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    The U.S. Food and Drug Administration (FDA) is requesting more than a half-century to review and release information to the Pfizer-BioNTech vaccine to the public. The agency is being sued by Public Health and Medical Professionals for Transparency, a group made up of more than 30 professors and scientists, hoping to access information they believe can help cure vaccine skepticism in some people. A Freedom of Information Act (FOIA) request was filed by the group in September and they were hoping the courts could expedite the process of getting them the requested information. The FDA is asking the court to give them 55 years, or up to 2076, to gather and release the data to the general population. The FDA is requesting 55 years worth of time to provide more than 300,000 pages worth of information being asked for in a FOIA request. The agency wants to release the pages in chunks of 500 pages every month, which would take until 2076 (file photo) The Pfizer-BioNTech vaccine is the most commonly used in the U.S., having been administered nearly 260...
    Regeneron Pharmaceuticals Inc announced on Monday that its antibody cocktail can severely slash the risk of being infected with COVID-19 for up to eight months.  The combo therapy, REGEN-COV, was approved in November 2020 for emergency use to treat people with mild-to-moderate COVID-19 cases in the U.S. But the U.S. Food and Drug Administration (FDA) expanded authorization in July 2021 so the drug can also be used as a preventive treatment. Late-stage trial data showed a single dose can lower the risk of contracting Covid by 81.6 percent between two and six-months after the cocktail is administered.  The FDA has previously stated that REGEN-COV is not a replacement for vaccination, but rather can be used in conjunction with people who develop a weak immune response to the shots. Regeneron say its antibody cocktail REGEN-COV (above) reduces the risk of contracting COVID-19 by 81.6% two to eight months after it is administered During this period, seven people in the treatment group developed Covid compared to 38 in the placebo group. Pictured: View of Regeneron headquarters, October 2 'Today's new data demonstrate...
    The former commissioner of the U.S. Food and Drug Administration (FDA) believes the COVID-19 pandemic could end by the beginning of next year. In an appearance on CNBC's Squawk Box on Friday, Dr Scott Gottlieb said America is about to gain new tools to fight the disease in the form of antiviral pills from Pfizer Inc and Merck & Co. Gottlieb said recent Covid vaccine mandates implemented by President Joe Biden in workplaces may not even be necessary by the time they go into effect. Starting January 4, the mandate requires all companies with at least 100 employees to test weekly those who aren't fully vaccinated.  'These mandates that are going to be put in place by January 4 really are coming on the tail end of this pandemic,' Gottlieb told host Joe Kernen.   'By January 4, this pandemic may well be over, at least as it relates to the United States after we get through this Delta wave of infection. And we'll be in a more endemic phase of this virus.'  Former FDA commissioner Dr Scott Gottlieb said on...
    Dr Michael Kurilla (pictured), of the NIH's National Center for Advancing Translational Sciences, was the only member to abstain  in the FDA's advisory committee vote of 17-0-1 to recommend approval of COVID-19 vaccines in children ages five to 11 The only member of the U.S. Food and Drug Administration's (FDA) advisory committee to abstain from a vote on recommending Pfizer-BioNTech's COVID-19 vaccine to young children says he did so because there is not enough evidence that all children need the shot. On Tuesday, the Vaccines and Related Biological Products Advisory Committee voted 17-0-1 that benefits of the vaccine for kids aged five to 11 outweigh the potential risks.  Dr Michael Kurilla, the director of the Division of Clinical Innovation, at the National Institutes of Health's (NIH) National Center for Advancing Translational Sciences, who was the only member to not vote 'yes', told DailyMail.com there were several reasons behind his abstention.   Kurilla says there are children at high-risk of severe Covid due to underlying conditions who would benefit from the shot, but he's not sure if this applies to all kids...
    (CNN)As the number of new daily cases of Covid-19 continues to fall in the US, the country awaits a major milestone that could provide another critical tool in the fight against the pandemic -- the first vaccine for 5 to 11-year-olds.And former US Food and Drug Administration (FDA) commissioner and Pfizer Board member, Dr. Scott Gottlieb, said the company is ready to ship out doses for children as soon as the agency signs off.The FDA's independent vaccine advisory board will meet Tuesday to discuss whether the Pfizer-BioNTech Covid-19 vaccine should be authorized for younger kids. On Friday, Pfizer released documents on the efficacy of a children's dose of its Covid-19 vaccine, saying the company found the vaccine was 90.7% effective against symptomatic disease in children ages 5-11. Children are expected to be eligible for the vaccine in early November, Dr. Anthony Fauci saysOnce the FDA makes its authorization, the issue goes to the US Centers for Disease Control and Prevention's (CDC) vaccine advisory group, which is set to meet on November 2 and 3, and from there the CDC director...
    (CNN)The nation's top infectious disease expert says some 28 million children ages 5 to 11 in the United States may be able to receive their Covid-19 vaccine in the first two weeks of November.With the US Food and Drug Administration's vaccine advisory group set to discuss a vaccine for children this week, Dr. Anthony Fauci, President Biden's chief medical adviser, said on ABC's "This Week Sunday" he is optimistic children can get shots in the first two weeks of November."You never want to get ahead of the FDA in their regulatory decisions, nor do you want to get ahead of the CDC and their advisers on what the recommended would be," Fauci told ABC News' George Stephanopoulos. "But if you look at the data that's been made public and announced by the company, the data looked good as to the efficacy and the safety." Not getting vaccinated against Covid-19 is like driving while intoxicated, health expert saysOn Friday, both Pfizer and the FDA publicly released documents on the efficacy of a children's dose of Pfizer's Covid-19 vaccine. Company data found...
    Anthony Fauci said Sunday that children between the ages of five and 11 will 'very likely' be able to receive the coronavirus vaccine by the first or second week of November. This means, kids may be able to get the jab as soon as eight days from Sunday, according to the nation's top expert on infectious diseases at the National Institutes of Health. 'The FDA [Food and Drug Administration] and their advisory committee will be meeting next week on October the 26th. And then their regulatory decision will be handed over to the CDC, likely November 2 or 3,' Fauci explained to ABC This Week host George Stephanopoulos. 'So, if all goes well, and we get the regulatory approval and the recommendation from the CDC, it's entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,' he continued. Dr. Anthony Fauci said Sunday that the vaccine could get emergency use authorization for children 5-11 by the first or second week of November COVID-19 vaccines for...
    Dr. Anthony Fauci believes Johnson & Johnson should have made their COVID-19 vaccine a two-dose shot and encourages Americans to get a booster for the one-jab vaccine as soon as it becomes available. 'What the advisors to the FDA felt is that, given the data that they saw, very likely, this should have been a two dose vaccine to begin with,' Fauci said during a Sunday morning interview on This Week ABC. 'So the idea of making a recommendation that people who originally received J&J should receive a second dose — 18 or older with none of the restrictions about whether or not you're at a high risk or not at a high risk — is that everyone who received that first dose of J&J who are 18 and older should receive it.' His comments came just days after a Food and Drug Administration (FDA) advisory committee unanimously voted to recommend booster shots for adult J&J recipients. Fauci notes, however, that Americans who got the one-dose shot should 'feel good' about the FDA recommendation and should get the jab as soon as possible. Dr....
    (CNN)I never add salt to my food at home or in restaurants. Nor do I add salt to any recipe while I'm cooking. I'm well aware of the link between salt, high blood pressure and heart disease, which is the leading killer of American men and women.Yet I am still getting over the recommended daily limit of 2300 milligrams of sodium by eating out or by adding processed or prepared ingredients to the meals I make. Take salad dressing, for example. How to eat less meat and more plants"I've found salad dressings where a single serving (2 tablespoons) had over 23% of one's daily value in sodium," said Dr. Stephen Juraschek, an assistant professor at Harvard Medical School who researches sodium and hypertension."Most of my patients do not add salt at the dinner table, but don't realize that bread rolls, canned vegetables and chicken breasts are among the worst culprits in the US," he said.Read MoreChicken breasts? Yes, because salt is added in the manufacturing process to plump up the breasts so they look bigger and more appetizing. In fact,...
    Millions of Americans rolled up their sleeves after the U.S. Food and Drug Administration (FDA) authorized COVID-19 vaccine booster shots. Third shots of the Pfizer-BioNTech vaccine were given emergency use authorization on September 22 for those aged 65 or older, or 18 and older who are high risk of severe complications from the virus due to underlying conditions or their jobs.  Between September 22 and September 29, the White House reported that almost two million people received boosters.  The shots were in high demand after the White House announced plans to roll out boosters by September 20, though regulatory barriers prevented the shots from becoming available until a few days later. Almost two million Americans received Covid boosters last week, according to the White House. More than five million boosters have been distributed overall with a majority going to people over the age of 65. Pictured: an elderly woman in London, England, receives a shot of the Pfizer Covid vaccine on March 10 Jeff Zients, the White House COVID-19 response coordinator, announced the marker during a news briefing on Friday....
    (CNN)The US Food and Drug Administration (FDA) could soon authorize a Pfizer/BioNTech Covid-19 vaccine for young children, experts said -- a development that offers hope in the midst of a dangerous time in the pandemic for kids, who account for a quarter of all cases reported last week. "It is conceivable that by Halloween, we could see shots going into arms, but it's going to take a number of weeks for that process to work its way through," Dr. James Hildreth, a vaccine adviser to the FDA, told CNN's Don Lemon Monday.Nearly 226,000 Covid-19 cases were reported in children last week, pediatrician group saysThat process is happening as the second highest total of new cases in children was reported last week and cases among that group continue to rise exponentially, according to data from the American Academy of Pediatrics published Monday. And rising cases have yielded rising hospitalizations. An average of 311 children were hospitalized with Covid-19 every day over the past week, according to data from the US Centers for Disease Control and Prevention (CDC).In Pittsburgh, officials at UPMC...
    Pfizer announced Monday clinical data shows its COVID-19 vaccine is safe and effective in kids aged 5-11, and the company plans to apply for emergency approval from the Food and Drug Administration (FDA) by the end of the month. Children aged 5-11 developed equivalent antibody levels to teenagers and young adults in tests despite only receiving a third of the dose that is currently being given to individuals aged 16 and over, Pfizer senior vice president Dr. Bill Gruber told the Associated Press. The kids’ dose resulted in similar or fewer side effects than have been seen in teens, Gruber added. BREAKING: Pfizer says its COVID-19 vaccine works for kids ages 5 to 11; plans to seek authorization for this age group soon. https://t.co/YDoxAlNmab — The Associated Press (@AP) September 20, 2021 “I think we really hit the sweet spot,” Gruber said. (RELATED: FDA Panel Votes Against Biden Booster Plan, Only Approves For Seniors And At-Risk Americans) The company will apply for Emergency Use Authorization (EUA) from the FDA by the end of September, and regulators will try to...
    Pool/Getty Images News Fight disinformation. Get a daily recap of the facts that matter. Sign up for the free Mother Jones newsletter.On Friday, an independent advisory panel for the Food and Drug Administration voted against recommending a Pfizer booster shot for the general public. It did, however, vote to recommend that those 65 and older and at risk of severe disease be eligible for a third dose of the COVID vaccine. Top health official Dr. Anthony Fauci, a proponent of the wide use of boosters, responded to the decision on Sunday, saying it “is not the end of the story.”   “I don’t think they made a mistake,” Fauci told CNN’s Jake Tapper on State of the Union, “but the one thing I think people need to realize: That data are coming in, literally on a daily and weekly basis…They’re going to continue to look at this literally in real-time.”  Dr. Anthony Fauci to @jaketapper: The FDA advisory committee did not make a mistake on the booster shot recommendations and the FDA "absolutely should not ignore them." pic.twitter.com/KxxTH5RHcR — The Recount...
    (CNN) — Weeks of deliberation are coming to a head Friday when the US Food and Drug Administration meets to discuss Covid-19 boosters. But the science of the vaccine’s effectiveness will not be up for debate, one expert said. There is widespread agreement that the vaccines are primarily intended to reduce hospitalizations and deaths — which data shows they do well, CNN Medical Analyst Dr. Leana Wen said. READ MORE: WATCH LIVE: Prince Georges County Police To Provide Update After Arrest In Murder Of 8-Year-Old PJ Evans “What not everybody would agree to is the second thing, which I believe, that the point of vaccination is to also reduce the level of infection,” Wen said. That is the issue now being debated by officials and health experts, just as the average of new daily cases has shot up over the past two months. President Joe Biden and many experts say there’s a good reason for a third booster dose. And three reports published Wednesday support the argument that people may need a booster dose of Pfizer’s Covid-19 vaccine over time,...
    (CNN)Weeks of deliberation are coming to a head Friday when the US Food and Drug Administration meets to discuss Covid-19 boosters. But the science of the vaccine's effectiveness will not be up for debate, one expert said.There is widespread agreement that the vaccines are primarily intended to reduce hospitalizations and deaths -- which data shows they do well, CNN Medical Analyst Dr. Leana Wen said."What not everybody would agree to is the second thing, which I believe, that the point of vaccination is to also reduce the level of infection," Wen said.That is the issue now being debated by officials and health experts, just as the average of new daily cases has shot up over the past two months. Three reports support arguments for booster doses of Pfizers Covid-19 vaccinePresident Joe Biden and many experts say there's a good reason for a third booster dose. And three reports published Wednesday support the argument that people may need a booster dose of Pfizer's Covid-19 vaccine over time, and suggest such boosters would be safe.Read MoreThe reports are part of a...
    Pfizer Inc says it is planning to have data from its clinical trials among young children available by the end of the month and will file for approval with the U.S. Food and Drug Administration (FDA) shortly thereafter.  Frank D’Amelio, the company's CFO and executive vice president of global supply, gave an update on the timeline while speaking at the Morgan Stanley Annual Global Healthcare Conference on Tuesday. 'We expect to have safety and immunogenicity data for children between the ages of five and eleven...by the end of September,' he said on the webcast. 'And then we would expect to file that with the FDA in early October for a potential [emergency use authorization].' Currently, the Pfizer vaccine, made with German partner BioNTech, is only approved for children aged 12 and older in both the U.S. and the European Union. Parents and doctors have been debating about whether or not to inoculate children because they make up 0.1 percent of all Covid deaths in the U.S.  Pfizer CFO Frank D’Amelio spoke at the Morgan Stanley Annual Global Healthcare Conference...
    The director of the Centers for Disease Control and Prevention (CDC) said she is hoping that COVID-19 vaccines will be available for children under age 12 by the end of the year. In an appearance on NBC's TODAY on Monday,  Dr Rochelle Walensky said there isn't a definitive timeline, but that officials from the U.S. Food and Drug Administration (FDA) are working to approve the shots in younger children. 'We're waiting for the companies to submit the data to the FDA, we're anticipating that will happen in the fall,' she told host Savannah Guthrie. 'We will look at that data from the FDA, from the CDC, with the urgency that we all feel for getting our kids vaccinated and we're hoping by the end of the year.'  It comes as Covid cases among children reached a record-high in recent weeks with 20,000 kids being hospitalized as well.   However, most pediatric cases are not severe and virus-related fatalities among children are rare with pediatric deaths making up just 0.1 percent of all COVID-19 deaths. Dr Rochelle Walensky (pictured) told the TODAY...
    12-year-old Justing Concepcion receives a dose of the Pfizer-BioNTech vaccine for the coronavirus disease (COVID-19) from registered nurse Angela Nyarko, during a vaccination event for local adolescents and adults outside the Bronx Writing Academy school in the Bronx, New York City, June 4, 2021.Mike Segar | Reuters The Food and Drug Administration said Friday that U.S. regulators are "working around the clock" to support the approvals of Covid-19 vaccines for kids under age 12. So far, the Pfizer-BioNTech Covid vaccine has been cleared by the FDA for people as young as 12, while Moderna and Johnson & Johnson's vaccines have been authorized for adults. Federal regulators are "eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible," acting FDA commissioner Dr. Janet Woodcock and Dr. Peter Marks, the agency's top vaccine regulator, said in a joint statement. "We have to let the science and data guide us." To ensure safety, clinical trials testing the vaccines are expected to include a monitoring period of at least two months after half the participants get the shots, they said....
    (CNN)As the first full FDA approval is granted to a Covid-19 vaccine, Dr. Anthony Fauci urged the public to take part, saying if the "overwhelming majority" of the population gets vaccinated, the US could have the pandemic under control by spring of 2022."We hope we'll be there ... but there's no guarantee because it's up to us," Fauci, director of the National Institute of Allergy and Infectious Diseases and the President's chief medical adviser, told CNN's Anderson Cooper Monday. It isn't yet clear to health experts exactly what proportion of the population needs to be vaccinated to reach a level of protection that could sustain a return to normalcy, like safely attending restaurants and theaters, Fauci said. So, the best way forward is to vaccinate as many people as possible, he said. As hospitalization rates soar, FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine On Monday the US Food and Drug Administration granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people 16 and older.With only 51.5% of the population fully vaccinated, according to data from the US Centers for...
    (CNN) — Public health officials are aggressively dispelling claims by right-wing media personalities who have been promoting an anti-parasitic drug used for livestock as a potential Covid-19 treatment. “You are not a horse. You are not a cow,” the US Food and Drug Administration tweeted Saturday. “Seriously, y’all. Stop it.” READ MORE: Morgan State University Welcomes Back Students For First Day Of Class Top conservative media personalities — including Fox News hosts Tucker Carlson, Sean Hannity, and Laura Ingraham — have mentioned ivermectin as a drug that could possibly be used to treat Covid-19. This is part of a recent theme in right-wing media of attacking public health officials for promoting the highly effective coronavirus vaccines as the best path out of the pandemic instead of potential therapeutics to treat the virus. Throughout the pandemic, Fox News, talk-radio, and right-wing websites have promoted unproven therapeutics to treat Covid-19 while simultaneously casting doubt on the effectiveness of vaccines and masks. For example, for months in 2020, these same personalities pushed the antimalarial drug hydroxychloroquine as a possible treatment, despite studies indicating...
    New York (CNN Business)Public health officials are aggressively dispelling claims by right-wing media personalities who have been promoting an anti-parasitic drug used for livestock as a potential Covid-19 treatment."You are not a horse. You are not a cow," the US Food and Drug Administration tweeted Saturday. "Seriously, y'all. Stop it."Top conservative media personalities — including Fox News hosts Tucker Carlson, Sean Hannity, and Laura Ingraham — have mentioned ivermectin as a drug that could possibly be used to treat Covid-19.This is part of a recent theme in right-wing media of attacking public health officials for promoting the highly effective coronavirus vaccines as the best path out of the pandemic instead of potential therapeutics to treat the virus.Throughout the pandemic, Fox News, talk-radio, and right-wing websites have promoted unproven therapeutics to treat Covid-19 while simultaneously casting doubt on the effectiveness of vaccines and masks.Read MoreFor example, for months in 2020, these same personalities pushed the antimalarial drug hydroxychloroquine as a possible treatment, despite studies indicating it was not effective and health officials warning that taking it could have negative side effects.Researchers...
    As COVID-19 vaccine boosters start to roll out across the country, there is one group that seems to have been left out of the conversation. Recipients of the one-shot Johnson & Johnson vaccine are not yet eligible for an extra dose while they are becoming available to those who received the two-shot Pfizer-BioNTech and Moderna jabs. This has left J&J vaccine recipients in limbo, especially the immunocompromised who may be at risk from the Indian 'Delta' variant despite being fully vaccinated. The U.S. Food and Drug Administration (FDA) says they plan to eventually approve booster shots for J&J recipients, but can not yet do so due to a lack of data. But some people who got the J&J shot have resorted to receiving extra doses before being authorized. The 13.9 million recipients of the Johnson & Johnson COVID-19 vaccine have been left in limbo, as they await word on when booster shots will be made available for them Expert recommends that some J&J recipients concerned about booster shots should contact physician about receiving an additional jab. Pictured: A woman...
    Dr. Anthony Fauci said Friday that businesses and schools across the country will issue a “flood” of vaccine mandates as soon as the Food and Drug Administration issues full approval for the COVID-19 vaccine. “Organizations, enterprises, universities, colleges that have been reluctant to mandate at the local level will feel much more confident,” Fauci told USA Today. Dr. Anthony Fauci: A flood of COVID vaccine mandates to follow FDA full approval https://t.co/i0zd0ARfg0 — Jack Posobiec ???????? (@JackPosobiec) August 7, 2021 “They can say, ‘If you want to come to this college or this university, you’ve got to get vaccinated,” he added. “If you want to work in this plant, you have to get vaccinated. If you want to work in this enterprise, you’ve got to get vaccinated. If you want to work in this hospital, you’ve got to get vaccinated.’” Fauci told USA Today he does not anticipate any more lockdowns.  (RELATED: ‘Things Are Going To Get Worse’: Fauci Predicts More Delta Infections, But Not Enough For Lockdowns) “The rationale for shutting down was that the hospital system would...
    Joe Biden's top health official said in a Wednesday interview that it's highly likely children under 12-years-old will be approved to get vaccinated against coronavirus by the start of this upcoming school year. 'What are the odds that a vaccine for kids under 12 will be approved during the next school year?' Surgeon General Vivek Murthy was asked as part of the 'Skimm This' podcast, which will air Thursday. 'I think the odds are high,' he responded, but did not expand as it was part of the lightning round of questioning. Three COVID-19 vaccines – from pharmaceutical Pfizer, biotechnical company Moderna and medical device company Johnson & Johnson – have been approved for emergency use authorization in the U.S. Surgeon General Vivek Murthy said the 'odds are high' that the FDA will approve emergency use authorization for COVID-19 vaccines in children under 12 by the start of next school year Vaccinations are been approved under the emergency order since December 2020 for American adults, and in May opened up to those over the age of 12. The rate,...
    What are the details? According to a Forbes report on Monday, Gottlieb — who also sits on Pfizer's board — warned that the coronavirus' resurgence across the country is probably more widespread than what's being reported, but he believes that could mean that the U.S. is turning the corner on the latest Delta variant outbreak. "I believe there's more virus than we're picking up right now," Gottlieb said on Sunday's "Face the Nation," basing his theory on the Delta variant's trajectory in the United Kingdom — which he says is about three to four weeks ahead of the U.S. in terms of the infection rate. "If you look at the U.K. in the last seven days, they do appear to be turning the corner," he continued. "It's unclear whether that's going to be sustained [since] they just lifted a lot of the mitigation they had in place, but if the U.K. is any guide, we are perhaps further into this epidemic and hopefully going to turn a corner in the next two or maybe three...
    Jason Bourne and Ford v Ferrari star Matt Damon believes people should trust “science” when it comes to the decision to get a vaccine for the Chinese coronavirus but acknowledged that, at the end of the day, it is a “personal choice.” Speaking about vaccine hesitancy in an interview with Yahoo! Entertainment, Damon acknowledged the concerns of the unvaccinated and told the outlet he does not want to “belittle them.” “There are a lot of reasons that people have, and I don’t want to belittle them,” he said. “It’s tough for me, I have a couple friends who are immunocompromised and they can’t get the vaccine, so they have no choice but to rely on the rest of us to do our part to get to herd immunity. So I look at it that way.” “I wish at the beginning of this people came out and said, ‘Look, if we all do this, then we’ll protect each other better,’ rather than ‘Well, I’m not in this cohort so I don’t have to worry and it’s not going to hurt me that much.’ It’s just about looking...
    (CNN)To date, more than 339 million doses of Covid-19 vaccine have been administered to give people protection from the coronavirus; several studies show that the three vaccines authorized for emergency use in the United States work and are safe; and the government continues to give them out in schools and at ball fields, and yet, not one has been formally approved by the US Food and Drug Administration.By all accounts, the approval process for the vaccines is moving faster than it ever has before. However, the FDA has yet to disclose a timeline for when its work will be complete and data is still being reviewed.On Wednesday, President Joe Biden told CNN's Don Lemon during a CNN Townhall that he expects Covid-19 vaccines could get full approval "quickly.""They're not promising me any specific date, but my expectation, talking to the group of scientists we put together... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they'll get a final approval," Biden said. JUST WATCHEDCDC warns...
    The former commissioner of the U.S. Food and Drug Administration (FDA) is warning that the country is likely to see outbreaks of the Indian 'Delta' coronavirus variant in some communities. In an appearance on CBS' Face the Nation on Sunday, Dr Scott Gottlieb said he expects cases to rise in areas with low vaccination rates. 'It's not going to be as pervasive,' Gottlieb said.  'It's going to hyper-regionalized. There's certain pockets of the country where you're going to have very dense outbreaks.'    This means southern and western states such as Arkansas, Mississippi and Wyoming  - who have less than one-third of their population fully vaccinated - are at high risk, and already seeing a rise in cases. It comes as the variant continues to ravage the UK, with Delta driving an explosion of new cases, and COVID-19 infections up 60 percent from a week ago, Gottlieb warned that the U.S. is only 'about a month or two' behind the UK and that America should expect to see a similar situation.  Former FDA commissioner Dr Scott Gottlieb said on Sunday...
    (CNN)As some states report they have Johnson & Johnson Covid-19 vaccine doses that might expire before they get used, the company and federal officials say they're looking at whether expiration dates can be extended -- and whether the doses could be put to use elsewhere."We're working very hard, both at the federal level and at the local level, to do everything we can to make sure that these vaccines can be used and deployed in the very best possible way," Johnson & Johnson Chairman and CEO Alex Gorsky said Wednesday during a Wall Street Journal Tech Health event. "The good news was we got a lot of vaccines out to meet this initial surge in demand and now making sure we get the very best possible deployment and allocation, and the distribution system gets even more agile, more flexible -- not only here in the United States, between states, but in fact around the world -- will be work that we need to continue to stay focused on in the weeks and months ahead." Biden administration faces uphill battle to...
    Republican Texas Rep. Mike McCaul believes it's 'more likely than not' COVID came from the Wuhan lab and has accused China of the 'worst cover-up in human history'. McCaul told CNN's State of the Union that President Biden's investigation was 'long overdue' but fears it may turn up nothing because scientists have 'destroyed everything at the lab.  He also called for the US to stop buying medical products from China as members of both the Democrats and Republicans called for a congressional investigation into the origins of COVID. 'If we can pull these chains out of China, it will hurt them economically,' McCaul said. 'And that would be very punitive in nature.' The Senate has already adopted a measure from Republican Joni Ernst that would prohibit U.S. funding from the Wuhan Institute of Virology. Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb also said Sunday that accidental lab leaks 'happen all the time'. Republican Texas Rep. Mike McCaul believes it's 'more likely than not' COVID came from the Wuhan lab and has accused China of the 'worst cover-up...
    Former Food and Drug Administration Commissioner Scott Gottlieb said Sunday that accidental lab leaks "happen all the time" amid mounting concern regarding the origins of the COVID-19 pandemic. Gottlieb expressed concern about safety protocols at research labs in the U.S. and abroad during an appearance on CBS' "Face the Nation." The former commissioner said a conclusive determination on where the pandemic originated was critical to prevent deadly outbreaks in the future. "These kinds of lab leaks happen all the time, actually," Gottlieb said. "Even here in the United States, we’ve had mishaps, and in China, the last six known outbreaks of SARS-1 have been out of labs, including the last known outbreak, which was a pretty extensive outbreak that China initially wouldn’t disclose that it came out of a lab." Calls for further investigation of the pandemic’s origins have intensified in recent days. Earlier this month, the Wall Street Journal reported three researchers at China’s Wuhan Institute of Virology displayed symptoms severe enough to seek hospital treatment with symptoms consistent with COVID-19 in late 2019.  FACEBOOK ENDS BAN ON POSTS...
    America's bans on travel from countries including the United Kingdom, India and China 'don't make sense' for blocking the spread of COVID-19 variants, according to a former head of the Food and Drug Administration.   Scott Gottlieb, who served as FDA commissioner from 2017 to 2019 and sits on the board of vaccine maker Pfizer, appeared on CBS News' Face the Nation on Sunday morning to share his view on where the US stands in the fight against coronavirus.  Asked about the Biden administration's recent restrictions on travel from India, which is experiencing a deadly second wave due to a variant called B.1.617, Gottlieb said he doesn't see them having much of an impact.  'I'm not sure what we're hoping to accomplish if the goal is to try to prevent introduction of virus into the United States,' he said.  'There's plenty of virus here already if the goal is to try to prevent introduction of that new variant, B.1.617 that's circulating in India, I assure you it's here already.'  'These travel restrictions could serve a purpose, but we need to be...
    Johnson & Johnson's coronavirus vaccine will now include a warning that rare blood clotting events might occur after the shot is administering, primarily among women under age 50. Two weeks ago, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) suggested clinicians stop using the shot after more than a dozen reports of rare, but serious, blood clots out of 7.2 million vaccinations.  Fifteen reports after the vaccine was approved for emergency use authorization in February and two occurred during clinical trials. On Friday, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended the rollout be resumed and the FDA add the vaccine doses came with a notice about blood clots. In a report published on Tuesday, the ACIP said it believed that pause should be lifted after it found that the benefits of resuming J&J's vaccine outweighed risks and that limiting vaccine use to specific populations would not do enough to prevent hospitalizations or death linked to COVID-19.   It comes as the CDC reports it is investigating been two more cases of...
    Donald Trump is looking 'very seriously' at running for president again in 2024, he announced on Monday night, as he attacked Joe Biden for his handling of the southern border and returned to his 2016 campaign warning that Latin America was 'sending rapists' into the United States. In his first televised interview since leaving the White House, Trump told Fox News' Sean Hannity that he was definitely weighing up a bid to retake the presidency. 'I am looking at it very seriously,' he said. 'Beyond seriously.' Donald Trump, in his first post-White House televised interview, spoke on Monday night The Wrap News Inc. Privacy Policy The former president invited Sean Hannity of Fox News into his Mar-a-Lago estate He said he believed his high poll ratings - what he termed his 'tremendous numbers' - was due to disappointment in Biden's rule. 'I've got tremendous numbers. Nobody has ever gotten the numbers I got. No sitting president has come even close. There is more popularity now the end there was the day before the election,' he said. But,...
    The Centers for Disease Control and Prevention (CDC) is reviewing additional reports of people who suffered severe side effects after receiving the Johnson & Johnson coronavirus vaccine. On Tuesday, the CDC and the U.S. Food and Drug Administration (FDA) suggested clinicians stop using the shot after nine reports of rare, but serious, blood clots out of more than 7.2 million vaccinations.   'We are encouraged that it hasn't been an overwhelming number of cases but we're looking and seeing what's come in,' said CDC director Dr Rochelle Walensky during a press briefing on Monday.  She added that the agency and the FDA were monitoring the U.S. government's database for additional reports of side effects.   No details were available on how many additional people suffered side effects or what those side effects were. SCROLL DOWN FOR THE VIDEO  CDC director Dr Rochelle Walensky said on Monday (pictured) the agency is looking into additional reports of people who suffered severe side effects from the J&J vaccine Walensky did not elaborate on how many people suffered side effects from the J&J vaccine...
    Pollster Frank Luntz said on Fox News on Sunday that new polling will show people are “more confident in the vaccine” after the Johnson & Johnson pause. Howard Kurtz asked about the challenge of convincing people to get the vaccine “when they think it’s related to mail ballots or Bill Gates trying to kill them.” Luntz talked about the importance of local doctors being the ones making the case, and of “taking the politics out of it.” He said Donald Trump and Joe Biden should be giving each other’s administrations credit for important vaccine progress. Kurtz then asked about the J&J vaccine pause — recommended by the CDC and FDA following a reported six cases of serious blood clots out of millions of people who got the one-dose shot — and how it would affect “a potential setback for your efforts.” Luntz responded by breaking some news from a poll coming out soon: “We’re going to produce a poll tomorrow night — I’ve seen the data, we’re going to release it — that’s going to show that the American people are more likely...
    The Biden administration said the pause in the Johnson & Johnson vaccine rollout will not impact their vaccine goals.  Jeff Zients, the White House COVID-19 Response Coordinator, downplayed the pause in the vaccine distribution, saying it was being done 'out of an abundance of caution.' He said the Johnson & Johnson does not make up enough of the U.S. supply to affect the administration's goals of getting a shot in the arm of 200 million Americans by President Joe Biden's 100th day in office on April 30th and to have enough shots for every adult American by the end of May. 'This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,' he said in a statement released by the White House. He noted the U.S. has enough supply of the Pfizer and Moderna vaccines to meet their goal. Those vaccines require two shots unlike Johnson & Johnson's single dose. 'The United States has secured enough Pfizer and...
    A former chief regulator is predicting that the 'fourth wave' of Covid that some officials keep warning over will never crash over the U.S., despite spiking in numerous hotspots.  'There's enough immunity in the population that you're not going to see a true fourth wave of infection,' Dr Scott Gottlieb, former Food and Drug Administration (FDA) commissioner told CBS Face the Nation.  The U.S. is now seeing a seven-day average of 63,282 new coronavirus cases a day, up from 54,507 three weeks prior.  But the trend is driven mostly by a handful of states, and certain lower-risk demographics who are not yet vaccinated, Dr Gottlieb says.  As a result, the average number of daily deaths has remained below 1,000 for the past five days. As of Sunday, 797 Americans were dying a day, including 222 that day, and the death toll has now surpassed 555,000.  Hundreds of deaths a day are nothing to be dismissed, but the U.S. recorded less than half a many deaths yesterday than it did the previous Sunday.  Half of U.S. states - including Michigan, Nebraska an Vermont...
    (CNN) — Mass vaccinations and natural protection from those already infected are likely to prevent a fourth wave of Covid-19 in the United States, Dr. Scott Gottlieb, former commissioner of the Food and Drug Administration, said Sunday. “We’re talking about some form of protective immunity in about 55% of the population,” Gottlieb said on CBS’s Face the Nation. “There’s enough of a backstop here that I don’t think you’re going to see a fourth surge.” READ MORE: Marylands Highest Court Upholds Baltimore Billboard Tax About 81 million people have had at least one dose of a vaccine, a number that is going up significantly every day. In addition, about 29 million people have tested positive for the virus and recovered, and tens of millions more have had Covid-19 without a positive test and have some natural immunity. Still, the US will continue to see Covid-19 cases and deaths, Gottlieb cautioned, particularly as a dangerous variant first identified in the United Kingdom spreads. “I think what you could see is a plateauing for a period of time before we continue on...
    The United States is unlikely to require a new mass lockdown or see a fourth wave of infections, as is currently happening in parts of Europe, because the U.S. vaccination program is further advanced, the former FDA chief has said. Dr Scott Gottlieb served as commissioner of the Food and Drug Administration (FDA) from 2017 until 2019. On Monday he told CNBC that he was optimistic that the U.S. would not need to follow Italy's lead and reimpose lockdown. 'Earlier I said we were sort of four to maybe six weeks behind Europe, and we pretty much were,' Gottlieb said, referring to previous phases of the global health crisis. 'Everything that happened in Europe eventually happened here. Now I think the tables have turned. We're ahead of Europe.' Scott Gottlieb said on Monday that he hoped the U.S. would not need another lockdown nbcuniversal Privacy Policy Gottlieb appeared on CNBC to discuss the progress of the fight against COVID-19 Gottlieb, who is on the board of pharmaceutical firm Pfizer, one of the main producers of the COVID-19...
    Biden marks 50M vaccine doses in 37 days; global coronavirus death toll hits 2.5M: Live COVID-19 updates Netflixs Canine Intervention is about humans training dogs — and dogs training humans Unique Tip If Your Car Has Automatic Headlights Ad Microsoft Full screen 1/9 SLIDES © Provided by Best Life These Are the Side Effects of the New Johnson & Johnson Vaccine, FDA Says With two COVID vaccines already on the market, the U.S. is on the verge of having a third within the week—as long as it's approved for emergency-use authorization by the U.S. Food and Drug Administration (FDA) on Feb. 26. This new vaccine, created by Johnson & Johnson, is different from the Moderna and Pfizer vaccines in several ways, including the fact that it only requires one dose. In a new report released by the FDA before its approval meeting, the agency has identified the possible side effects you could experience with the Johnson & Johnson...
    This article was medically reviewed by Kailey Proctor, MPH, RDN, CSO, a board-certified oncology dietitian at the Leonard Clinical Cancer Institute with Mission Hospital.  Medically Reviewed Reviewed By Check Mark Icon A check mark. It indicates that the relevant content has been reviewed and verified by an expert Our stories are reviewed by medical professionals to ensure you get the most accurate and useful information about your health and wellness. For more information, visit our medical review board. Adding sugar to your morning cup of coffee would be an example of added sugars. Glasshouse Images/Getty Images Table of Contents Chevron icon It indicates an expandable section or menu, or sometimes previous / next navigation options. What are total sugars? What are added sugars? Are added sugars worse than total sugars?  How much sugar should I eat a day?  What are total sugars? What are added sugars? Are added sugars worse than total sugars?  How much sugar should I eat a day?  ...
    The Rich Are Costing Social Security Billions a Year Why the New USPS Mail Truck Looks So Strange Unique Tip If Your Car Has Automatic Headlights Ad Microsoft Full screen 1/5 SLIDES © Provided by Best Life The Johnson & Johnson Vaccine Has This Surprising Benefit, FDA Says For the entire vaccination rollout to date, the U.S. has relied entirely upon two double-dose vaccines developed by pharmaceutical companies Moderna and Pfizer-BioNTech. However, a third type developed by Johnson & Johnson has gained attention while awaiting approval as a simplified single-dose option that is still highly effective against the SARS-CoV2 virus. Now, a new report from the U.S. Food and Drug Administration (FDA) finds that not only does the vaccine provide sufficient protection, but it also has a surprising added benefit when it comes to how patients react to their shots. Read on to see what the agency found, and for more on what you should hold off on once you get immunized, check out Don’t Do...
    AstraZeneca expects to get US emergency authorization for its COVID-19 vaccine in April, the firm's president told lawmakers on Tuesday.  As soon as it gets the Food and Drug Administration's (FDA) greenlight, AstraZeneca will have 30 million doses of the 62 percent effective shot ready to ship to the US, said president of the biopharmaceuticals arm of the company, Dr Ruud Dobber on Tuesday.  He told members of the House of Representatives' Committee on Energy and Commerce that the company could deliver 'up to 50 million' doses by the end of April.  The Trump Administration inked a deal with AstraZeneca for 300 million doses of its Oxford University-designed vaccine.  It has already been authorized by more than 50 countries and the World Health Organization, but mistrust brewed between the pharma giant and US regulators, who placed its large late-stage US trial on a nearly seven-week hold.  Meanwhile, AstraZeneca's easily stored, $4 shot has helped countries like the UK speed ahead of the US in the vaccination race, and data from Scotland this week suggested the shot reduces hospital admissions by...
    Amid emerging coronavirus variants, the "direction of the future" will be in developing "potent antivirals" that directly act on the SARS-CoV-2 virus, Dr. Anthony Fauci said on Monday. Fauci, who was partaking in the White House’s COVID-19 briefing, said the nation would need to approach therapeutics similar to the "highly successful drug development program for HIV as well as Hepatitis C." To do so, Fauci said work would need to be done in identifying vulnerable targets within the SARS-CoV-2 replication cycle.  "This is going to be the direction of the future," he said, later adding that the FDA on Monday also issued updated guidance for medical product developers, including those making vaccines, therapeutics and tests. FDA ADDRESSES CORONAVIRUS VARIANTS IN UPDATED GUIDANCE FOR MEDICAL DEVELOPERS Fauci said that while several therapies have already received emergency use authorization, more work has to be done, particularly to address advanced disease. The therapeutics currently approved typically rely on early intervention to see best results. The briefing was held ahead of a moment of silence led by President Joe Biden and Vice President Kamala...
    The former commissioner of the FDA has said he believes the downward trend in coronavirus infection rates will continue until the summer. Dr. Scott Gottlieb said that despite new variants of the virus springing up which still creates a risk of infection, he believes that rates will continue to fall. Daily average deaths and hospitalizations have fallen to their lowest levels since before the Thanksgiving and Christmas holidays.  There were 1,286 daily deaths recorded in the last 24 hours with figures now at their lowest since October 23, at the start of this winter's wave of infections. Former FDA commissioner Dr. Scott Gottlieb said that the US will likely 'continue to see infection rates decline into the spring and the summer.' The number of daily cases, hospitalizations and deaths are all now falling So far, less than 15 per cent of the US population has received at least one vaccine dose, with nearly 43 million getting at least one shot and nearly 18 million getting a second shot, statistics show On Sunday, the number of people...
    The Food and Drug Administration (FDA) will allow Moderna to fill vials with 40 percent more coronavirus vaccine, according to the New York Times.  People familiar with the company told the outlet that FDA regulators told Moderna it can fill its vials with up to 14 doses instead of 10 on Friday.  It's a shift that Moderna requested last month, in an effort to alleviate production bottlenecks.  'Beyond the amount of drug product available, one potential capacity constraint is how many vials can be filled in a given period of time,' a firm spokesperson previously told the Times.  Moderna's vaccine doses account for a little more than half of the US supply, meaning the green light to fill vials with extra doses could expand the amount of vaccine available by about 20 percent.  The FDA told Moderna on Friday it will allow the firm to  fill its vials of coronavirus vaccine with 14 instead of 10 doses, according to the New York Times. The change could come in as little as two or three weeks   RELATED ARTICLES Previous...
    Yale investigation: MIT graduate student a person of interest, New Haven police say Massachusetts to Vaccinate Anyone Who Accompanies Older People to Appointments Best & Worst Refinance Mortgage Companies of 2021 Ad Microsoft Full screen 1/5 SLIDES © Provided by Best Life If You See This on Your Mask, the FDA Says Toss It Immediately You're probably used to wearing a mask day in and day out by now, but over time, it's possible that your seemingly dependable PPE is no longer working to protect you. Face masks, whether cloth coverings, surgical masks, or respirators, are only effective against COVID if used correctly—and they may need to be replaced sooner than you realize. According to the U.S. Food and Drug Administration (FDA), there are several signs that indicate your mask needs to be discarded and replaced. Read on to find out if your face covering has surpassed its usefulness, per the FDA's guidelines, and for more on masks that don't pass the test, find out why...
    With Jeff Bezos at helm, Amazon’s stock performance has made the S&P 500 look like a flat line 2021 Porsche Taycan Does Sensible EV Performance Best & Worst Refinance Mortgage Companies of 2021 Ad Microsoft Full screen 1/5 SLIDES © Provided by Best Life If You're Using This to Relax, the FDA Says Stop Immediately With 12 months of staying at home, working at home, schooling at home, and illness and economic strife to contend with, it's understandable that many of us have been feeling our stress levels rise. Additionally, the combination of working at the kitchen table, binge watching Netflix all weekend, and generally being less active has resulted in more back and muscle pain for many of us. According to The New York Times, a 2020 survey from the American Chiropractic Association found that 92 percent of chiropractors said that patients reported more neck pain, back pain, or other muscle issues since lockdowns began. However, if you've been coming up with your own ways...
    LIVE: Jim Cramer on GameStop, Silver, Robinhood, Reddit, Stock Market Monday Low-Volume Manufacturers’ Law is Set, Now Where Are the Engines? Best & Worst Refinance Mortgage Companies of 2021 Ad Microsoft Full screen 1/5 SLIDES © Provided by Best Life If You're Eating This for Breakfast, the FDA Says Stop Immediately If your new year health kick is off to a good start, you've probably been switching out some of your more calorific breakfast choices, like sugary cereals and carb-heavy bagels, for healthier options, like yogurt or oatmeal. But if you've been enjoying one particular brand of the latter, you need to check the label carefully now that the FDA has announced a recall on a popular brand of oatmeal products. Read on to find out if your oatmeal is safe to eat, and for another popular breakfast product that you need to avoid, find out why If You Have This Coffee at Home, the FDA Says Get Rid of It Now. Read the original article...
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