What is the Emergency Use Authorization (EUA) for remdesivir?

On May 1, 2020, the Food and Drug Administration (FDA
Food and Drug Administration (FDA
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or Agency) issued an Emergency Use Authorization (EUA) for the emergency use of Veklury® (remdesivir)3 for treatment of hospitalized patients with severe 2019 coronavirus disease (COVID-19)4, pursuant to Section 564 of the Act.
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Is Remdesivir approved for treatment of COVID-19?

Remdesivir is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adult and pediatric patients (aged ≥12 years and weighing ≥40 kg).
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What is Emergency Use Authorization (EUA) amidst the COVID-19 pandemic?

The FDA can issue EUA during a public health emergency—like a pandemic—to allow the use of unapproved medical products to diagnose, treat or prevent serious or life-threatening diseases. Prior to issuing EUA, safety and efficacy must be demonstrated and certain FDA criteria must be met; there also must be evidence that strongly suggests that patients have benefited from a treatment or test, and there are no adequate, approved or available alternatives.

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What is an Emergency Use Authorization for COVID-19 vaccine?

In emergencies, the experts at the FDA can decide that the benefits of a drug justify a shorter process. If so, the FDA can issue an Emergency Use Authorization (EUA). Under an EUA, the FDA maintains its strict standards but makes decisions more quickly than usual.
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When should I take Paxlovid?

When should I take Paxlovid? You have to take Paxlovid within five days of developing symptoms.
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Antimicrobial Drugs Advisory Committee Meeting



How can I get Paxlovid?

Right now, only people with certain medical conditions can be prescribed the drug. Experts say people who test positive for COVID-19 and are eligible for Paxlovid should ask their doctor to prescribe it.
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Does Paxlovid work after 5 days?

To be effective, treatment must begin within five days of symptom onset, so you are not eligible to take Paxlovid if you have had COVID-19 symptoms for more than five days.
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Do I qualify for an exception or can I apply for an exception to the COVID-19 vaccine requirement?

Categories of noncitizen, nonimmigrants that meet the criteria for an exception under the proclamation and CDC’s order include: Persons on diplomatic or official foreign government travel Children under 18 years of age Persons with documented medical contraindications to receiving a COVID-19 vaccine Participants in certain COVID-19 vaccine trials Persons issued a humanitarian or emergency exception Persons with valid visas [excluding B-1 (business) or B-2 (tourism) visas] who are citizens of a foreign country with limited COVID-19 vaccine availability. Members of the U.S. Armed Forces or their spouses or children (under 18 years of age). Sea crew members traveling pursuant to a C-1 and D nonimmigrant visa Persons whose entry would be in the national interest, as determined by the Secretary of State, Secretary of Transportation, or Secretary of Homeland Security (or their designees)

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What are some exemptions from the COVID-19 vaccine?


Some people may be at risk for an adverse reaction because of an allergy to one of the vaccine components or a medical condition. This is referred to as a medical exemption. Some people may decline vaccination because of a sincerely held religious belief. This is referred to as a religious exemption.

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Can you get COVID-19 from sex?

All close contact (within 6 feet or 2 meters) with an infected person can expose you to the virus that causes coronavirus disease 2019 (COVID-19) — whether you're engaged in sexual activity or not.
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Has there been a national emergency declared regarding COVID-19?


On March 13, 2020, by Proclamation 9994, the President declared a national emergency concerning the coronavirus disease 2019 (COVID-19) pandemic. The COVID-19 pandemic continues to cause significant risk to the public health and safety of the Nation.

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Is it mandatory to get a COVID-19 vaccine to travel to the US during the COVID-19 pandemic?


The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines.

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What if I don't get the second COVID-19 vaccine shot?


The bottom line is that if you didn't get your second shot on time, you'll want to get it as soon as possible. If you didn't get your second shot because you developed COVID-19 at some point during the vaccination process, it's still recommended that you get your second dose.

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Is Remdesivir approved in Europe for treatment of COVID-19?

Since July 2020, remdesivir has been conditionally approved in Europe for the treatment of coronavirus disease (COVID-19) in adults and adolescents aged 12 years and older with pneumonia who require supplemental oxygen but no invasive ventilation.
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How does Remdesivir injection work to treat COVID-19?

Remdesivir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body.
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What are the side effects of Remdesivir?

Remdesivir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
• nausea
• constipation
• pain, bleeding, bruising of the skin, soreness, or swelling near the place where the medication was injected

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How do you know if you are allergic to the COVID-19 vaccine?

An immediate allergic reaction happens within 4 hours after getting vaccinated and could include symptoms such as hives, swelling, and wheezing (respiratory distress).
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Should you get the Covid vaccine if you have an autoimmune disease?

The American College of Rheumatology COVID-19 Vaccine Clinical Guidance recommends that people with autoimmune and inflammatory rheumatic disease (which includes lupus) get the vaccine unless they have an allergy to an ingredient in the vaccine.
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What to do if you get an allergic reaction from the COVID-19 vaccine?

If you get a COVID-19 vaccine and you think you might be having a severe allergic reaction after leaving the vaccination provider site, seek immediate medical care by calling 911.
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Why do I not have a reaction to COVID-19 vaccine?

It's likely related to variations in the immune system and its response, which may be influenced by things like age, genetics or underlying medical conditions.
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Is having a heart condition considered as high risk for COVID-19?

Having heart conditions such as heart failure, coronary artery disease, cardiomyopathies, and possibly high blood pressure (hypertension) can make you more likely to get severely ill from COVID-19.
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Can I get the COVID-19 vaccine if I have an underlying condition?

People with underlying medical conditions can receive a COVID-19 vaccine as long as they have not had an immediate or severe allergic reaction to a COVID-19 vaccine or to any of the ingredients in the vaccine. Learn more about vaccination considerations for people with underlying medical conditions. Vaccination is an important consideration for adults of any age with certain underlying medical conditions because they are at increased risk for severe illness from COVID-19.
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What is Paxlovid used for?

Paxlovid is an oral antiviral pill that can be taken at home to help keep high-risk patients from getting so sick that they need to be hospitalized. So, if you test positive for the coronavirus and a health care provider writes you a prescription, you can take pills at home and lower your risk of going to the hospital.
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Does Paxlovid give you a bad taste in your mouth?

Its also a side effect of several illnesses and medications, including Paxlovid, the new antiviral medication to treat COVID infection. Although it affects fewer than 6% of people who are given Paxlovid, some report a “horrible” taste that came on soon after they started taking the drug.
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How long after the COVID-19 booster is it effective?


The first COVID-19 booster shot is now in the rearview mirror for millions of Americans -- for the 28% who got it, at least -- but new data finds it's less effective after about 4 months. The CDC has already recommended a second booster for immunocompromised people.
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