September 8th, 20220After the federal government's approval, the state now has "bivalent" booster shots available that target the Omicron variant of COVID-19, Michigan's health officials said Wednesday.
The updated, or bivalent, boosters target the most recent COVID-19 Omicron subvariants, BA.4 and BA.5, which are more contagious and more resistant than...
August 24th, 20220– David Thomas, MS, is vice president of industry research at the Biotechnology Innovation Organization. Emily Wheeler is director of infectious disease policy at the Biotechnology Innovation Organization. A version of this piece originally ran in MedPage Today.
Drug-resistant infections pose a growing threat to public health....
August 11th, 20220LANSING — Michigan residents ages 18 and older now have another COVID-19 vaccine option – Novavax – to help protect them from serious illness and death due to the virus.
On July 13, the FDA issued an Emergency Use Authorization for the Novavax COVID-19 vaccine for use among people ages 18 years and older for a two-dose primary...
June 21st, 20220LANSING — Both the Pfizer and Moderna COVID-19 vaccines are now approved for children under 5 years of age, after an emergency use authorization from the federal government, and may be available as soon as Tuesday.
The Pfizer vaccine, which was already authorized for ages 5 and up, is now authorized down to 6 months of age, while...
May 27th, 20220DEARBORN — Dearborn officials are holding an emergency baby formula distribution event on Friday, spurred by a nationwide formula shortage.
Mayor Abdullah Hammoud, Public Health Director Ali Abazeed, other city officials and non profit partners will host the event from 10:30 a.m. to 2 p.m. on Friday at the west entrance of the Ford...
May 17th, 20220WASHINGTON D.C. — The U.S. Food and Drug Administration (FDA) has announced expanded approval for Pfizer’s COVID-19 booster shot.
Now, children ages 5-11 are now eligible for the COVID-19 booster shot made by Pfizer-BioNTech and which is recommended at least five months after the initial two-dose series of the vaccine.
The...
February 7th, 20220LANSING — With the eligibility criteria for antivirals expanding to include more at-risk Michiganders, state health officials are urging those who test positive for COVID-19 to speak to their health care provider about treatment with oral medication.
The Michigan Department of Health and Human Services (MDHHS) says that the supply...
February 2nd, 20220WASHINGTON D.C. — Pfizer-BioNTech has asked the FDA for emergency authorization for a two-dose COVID-19 vaccine for children 6-months- to 5-years-old.
The company is still awaiting data on a three-dose course.
Early data from Pfizer has shown that the vaccine is safe and produces an immune response. For the youngest age group,...
January 4th, 20220WASHINGTON, D.C. — On Monday, the U.S. Food and Drug Administration (FDA) authorized the use of a third dose of the Pfizer and BioNTech COVID-19 vaccine for children ages 12 to 15, and narrowed the interval for booster shot eligibility to five months from six.
The agency also authorized a third shot for children aged 5- through...
December 22nd, 20210WASHINGTON D.C. — Health regulators have officially authorized the first pill against COVID-19 that Americans can take at home.
The milestone comes as cases, hospitalizations and deaths are rising at rapid speeds, with the omicron variant also spreading rapidly.
The drug Paxlovid, created by Pfizer, will have limited supplies...
December 14th, 20210On Tuesday, Pfizer Inc. said final analysis of its antiviral COVID-19 pill still showed near 90 percent efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus.
Last month the U.S. drugmaker...
November 23rd, 20210LANSING — The state reported this week that as of last Friday, more than 87,000 (10.5 percent) of Michigan children ages 5 to 11 have received their first dose of the COVID-19 vaccine.
The Michigan Department of Health and Human Services (MDHHS) is urging parents and caregivers to get their children vaccinated before the...
October 7th, 20210WASHINGTON, D.C. — The U.S. Food and Drug Administration has confirmed Oct. 26 for its panel of outside advisers to meet and discuss the use of Pfizer’s COVID-19 vaccine in children as young as 5.
If approved by that advisory panel, children ages of 5- 11-years-old, numbering around 28 million, will begin receiving the two-dose...
September 30th, 20210LANSING — Following FDA approval, recommendations from the CDC's Advisory Committee on Immunization Practices (ACIP) and additional recommendations by the CDC director, the Michigan Department of Health and Humans Services (MDHHS) is urging certain Michiganders to get a booster shot if they received Pfizer’s COVID-19...
September 15th, 20210WASHINGTON D.C. — The Food and Drug Administration (FDA) has released new data regarding booster shots for the Pfizer vaccine.
In the data, Pfizer said that vaccine booster shots would restore protection against COVID-19 up to 95 percent in real-world settings.
Pfizer also noted that it would be safe and necessary to take a...
September 1st, 20210Adding to expert confidence over the Pfizer COVID-19 vaccine, the CDC announced this week that its advisory committee on immunization has given the vaccine a "unanimous recommendation" for those ages 16 and up.
The committee’s 14-0 vote came a week after the FDA gave the Pfizer vaccine full approval.
The CDC's Advisory Committee...
August 11th, 20210WASHINGTON D.C. — While nearly half of all Americans have been fully vaccinated against COVID-19, the FDA is reportedly on the verge of administering booster doses.
According to The Wall Street Journal, the FDA is expecting to roll out its booster strategy by early September.
The Biden administration has been pushing for the...
April 13th, 20210WASHINGTON D.C. — In a joint statement, the CDC and FDA announced the recommendation of a “pause” on using the single-dose Johnson & Johnson (J&J) COVID-19 vaccine.
The agencies are investigating unusual blood clots in six women that occurred from six to 13 days after being vaccinated.
The clots occurred in veins...
December 15th, 20200WASHINGTON D.C. — A rapid, at-home COVID-19 test that can be purchased over the counter without a prescription will be available on store shelves soon.
Regulators authorized the test, which can be done entirely at home.
“The test will be sold in places like drugstores,” FDA Commissioner Stephen Hahn said, “where a patient...
November 25th, 20201LONDON — A peer-reviewed scientific study published on Wednesday says known mutations of the SARS-CoV-2, or coronavirus, do not increase virus transmissibility.
Researchers also say the mutations do not pose a threat to vaccine efficacy. Viruses mutate, or change, constantly and some, like the flu, mutate more than others. The...
November 18th, 20200WASHINGTON, D.C. — Just as the FDA allowed an emergency use rapid at home COVID test, Pfizer announced that it was just days away from requesting emergency use of a vaccine.
The announcement from the Food and Drug Administration to allow for rapid COVID testing at home will require a prescription and can be utilized on an emergency...
April 21st, 20202DEARBORN — Governor Whitmer announced on Monday further expansion of state-wide testing sites and capabilities. Part of this expansion is a partnership between the state and CVS Health, which will provide rapid, drive-through COVID-19 testing in Dearborn.
According to Whitmer's office, testing will be conducted in the parking lot...
March 31st, 20200WASHINGTON, D.C. (Reuters) - The U.S. Food and Drug Administration has authorized the emergency use of Bodysphere Inc’s test that can detect the coronavirus in nearly two minutes, the privately held company said on Tuesday.
The FDA has been rushing to approve tests on an emergency basis and last week approved Abbott...
December 27th, 20190WASHINGTON, D.C. – U.S. Senator Gary Peters (D-MI), ranking member of the Senate Homeland Security and Governmental Affairs Committee, unveiled a new report on skyrocketing prescription drug prices and drug shortages.
At St. Joseph Mercy Oakland hospital in Pontiac on December 6, Peters joined Michiganders struggling with...
September 13th, 20190WASHINGTON – President Trump announced plans to ban flavored e-cigarettes on Wednesday.
Trump appeared with Health and Human Services Secretary Alex Azar, First Lady Melania Trump and Food and Drug Administration Commissioner Ned Sharpless to speak to reporters in the Oval Office.
The announcement came as health authorities and...
September 16th, 20180LOS ANGELES — The U.S. Food and Drug Administration is considering a ban on flavored e-cigarettes from Juul Labs and other companies as it grapples with an “epidemic” of youth e-cigarette use that threatens to create a new generation of nicotine addicts, the agency’s head said on Wednesday.
In a speech at FDA headquarters,...
December 2nd, 20171WASHINGTON — The U.S. Food and Drug Administration (FDA) has approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.
The medicine is a version of Otsuka Pharmaceutical Co. Ltd.'s established...
October 23rd, 20170DEARBORN--A recall has been issued by Meijer Inc. for over 30 packaged produce items dating from September 27 through October 20. The items listed below may have been contaminated with listeria, and the items will are getting pulled from Meijer stores immediately.
Also in October, Trader Joe's recalled a salad item, and Walmart had...
