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04.05.2021 / 03:37

U.S. FDA expected to approve Pfizer COVID-19 vaccine for children 12 to 15 by next week

Food and Drug Administration (FDA) is expected to authorize Pfizer’s COVID-19 vaccine for young adults age 12 and older by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.The announcement is set to come barely a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.

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U.S. faces final step in race to give Pfizer’s coronavirus vaccine the green light

Pfizer’s COVID-19 vaccine faces one final hurdle as it races to become the first shot greenlighted in the U.S.: a panel of experts who will scrutinize the company’s data for any red flags.Thursday’s meeting of the Food and Drug Administration’s vaccine advisory panel is likely the last step before a U.S. decision to begin shipping millions of doses of the shot, which has shown strong protection against the coronavirus.The FDA panel functions like a science court that will pick apart the data and debate — in public and live-streamed — whether the shot is safe and effective enough to be cleared for emergency use.

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Pfizer meets safety, efficacy guidelines for its coronavirus vaccine: FDA

COVID-19 vaccine approved for emergency use on Tuesday after the U.S. Food and Drug Administration (FDA) released documents that did not raise any new issues about its safety or efficacy.Data on the vaccine submitted to the agency was in line with its guidance on emergency use authorization, FDA staff said in documents released ahead of Thursday’s meeting of outside experts.

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U.S. allows emergency use of 1st antibody drug for coronavirus

COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization. It’s a one-time treatment given through an IV.

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White House blocks new coronavirus vaccine guidelines that would delay approval

COVID-19 to market that would almost certainly have prevented their approval before the Nov. 3 election.At issue was the FDA’s planned requirement that participants in the ongoing mass clinical trials for nearly a half-dozen vaccine candidates be followed for two months to ensure there are no side effects and that the vaccines provide lasting protection from the virus in order to receive emergency approval.

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Should e-cigarettes be banned amid coronavirus? Why some U.S. lawmakers are pushing for it

study found those who vaped were five times more likely to be diagnosed with the novel coronavirus than non-users, prompting some United States lawmakers to try to temporarily ban the sale of e-cigarettes until more research can be done on their effects.In a letter to the FDA commissioner, U.S. Congressman Raja Krishnamoorthi called for the prohibition, saying e-cigarette users were much more likely to test positive for the virus and experience symptoms.“This is true in vapers as young as 13, which is particularly concerning, given that young people are increasingly driving the spread of COVID-19, threatening the health and safety of Americans of all ages,” he said.

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U.S. FDA approves emergency authorization for coronavirus antigen test with fast results

U.S. regulators have approved a new type of coronavirus test that administration officials have promoted as a key to opening up the country.

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First at-home saliva test to detect coronavirus authorized by U.S. FDA

The U.S. Food and Drug Administration said on Friday it has authorized the first diagnostic test for the new coronavirus that allows patients to collect saliva samples at-home.

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Remdesivir, hailed as potential COVID-19 treatment, gets emergency U.S. FDA green light

Remdesivir has received emergency use authorization (EUA) from the U.S. Food and Drug Administration after a major study showed that it can reduce recovery time for hospitalized COVID-19 patients.

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FDA expected to quickly approve experimental coronavirus drug Remdesivir: U.S. official

The nation’s top infectious diseases expert says he expects the U.S. Food and Drug Administration to quickly approve a new experimental drug that showed promising signs in treating patients with COVID-19.

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Coronavirus: U.S. approves 1st at-home test for health-care workers, first responders

WASHINGTON — U.S. health regulators on Tuesday OK’d the first coronavirus test that allows people to collect their own sample at home, a new approach that could help expand testing options in most states.

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FDA to Alex Jones: Stop pitching bogus coronavirus remedies

U.S. health officials are warning conspiracy theorist and radio host Alex Jones to stop pitching bogus remedies for the coronavirus.

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