FDA

FDA questions safety of COVID-19 pill during pregnancy

WASHINGTON – Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems in pregnant women. The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts…

FDA paves way for COVID-19 vaccinations in young kids

WASHINGTON – The Food and Drug Administration has paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine. The agency authorized the kid-size doses on Friday. They are just a third of the amount given to teens and adults. But there’s one more regulatory hurdle. Next week, advisers to the Centers for Disease Control and Prevention…

FDA advisers back Pfizer’s COVID-19 vaccine for young kids

WASHINGTON (AP) – A panel of U.S. health advisers on Tuesday endorsed kid-size doses of Pfizer’s COVID-19 vaccine, moving the U.S. closer to beginning vaccinations in children ages 5 to 11. A Food and Drug Administration advisory panel voted unanimously with one abstention that the vaccine’s benefits in preventing COVID-19 in that age group outweigh any potential risks — including…

FDA approves mixing COVID vaccines; backs Moderna, J&J boosters

WASHINGTON – Regulators are extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine.  They also said Wednesday anyone eligible for an extra dose can get a brand different from the one they received initially. The Food and Drug Administration announcement marks a big step toward expanding the U.S. booster campaign, which began with extra doses of…

Moderna And Johnson & Johnson Boosters To Be Considered This Week

WASHINGTON (AP) – With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it’s their turn. Federal regulators begin tackling that question this week. On Thursday and Friday, the Food and Drug Administration convenes its independent advisers…

Children under 12 could soon be eligible for Pfizer vaccine

"We're hoping in the latter parts of October the FDA will give its approval for use."

FARGO, N.D. (KVRR) — With Pfizer announcing positive results on the effectiveness of their vaccine for five to 11-year-olds, it may not be long before that vaccine becomes readily available. With vaccines against COVID-19 being available to only those who are 12 years of age and older, kids who are under that age group could soon have protection against the…

Federal panel rejects COVID-19 booster shots for most Americans

WASHINGTON (AP) – An influential federal advisory panel overwhelmingly rejected a plan Friday to offer Pfizer booster shots against COVID-19 to most Americans, dealing a heavy blow to the Biden administration’s effort to shore up people’s protection amid the highly contagious delta variant. The vote by the committee of outside experts assembled by the Food and Drug Administration was 16-2,…

Pfizer vaccine gets full FDA approval, local doctor doesn’t believe more people will get it

FARGO, N.D. (KVRR) – The Food and Drug Administration giving full approval to Pfizer’s Covid-19 vaccine is what many in health care expected, but will that lead more people to getting their shot? “This will push people over the edge to go get the vaccine because it is our, our best protection,” Former Acting FDA Commissioner Retired Admiral Brett Giroir…

University of Minnesota vaccine mandate takes effect with FDA’s approval

MINNEAPOLIS – The University of Minnesota is among hundreds of colleges nationwide in requiring a COVID-19 vaccination for students and staff at its five campuses. The mandate went into effect because the U.S. Food and Drug Administration has given final approval to a coronavirus vaccine, not just emergency use status. Faculty and staff at the Twin Cities, Duluth, Rochester, Crookston…

Adolescent Covid-19 Rate is low in North Dakota

North Dakota's health department shows that nearly 13% of the state's adolescents are fully vaccinated.

NORTH DAKOTA (KVRR) — New data is showing teens are not getting their Covid vaccines since being authorized to do so. North Dakota’s health department shows that nearly 13 percent of the state’s adolescents are fully vaccinated. This comes after the FDA and CDC gave Pfizer and Moderna emergency authorization to administer doses. A Sanford official says some barriers could…