FDA

Johnson & Johnson

After six people were found to have blood clot-related side effects, federal health officials have recommended a pause on Johnson & Johnson coronavirus vaccines.

Oklahoma health officials are following suit.

With two COVID-19 vaccines available in the United States and more on the way, things are starting to look up. But virus mutations being detected around the world mean the vaccines may one day need updates to ensure they stay effective.

The Food and Drug Administration is already working on a playbook for how it could greenlight vaccine changes.

A third coronavirus vaccine candidate has requested emergency use authorization from the Food and Drug Administration. Johnson & Johnson submitted its application Thursday for the company's single-dose inoculation.

Health care workers across the U.S. are getting a new arrow in their quiver.

In a 20-0 vote, with one abstention, a panel of advisers to the Food and Drug Administration recommended that the COVID-19 vaccine being developed by Moderna be authorized for emergency use in adults during the pandemic.

If the agency authorizes the vaccine for emergency use, as is expected, it would become the second to be deployed in the U.S to fight the coronavirus.

The vote in favor of the vaccine was taken to answer the agency's question: Do the benefits of the Moderna vaccine outweigh its risks for use in people age 18 and older?

The U.S. Food and Drug Administration on Tuesday authorized the first coronavirus test that people will be able to buy at a local store without a prescription and use for immediate results at home to find out if they're positive or negative.

The test will cost about $30 and be available by January, according to the Australian company that makes it, Ellume.

The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from drugmaker Moderna that supports the authorization of the company's vaccine for emergency use.

The FDA's briefing document along with one from Moderna were posted two days before a group of experts will convene to advise the agency on whether to grant the vaccine emergency authorization for use, or EUA, during the pandemic.

An important federal advisory committee at the Centers for Disease Control and Prevention has added its vote of support for the Pfizer-BioNTech COVID-19 vaccine.

In an emergency meeting Saturday, the CDC's Advisory Committee on Immunization Practices voted to recommend the first COVID-19 vaccine for use for people 16 or older in the U.S, expressing hope that the vaccine would help curb the spread of the disease that has killed more than 295,000 people in the U.S.

Federal officials have authorized emergency use of the COVID-19 vaccine produced by Pfizer and BioNTech in a landmark decision that promises to alter the fight against the coronavirus radically in the United States.

The Food and Drug Administration released its letter to Pfizer granting the authorization Friday evening.

Updated at 8:22 p.m. ET

In a 17-4 vote, with one abstention, a panel of advisers to the Food and Drug Administration recommended Thursday that the COVID-19 vaccine being developed by Pfizer and BioNTech be authorized for emergency use during the coronavirus pandemic.

The vote in favor of the vaccine was taken to answer the agency's question: Do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in people age 16 and older?

The agency typically follows the advice of its expert advisers.

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