug.
He called this a “practical approach” that would enable individual physicians in consultation with their patients to make decisions about whether using the drug might be helpful.
Chari said Covis is committed to conducting additional studies to address questions about the drug’s potential risks and benefits, emphasizing that reducing preterm birth is a public health priority and an area of unmet need in drug development.
“We are not proposing that race biologically differentiates patients,” he said Wednesday. “At the same time, it is well-documented that preterm birth disproportionately impacts women who are Black and other minorities in the United States. These and other social determinants of risk are factors in defining the higher-risk population where Makena is most likely to be effective.”
But Joseph Alukal, a urologist who is director of men’s health at Columbia/NewYork-Presbyterian, suggested the racial inequity argument “implies the drug is effective and implies the drug is safe” when we do not actually have an answer on that.
Mark Hudak, a neonatologist the University of Florida College of Medicine, said he is “sensitive to the disparity issues that have been raised.” However, he said allowing Makena to remain on the market is not appropriate and would result in “complete regulatory chaos.”
Makena was approved by the FDA in 2011 under an accelerated approval program for drugs that treat serious conditions for which there are no treatments. The drugmakers are then required to conduct studies confirming the drug’s benefits to continue selling the medication. But the debate over Makena’s effectiveness more than a decade after its approval underscores the complexities of that program, highlighting how it can take the agency years to pull a drug from the market even if officials believe it’s ineffective.
In the case of Makena, the FDA’s Center for Drug Evaluation and Research proposed withdrawing it from the market in October 2020 — a move that followed an expert advisory panel’s 9-7 vote a year earlier to pull it from the market based on disappointing results from a large confirmatory study. But regulatory requirements, as well as the pandemic, have slowed the process.
The FDA’s Stein argued that leaving Makena on the market for a narrowed use would “upend the intention of the accelerated pathway.” He argued that “absent evidence of effectiveness, we are only left with risk. The benefit-risk balance for Makena is not favorable.”
FDA advisers recommend approval of controversial ALS drug
But on Wednesday, after hours of discussion, several advisers said that additional analyses submitted by the drug’s manufacturer, Cambridge-based Amylyx, bolstered the case for approval, even though uncertainties remain. Advisers were also affected by the disease’s severity and the lack of effective treatments. A vow by a top Amylyx official to pull the drug from the market if a larger study, with 600 patients, fails to show effectiveness was also a factor in the vote.
The FDA, which usually follows the recommendation of its outside advisers but is not required to, is expected to decide whether to approve the drug by Sept. 29.
The improved fortunes of the medicine came despite criticism from FDA staff as recently as last week about the treatment’s effectiveness, the conduct of its clinical trial and the researchers’ interpretation of the data.
But the medicine is considered safe, and the agency has been under intense pressure from ALS patients and physicians who say the treatment holds promise for a fatal disease that typically causes rapid deterioration and death.
Wednesday’s vote came after a dramatic moment featuring Billy Dunn, director of the FDA’s Office of Neuroscience, who stressed the agency may use broad flexibility to clear drugs for diseases like ALS that lack effective treatments.
Dunn also noted the large trial being conducted by the manufacturer will be completed late next year or in early 2024; that trial is expected to show definitively whether the drug works. In a highly unusual move, he asked company officials whether they would voluntarily withdraw the product if it was approved now but the larger trial failed to show effectiveness.
Justin Klee, co-chief executive of the Cambridge-based biotech company, agreed. If the larger trial is not successful, “we will do what is right for patients, which includes withdrawing the product from the market,” he said.
Other experts cautioned, however, that a voluntary commitment like Klee’s is not legally binding.
Still, the commitment from Amylyx and its new analyses convinced some panel members to change their votes from March. Liana G. Apostolova, a neurologist at Indiana University School of Medicine, said the new analyses left her “mildly to moderately” persuaded the drug extends life by at least several months. “To deprive ALS patients of a drug that might work is not something I feel terribly comfortable with,” she said.
Kenneth Fischbeck, a scientist at the National Institute of Neurological Disorders and Stroke, voted no, as he had in March. He said he did not believe the drug had met the standard of substantial evidence of effectiveness.
ALS, or amyotrophic lateral sclerosis, destroys nerve cells in the brain and spinal cord. It typically paralyzes patients, robbing them of their ability to walk, talk and eventually breathe. About 30,000 people in the United States have ALS, sometimes called “Lou Gehrig’s disease.” Another 6,000 are diagnosed every year. There are two FDA-approved therapies on the market but they have limited effectiveness.
The experimental treatment was dreamed up almost a decade ago by Brown University undergraduates who went on to found Amylyx — Klee and Josh Cohen, now co-chief executives.
The ALS medicine is made up of two components — a prescription drug called sodium phenylbutyrate that is used to treat rare liver disorders and a nutritional supplement called taurursodiol — designed to protect neurons from destruction. The treatment comes in a powder that is dissolved in room-temperature water and drunk or administered through a feeding tube.
ALS advocates were delighted by Wednesday’s vote. “We applaud and thank the FDA Advisory Committee for their vote to support approval of AMX0035 and we urge the FDA to swiftly approve,” said Scott Kauffman,” chairman of the ALS Association’s board of trustees. “Americans living with ALS cannot wait.”
During the public hearing portion of Wednesday’s session, leading ALS doctors pleaded for the drug’s approval, saying even small benefits could provide enormous help in dealing with a fatal neurodegenerative disease. Several patients who have gotten the drug through clinical trials gave emotionally wrenching testimonials asking for approval.
Vance Burghard said he was diagnosed with ALS in 2017 and soon needed help pulling up his pants. Through a clinical trial, he has been on AMX0035 for three years, something he called “life-changing.” He said his condition has stabilized and he has been able to hike in China and Tibet.
Gregory Canter said he participated in the ALS Association’s Ice Bucket Challenge several years ago, although “I didn’t have ALS and I didn’t know anyone who did.” A few years later, he was diagnosed with the illness and subsequently enrolled in the six-month Amylyx trial. He believes he got the placebo, but as a trial participant was offered the drug after the trial was over, as part of what is called an open-label study.
Canter said the drug has stabilized his breathing and helped him in other ways. “I am still alive, living independently and my disease progression has noticeably decreased,” he said.
Brian Wallach, a former Obama White House staffer who was diagnosed five years ago, noted that some panel members said they had voted against the drug in March to protect patients from false hope.
“I don’t need you to protect me from myself,” he said. Such “antiquated paternalism is misplaced,” he said through an aide because his speech is severely affected. “There is only one right answer here. I only hope you have the courage to recommend approval.”
Amylyx applied to the FDA for approval of the drug in November 2021. The company submitted data from a 24-week week trial that showed the drug was safe and slowed a decline in essential functions such as walking, talking and cutting food, by 25 percent.
In a follow-on study, in which all participants were offered the drug, patients who received the treatment from the start of the trial lived a median of more than six months longer than those who did not, the investigators found.
More recent analyses submitted by the manufacturer showed AMX0035 extended median survival several months longer than originally thought, delayed first hospitalizations and reduced severe complications.
Still, the FDA has signaled for months it had doubts about approving the drug on a single study, especially when the agency said it did not find the data “exceptionally persuasive.” The agency said the company did not adequately account for deaths during the trial and took issue with other aspects of the study. It said the additional analyses included no new information.
Canada recently approved AMX0035 on a conditional basis. That means Amylyx can sell the drug but is required to confirm its benefits based on the results of the larger trial. But the FDA’s approval processes are somewhat different from Canada’s.
Some ALS patients are already taking one or both components of AMX0035. Since sodium phenylbutyrate is approved for another purpose, doctors are allowed to prescribe it off label for ALS. And the nutritional supplement, sometimes called TUDCO, is available on a variety of websites.
Some health policy experts said in the hearing that the drug should not be approved until additional data proves its effectiveness.
Others agreed the FDA has a legal responsibility to determine that drugs are safe and effective — but noted it has flexibility about how to do that. Murky data can complicate the picture.
“Science is messy and even well-designed trials will not always give you a clear-cut answer,” said Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania who is not on the panel.
Trump Advisers Said Steve Bannon’s Job Was Leaking Stories to the Press
- Former Trump adviser Jared Kushner wrote that he and Steve Bannon clashed in the White House.
- Bannon threatened to “break” Kushner “in half” if he decided to oppose him.
- After Bannon was fired advisers joked his only role was leaking stories to the press, Kushner wrote.
After former President Donald Trump fired Steve Bannon, other White House advisers joked that Bannon’s only job was leaking stories to the press, Jared Kushner wrote in his new memoir.
“Stephen Miller joked to Hope [Hicks] and me, ‘I have a plan to split up Steve Bannon’s extensive workload. Hope, you leak to Jonathan Swan at Axios. Jared, you call Mike Bender from the Wall Street Journal. I’ll call Jeremy Peters from the New York Times, and … we’re done,'” Kushner wrote, according to CNN.
“Breaking History: A White House Memoir,” details the fallout between former Trump adviser Kushner and Bannon.
Kushner calls Bannon skilled in “media manipulation,” and writes that Bannon had threatened to “leak out” Kushner to the press following a call he made with The New York Times. At the time, Kushner was trying to stop a story about Trump’s displeasure with Bannon and former White House Chief of Staff Reince Priebus, CNN reported.
According to Kushner’s account, after he told Bannon to stop leaking stories about Senior Economic Adviser Gary Cohn, Bannon said he would “break” Kushner “in half.”
“‘Jared, right now, you’re the one undermining the President’s agenda,’ he continued, his eyes intense and voice escalating into a yell. ‘And if you go against me, I will break you in half. Don’t f— with me,'” Kushner wrote, according to CNN.
Kushner wrote that Bannon’s termination as Trump’s chief strategist and senior counsel in 2017 was an accomplishment of his.
“Admitting that I didn’t yet have any major policy successes to show for my seven months in government, I joked, ‘At least I was able to get Steve Bannon fired,'” Kushner wrote.
Lawyers for Bannon did not immediately respond to Insider’s request for comment.
Lawmakers want US military advisers sent to Ukraine
Day 150 of Russia’s brutal invasion of Ukraine
Fox News correspondent Lucas Tomlinson detailed a summit in Kyiv hosted by President Zelenskyy and the first lady of Ukraine, and shared reactions to Russia’s attack on Odesa on ‘Fox News Live.’
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Kyiv, Ukraine–The Biden administration should allow the Pentagon to deploy U.S. military advisers to Ukraine to help coordinate the billions of dollars of arms flowing into the country and to keep better tabs on the weapons, members of a bipartisan congressional delegation visiting Kyiv said Saturday.
“I think we should do more,” Rep. Michael Waltz, R-Fla., the first Green Beret elected to Congress, told Fox News after meeting Ukrainian President Volodymyr Zelenskyy.
“That said,” Waltz continued, “it should come with appropriate safeguards, with appropriate oversight and the only way we can get that oversight is to actually have some advisors in Ukraine helping their military with the planning and logistics.”
In this photo provided by the Ukrainian Presidential Press Office, Ukrainian President Volodymyr Zelenskyy, left, listens to a servicemen report close to the front line in Donetsk region, Ukraine, Sunday, June 5, 2022.
(Ukrainian Presidential Press Office via AP, File)
Asked if that includes sending U.S. military personnel to Ukraine, Waltz said it might.
“It could be contracted, it could be civilian, but it could be military as well,” Waltz said. Those advisers running logistics and weapons transfers are currently deployed to Germany and Poland.
Rep. Mikie Sherrill, D-N.J., also traveled to Ukraine Saturday as part of the delegation. She signaled her support for a larger American presence on the ground as well.
“It would be good to have a logistics officer here to make sure that we understand and track the weaponry that we’re sending,” Sherrill told Fox News.
US MUST SEEK INTERNATIONAL CYBERSPACE NORMS WITH CHINA, RUSSIA: EXPERTS
Both lawmakers said the advisers would help beef up the presence at the U.S. Embassy in Kyiv and assist in other areas.
“I don’t think anybody is advocating for any [American] military on the front line, but helping with logistics, planning those operations, integrating the intelligence is incredibly important right now,” said Waltz.
“The Ukrainians are doing a very good job,” Sherrill said, “But they even said they would like to pass on the information about how they’re tracking [weapons] but they need someone to pass that on to.”
Waltz also called for Europe to “step up” and contribute more weapons and aid to help Ukraine. The United States has committed three times more money for Ukraine than the entire 27-nation European Union combined, according to the New York Times.
Waltz noted Britain’s contributions to the war effort by sending billions in weapons. The British government has been one of the few in NATO nations calling on Russia to be routed completely in Ukraine, including calling for its occupied territory in Crimea and eastern Ukraine to be recaptured.
Secretary of State Antony Blinken speaks, Wednesday, June 1, 2022, during a news conference with NATO Secretary General Jens Stoltenberg, at the State Department in Washington.
(AP Photo/Jacquelyn Martin)
The Biden administration should “not just help Ukraine play for a time, but help them go for a win,” Waltz said. “At a minimum, what we talked about today was getting them back to that 2014 line.”
Asked if current rules of engagement restrictions should be lifted barring U.S.-supplied weapons for striking targets inside Russian territory, Waltz said there were plenty of targets inside Ukraine to destroy first.
RUSSIA-UKRAINE WAR: WHITE HOUSE STILL HELPING TO ‘FACILITATE’ ZELENSKYY PROTECTION
Saturday, Russia launched a missile strike on Odesa, Ukraine’s largest port, less than 24 hours after both countries separately signed a U.N.-brokered agreement in Turkey Friday allowing both countries to export grain.
“This is critical for world food supplies and the fact that just a day after this negotiation, Russia in bad faith would then do exactly what they had just agreed not to do,” Sherrill said. “The day after is really shocking and quite frankly, quite depressing.”
Secretary of State Anthony Blinken also condemned the strike in a statement Saturday, “Russia breached its commitments by attacking the historic port from which grain and agricultural exports would again be transported under this arrangement.”
Russian forces have expanded its missile strikes in recent days to cities across Ukraine killing dozens, including children.
The Biden administration announced late Friday it would send four more satellite-guided rocket launchers, known as HIMARS, to Ukraine –bringing the total to 16. Experts say Ukraine needs at least 60. Ukraine’s defense minister says he needs 100.
President Biden will turn 80 in November.
(AP Photo/Susan Walsh)
In the latest weapons package to Ukraine hundreds of drones and 36,000 artillery rounds were also included. An American fighter on the front lines in eastern Ukraine, who asked not to be named, told Fox News Ukrainian drones are shot down by the Russians every “four or five” missions.
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Ukraine has enough weapons to keep them from losing, but not enough to defeat Russia who continues making incremental gains in the eastern Donbas region, some American officials admit.
Asked this week if Ukraine’s Donbas region was lost, the chairman of the Joint Chiefs of Staff Gen. Mark Milley told reporters it was not lost “yet.”
Coronavirus vaccines should be updated for fall, FDA advisers say
Companies need several months to manufacture a new vaccine, so the deadline to choose a vaccine formula to be ready to roll out in October has arrived. The FDA is expected to issue a final decision in the coming days.
But no one knows what variants will be circulating this winter, and it is reasonable to expect that any omicron variant incorporated into the updated vaccine will be in the rearview mirror by the time shots are going into arms. Updated vaccines that include BA.1 have been in human tests for months, but that variant circulated this winter and has already been eclipsed by other versions of omicron; the subvariants BA.4 and BA.5 already make up half of the cases in the United States.
There is also uncertainty about whether updated vaccines will really protect people better. Companies showed they were able to trigger modestly higher levels of virus-blocking antibodies, but it remains unknown whether that will translate into better protection against hospitalization or infection. The hope is that a revamped vaccine will broaden the immune response.
“We’re being asked, more or less, to have a crystal ball today,” said Arnold Monto, acting chairman of the FDA advisory committee and an emeritus professor of public health at the University of Michigan School of Public Health.
In discussion, many members of the committee said the vaccine should be a multi-strain vaccine that includes the original version of the virus and a component of omicron. Many members and FDA officials favored the BA.4 and BA.5 omicron subvariants, but some saw promise in including the BA.1 version of omicron.
“I think given the speed of evolution [of the virus] we’re going to be behind the eight ball if we wait longer,” said Mark Sawyer, a professor of clinical pediatrics at the University of California San Diego School of Medicine. “Public perception is that FDA is already delaying approvals. I think we have enough data here presented today to move forward with a strain change.”
Vaccine companies, including Moderna, Novavax, Pfizer and its German partner BioNTech, presented sometimes conflicting data on potential booster strategies, leaving committee members to triangulate between overlapping, sometimes divergent results.
Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, called the data “uncomfortably scant” and voted against changing the strain. He questioned whether the modest difference in how modified vaccines triggered an immune response was a big enough difference to translate into a benefit for people.
“I don’t think it’s fair to ask people to take a risk … if we don’t feel comfortable with the level of protection that we’re likely to get,” Offit said.
The companies each presented data to support their preferred strategy.
Moderna, for example, favors a bivalent vaccine tailored to protect against the original version of the virus and the omicron BA.1 variant. The company said it could start delivering the vaccine this summer, but cautioned that a vaccine that includes BA.4 and BA.5 could take until late October or early November.
Pfizer and its German partner BioNTech, however, found that a vaccine that targets a single variant of the virus, BA.1, was better than a bivalent formulation. The company also presented mouse data suggesting that a vaccine tailored to fight the omicron subvariants that are projected to soon dominate in the United States, BA.4 and BA.5, might provoke stronger and broader immune responses. The company would be ready to supply either version of the vaccine by the first week of October.
Novavax’s vaccine has not yet been authorized in the United States, but uses a different technology — delivering a viral protein brewed in a laboratory. The company presented data suggesting that additional doses of its existing vaccine could be protective, even against omicron subvariants. Clinical testing of its omicron booster is ongoing, with results expected in September.
Adam Berger, director of the division of Clinical and Healthcare Research Policy at the National Institutes of Health, said that the data presented at the meeting suggest that while a universal recommendation to change vaccines is preferred for simplicity, the array of results suggest “there isn’t a one-size-fits-all answer to whether a strain change is necessary.”
Several experts raised the concern that if the United States switched its vaccine composition, it could exacerbate global vaccine equity issues and perceptions of vaccines. It also was unclear whether a vaccine change would apply to adults or also include children. Several experts said that if the vaccine is changed for children, they would like to see more testing.
But during the public comment session, several parents made impassioned pleas that the vaccines be updated for all age groups, including the youngest children.
The wait for vaccines for children under 5 was “long and excruciating,” said Kate Schenk, a mother of three children. “We cannot let this happen again. Children need to be eligible to receive these updated boosters alongside older cohorts — not lagging behind, unprotected.”
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research pointed out that half of Americans haven’t received a booster, despite clear evidence that a third shot re-ups and broadens protection. Even those who have received boosters will become vulnerable again over time as immunity wanes.
“The better the match of the vaccines to the circulating strain, we believe may correspond to improved vaccine effectiveness and potentially to a better durability of protection,” Marks said.
But even an updated vaccine won’t reset the pandemic and provide perfect protection against a rapidly evolving and highly transmissible virus. The omicron subvariants that are already growing in frequency today are not likely to be the ones that the world faces in the fall. How well vaccines based on them will protect against the future iterations of the virus won’t be fully known until they’re being used.
The process has been compared to picking the flu vaccine each year. Some years, it is a better match to the flu strains that circulate than others.
But flu is a different virus, and the meeting is an early step in the long-term challenge of trying to craft a vaccination strategy.
“I will remind you that the parallel track of influenza strains selection, which works very well, was a process that was honed over many, many years. And so we probably have quite a bit of work,” said Jerry Weir, director of the Division of Viral Products in the Office of Vaccines Research and Review. “This is a different virus. We have a lot of work to do on the strain selection process for covid vaccines.”
FDA advisers vote in favor of authorizing Covid-19 vaccines for children as young as 6 months
All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to the question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?”
And all the committee members voted yes in response to the question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 3-dose series (3 micrograms each dose) outweigh its risks for use in infants and children 6 months through 4 years of age?”
The FDA, which typically follows the committee’s decisions, will now decide whether to authorize the vaccines for emergency use in the youngest children.
However, shots can’t be given until the US Centers for Disease Control and Prevention’s own vaccine advisers have voted on whether to recommend them and CDC Director Dr. Rochelle Walensky has signed off on the recommendation.
The CDC’s vaccine advisers are expected to vote Saturday. The White House has said shots could begin as early as next week.
Children younger than 5 are the only age group not currently eligible to be vaccinated against Covid-19. About 17 million kids will become eligible for Covid-19 vaccines once they’re authorized for this age group.
“To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly disease is a very important thing,” said committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University.
She compared the day to December 2020, when the first Covid-19 vaccines were authorized for adults and older teens.
‘Benefits seem to clearly outweigh the risks’
“The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care,” committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School, said of the Moderna vaccine.
Committee member Dr. Art Reingold added that even though the risk of Covid-19 hospitalization and death is lower for young children than for adults, children already get vaccinations to protect them against diseases for which their risk is low.
“If we have a vaccine with benefits that outweigh the risks, then making it available to people is a reasonable choice,” said Reingold, of the University of California, Berkeley.
“I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized of those diseases are pretty close to zero,” he said, such as polio and measles.
The number of Covid-19 hospitalizations and deaths in children is concerning and much higher when compared with influenza-related deaths and hospitalizations, FDA official Dr. Peter Marks said at Wednesday’s meeting.
“There still was, during the Omicron wave, a relatively high rate of hospitalization during this period,” said Marks, director of the FDA’s Center for Biologics Evaluation and Research. “That rate of hospitalization actually is quite troubling, and if we compare this to what we see in a terrible influenza season, it is worse.”
Marks said the number of deaths for children 4 and under during the first two years of the pandemic “also compares quite terribly to what we’ve seen with influenza in the past.”
“We are dealing with an issue where I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important,” he said, adding that “vaccine-preventable deaths are ones we would like to try to do something about.”
Marks said the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been broadly and routinely used and accepted to prevent deaths.
Moderna vaccine ‘well-tolerated’ in youngest children
The Moderna vaccine is already authorized for adults. In a meeting Tuesday, the FDA’s advisers voted unanimously in favor of expanding the emergency use authorization to include older children and teens, ages 6 to 17, saying it would also offer more benefits than risks.
Moderna’s Covid-19 vaccine, when given as a 25-microgram dose, is “well-tolerated” in children ages 6 months to 5, said Dr. Rituparna Das, Moderna’s vice president of Covid-19 vaccines clinical development, during Wednesday’s meeting as she described the safety profile of the vaccine among this age group and adverse reactions.
“Pain was the most common event,” Das said. “Young children’s events included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting and chills. For infants and toddlers, events included fever, irritability, crying, sleepiness and loss of appetite.”
These reactions were more common after the second dose of vaccine and resolved within two or three days, Das said, adding that fever was an important assessment of the vaccine’s safety for this age group.
Fever after any dose of vaccine happened in about a quarter of the children, but more often after the second dose, and one incident of febrile seizure was considered to be related to vaccination, Das told the committee members. The child who had the seizure remained in the vaccine study and got a second dose of vaccine with no serious events.
No deaths or cases of myocarditis or pericarditis were reported among vaccine recipients, Das said.
“In summary, mRNA-1273 was well tolerated,” she said, using the technical name of Moderna’s vaccine. “Local and systemic reactions were seen less frequently in these youngest groups.”
Concern over number of doses
VRBPAC member Dr. Paul Offit said in Wednesday’s meeting that children who get the Pfizer/BioNTech vaccine will have to complete a three-dose series to get sufficient protection.
” ‘Do the benefits outweigh the risks’ is something I can support, but I do have some concerns about this vaccine,” said Offit, director of the Vaccine Education Center at Children’s Hospital of Pennsylvania.
Committee member Dr. Jeannette Lee of the University of Arkansas for Medical Sciences also mentioned concern that some children might not complete all three doses and that uptake of the vaccine will be slow.
“Three doses will certainly benefit. I have a lot of concern that many of these kids will not get a third dose,” she said. “My concern is that you have to get the three doses to really get what you need.”
Data from a phase 2/3 trial of the Pfizer vaccine included 1,678 children who had received a third dose during the period when the Omicron coronavirus variant dominated. The vaccine appeared to be safe and had a strong immune response. The data has not been peer-reviewed or published in a medical journal.
Antibody levels tested one month after the third dose showed that the vaccine produced a similar immune response as two doses in 16- to 25-year-olds, the companies said.
In FDA briefing documents, it was noted that among young children who had received the vaccine in trials, there were no cases of anaphylaxis, myocarditis or pericarditis, and the most common adverse reactions among children 6 months to 23 months were irritability, drowsiness, decreased appetite and tenderness at the injection site. For children 2 to 4 years old, the most common adverse reactions were fatigue and pain and redness at the injection site.
Will these children get vaccinated?
There is already slow uptake of Covid-19 vaccines among children in the United States.
“Having vaccine options for the youngest children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5- to 12-year-old group, and so my concern is that uptake in the youngest children under 5 years old might also be lower than we would like,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.
Barouch, who is not a member of the FDA advisory committee, helped develop and study the Johnson & Johnson Covid-19 vaccine.
He said there were “striking” differences in how many adults are fully vaccinated compared with children and teens.
Children 5 to 11 were the most recent group to become eligible for vaccination, in November. But just 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC, compared with about:
- 60% of adolescents 12 to 17
- 64% of adults 18 to 24
- 67% of adults 25 to 39
- 75% of adults 40 to 49
- 82% of adults 50 to 64
- 94% of adults 65 to 74
- 88% of adults 75 and older
CNN’s Carma Hassan and Deidre McPhillips contributed to this report.
U.S. FDA advisers overwhelmingly back Moderna COVID vaccine for ages 6-17
A pharmacist holds a vial of the Moderna coronavirus disease (COVID-19) vaccine in West Haven, Connecticut, U.S., February 17, 2021. REUTERS/Mike Segar
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June 14 (Reuters) – Advisers to the U.S. Food and Drug Administration on Tuesday unanimously recommended that the agency authorize Moderna Inc’s (MRNA.O) COVID-19 vaccine for children and teens aged 6 to 17 years of age.
Around 77 million people in the United States have received at least a two-dose course of Moderna’s vaccine, which has long been available for people aged 18 and older.
The committee of outside experts is scheduled on Wednesday to consider the Moderna shot for children under 6, and Pfizer (PFE.N) and BioNTech’s (22UAy.DE) COVID vaccine for children under 5 – and in both cases as young as 6 months.
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There is unlikely to be significant immediate demand the Moderna shots for 6- to 17-year olds. The Pfizer/BioNTech vaccine was authorized for children aged 5 to 11 in October, and approval for teenagers preceded that by months.
Yet only around 30% of those ages 5 to 11 and 60% of 12- to 17-year olds are fully vaccinated in the United States, according to data from the U.S. Centers for Disease Control and Prevention (CDC).
“I’d like to give parents as many choices as possible, and let them make the decisions about this for their children,” committee member and UC Berkeley professor Dr. Arthur Reingold said at the meeting.
The FDA – which generally follows the recommendations of its advisers but is not obligated to do so – is likely to authorize the Moderna vaccine for ages 6-17 soon. The CDC also needs to recommend the vaccine’s use. A committee of its advisers is scheduled to meet Friday and Saturday.
There have long been concerns that the Moderna vaccine, which is given at a higher dose than the Pfizer/BioNTech shot, may cause types of heart inflammation known as myocarditis and pericarditis at higher rates, primarily in younger males.
Some countries in Europe have limited use of Moderna’s vaccine for younger age groups after surveillance suggested it was tied to a higher risk of heart inflammation, and the FDA delayed its review of the shot to assess the myocarditis risk.
U.S. regulators presented data at the meeting on Tuesday suggesting that Moderna’s vaccine may have a higher risk of heart inflammation in young men, but said the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.
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Reporting by Manas Mishra in Bengaluru; Additional reporting by Michael Erman in New Jersey; Editing by Jason Neely and Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.