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    CHAMPAIGN, Ill. (AP) — The U.S. Food and Drug Administration announced Monday it has authorized the emergency use of a COVID-19 saliva test developed by the University of Illinois. Despite the lack of FDA approval until Monday, officials said the test, known as covidSHIELD, has been used more than 1.5 million times at the university’s campuses in Urbana, Springfield and Chicago. University officials also said that because the test had been properly lab-certified, dozens of organizations around the world were sold the test, including the University of Wisconsin-Madison, American University and a Toyota plant in Kentucky. In a statement, Gov. J.B. Pritzker said the emergency-use authorization unlocks federal COVID-19 funding to provide 1 million tests to public universities in Illinois. “Even as we lead large-population states in vaccinations, widespread testing remains a critical tool in combating this pandemic, and I’m dedicating $20 million in CARES Act funding to provide 1...
    The University of Illinois has received FDA emergency use authorization for its saliva-based COVID-19 test called covidSHIELD, the university announced Monday.U of I campuses have already been using the test and now it can expand outside of the university system. So far, U of I has conducted more than 1.5 million tests at its universities in Urbana-Champaign, Chicago and Springfield.The covidSHIELD test only requires saliva and does not need a nasal swab and results can come back within 24 hours of a sample reaching a covidSHIELD lab. The university says the test is a fraction of the cost of many widely available tests and it was shown to be highly accurate in a clinical study.RELATED: COVID-19 saliva tests begin at University of Illinois Urbana-Champaign"The University of Illinois has been a national leader in innovation for decades, and the campus' groundbreaking work to develop rapid, saliva-based COVID-19 testing is but the...
    (CBS DETROIT)– After receiving emergency authorization from the FDA over the weekend Johnson and Johnson started rolling out their one dose vaccines on Monday. As hospitals in Michigan await the distribution of the J & J vaccine, doctors say the effectiveness may be less than the current vaccines, but it’s still effective in preventing hospitalizations and deaths says Dr. Matthew Sims, Director of Infectious Disease Research at Beaumont Health. READ MORE: Stimulus Check Update: Some May See Even More Money From Potential Economic Relief Package “It did seem to completely prevent people from really getting so sick that they died from the virus. It is an effective vaccine even though it’s not as strong as the Moderna or Pfizer.” Dr. Sims says studies show the Johnson and Johnson vaccine is about 75% effective compared to the 95% effectiveness in the Pfizer and Moderna vaccines, but says this should not discourage anyone...
    The Food and Drug Administration (FDA) issued an emergency use authorization on Monday for a rapid at-home COVID-19 test that delivers results without the use of an outside laboratory. The QuickVue At-Home COVID-19 Test must be obtained via prescription and can be used by individuals 14 and older, or individuals 8 and older as long as an adult collects the nasal swab sample. The test can be prescribed by a health care provider for individuals who are within six days of symptom onset. "The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic," Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a news release. "The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public." JOHNSON & JOHNSON COVID-19 VACCINE BEGINS SHIPPING The test,...
    PITTSBURGH (KDKA) — The FDA is giving the green light to a third COVID-19 vaccine. This one is being called a possible game changer. The new shot comes from Johnson & Johnson, and a rapid rollout for the vaccine is imminent. Johnson & Johnson says it’s ready to begin shipping doses as early as today. Four million doses could be shipped out this week. Twenty million doses are anticipated to be shipped by the end of March and 200 million doses by June. The main difference between this vaccine and the ones from Pfizer and Moderna is that this one only requires one dose and doesn’t require special storage conditions. The FDA has approved this vaccine for people over the age of 18. The FDA confirms that this vaccine is slightly less effective than the Moderna and Pfizer shots overall — but showed 85% efficacy against severe illness and complete...
            by Andrew Trunsky  The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide. The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself. Though the panel’s decision is merely advisory, the FDA has said that it will follow its recommendation, meaning that Johnson & Johnson’s vaccine could be approved as soon as Saturday if it follows the timeline of Pfizer and Moderna. If authorized, it will be the third coronavirus vaccine approved. Johnson & Johnson’s clinical data showed that its vaccine was overwhelmingly...
    February 26, 2021 | 4:40 pm Editor’s Note: This note was published on February 24 and is updated with expert committee results A committee of experts unanimously recommended on Friday the emergency authorization in the United States of the Johnson & Johnson single-dose COVID-19 vaccine for people 18 years and older. The opinion of this committee, composed mainly of independent scientists, is advisory, but it is an indicator of the probable authorization of the vaccine by the US health authorities. This vote is the last step before the Food and Drug Administration (FDA) issues a decision, which is expected on Saturday. The panel, a group of 22 medical specialists in fields such as internal medicine, pediatrics, vaccines and epidemiology, regularly advises the FDA on experimental vaccines. He voted to recommend intakes from Pfizer and its partner BioNTech and Moderna before the agency authorized them in December. J &...
    (CNN/CBS13) — The US Food and Drug Administration authorized Johnson & Johnson’s coronavirus vaccine Saturday. It is the first single-dose COVID-19 vaccine available in the US, and is one that “checks nearly all the boxes.” With more than 28.4 million confirmed COVID cases in the United States and nearly 511,000 reported deaths since the start of the pandemic, and while the demand for vaccines still far exceeds supply, these vaccines can’t come soon enough. READ MORE: Trailblazer Flew Through Glass Ceilings As First Female African American Pilot To Fly U-2 Aircraft “A third safe and effective vaccine is very welcome news,” Andy Slavitt, the White House’s senior for COVID Response, tweeted on Friday. NEW: Johnson & Johnson single shot vaccine just approved by FDA for 18 and older. We are ready to roll it out! — Andy Slavitt (@aslavitt46) February 27, 2021 The vaccine, made by Janssen, Johnson &...
    The Food and Drug Administration granted emergency use authorization for the COVID-19 vaccine from Johnson & Johnson on Saturday, an addition to the national supply that will further accelerate the immunization rate. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.” The vaccine is the third to be authorized by the FDA for public use and will be added to a growing national stockpile. The U.S. is now on track to...
    (CNN)The US Food and Drug Administration authorized Johnson & Johnson's Covid-19 vaccine Saturday. It is the first single dose Covid-19 vaccine available in the US, and is one that "checks nearly all the boxes." Why Americans shouldnt turn their noses up at Johnson & Johnsons vaccineWith more than 28.4 million confirmed Covid-19 cases in the US and nearly 511,000 reported deaths since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can't come soon enough."A third safe and effective vaccine is very welcome news," Andy Slavitt, the White House's senior for Covid Response, tweeted on Friday.The vaccine, made by Janssen, J&J's vaccine arm, is safe and effective, and it's considered flexible. It's a single dose, and it doesn't require special storage.The vaccine is authorized for people ages 18 and older.Read More"We need a vaccine that can be quickly mass produced," Dr. Greg...
    SAN FRANCISCO (KGO) -- The COVID-19 pandemic is having a major impact across the world and also in cities across Northern California. The latest number of confirmed cases in the U.S. can be found at the CDC's 2019 Novel Coronavirus in the U.S. page. (The CDC updates the webpage on Monday, Wednesday and Friday.)Join anchor Kristen Sze for ABC7's daily interactive newscast about the novel coronavirus outbreak in the Bay Area and other hot topics. You can check here to stream the show Monday-Friday at 3 p.m. GET HELP: Resources and information about COVID-19 CA REOPENING TIERS: Map shows which counties can, can't reopen under Newsom's new 4-tier system LATEST LOCAL CASES: Updated number of COVID-19 cases, deaths in San Francisco Bay Area Here are the latest developments on the respiratory illness in the U.S.: Feb. 26, 20212 p.m.US advisers endorse single-shot COVID-19 vaccine from Johnson & JohnsonU.S....
    (CNN)Vaccine advisers to the US Food and Drug Administration voted Friday to recommend the agency grant emergency use authorization to Johnson & Johnson's coronavirus vaccine.The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend EUA of the vaccine in people 18 and older.If the FDA acts on the recommendation -- and it's expected to do so quickly -- the vaccine will become the third authorized for use in the United States. It will be the first one-shot vaccine, and one that can be stored in regular refrigerators, making it easier to distribute than the Pfizer/BioNTech and Moderna vaccines, which are more delicate and require two doses.The vaccine, made by Johnson & Johnson's vaccine arm, Janssen, was tested in advanced clinical trials in more than 44,000 people in the US, South Africa and Latin America. Globally, it showed an overall efficacy of 66% in preventing moderate-to-severe disease....
    The Food and Drug Administration’s vaccine advisory panel voted 22-0 Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide. The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself. Though the panel’s decision is merely advisory, the FDA has said that it will follow its recommendation, meaning that Johnson & Johnson’s vaccine could be approved as soon as Saturday if it follows the timeline of Pfizer and Moderna. If authorized, it will be the third coronavirus vaccine approved. Johnson & Johnson’s clinical data showed that its vaccine was overwhelmingly...
    A panel of vaccine experts has voted unanimously to recommend authorization of Johnson & Johnson’s COVID-19 shot, setting the vaccine up for the Food and Drug Administration to allow its release within hours. WHAT YOU NEED TO KNOW ABOUT THE JOHNSON & JOHNSON CORONAVIRUS VACCINE HEADED TOWARD APPROVAL The vaccine, developed by Johnson & Johnson-owned Janssen Pharmaceuticals, takes a single shot to provide the full measure of protection from illness due to COVID-19, whereas the Pfizer and Moderna vaccines already in use in the U.S. require two separate shots spaced out three and four weeks, respectively. The J&J vaccine is also much easier to store and transport than other vaccines as it doesn’t require ultracold temperatures to keep it viable for up to three months. While the FDA does not have to act on the panel’s recommendation, it often does. The consensus among vaccine experts Friday...
    Pharmacy manager Christine Huynh, left, grabs the box of vaccines on the loading dock from a delivery driver in Boston on Dec. 15, 2020.John Tlumacki | Boston Globe | Getty Images The United States stands ready to deliver up to 4 million doses of Johnson & Johnson's Covid-19 vaccine as soon as next week if the Food and Drug Administration authorizes the shot for emergency use, the Biden administration's Covid-19 response team said Wednesday. "The governors are carefully planning their efforts and are getting ready for the possible new vaccine," Jeff Zients, President Joe Biden's Covid czar, said at a news briefing. "If authorized, we're ready to roll out this vaccine without delay." "If the EUA is granted, we will waste no time getting this life-saving vaccine into the arms of Americans," he said, referring to the emergency use authorization that would allow the U.S. to start distributing the shots....
    WASHINGTON (CBS/CNN) — A New Jersey-based company’s single-dose COVID-19 vaccine meets the requirements for emergency use. In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization. The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single dose vaccination and 66.1% at least 28 days after vaccination, a new analysis meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee said. READ MORE: Florida Man Juan Piedrahita Wanted For Posing As Attorney, Scamming New Jersey Senior Citizen “There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the analysis said. READ MORE: Suspect Wanted In Rape At Center City Macys Taken Into Custody At His West Philadelphia...
    The Food and Drug Administration reported Wednesday that Johnson & Johnson’s single-dose vaccine to protect against COVID-19 was safe and 72% efficacious in the U.S., setting it up for a quick authorization process in the coming days. The FDA’s 62-page report showed that the single-shot vaccine developed by Johnson & Johnson-owned Janssen Pharmaceutical had an efficacy rate of 72% in its U.S.-based trial and 66% overall across three regions where the shot was tested. The vaccine is also 85% effective overall at preventing hospitalization and 100% effective at preventing death due to COVID-19. The report’s authors also concluded that the shot has a “favorable safety profile with no specific safety concerns identified that would preclude issuance of an [Emergency use authorization].” The FDA’s panel of vaccine experts will meet for an all-day meeting on Friday to determine whether the vaccine should be authorized for public use. The...
    BALTIMORE (CNN/WJZ) — In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization. The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single dose vaccination and 66.1% at least 28 days after vaccination, a new analysis meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee said. READ MORE: Man Shot In Ankle Overnight In Baltimore “There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the analysis said. READ MORE: States Could Begin To Get Single-Dose Johnson & Johnson Vaccine Allocations As Soon As Next Week, Maryland Gov. Larry Hogan Says In a briefing document, the FDA said that it has reviewed the data for...
    (CNN)In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization.The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single dose vaccination and 66.1% at least 28 days after vaccination, a new analysis meant to brief the FDA's Vaccines and Related Biological Products Advisory Committee said. "There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," the analysis said.Get CNN Healths weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.In a briefing document, the FDA said that it has reviewed the data for the vaccine and has determined that it is "consistent with the recommendations set...
    (CNN)Johnson & Johnson says that it has 4 million doses of its Covid-19 vaccine ready to ship "immediately" once it receives emergency use authorization, which could happen this week, but as the decision nears, it's unclear when or where those doses will be delivered.On Monday, the White House did not disclose its plans for the J&J vaccine, although an administration official said they have worked closely with the company to formulate a distribution outline in recent weeks. Federal officials have expressed disappointment that fewer doses than initially expected will be ready if the vaccine is authorized soon.FDA advisers to consider recommending single-dose Johnson & Johnson Covid-19 vaccine this weekWhile a Johnson & Johnson executive said Tuesday that 4 million doses would be ready to ship if the vaccine receives an EUA from the US Food and Drug Administration, Biden administration officials said during call with governors to expect an estimated...
    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,...
    Pharmaceutical giant Johnson & Johnson is prepared to distribute 20 million doses of its single-shot vaccine to prevent COVID-19 if it wins regulatory authorization in the coming days. “Assuming necessary regulatory approvals relating to our manufacturing processes, our plan is to begin shipping immediately upon emergency use authorization, and deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans,” said Richard Nettles, Johnson & Johnson’s vice president of medical affairs for the company's pharmaceutical division Janssen. Nettles will face the House Energy and Commerce Committee Tuesday to discuss positive findings in clinical trials for its shot, which will be considered for emergency use authorization by the Food and Drug Administration’s outside panel of experts on Friday. The vaccine can be stored in temperatures of 36 degrees to 46 degrees Fahrenheit for up to three months, making it most appealing...
    The company producing a diagnostic test that can detect both the coronavirus and the flu says it has received an emergency use authorization from the Food and Drug Administration. Becton, Dickinson and Company’s test can detect both viruses using a single specimen and can do so in as little as two to three hours. The test is recommended for patients who are hospitalized or for patients who are not hospitalized but for whom a positive result will change the treatment they receive. The test is also highly accurate at detecting the U.K. and South African variants of the coronavirus. “A computer analysis showed that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for the test,” BD said in a press release Friday. The company also states that it has also received approval to market the test...
    The medical technology company behind a molecular diagnostic test that can detect both the influenza virus and coronavirus in a little as two to three hours said it received Emergency Use Authorization from the FDA on Friday. Becton, Dickinson and Company (BD), said its test, which runs on the company’s existing BD Max platform, is also capable of detecting the U.K. and South African coronavirus variants with 99.9% accuracy.   "A computer analysis showed that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for the test," the company said in a news release. "This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD Max System." IS THERE A LIMIT TO CORONAVIRUS MUTATIONS? The test, which also detects influenza A and B strains, provides a positive or negative result for each...
    PITTSBURGH (KDKA) — Johnson & Johnson has applied for emergency use authorization from the FDA. This third possibility as a choice under EUA would be a welcomed addition when the country’s supply of vaccine is stretched thin. “To have an option with more manufacturers, more vaccine availability is definitely a good thing,” says AHN Infectious Diseases specialist Dr. Nitin Bhanot. This vaccine has some advantages. It’s a single shot and can be shipped and stored at refrigerator temperatures, making it easier to be at a doctor’s office. “You can put it in the fridge for about three months,” says Dr. Bhanot. “The PCPs have it, and they can give it to patients, they walk in, they get a shot.” In contrast to the Pfizer and Moderna versions, this vaccine does not use mRNA. Johnson & Johnson uses a modified common cold virus, an adenovirus, to carry coronavirus spike...
    Artur Widak | NurPhoto | Getty Images Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine after releasing data last week showing it was about 66% effective in protecting against the virus. If J&J's application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind vaccines developed by Pfizer-BioNTech and Moderna. Pfizer's vaccine was authorized by the FDA on Dec. 11, and Moderna's was authorized a week later. U.S. officials and Wall Street analysts are eagerly anticipating the authorization of J&J's vaccine, which could happen as early as this month. President Joe Biden is trying to pick up the pace of vaccinations in the U.S. and experts say his administration will need an array of drugs and vaccines to defeat the virus, which has killed more than 450,000 Americans over the last year. Unlike Pfizer's...
    Amazon is trying to make it easier for people to get tested for COVID-19 from the comfort of their own home.The FDA authorized testing kit called Dxterity is now available on the tech company's website.One kit is currently available for $110, or you can get a 10-pack for $1,000.The box includes an empty tube for saliva that you sent to a Los Angeles-based lab with prepaid shipping.According to Amazon's website, the turnaround time for test results is between 24 and 72 hours after the sample is received.Emergency use authorization for the test was given last month.This is the first at-home saliva test to receive the FDA emergency use authorization for symptomatic and asymptomatic testing.ALSO READ: American Airlines is grounding emotional support animalsEMBED More News Videos The airline is making changes that are going into effect on Jan. 11, but what about if you already have a flight with your emotional-support...
    SAN FRANCISCO (KPIX 5) – As the number of COVID-19 cases across the state continue to surge, doses of a second vaccine approved by the FDA are on their way to the Bay Area. So far, more than 110,000 doses of the Moderna vaccine have already been delivered across the state, with more than 600,000 more expected by the end of the week. Cardboard boxes full of Moderna vaccine vials started getting delivered to 31 sites across California on Monday. The company started shipping more than 6 million doses across the country Sunday, only two days after the Food and Drug Administration granted emergency approval. “Moderna vaccine has arrived and that is indeed good news. 672,600 to be exact, is what we anticipate receiving this week,” said Gov. Gavin Newsom during a virtual press conference Monday afternoon. Michelle Chester, DNP, director of employee health services at Northwell Health, shows the...
    WASHINGTON -- The U.S. added a second COVID-19 vaccine to its arsenal Friday, boosting efforts to beat back an outbreak so dire that the nation is regularly recording more than 3,000 deaths a day.Much-needed doses are set to arrive Monday after the Food and Drug Administration authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.The move marks the world's first authorization for Moderna's shots. The vaccine is very similar to one from Pfizer Inc. and Germany's BioNTech that's now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up.Find out how many people may get a COVID-19 vaccine before you:Interactive not displaying correctly? Click here to open in a new window.The two work "better than we almost dared to hope," NIH Director Dr. Francis Collins told The Associated...
            by Andrew Trunsky  The FDA approved Moderna’s coronavirus vaccine for emergency use Friday, making the United States the first country to have approved two safe and effective vaccines against COVID-19. Its approval follows a key FDA panel’s overwhelming vote Thursday to endorse the vaccine’s safety and efficacy. The Moderna vaccine’s approval means that its distribution could begin within hours, providing hospitals and long-term care facilities across the country thousands of much-needed doses. Moderna said that it was prepared to distribute nearly six million doses once its vaccine was given approval, more than twice the amount initially distributed by Pfizer last weekend. The Moderna vaccine’s path to FDA emergency authorization mirrored that of Pfizer’s vaccine, which was granted emergency approval last Friday. The same advisory panel voted to recommend Pfizer’s vaccine a day earlier, and the FDA released data reaffirming both vaccines’ safety and effectiveness exactly a week apart. Though the United...
    WASHINGTON -- The U.S. added a second COVID-19 vaccine to its arsenal Friday, boosting efforts to beat back an outbreak so dire that the nation is regularly recording more than 3,000 deaths a day.Much-needed doses are set to arrive Monday after the Food and Drug Administration authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.The move marks the world's first authorization for Moderna's shots. The vaccine is very similar to one from Pfizer Inc. and Germany's BioNTech that's now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up.Find out how many people may get a COVID-19 vaccine before you:Interactive not displaying correctly? Click here to open in a new window.The two work "better than we almost dared to hope," NIH Director Dr. Francis Collins told The Associated...
    (Reuters) - Moderna Inc's coronavirus vaccine on Friday became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration, providing some welcome news to a nation with a staggering COVID-19 death toll of over 307,000 lives lost. The FDA announced the authorization on Friday after the agency's panel of outside experts on Thursday endorsed its use. (Reporting by Kanishka Singh in Bengaluru; editing by Diane Craft) Copyright 2020 Thomson Reuters. Tags: infectious diseases, vaccines, United States, India, United Kingdom, Germany, diseases, public health, coronavirus, European Union, Europe
    WASHINGTON -- The U.S. added a second COVID-19 vaccine to its arsenal Friday, boosting efforts to beat back an outbreak so dire that the nation is regularly recording more than 3,000 deaths a day.Much-needed doses are set to arrive Monday after the Food and Drug Administration authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.The move marks the world's first authorization for Moderna's shots. The vaccine is very similar to one from Pfizer Inc. and Germany's BioNTech that's now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up.Find out how many people may get a COVID-19 vaccine before you:Interactive not displaying correctly? Click here to open in a new window.The two work "better than we almost dared to hope," NIH Director Dr. Francis Collins told The Associated...
    The Food and Drug Administration has granted Moderna’s two-shot coronavirus vaccine emergency use authorization, the second vaccine to be green-lit in two weeks. The agency made quick work of authorizing the vaccine just one day after its vaccine advisory panel recommended by a vote of 20 to 0 with one abstention that it be approved for limited public use. Similar to last week’s authorization of Pfizer’s vaccine, the first doses of the Moderna vaccine will be shipped out over the weekend to be delivered to U.S. hospital systems Monday through Wednesday. Gen. Gus Perna, the chief operating officer for the Trump administration’s vaccine initiative Operation Warp Speed, told reporters Monday the administration will ship almost 6 million doses to more than 3,000 locations. “It'll be a very similar cadence that was executed this week with Pfizer,” Perna added, referring to the distribution this week of the Pfizer/BioNTech...
    The FDA approved Moderna’s coronavirus vaccine for emergency use Friday, making the United States the first country to have approved two safe and effective vaccines against COVID-19. Its approval follows a key FDA panel’s overwhelming vote Thursday to endorse the vaccine’s safety and efficacy. The Moderna vaccine’s approval means that its distribution could begin within hours, providing hospitals and long-term care facilities across the country thousands of much-needed doses. Moderna said that it was prepared to distribute nearly six million doses once its vaccine was given approval, more than twice the amount initially distributed by Pfizer last weekend. The Moderna vaccine’s path to FDA emergency authorization mirrored that of Pfizer’s vaccine, which was granted emergency approval last Friday. The same advisory panel voted to recommend Pfizer’s vaccine a day earlier, and the FDA released data reaffirming both vaccines’ safety and effectiveness exactly a week apart. (RELATED: FDA Review Reaffirms Moderna...
    WASHINGTON (AP/KDKA) — The U.S. added a second COVID-19 vaccine to its arsenal Friday, boosting efforts to beat back an outbreak so dire that the nation is regularly recording more than 3,000 deaths a day. Much-needed doses are set to arrive Monday after the Food and Drug Administration authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health. The move marks the world’s first authorization for Moderna’s shots. The vaccine is very similar to one from Pfizer Inc. and Germany’s BioNTech that’s now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up. The two work “better than we almost dared to hope,” NIH Director Dr. Francis Collins told The Associated Press. “Science is working here, science has done something amazing.” Early results of large, still unfinished studies show...
    In most contexts, it’s perfectly acceptable to use “approval” and “authorization” interchangeably. But not at the Food and Drug Administration (FDA), and definitely not when it comes to COVID-19 vaccines. If the topic comes up at your Zoom holiday party, here’s a cheat sheet for the specific uses of these similar terms. Approval — No COVID-19 vaccines have been approved. Approval means the FDA has officially decided that a product is safe and effective for its designated use. The process for approval involves rigorous reviews of all available data on the product and can take several months. Authorization — To speed things up in an emergency like a pandemic, the FDA can grant an Emergency Use Authorization (EUA). An EUA, as its name implies, authorizes a product for use during unusually urgent circumstances if the benefits of its use outweigh any known or potential risks. A vaccine that combats...
    (Reuters) - The U.S. Food and Drug Administration (FDA) informed Moderna Inc that it will rapidly work towards the finalization and issuance of emergency use authorization (EUA) for its COVID-19 vaccine candidate, commissioner Stephen Hahn said late Thursday. Earlier in the day, a panel of external advisers to the FDA overwhelmingly endorsed emergency use of Moderna vaccine candidate, virtually assuring a second option for protecting against COVID-19 for a pandemic-ravaged nation. The FDA is expected to grant the EUA as early as late Thursday or Friday, providing another ray of hope to a nation that has lost more than 300,000 lives to COVID-19 and as record numbers of patients threaten to overwhelm U.S. hospitals and healthcare workers. (Reporting by Shubham Kalia in Bengaluru, Editing by Sherry Jacob-Phillips) Copyright 2020 Thomson Reuters. Tags: vaccines, United States, India, coronavirus, European Union, United Kingdom, Europe, Germany
    (CNN)Vaccine advisers to the US Food and Drug Administration voted easily and quickly to recommend that the agency give emergency use authorization to Moderna's coronavirus vaccine -- but not without a lengthy side discussion about whether volunteers in the clinical trial who got placebo shots should be offered the vaccine early.And the committee got briefly sidelined when the final vote got mixed up with last week's question about Pfizer/BioNTech's vaccine, which already has an EUA.The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20-0 with one abstention to recommend EUA for the Moderna vaccine, which is very similar in design, composition, safety and efficacy to Pfizer/BioNTech's vaccine. That was the only question facing the committee -- whether to recommend EUA."There's no doubt in my mind that the data -- it looks like the benefits outweigh the risks, from what I've seen," committee member Dr. Steven Pergam, of the University...
    Reuters December 17, 2020 0 Comments A panel of outside advisers to the U.S. Food and Drug Administration on Thursday overwhelmingly endorsed emergency use of Moderna Inc’s coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation. The committee voted 20-0 with one abstention that the benefits of the vaccine outweigh its risks in people aged 18 and older, one week after the same panel backed a similar vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later. The FDA is expected to grant the EUA as early as late Thursday or Friday, providing another ray of hope to a nation that has lost more than 300,000 lives to COVID-19 – including a one-day high of 3,580 deaths on Wednesday – while record numbers of patients threaten to overwhelm U.S. hospitals and healthcare workers. “To...
    The FDA advisory committee voted overwhelmingly in favor of approving the Moderna coronavirus vaccine for emergency use authorization. During a remote vote on Thursday, the FDA’s safety and efficacy review panel almost unanimously endorsed Moderna’s  vaccine, with 20 votes in favor and just one abstention. Exactly one week ago, the same FDA committee voted to approved Pfizer’s Covid-19 vaccine, which has subsequently gotten full FDA approval and is currently being deployed across the county to inoculate frontline health care workers. Moderna’s vaccine, though it is also uses mRNA and is a two-shot dose, differs in small ways from Pfizer’s. It does not require extreme cold storage and its lag time between the primary and boost host is four weeks, rather than three. Also, the FDA advisory panel recommended it for only those 18 years and older, while Pfizer’s was cleared for inoculating those 16 and up. “No one voted...
    PITTSBURGH (KDKA) – The FDA’s vaccine advisory committee met in a daylong session to discuss Moderna’s mRNA COVID-19 vaccine, just one week after Pfizer’s vaccine received emergency use authorization. The committee voted overwhelmingly yes that the benefits of the Moderna vaccine outweighed the risks for people 18 and up. The FDA will now decide on EUA for the vaccine. “We’re on a roll here. Another remarkable vaccine with awesome efficacy,” says Kelly Stefano, Director of Microbiology at the Allegheny Health Network. “This doesn’t guarantee FDA approval, obviously, but to end a pandemic like this, we are really going to need the best of anything we can get right now.” Because no vaccine is FDA approved and because supplies are limited, EUA for another vaccine is appropriate. Modern’s vaccine does not need mixing, and it stays stable in the refrigerator. It’s 94% effective and might prevent asymptomatic infections, as...
    The Food and Drug Administration’s panel of vaccine advisers on Thursday gave the green light for federal regulators to grant Moderna’s vaccine emergency use authorization, setting the government up for another massive vaccine distribution program. The final vote was 20-to-0, with one abstention. During the day-long meeting, streamed online for public access, Moderna executives and members of the Vaccines and Related Biological Products Advisory Committee answered questions from public health experts and epidemiologists. The extensive range of topics discussed included the severity of side effects and the company’s plan to offer placebo recipients the vaccine, a move that the FDA panelists cautioned would limit the quality of the data about the vaccine’s long-term efficacy and side effects. Members also called for the ongoing investigation into potentially fatal side effects, particularly in people of color who get the shots. The vaccine trial’s pool of volunteers was 79.2% white...
    The Food and Drug Administration’s panel of vaccine advisors on Thursday gave the green light for federal regulators to grant Moderna’s vaccine emergency use authorization, setting the government up for another massive vaccine distribution program. The final vote was 20 to 0 with one abstention. During the day-long meeting, streamed online for public access, Moderna executives and members of the Vaccines and Related Biological Products Advisory Committee answered questions from public health experts and epidemiologists. The extensive range of topics discussed included the severity of side effects and the company’s plan to offer placebo recipients the vaccine, a move that the FDA panelists cautioned would limit the quality of the data about the vaccine’s long-term efficacy and side effects. Members also called for the ongoing investigation into potentially fatal side effects, particularly in people of color who get the shots. The vaccine trial’s pool of volunteers was...
    The same advisory panel that recommended the Food and Drug Administration approve Pfizer's coronavirus vaccine is discussing Moderna's version of the vaccine on Thursday. The Vaccines and Related Biological Products Advisory Committee, which provides advice to the agency, is expected to vote this afternoon on whether to recommend the FDA authorize the vaccine for emergency use. If the committee, which will evaluate the vaccine's safety, recommends the FDA grant authorization, the agency is expected to give it swift approval. The vaccine could roll out as early as next week if approved.How to watch FDA advisory board vote on Moderna's COVID-19 vaccine What: Vaccines and Related Biological Products Advisory Committee is debating and voting on whether to recommend that the FDA approve Moderna's vaccine for emergency use. Date: December 17, 2020 Time: Debate scheduled to start at 9 a.m. ET; Vote is expected around 3:10-5:15 p.m. ET Online...
    Reuters December 17, 2020 0 Comments A panel of outside advisers to the U.S. Food and Drug Administration is expected to endorse emergency use of Moderna Inc’s coronavirus vaccine during a meeting on Thursday, as the nation prepares to roll out a second vaccine. The panel vote on whether the vaccine’s benefits outweigh its risks is likely to come some time after 3 pm ET (2000 GMT), with an FDA authorization expected as soon as Friday. This is the same committee of expert advisers that last week backed the COVID-19 vaccine from Pfizer Inc and German partner BioNTech SE, clearing the way for the FDA emergency use authorization (EUA) a day later. That vaccine is being distributed throughout the country. A massive inoculation program began at U.S. hospitals on Monday. The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer/BioNTech shot,...
    (CNN)Vaccine advisers to the US Food and Drug Administration are scheduled to meet Thursday to discuss the second coronavirus vaccine aimed at the US market, this one made by biotechnology company Moderna.The FDA has already telegraphed that a quick emergency use authorization can be expected and this one could go through even faster than the EUA for Pfizer last week -- itself a speedy process.The Moderna vaccine is very similar to Pfizer's and BioNTech's vaccine. Both use a new approach involving genetic material known as messenger RNA or mRNA. Key committee meets Thursday to consider FDA authorization for Pfizer/BioNTech Covid-19 vaccine"It's based on the same technology," Dr. Elissa Malkin, co-investigator for the Moderna Clinical Trial at the George Washington University in Washington, DC, told CNN."Really, they do seem quite similar," added Malkin, who has studied both the Pfizer and the Moderna data.Read More"I think they are very likely to...
            by Andrew Trunsky  The Food and Drug Administration approved the first over-the-counter, at-home coronavirus test Tuesday. The test, developed by the Australian company Ellume Limited, is a rapid antigen test that can deliver results in approximately 20 minutes, and works on any patient older than two years of age, the FDA said in its announcement. “Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen Hahn said Tuesday. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.” The announcement follows the FDA’s approval of an at-home prescription coronavirus test in November. The agency has now authorized over 225 coronavirus tests since the pandemic began, according to its release. The FDA on...
    The Food and Drug Administration approved the first over-the-counter coronavirus test just days before the agency is expected to authorize a second vaccine manufactured by Moderna. The FDA issued an emergency use authorization Tuesday for the Ellume COVID-19 Home Test, the first over-the-counter diagnostic test for COVID-19. Ellume Health, a developer of diagnostic medical tests based in Australia, says the test can be used anywhere and returns results in 15 minutes. The test employs nasal swabs to look for fragments of coronavirus proteins. The results are then sent to the user’s smartphone. It can be used to test anyone age 2 or older. The FDA’s Vaccines and Related Biological Products Advisory Committee announced Tuesday that Moderna’s COVID-19 vaccine is both safe and effective for public use. The committee said its analysis “supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of...
    EVANSTON, Ill. (WLS) -- Moderna's COVID-19 vaccine is the next to be considered for emergency use authorization in the United States after the vaccine by Pfizer and BioNTech was approved last week.Shipments of a second vaccine are likely to coming soon as the FDA gives authorization for the Moderna vaccine."The FDA found no serious safety concerns with the Moderna vaccine and affirmed its 95% efficacy," Gov. JB Pritzker said.Moderna and Pfizer vaccines are similar in terms of dosage. Both vaccines require two doses with three weeks in between for Pfizer and four weeks for Moderna. However, they differ in storage. Moderna does not require extremely low temperatures. It is likely that the Pfizer vaccine stays at hospitals when it comes to distribution."Using that to vaccinate healthcare workers makes more sense than taking that to the long-term care facilities, so it might be that Moderna is used more for that upfront...
    The Food and Drug Administration approved the first over-the-counter, at-home coronavirus test Tuesday. The test, developed by the Australian company Ellume Limited, is a rapid antigen test that can deliver results in approximately 20 minutes, and works on any patient older than two years of age, the FDA said in its announcement. “Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen Hahn said Tuesday. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.” The announcement follows the FDA’s approval of an at-home prescription coronavirus test in November. The agency has now authorized over 225 coronavirus tests since the pandemic began, according to its release. The FDA on Tuesday also released data reaffirming...
    WASHINGTON -- The first home test for COVID-19 that doesn't require a prescription will soon be on U.S. store shelves.U.S. officials Tuesday authorized the rapid coronavirus test which can be done entirely at home. The announcement by the Food and Drug Administration represents another important - though incremental - step in U.S. efforts to expand testing options.The agency's action allows the test to be sold in places like drugstores "where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes," said FDA Commissioner Stephen Hahn, in a statement.Regulators granted emergency use for a similar test last month, but that one requires a doctor's prescription.Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.A company spokesperson said...
    The Food and Drug Administration granted emergency use authorization to the first over-the-counter antigen test for COVID-19 that can be used at home in individuals ages 2 and up, including those not showing symptoms. The approval comes a week after the agency approved another non-prescription, at-home test, but that one requires samples to be sent to an outside lab. With the Ellume COVID-19 Home Test, patients collect a mid-turbinate nasal swab to detect virus antigens. The test uses an analyzer that is connected with a software application on a smartphone to help users perform the test and interpret results in as little as 20 minutes, according to the FDA press release. MORE STATES SEE FIRST COVID-19 VACCINATIONS The test has boasted a 96% accuracy rating in positive samples taken from symptomatic people, and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of...
    A CDC panel recommended Saturday that Pfizer’s coronavirus vaccine be used by people over the age of 16. The CDC’s Advisory Committee on Immunization Practices made the recommendation in an 11-0 vote, according to CNBC. An FDA panel made the same recommendation following deliberations on Thursday, but President Donald Trump and many lawmakers are frustrated with how long the process has taken. White House Chief of Staff Mark Meadows reportedly called FDA head Stephen Hahn and told him to approve the vaccine by Friday or resign. Hahn denied that characterization of the phone call, however. (RELATED: Pfizer Vaccine ‘Likely’ To Be Discouraged For Pregnant Women, FDA Adviser Says) UPDATE: “This is an untrue representation of the phone call with the CoS. The FDA was encouraged to continue working expeditiously on […] EUA request. FDA is committed to issuing this authorization quickly as we noted in our statement this morning” -Dr...
    WASHINGTON -- The U.S. gave the final go-ahead Friday to the nation's first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.WATCH LIVE: CDC briefing on Pfizer vaccineREAD: FDA emergency authorization use letter to Pfizer EMBED More News Videos FDA chief Stephen Hahn discusses the emergency use authorization of the Pfizer COVID-19 vaccine. Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has...
    WASHINGTON -- The U.S. gave the final go-ahead Friday to the nation's first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.WATCH LIVE: CDC briefing on Pfizer vaccineREAD: FDA emergency authorization use letter to Pfizer EMBED More News Videos FDA chief Stephen Hahn discusses the emergency use authorization of the Pfizer COVID-19 vaccine. Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has...
    WASHINGTON -- The head of the Food and Drug Administration denied news reports of a White House official threatening his job Friday over the speed of the agency's COVID-19 vaccine authorization.ABC News and several news outlets reported that White House chief of staff Mark Meadows called FDA Commissioner Stephen Hahn Friday and told him that he could face firing if the FDA did not grant emergency use authorization for Pfizer's coronavirus shot by the end of the day."First of all, the representations in the press that I was threatened to be fired if we didn't get it done by a certain date is inaccurate," Hahn said during a Saturday morning press conference."Science and data guided the FDA's decision. We worked quickly based on the urgency of this pandemic, not because of any other external pressure," he added.His comments come after President Donald Trump injected himself into the process on Friday...
    WASHINGTON -- The U.S. gave the final go-ahead Friday to the nation's first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.READ: FDA emergency authorization use letter to Pfizer Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has surged to catastrophic levels in recent weeks and already claimed 1.5 million lives globally.While the FDA decision came only after public review of data from...
    WASHINGTON -- The U.S. gave the final go-ahead Friday to the nation's first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.READ: FDA emergency authorization use letter to Pfizer Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has surged to catastrophic levels in recent weeks and already claimed 1.5 million lives globally.While the FDA decision came only after public review of data from...
    Madison Summers December 12, 2020 0 Comments President Donald Trump is offering praise after the U.S. Food and Drug Administration (FDA) issued emergency use authorization for Pfizer/BioNTech’s COVID-19 vaccine. In a video posted to Twitter on Friday, Trump said, “Today our nation has achieved a medical miracle.” He continued, “We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history. It will save millions of lives and soon end the pandemic once and for all.” The president also applauded those who worked to make “this all possible.” “On behalf of the American people, I’d like to thank all of the brilliant scientists, technicians, doctors and workers who made this all possible.” In the press release announcing the emergency use authorization of the first coronavirus vaccine, FDA Commissioner Stephen M. Hahn called it “a significant milestone in battling this...
    (CNN)Trucks and planes loaded with Pfizer and BioNTech's vaccine will soon be departing from Kalamazoo, Michigan, to hospitals around the country, following the Food and Drug Administration's emergency use authorization (EUA). "We need to take a moment, I think, and just consider that we are having this mass casualty event every day here in the US, but now we have this vaccine developed in record time that can in time really save us and save our country and save the world from this awful pandemic," emergency physician Dr. Leana Wen told CNN's Chris Cuomo moments after the authorization. "This is really a monumental moment for us," she added. The news comes during the most difficult weeks the US has faced since the pandemic's start. Friday saw the highest number of new cases, hospitalizations and daily deaths since the pandemic's start. More than 3,300 American deaths were reported. US Covid-19 vaccine...
    The Food and Drug Administration on Friday granted an emergency use authorization for the coronavirus vaccine developed by Pfizer and BioNTech, marking a major milestone in the pandemic that has claimed close to 300,000 American lives. "It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the world," Health and Human Services Secretary Alex Azar said in a statement. The highly-anticipated approval allows vaccine shipments to begin. However, shots cannot be administered until a Centers for Disease Control and Prevention advisory committee votes Saturday on whether to recommend the vaccine for the public and if certain groups of people should not receive the shot. CDC Director Robert Redfield would then need to sign off on the committee's recommendation. Azar on Friday said that the first vaccinations could start Monday...
    Photo credit: Joel Saget, AFP via Getty Images The FDA has officially approved he Pfixer BioNTech vaccine for emergency use authorization to inoculate against the Covid-19 virus. According to the New York Times, which first reported the news, the nation’s first vaccine for the coronavirus received full approval on Friday evening. The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures. Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public. On Thursday, the FDA Advisory Committee voted to approve the Pfizer vaccine for emergency...
            by Andrew Trunsky  The FDA approved Pfizer’s coronavirus vaccine for emergency use Friday, officially beginning a nationwide mass vaccination effort in an attempt to overcome the coronavirus pandemic. Its approval follows a key FDA panel’s overwhelming vote to endorse the vaccine’s safety and efficacy. President Donald Trump called for the agency to approve Pfizer’s earlier Friday, telling its director, Dr. Stephen Hahn, to “get the dam vaccines out” as soon as possible. While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!! — Donald J. Trump (@realDonaldTrump) December 11, 2020 The FDA said Friday that it has been operating in tandem with the Centers for Disease Control and Operation Warp Speed in...