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News Articles: FDA

The Pfizer-BioNTech Covid-19 vaccine can now be stored at regular refrigerator temperatures for up to a month.

Tagged as: 

  • Health

Pfizer Vaccine Can Stay Longer At Warmer Temperatures Before Being Discarded

The FDA has authorized storing the Pfizer-BioNTech COVID-19 vaccine at refrigerator temperatures for up to a month. Previously the vaccine could only be kept in a regular fridge for up to 5 days.

May 20, 2021
|
By:
  • Jane Greenhalgh
This 16-year-old got a Pfizer-BioNTech COVID-19 shot late last month at the UCI Health Family Health Center in Anaheim, Calif. Students as young as 12 are now eligible to get the vaccine, too, the FDA says.

Tagged as: 

  • Health

FAQ: What You Need To Know About Pfizer's COVID Vaccine And Adolescents

Ages 12 and older are now eligible to be vaccinated against COVID-19, the FDA and the CDC say. But when and where, and what about younger kids? You have questions. We have answers.

May 12, 2021
|
By:
  • Pien Huang
The FDA said Wednesday that Abbott's BinaxNow test and Quidel's QuickVue can now be sold without a prescription for consumers to test themselves at home.

Tagged as: 

  • Science

FDA Authorizes 2 Rapid, At-Home Coronavirus Tests

The Food and Drug Administration says Abbott's BinaxNOW test and Quidel's QuickVue can be sold without a prescription.

April 01, 2021
|
By:
  • Jaclyn Diaz and
  • Selena Simmons-Duffin
A health care worker holds a vial of the Johnson & Johnson COVID-19 vaccine at Klerksdorp Hospital in Klerksdorp, South Africa, on Feb. 18.

Tagged as: 

  • Health

FDA Authorizes Johnson & Johnson's One-Shot COVID-19 Vaccine

The Food and Drug Administration gave Johnson & Johnson's vaccine the green light for emergency use Saturday, a day after a panel of advisers to the agency endorsed it in a unanimous vote.

February 27, 2021
|
By:
  • Scott Hensley
A health care worker looks away as she's immunized with Johnson & Johnson's COVID-19 vaccine at Klerksdorp Hospital in Klerksdorp, South Africa, on Feb. 18.

Tagged as: 

  • Health

FDA Analysis Of Johnson & Johnson COVID-19 Vaccine Finds It Safe, Effective

The Food and Drug Administration released an analysis of Johnson & Johnson's COVID-19 vaccine Wednesday morning that appears to support its authorization for emergency use.

February 24, 2021
|
By:
  • Scott Hensley
Lots of manufacturers offer a rainbow of ink colors. People can even go online and order a bottle. The Food and Drug Administration has not regulated the pigments in tattoo inks so far, but agency officials will investigate and recall tattoo inks if they hear of a specific safety concern, like bacterial contamination that could lead to infections.

Tagged as: 

  • Science

As Scientists Study Tattoo Ink Safety, Europe Bans Two Widely Used Pigments

Tattoo artists are unhappy about a new ban on blue and green pigments in Europe, while scientists say the basic science of tattoo ink is still fairly mysterious.

February 13, 2021
|
By:
  • Nell Greenfieldboyce
Acting FDA Commissioner Janet Woodcock said the agency would likely hold advisory panel meetings to consider changes in COVID-19 vaccines made in response to coronavirus variants.

Tagged as: 

  • Health

FDA Aims To Be 'Nimble' On COVID-19 Vaccine Changes For Variants

The Food and Drug Administration is working on a playbook for how it could greenlight vaccine tweaks. Studies in hundreds of people, rather than tens of thousands, seem likely.

February 11, 2021
|
By:
  • Sydney Lupkin
A U.S. Supreme Court's decision on Tuesday reinstates a requirement for patients to pick up the abortion drug mifepristone in person at a hospital or doctor's office, regardless of the COVID-19 pandemic.

Tagged as: 

  • Law

Supreme Court OKs White House Request To Limit Abortion Pill Access During Pandemic

The case was the first abortion-related decision faced by the new conservative majority of the U.S. Supreme Court after Justice Amy Coney Barrett was sworn in last year.

January 13, 2021
|
By:
  • Jaclyn Diaz
The FDA has learned of reports that some health care facilities are trying to stretch the number of limited doses by cutting them in half, extending the length of time between doses, or mixing and matching vaccines in order to immunize more people against COVID-19.

Tagged as: 

  • Medical Treatments

FDA Warns Health Officials Not To Mess With COVID-19 Vaccine Doses Schedule

Agency officials said reducing the number of doses creates a potential for harm in patients because "they may assume that they are fully protected when they are not" and may "take unnecessary risks."

January 04, 2021
|
By:
  • Vanessa Romo
A COVID-19 vaccine made by Moderna is next in line with the Food and Drug Administration for possible authorization for emergency use during the pandemic.

Tagged as: 

  • Health

FDA Panel Recommends Moderna's COVID-19 Vaccine For Emergency Use

Advisers to the Food and Drug Administration voted 20-0 to recommend that the agency authorize Moderna's vaccine for emergency use during the pandemic. There was a single abstention.

December 18, 2020
|
By:
  • Scott Hensley
A worker passes through the security gate at the Moderna campus in Norwood, Mass., one of the sites where the biotechnology company is manufacturing its COVID-19 vaccine.

Tagged as: 

  • Health

How Will Moderna Meet The Demand For Its COVID-19 Vaccine?

Despite being founded a decade ago, Moderna has never had a product make it to market. And the company registered its first factory with the Food and Drug Administration just this week.

December 17, 2020
|
By:
  • Sydney Lupkin
Health care workers have been throwing out the excess vaccine, fearing it would be against FDA rules to use it.

Tagged as: 

  • Medical Treatments

Some Vials Of COVID-19 Vaccine Contain Extra Doses, Expanding Supply, FDA Says

The Food and Drug Administration says is advising health workers to use "every full dose obtainable" to help speed up the nationwide immunization campaign.

December 17, 2020
|
By:
  • Vanessa Romo
Moderna is making its COVID-19 vaccine at a company factory in Norwood, Mass.

Tagged as: 

  • Health

FDA Analysis Of Moderna COVID-19 Vaccine Finds It Effective And Safe

Two days before a panel of experts is set to review Moderna's COVID-19 vaccine and advise the Food and Drug Administration, documents show the vaccine is 94% effective and well-tolerated.

December 15, 2020
|
By:
  • Scott Hensley
Pfizer-BioNTech's COVID-19 vaccine has been tested for safety and efficacy in more than 44,000 people. Still, stopping viral spread will take more than immunizations, says the CDC. The agency is calling for those who are vaccinated to continue wearing masks and practicing safe physical distancing.

Tagged as: 

  • Health

What You Need To Know As The First COVID-19 Vaccine Heads Your Way

States are starting to administer their first doses of Pfizer's newly FDA-authorized COVID-19 vaccine. It marks a new phase in the pandemic, but what's that mean for you?

December 15, 2020
|
By:
  • Joanne Silberner
Food and Drug Administration building is shown Thursday, in Silver Spring, Md. A U.S. government advisory panel convened to decide whether to endorse emergency use of Pfizer's COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans.

Tagged as: 

  • National

Transporting And Distributing Vaccines Will Be 'Unprecedented' Logistical Operation

As FDA emergency use authorization of Pfizer and Moderna vaccines nears, airlines, FedEx and UPS prepare to transport millions of vials of life saving shots.

December 12, 2020
|
By:
  • David Schaper
  • Load More

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