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Tag: FDA

HEALTH
Moderna to distribute 6 million COVID-19 vaccines as soon as Friday upon FDA emergency approval
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U.S. officials said on Monday they are planning to ship just under 6 million doses of Moderna’s COVID-19 vaccine once it receives emergency use authorization from the Food and Drug Administration.



a hand holding an object in his hand: Moderna to distribute 6 million COVID-19 vaccines as soon as Friday upon FDA emergency approval

© UPI Photo
Moderna to distribute 6 million COVID-19 vaccines as soon as Friday upon FDA emergency approval

CNBC reports that McKesson, a medical supply company, will receive doses of the Moderna vaccine for packaging and distributing to 3,285 sites, according to Gen. Gustave Perna who is in charge of logistics for Operation Warp Speed, the White House’s COVID-19 vaccine program. Perna said that UPS and FedEx have been tasked with getting the vaccine doses to their final locations.

CNBC reports that the vaccine could be approved as early as Friday, one week after Pfizer’s coronavirus vaccine was granted emergency use authorization. Similar to Pfizer, Moderna’s vaccine is given in two doses spaced four weeks apart.

Video: FDA to

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HEALTH
FDA OKs Emergency Use of Pfizer COVID-19 Vaccine
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Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The US Food and Drug Administration (FDA) has authorized Pfizer/BioNTech’s COVID-19 vaccine for emergency use in people 16 years of age and older. 

The much-anticipated emergency use authorization (EUA) of this vaccine — the first such approval in the United States — was greeted with optimism by infectious disease and pulmonary experts, although unanswered questions remain regarding use in people with allergic hypersensitivity, safety in pregnant women, and how smooth distribution will be.



Dr William Schaffner

“I am delighted. This is a first, firm step on a long path to getting this COVID pandemic under control,” William Schaffner, MD, professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee, said in an interview with Medscape Medical News.

The FDA gave the green light after the December 10 recommendation from the agency’s Vaccines and

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HEALTH
Refuting Trump, FDA commissioner says vaccine could not have been authorized sooner
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As the first United States shipments of the Pfizer-BioNTech coronavirus vaccine set out across a beleaguered nation ravaged by nine months of illness and death, the leader of the agency responsible for approving the immunization maintained Sunday that the authorization was made as quickly as possible, despite claims to the contrary by President Donald Trump.

In an interview with Fox News Saturday, Trump, after seeming to take credit for the speed of the vaccine’s development, said that the Food and Drug Administration could have authorized the shot for emergency use “last week.”

“They could have even done it a week sooner,” the president continued.

“We do not feel that this could have been out a week earlier,” Dr. Stephen Hahn, the FDA commissioner, said on ABC’s “This Week.” “We went through our process. We promised the American people that we would do a thorough review of the application and that’s

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HEALTH
As coronavirus vaccine begins to roll out, FDA seeks to reassure the public on safety
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At a news conference, FDA Commissioner Stephen Hahn said he would “absolutely” get the vaccine as soon as he is eligible.

Hahn denied, as he did Friday, that the White House had threatened his job if the agency didn’t move quickly on the vaccine. The Washington Post reported Friday that White House Chief of Staff Mark Meadows called Hahn on Friday morning to warn him to be ready to submit his resignation if the agency didn’t clear the shots by the end of the day, according to multiple people knowledgeable about the situation and who spoke on the condition of anonymity because they but did not have permission to speak publicly.

“Science and data guided the FDA’s decision,” Hahn told reporters, adding the agency had maintained “the integrity of the scientific process” while moving as quickly as possible given the urgent situation.

Discussing the possibility of rare severe allergic reactions,

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PREGNANCY
FDA Gives Guidance on Allergy, Pregnancy Concerns for COVID Vaccine
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The US Food and Drug Administration (FDA) has clarified its guidance on administration of the Pfizer/BioNTech COVID-19 vaccine, stating that it is safe for people with any history of allergies, but not for those who might have a known history of severe allergic reaction to any component of the vaccine.

The warning is included in the FDA’s information sheet for health care providers, but questions are arising as to whether the vaccine — which was authorized for emergency use by the FDA on Friday — should not be given to anyone with a history of allergies.

Sara Oliver, MD, an epidemic intelligence service officer with the Centers for Disease Control and Prevention (CDC) reported at a December 11 meeting of the agency’s Advisory Committee on Immunization Practices that two UK health care workers with a history of significant allergic reactions had a reaction to the Pfizer vaccine. A third health

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HEALTH
FDA authorizes Pfizer vaccine; Trump tweets
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CLOSE

As the COVID-19 vaccine rolls out, people are wondering if they will be required to take it to go back to work. History provides some clues.

USA TODAY

Ten months and 20 days after the first case of COVID-19 was confirmed in the United States, the Food and Drug Administration has granted emergency authorization to a vaccine that data shows is highly effective at preventing a disease that has killed nearly 300,000 Americans. 

The vaccine, from Pfizer and its German partner BioNTech, was developed at a historically swift pace, besting early estimates that projected it would be a year or more before a COVID-19 vaccine would be authorized.

Cutting-edge science and extraordinary funding helped compress that timeline, leading to a vaccine believed to be more than 90% effective in blocking the symptoms of COVID-19 and that has shown no major, unexpected safety problems.

“This is a light at the

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HEALTH
F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away
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The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days.

The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.

The F.D.A.’s decision followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized

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HEALTH
White House threatens to fire FDA chief unless Covid vaccine OKed Friday: reports
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U.S. President Donald Trump and Stephen Hahn, Director of the Food and Drug Administration participate in the daily coronavirus task force briefing at the White House on April 24, 2020 in Washington, DC.

Drew Angerer | Getty Images

White House chief of staff Mark Meadows told the head of the Food and Drug Administration to submit his resignation if the agency doesn’t clear Pfizer’s coronavirus vaccine for emergency use by day’s end, The Washington Post reported Friday.

The warning led FDA Commissioner Stephen Hahn and the agency to accelerate its timetable for clearing America’s first Covid-19 vaccine from Saturday morning to later Friday, according to the Post, which cited anonymous sources.

The New York Times, Axios and Reuters also reported that Meadows told Hahn to resign if he didn’t move quickly to clear the vaccine.

In a statement, Hahn called the Post’s report “an untrue representation.”

“This is an untrue

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HEALTH
FDA Grants Emergency Use Authorization for Pfizer-BioNTech Coronavirus Vaccine | National News
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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 or Tuesday. Britain,

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HEALTH
FDA authorizes the first coronavirus vaccine, a rare moment of hope in the deadly pandemic
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The Food and Drug Administration on Friday gave emergency use authorization to the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nation’s social and political fabric and devastated the economy.



a close up of a bottle

© Joel Saget/AFP/Getty Images


The historic authorization of the vaccine from Pfizer and BioNTech for people age 16 and older, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.

The FDA action came after White House Chief of Staff Mark Meadows on Friday told FDA commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by day’s end, according to people familiar with the

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