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19.12.2020 / 19:43

FDA authorizes Moderna COVID vaccine for emergency use

The Food and Drug Administration (FDA) last night issued an emergency use authorization (EUA) for the Moderna COVID-19 vaccine, bringing a second vaccine to the United States' battle against the pandemic and making it the first country to have two authorized vaccines that come with clear and compelling efficacy data.

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U.S. gets 2nd coronavirus vaccine after FDA gives Moderna green light

Moderna’s coronavirus vaccine Friday, giving the country hardest hit by the pandemic two shots for inoculations against the virus.The approval is the first in the world for Moderna’s vaccine, which is similar to the two-dose Pfizer-BioNTech shot that was given the green light in the U.S. and several other countries last week.“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn in a statement.

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FDA to 'rapidly work toward' authorizing Moderna COVID-19 vaccine after panel endorsement

WASHINGTON - The head of the Food and Drug Administration said late Thursday that his agency will move to quickly authorize the second COVID-19 vaccine to fight the pandemic, hours after the shot won the key endorsement of a government advisory panel. FDA Commissioner Stephen Hahn said in a statement that regulators have communicated their plans to drugmaker Moderna, which co-developed the vaccine with the National Institutes of Health, and that it will "rapidly work toward finalization and issuance of an emergency use authorization." The announcement came after a panel of FDA advisers, in a 20-0 vote, ruled that the benefits of the vaccine outweighed the risks for those 18 years old and up.Once FDA's emergency use authorization is granted,

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US set to approve Moderna vaccine

The US Food and Drug Administration (FDA) will "rapidly" work towards granting emergency approval of Moderna Inc's Covid-19 vaccine candidate, FDA Commissioner Stephen Hahn has said.

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U.S. FDA plans to quickly approve Moderna coronavirus vaccine after panel endorsement

COVID-19 vaccine to fight the pandemic, hours after the shot won the key endorsement of a government advisory panel.FDA Commissioner Stephen Hahn said in a statement that regulators have communicated their plans to drugmaker Moderna, which co-developed the vaccine with the National Institutes of Health. The announcement came after a panel of FDA advisers, in a 20-0 vote, ruled that the benefits of the vaccine outweighed the risks for those 18 years old and up.Once FDA’s emergency use authorization is granted, Moderna will begin shipping millions of doses, earmarked for health workers and nursing home residents, to boost the largest vaccination effort in U.S.

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US authorises first at-home Covid-19 test, results in 20 minutes

The United States has authorised its first rapid at-home test for Covid-19, which is available over-the-counter and produces a result in around 20 minutes.

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Coronavirus: FDA commissioner comments on reported allergic reactions to COVID-19 vaccines

When discussing the COVID-19 vaccine on CNN Sunday, U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn advised that anyone with known allergies to the ingredients in the Pfizer-BioNTech vaccine not take it.

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Pfizer covid-19 vaccine will reach hospitals across US on Monday

- Regulatory approval -The US became the sixth country to green-light the Pfizer vaccine on Friday night.It was a triumphant moment for the American giant and its German partner BioNTech, who started work on their product, based on experimental mRNA (messenger ribonucleic acid) technology, just 11 months ago.But the move, while expected, was not without controversy after it was widely reported that President Donald Trump had called the chief of the Food and Drug Administration (FDA) and threatened to fire him if he didn't issue emergency approval on Friday.On Saturday, FDA commissioner Stephen Hahn denied this had occurred, telling reporters: "The representations in the press that I was threatened to be fired if we didn't get it done by a

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FDA approves use of Pfizer COVID vaccine; shipments begin

The Food and Drug Administration (FDA) last night announced it has issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, allowing shipments to begin and marking a significant milestone in the country's battle against the virus.

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With Covid-19 vaccine ready for distribution, U.S. FDA's Hahn ready for his shot

Covid-19 vaccine ready to be distributed after the United States authorized it on Friday, Food and Drug Administration head Stephen Hahn said he was ready for vaccination as soon as available.Hahn, speaking during a press conference, defended the fastest-ever vaccine process, saying the agency did not sacrifice safety in return for speed.He also described as inaccurate press reports that said President Donald Trump's administration had threatened to fire him if the FDA did not approve the authorization by a certain date.This story has been published from a wire agency feed without modifications to the text.Click here to read the Mint ePaperMint is now on Telegram.

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White House presses FDA chief to grant COVID-19 vaccine approval Friday or face possible firing

WASHINGTON - White House chief of staff Mark Meadows on Friday pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer's coronavirus vaccine by the end of the day or face possible firing, two administration officials said.The vaccine produced by Pfizer Inc.

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FDA Says It Will Work 'Rapidly' to Issue Emergency Use Authorization for Pfizer's Covid-19 Vaccine

COVID-19 vaccine for emergency use after an advisory panel voted in favor of it. «Following yesterday's positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S.

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White House presses Hahn to approve vaccine by end of day

WILMINGTON, Del. – White House chief of staff Mark Meadows on Friday pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer's coronavirus vaccine by the end of the day. The vaccine won approval Thursday from an FDA panel of outside advisers, and signoff from the FDA is the next step needed to get the shots to the public.

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FDA panel OKs Pfizer COVID vaccine for emergency use

Vaccine advisors for the Food and Drug Administration (FDA) today recommended emergency use authorization [EUA] for Pfizer-BioNTech's COVID-19 vaccine, clearing one of the last hurdles before immunization is set to begin within days for the first groups to receive it— healthcare workers and nursing home residents.

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20 million Americans could get coronavirus vaccine this year: FDA chief

coronavirus vaccine developed by Pfizer and 20 million Americans could be vaccinated this year, its commissioner said on Friday.FDA Commissioner Stephen Hahn declined to give a specific timeline of how long approval of the vaccine developed by Pfizer and BioNTech would take but said that he hoped there would be a decision by the regulator in December. Coronavirus cases surge in U.S.

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FDA chief says agency will get COVID-19 vaccine 'right' amid pressure for rushed release

FILE - Dr. Stephen Hahn, Commissioner Of Food And Drugs, United States Food and Drug Administration testifies during a US Senate Senate Health, Education, Labor, and Pensions Committee hearing on September 23, 2020.

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FDA chief called to White House as Trump pushes for vaccine

WASHINGTON – The head of the agency responsible for approving any COVID-19 vaccine for the U.S. was summoned to the White House Tuesday as an increasingly frustrated President Donald Trump complained approval wasn't coming faster.White House Chief of Staff Mark Meadows called in Stephen Hahn, the head of the Food and Drug Administration, for a meeting as the agency weighed whether to allow emergency use of the first vaccines that could help defeat the coronavirus.Trump has been livid with the FDA for not moving faster on the vaccine, blaming it in part for his reelection loss.

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US approves Regeneron antibody treatment given to Trump

A Covid-19 antibody therapy used to treat President Donald Trump has been approved by the US drug regulator for people who are not yet hospitalised by the disease but are at high risk.

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US grants emergency use authorization to Regeneron covid-19 antibody given to Donald Trump

COVID-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease."Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said Stephen Hahn, commissioner of the Food and Drug Administration.The treatment is by U.S.

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Pfizer/BioNTech seek first Covid-19 vaccine approval in US

Pfizer and its German partner BioNTech have formally submitted an application to the US Food and Drug Administration to authorise their Covid-19 vaccine for emergency use.

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FDA panel to discuss emergency use of Pfizer covid-19 vaccine on December 10

COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech for emergency use, the agency said on Friday.The move comes after Pfizer applied for the authorization of its COVID-19 vaccine earlier in the day, the first such application in a major step toward providing protection against the new coronavirus."While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible," FDA Commissioner Stephen Hahn said in a statement.The meeting of Vaccines and Related Biological Products Advisory Committee will discuss the safety and effectiveness of the vaccine candidate.The FDA is not obligated to abide by its advisory panel recommendations, but typically does.Reuters had reported,

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U.S. FDA approves 1st coronavirus self-testing kit for at-home use

Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.

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FDA head: Outside pressures won't rush COVID vaccine

The decision to authorize and approve a COVID-19 vaccine will be based on data and science—not politics, Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), said today in a Center for Infectious Disease Research and Policy (CIDRAP) webinar.

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Hopes of a covid vaccine before US election dim as regulators assert power

Donald Trump has always been the biggest backer of making a vaccine available before the election.

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Donald Trump says FDA pulled ‘political hit job’ with Covid-19 vaccine rules

November election.“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!" the president wrote in a tweet that tagged his hand-picked FDA commissioner, Stephen Hahn.Trump, who is battling a coronavirus infection himself, commented hours after the FDA issued strict new requirements for Covid-19 vaccine applications, including a review by a panel of experts and two months of safety data.

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Trump Administration Finalizes Rule Allowing States To Import Prescription Drugs From Canada.

Modern Healthcare (9/24, Brady, Subscription Publication) reports that on Thursday, the Trump Administration “unveiled its final rule allowing states to import some prescription drugs from Canada.” This “rule allows states and, under some circumstances, pharmacists or wholesale distributors to import drugs from Canada if their plan wouldn’t pose additional safety risks to the public and would save consumers a significant amount of money.” The FDA must “approve each plan.” The rule takes effect 60 days after being published in the Federal Register. FDA Commissioner Dr.

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Coronavirus: Warren grills top U.S. health officials about assets in companies developing vaccines

Sen. Elizabeth Warren on Wednesday grilled top U.S.

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FDA setting higher bar for emergency Covid vaccine clearance

coronavirus vaccine works before granting an emergency waiver -- something he called “EUA plus."FDA Commissioner Stephen Hahn tweeted later Thursday that the agency planned to release guidelines for drugmakers that aim to submit an EUA request for a Covid-19 vaccine.Hahn also tweeted that the guidelines for an EUA would lay out the type of data the FDA expects. This builds on guidance the agency put out in June that said any Covid-19 vaccine should be at least 50% effective.Marks said the data requirement will more closely mimic the standards that apply for an application for a regular approval.

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Ahead of covid vaccine review, US agency sends email to all 17,000 staff

Covid-19 vaccine -- has set off an effort by government officials and private industry to ensure the White House doesn’t interfere with a methodical, careful scientific process.Food and Drug Administration leaders are insulating the agency’s vaccine reviewers from outside political pressure by sticking by June guidelines that set the standard for what it will take for a vaccine to pass through the agency, said one official familiar with the planning, who asked for anonymity discussing private deliberations.They’re also making clear to FDA staff that the political noise shouldn’t influence the agency’s decisions.

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FDA chief says he could approve COVID-19 vaccine before completion of Phase 3 clinical trials

WASHINGTON - In an interview with the Financial Times, Food and Drug Administration Commissioner Dr. Stephen Hahn said a potential emergency authorization for a coronavirus vaccine before the completion of Phase 3 clinical trials would be “appropriate” if his agency found that the benefits outweighed the risks.“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said.

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US raises the possibility of early approval for covid vaccine

US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness.A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times."If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate.

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US to decide on covid vaccine in October, FDA chief promises transparency

Covid-19 vaccine in the U.S. will be transparent to the public, with any clearance by the agency driven by data alone.In an interview on Sunday, Commissioner Stephen Hahn responded to questions about the different ways the FDA could clear a vaccine for use: either under an emergency authorization, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use.“We’ve said all along we’re not going to pre-judge what mechanism we’re going to use to authorize or approve a vaccine," Hahn told Bloomberg News by phone.

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FDA commissioner disputes Trump, says no 'deep state' elements delaying coronavirus vaccine

WASHINGTON : The U.S. Food and Drug Administration (FDA) is not made up of "deep state" elements that are trying to delay a coronavirus vaccine as President Donald Trump has suggested, the agency's commissioner told Reuters on Monday.Dr.

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Trump accuses FDA 'deep state' of virus vaccine delay until after US election

US President Donald Trump has accused the "deep state" in the Food and Drug Administration (FDA) of trying to slow down the search for a vaccine until after the November election.

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FDA grants emergency approval for ‘groundbreaking’ coronavirus saliva test used by NBA

COVID-19, after a trial on National Basketball Association players and staff.SalivaDirect, the fifth saliva test approved by the FDA for the disease, requires no swab or collection device and uses spit from people suspected of having the coronavirus, the agency said.

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USFDA clears simple saliva test for faster detection of COVID-19

HOUSTON : The US health watchdog has authorised the emergency use of a new and expensive saliva based laboratory diagnostic test for COVID-19 that could be a game changer in the diagnosis of the infection as it will enable rapid testing amongst more people easily.Stephen Hahn, the Food and Drugs Administration Commissioner, said the new saliva test would increase efficiency and avoid shortage of crucial test components like reagents.“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents," he said in a statement.The agency has previously authorised four other tests that use saliva for sampling,

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‘Historic day’: Pence visits hard-hit Florida as final phase of COVID-19 vaccine testing begins

MIAMI - Vice President Mike Pence visited South Florida on Monday and held a roundtable to discuss progress of a coronavirus vaccine in its final stage of testing.Pence’s visit to the University of Miami marked the beginning of Phase 3 trials for a vaccine developed by the National Institutes of Health and Moderna Inc., which he called a “historic day.”“A day when we begin in earnest in phase three down the path toward securing a vaccine for the American people,” Pence said, who was joined at the roundtable by Florida Gov.

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Fauci: US could see 100,000 COVID-19 cases a day if surge continues

Testifying to the Senate Health, Education, Labor and Pensions Committee today about safe business and school reopenings, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, warned that the United States could see a daily COVID-19 case count of 100,000 if the current surge of cases continues.

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Fauci: US could reach 100,000 new coronavirus cases a day 'if this does not turn around'

WASHINGTON - Dr. Anthony Fauci delivered a dire warning regarding the United States’ handling of the COVID-19 pandemic, saying that he “would not be surprised” if the country saw up to 100,000 new coronavirus cases daily.“I’m very concerned,” Fauci said during a Congressional testimony on Tuesday, where he was joined by other health leaders, including CDC Director Dr.

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Coronavirus outbreak: 3 key White House officials in self-quarantine after COVID-19 exposure

Three key White House officials involved in the ongoing fight against COVID-19 in the U.S. have each gone into self-isolation after potential exposure to someone who tested positive for the coronavirus.

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US allows emergency use of drug shown to help virus recovery

WASHINGTON – U.S. regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster.

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FDA expected to quickly approve experimental coronavirus drug Remdesivir: U.S. official

The nation’s top infectious diseases expert says he expects the U.S. Food and Drug Administration to quickly approve a new experimental drug that showed promising signs in treating patients with COVID-19.

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Pence comes under fire for going maskless at Mayo Clinic

ROCHESTER, Minn. – Vice President Mike Pence chose not to wear a face mask Tuesday during a tour of the Mayo Clinic in Minnesota, an apparent violation of the world-renowned medical center's policy requiring them.

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FDA authorizes first at-home coronavirus test

The FDA has authorized the first diagnostic test with a home collection option for COVID-19, the disease caused by coronavirus.

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FDA Approves First At Home Coronavirus Testing Kit

An at-home Coronavirus testing kit has been approved, and could be available in the coming weeks, according to the U.S. Food and Drug Administration.

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Coronavirus outbreak: U.S. officials hopeful about May 1 target for reopening country

During Meet the Press on Sunday, U.S.

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Former FDA leaders decry emergency authorization of malaria drugs for coronavirus

After U.S. President Donald Trump advocated widespread use of two malaria drugs for COVID-19 patients, the FDA, led by Commissioner Stephen Hahn (left) produced an emergency use authorization for the medications.

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Rapid COVID-19 test that can deliver results in 15 minutes will be available Tuesday, FDA commissioner says

WASHINGTON - Food and Drug Administration Commissioner Dr. Stephen Hahn announced in a Coronavirus Task Force Press Briefing that a new coronavirus test would be available Tuesday from Avid, a pharmaceuticals company.

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United States	Cases: 46 252 513 Deaths: 750 423 Recovered: 0
India	Cases: 34 321 025 Deaths: 459 652 Recovered: 0
Brazil	Cases: 21 835 785 Deaths: 608 235 Recovered: 0
United Kingdom	Cases: 9 215 683 Deaths: 141 607 Recovered: 0
Russia	Cases: 8 494 589 Deaths: 237 619 Recovered: 0