U.S. FOOD AND DRUG ADMINISTRATION

A California company has expanded a July recall of nutritional drinks, creamers and other beverages because they may be contaminated by the organisms cronobacter sakazakii and clostridium botulinum. According to the U.S. Food and Drug Administration, the recall expansion adds more brands and more lot codes to the July 28 recall by Lyons Magnus. “Current ready-to-drink cold brew with best-by dates of Aug. 20 and Aug. 21, 2023, are not affected” by the recall. The previous recall included products from the brands Aloha, Oatly, Rejuvenate and Glucerna. For more information, people in all time zones can call Lyons recall support center at 800-627-0557 or go to the website where recall information is at the top of the page.

The USDA is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency's recent increased flexibilities.

The head of the Food and Drug Administration says a comprehensive review of the opioid painkillers that triggered the nation's ongoing overdose epidemic is in the works.

High levels of radiation can damage the skin and eyes after just a few seconds of exposure, regulators warn.

Gov. Gretchen Whitmer urged the U.S. Food and Drug Administration to remove restrictions on reproductive healthcare, specifically on the abortion pill mifepristone.

We're tracking monkeypox cases in Michigan.

Consumers urged not to eat any of two batches of Natierra-branded fruit, according to notice posted by FDA.

Consumers urged not to eat any of two batches of Natierra-branded fruit, according to notice posted by FDA.

The FDA has given vaccine-makers the green light to develop omicron-specific Covid vaccines. Here's what you should know about those upcoming shots.

The FDA appears to acknowledge an outbreak linked to Daily Harvest's lentil crumbles, and L.A. County public health confirms a case was reported locally.

Products marketed for water therapy can lead to death or serious injury in infants with special needs, agency says.

The U.S. Food and Drug Administration has issued a warning to parents, caregivers and health care workers to not use baby neck floats because the child may die or be injured. The FDA specifically said the neck floats should not be used “with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury.”The FDA said that although issues are rare, they do happen. The agency said it is aware of one infant that died and another who was hospitalized after being in a neck float. Neck floats are inflatable plastic rings that can be worn around a baby’s neck and allow babies to float freely in water.

U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match the latest changes of the shape-shifting coronavirus.

The U.S. Food and Drug Administration ordered Juul products removed from the U.S. market as the agency issued marketing denial orders for its vaping devices and pods.

Both the Pfizer-BioNTech and Moderna vaccines will be offered at the Washtenaw County Health Department’s ongoing COVID-19 clinic at 555 Towner St. in Ypsilanti.

The U.S. Centers for Disease Control and Prevention last week recommended all children 6 months to 5 receive COVID-19 vaccines. More than 400,000 additional Michigan children may now receive the inoculations. For the Pfizer vaccine, children 6 months to 4 years receive 1/10 of the adult dose. For the Moderna vaccine, children 6 months to 5 receive a quarter of the adult dose and each dose is separated by four weeks. Systemically, the most often noted symptoms were headache and fatigue in older children and irritability in younger children.

CDC advisers are set to meet Saturday, where they will decide on a formal recommendation.

Advisors to the U.S. Food and Drug Administration are unanimously recommending that the COVID-19 vaccine be made available to children ages 6 months through 4 years of age. Moderna’s vaccine is currently recommended in two doses spaced four weeks apart, though there was discussion of eventually needing a third dose. Now it’ll be up to the FDA to determine whether to expand authorization of the Pfizer and Moderna vaccines to the younger populations. Dr. Ofer Levy, a voting member, said he was pleased to reach the milestone, nearly 18 months after the first approval of a COVID-19 vaccine for older populations. The risk of severe illness from COVID-19 isn’t as high in children as it is in older individuals, however more than 200 children have died from their infections, according to the FDA.

A pharmaceutical company is voluntarily recalling a nasal spray that works to reduce snoring after the U.S. Food and Drug Administration (FDA) found a microbial contamination.

Specific lots of cheddar, brie and pecorino are among the products potentially tainted with a harmful bacteria.

Specific lots of cheddar, brie and pecorino are among the products potentially tainted with a harmful bacteria.

"The great Peanut Butter shortage of 2022 continues," proclaims theme park eatery in explaining holes in menu.

Americans urged not to eat array of snacks as officials probe salmonella outbreak that has sickened at least 16.

The U.S. Food and Drug Administration and Centers for Disease Control and Prevention said that an outbreak of hepatitis A may be linked to two brands of organic strawberries.

The U.S. Food and Drug Administration and Centers for Disease Control are investigating a link between strawberries sold nationwide in stores such as Walmart and Aldi and hepatitis A. The FDA announced Saturday people should not eat, serve or sell FreshKampo or H-E-B brand organic strawberries if they were purchased between March 5 and April 25th. “Currently, the potentially affected FreshKampo and HEB products are past shelf life. People who purchased FreshKampo and HEB fresh organic strawberries between March 5, 2022, and April 25, 2022, and then froze those strawberries for later consumption should not eat them,” the USDA said. Hepatitis A is a contagious disease that can cause liver damage and can be caused by consuming contaminated food or water.

Americans urged not to eat an array of sandwiches, treats and snacks after salmonella sickens 16 people in 12 states.

Congressman Fred Upton is eager for the baby formula plant in his district to be up and running again. Upton, R-St. Joseph, relayed his sense of urgency after touring the Abbott Nutrition facility Wednesday, May 25. The tour came as the country faces a shortage of baby formula worsened by the closure of the factory. Abbott Nutrition’s Michigan formula plant, the largest in the U.S., has been closed since February due to contamination problems. Related: Can’t find baby formula?

Members of Congress began a House subcommittee hearing Tuesday by accusing north suburban-based Abbott Laboratories of negligence

Americans urged not to eat an assorted treats and snacks amid a multistate salmonella outbreak that's sickened 14.

Americans urged not to eat an assorted treats and snacks amid a multistate salmonella outbreak that's sickened 14.

Parents hoping to get their youngest children vaccinated against COVID-19 have some encouraging news.

The U.S. Food and Drug Administration, along with Centers for Disease Control and Prevention, and others have been investigating a multistate outbreak of salmonella senftenberg infections and they are linked to a product so many of us enjoy daily.

Republicans argued that the plan didn't force federal agencies to look for formula that could be redirected to U.S. homes immediately.

The U.S. Food and Drug Administration (FDA), has announced expanded approval for Pfizer-BioNTech's COVID-19 vaccine booster shot.

The U.S. Food and Drug Administration has granted emergency use authorization for a booster dose of Pfizer/BioNTech's COVID-19 vaccine for children ages 5 to 11 at least five months after completion of the primary vaccine series.

Abbott has entered into a consent decree with the FDA, which must still be approved in court

Abbott could have some of its formulas back in stores in eight to 10 weeks after FDA approval, but it's not clear when that will come.

Marlboro-maker Philip Morris International confirmed Wednesday a $16 billion bid to buy rival Swedish Match as part of its accelerated push into smoke-free tobacco alternatives.

At retailers across the U.S., 40% of the top-selling baby formula products were out of stock as of late last month.

At retailers across the U.S., 40% of the top-selling baby formula products were out of stock as of late last month.

Federal regulators are limiting the use of Johnson & Johnson’s COVID-19 vaccine to cases where mRNA vaccines aren’t an option. An exception will be made if an adult elects to receive the J&J shot and would otherwise not receive a COVID-19 vaccine. After further review by the CDC’s advisory committee, and time for physicians to learn how to treat the condition, regulators allowed use of the Johnson & Johnson vaccine to resume. Among them, 393,366 residents received a Johnson & Johnson shot, including only 10,221 since Jan. 1. Spring surge pushes beyond metro Detroit: Michigan COVID data for Thursday, May 5Fire Watch issued for parts of Michigan with warm, dry weekend ahead

The chances of dying following after receiving the Janssen vaccine is about 1:2,000,000. But with multiple COVID-19 vaccines available, the FDA is limiting the use of the J&J vaccine.

A baby formula maker under investigation by federal agencies for reports of consumer complaints and infant illness will consider distributing some of its products on a case-by-case basis, according to a statement from the US Food and Drug...

The U.S. Food and Drug Administration, U.S. Centers for Disease Control and Prevention and Canadian agencies are investigating an outbreak of norovirus linked to raw oysters harvested in British Columbia, Canada. The CDC reported that there have been more than 100 cases in the United States. The CDC said, “Norovirus is the leading cause of foodborne illness in the United States. However, state, local, and territorial health departments are not required to report individual cases of norovirus illness to a national surveillance system. Each year, there are about 2,500 reported norovirus outbreaks in the United States.

The agency says the proposal has the potential to significantly reduce disease and death from tobacco by "reducing youth experimentation and addiction."

On Thursday, April 28, Moderna announced it had asked regulators at the U.S. Food and Drug Administration to authorize its low-dose COVID-19 vaccine for children younger than 6, according to an AP report. The company submitted data, which it said shows two low-dose shots are safe and effective for babies, toddlers and preschoolers. In Michigan, more than 6.66 million residents have gotten at least one dose of a COVID-19 vaccine, and nearly 5.7 million have completed their initial recommended dosage. If you have any COVID-19 questions that you’d like answered, please submit them to covidquestions@mlive.com to be considered for future MLive reporting. Read more on MLive:59 impacted by COVID outbreaks across Michigan schoolsAfter COVID-19, mRNA vaccines could treat flu, HIV and even cancerMichigan reports nearly 15,000 new COVID cases in last week; hospitalizations up about 20%

The U.S. Food and Drug Administration is investigating Lucky Charms cereal after dozens of consumers complained of illness after eating it. Several hundred people have also posted on a food safety website, iwaspoisoned.com, complaining of nausea, diarrhea and vomiting after eating Lucky Charms. Patrick Quade, founder of the website, told the Wall Street Journal that his site has received about 3,000 reports this year related to Lucky Charms, most of which have come in the past two weeks. General Mills Inc., the Minneapolis-based company that makes Lucky Charms and other cereals, told the Associated Press it’s taking the reports seriously, but added its own investigation has not found evidence of consumer illness related to Lucky Charms. General Mills said it encourages consumers to share their concerns directly with the company, according to the Associated Press.

Morning 4 is a quick roundup of stories we think you should know about to start your day.

Several hundred people have posted on a food safety website complaining of nausea, diarrhea and vomiting after eating Lucky Charms.

General Mills said it encourages consumers to share their concerns directly with the company.

General Mills said it encourages consumers to share their concerns directly with the company.

The U.S. Food and Drug Administration is investigating Lucky Charms cereal after dozens of consumers complained of illness after eating it.

The U.S. Food and Drug Administration is investigating Lucky Charms cereal after dozens of customers complained of illness after eating it. The FDA said Saturday it has received more than 100 complaints related to Lucky Charms so far this year. “The FDA takes seriously any reports of possible adulteration of a food that may also cause illnesses or injury,” the agency said in a statement.

The U.S. Food and Drug Administration has granted emergency use authorization to the first COVID-19 test that spots chemical compounds associated with the coronavirus in breath, the agency said.

Two chocolate products under the brand Kinder are being recalled due to a salmonella contamination concern.

European health officials say it’s too early to consider giving a fourth dose of messenger RNA coronavirus vaccines to most people, but say an extra booster can be administered to people over age 80

Baby Yoda and Mickey Mouse-themed products were sold nationwide at three retail locations, according to FDA notice.

Here, experts address questions for those considering a third or fourth vaccine dose. Previously, the FDA authorized a single booster dose for people with compromised immune systems after they have completed a three-dose primary vaccination series. Results suggest “maximal immunogenicity” is achieved after three doses and antibody levels can be restored by a fourth dose. “If you are 80 and you have hypertension, I’d be running to the pharmacy for the fourth dose. Should I time a booster dose with a big upcoming event or trip?

Shares of Biogen tumbled Wednesday, a day after regulators slapped strict limitations on coverage the drugmaker’s new Alzheimer’s disease treatment.

The bacteria was found during proactive, routine sampling in November. Because the mushrooms have a long shelf-life, MDARD said they could still be in consumer kitchens.

Pharmaceutical company Merck has agreed to allow other drug makers to make its COVID-19 treatment, the first pill that has been shown to be effective against the disease.

Opponents of a COVID-19 vaccine mandate for health care workers in Maine have filed an emergency appeal to the U.S. Supreme Court after being dealt another legal defeat.

The U.S. Food and Drug Administration will ask its outside experts to review Merck's pill to treat COVID-19 at a meeting in late November.

Australia’s capital Canberra has come out of lockdown with authorities reporting more than 99% of the population aged 12 and older having at least one dose of a COVID-19 vaccine.

Here’s what you missed on Local 4 News at 5:

On Monday, the U.S. Food and Drug Administration gave full approval to the Pfizer-BioNTech COVID-19 Vaccine, which will now be marketed as Comirnaty.

Here are this morning's top stories.

The FDA has given its full approval to a COVID-19 vaccine.

The White House announced Friday that Dr. Anthony Fauci, medical advisor to President Joe Biden, said he expects Americans who received the one-dose J&J vaccine against COVID-19 also will be recommended for a booster shot.

The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine.

The acting head of the Food and Drug Administration is calling for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.

Johnson & Johnson says U.S. health officials have extended the expiration date for its COVID-19 vaccine by six weeks.

U.S. regulators have approved the first medicine for patients with the most common type of lung cancer whose tumors have a genetic mutation long considered untreatable with drugs.

On Monday, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

Two of the nation’s largest university systems say they intend to require COVID-19 vaccinations for all students, faculty and staff on University of California and California State University campuses this fall.

Hawaii officials are moving forward with a plan to allow people who have been fully vaccinated against the coronavirus to skip pre-travel testing and quarantine requirements for flights between islands.

The Supreme Court is leaving in place an appeals court decision that upheld Tennessee’s rationing of life-saving hepatitis C drugs to prisoners as constitutional.

State lawmakers are taking actions to limit the emergency powers of governors — not just during the coronavirus pandemic, but for any future emergencies.

The Navajo Nation has issued a stay-at-home order for the weekend after reporting 26 more confirmed COVID-19 cases.

The study, conducted by a team from clinical research company Validcare, aims to help the FDA to determine how to appropriately regulate CBD products.

U.S. regulators have approved the first new drug in over a decade for children with ADHD, which causes inattention, hyperactivity and impulsivity.

Health officials say the first shipments of the Chinese and Russian vaccines will be used in low-income neighborhoods of Mexico City or its suburbs. — Millions of vulnerable U.S. residents will need COVID-19 vaccines brought to them because they rarely or never leave their homes. Johnson & Johnson in December agreed to provide up to 500 million doses of its vaccine to COVAX through 2022. Ad“If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries,” Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels said in a statement. The state health department has scheduled vaccination clinics during the weekend to replace those postponed due to a winter storm.

An associate professor of electrical engineering and computer science at U-M, Fu is the founder of the Archimedes Center for Medical Device Security. The university released the following Q&A with Fu, who discussed the medical device industry and the challenges it faces. Updating legacy medical device software is a huge challenge. A lot of medical device manufacturers have a difficult time grappling with computer security risks. The world needs five-year academic programs that combine biomedical engineering, software engineering and public policy to culminate with a master’s degree.

The U.S. Food and Drug Administration is warning patients and health care providers that a coronavirus test developed by California company Curative may produce false results. (AP Photo/Ted S. Warren, File)LOS ANGELES – Los Angeles will continue using a coronavirus test that federal regulators warned may produce false results while Congress, which has used the same test, is seeking an alternative. He said a third of the city's positive test results have been in asymptomatic people. No test is 100% accurate and even the most sensitive are expected to deliver a small percentage of false results. He wasn’t concerned that bad test results were contributing to the exponential spread of the virus in the county.

OLIVE BRANCH, MISSISSIPPI - DECEMBER 20: Boxes containing the Moderna COVID-19 vaccine are prepared to be shipped at the McKesson distribution center on December 20, 2020 in Olive Branch, Mississippi. CDC has accepted the Advisory Committee on Immunization Practices’ recommendation for use of the second authorized #COVID19 vaccine. Current recommendations: https://t.co/cYJxH31I3F pic.twitter.com/qOQwyASpSG — CDC (@CDCgov) December 20, 2020The CDC accepted the Advisory Committee on Immunization Practices’(ACIP) recommendation for use of the Moderna vaccine on Sunday, Dec. 20. President, American Medical AssociationThe Moderna vaccine began shipping out Sunday, just days after the Food and Drug Administration authorized it for emergency use. Both the Moderna vaccine and the Pfizer shot require individuals receive two doses several weeks apart.

ANN ARBOR, Mich. – The U.S. Food and Drug Administration granted an emergency use authorization for the Moderna COVID-19 vaccine Friday evening, the second vaccine to be authorized in the country. Prior to the authorization, the FDA advisory panel voted 20-0 with one abstention on Thursday to recommend the vaccine. UPDATE: US clears Moderna vaccine for COVID-19, 2nd shot in arsenalDr. A Oveta Fuller, a virologist and viral pathogen researcher at the University of Michigan, voted “No” to recommend the Pfizer vaccine. However, she said she voted “Yes” this time for Moderna. It seemed like their study was set up to meet that at the minimum but it wasn’t set up to do a whole lot else,” Fuller said.

DETROIT – A second COVID-19 vaccine has won backing from the U.S. expert panel, paving way for final FDA decision on emergency use. The approval comes about a week after Pfizer’s vaccine was endorsed. Moderna benefited by going second and was able to address a lot of the issues up front and have the additional data the experts wanted already prepared. The allergy concern is not going away after there’s been two reactions to Pfizer’s vaccine in Alaska and two in the United Kingdom. This is all happening as the Pfizer Vaccine is being given to health care workers across the country, including Local 4′s Dr. Frank McGeorge.

FILE - This undated photo provided by the University of Oxford shows of vial of coronavirus vaccine developed by AstraZeneca and Oxford University in Oxford, England. Trudeau said deliveries could begin within 48 hours of regulatory approval and health officials said they expect to approve use of the Moderna vaccine soon. Canadians began receiving vaccine shots developed by Pfizer and BioNTech on Monday and Trudeau said Canada expects to receive about 200,000 doses from Pfizer next week. The Moderna vaccine was more than 94% effective overall at preventing COVID-19 illness, and 86% effective in people 65 and older. Trudeau noted the Moderna vaccine does not need some of the extra special handling requirements of the one from Pfizer, including ultra cold freezers.

DETROIT – As the first vaccinations are being given to frontline health care workers, many are anxious to know when it will be their turn to receive the vaccine. READ: Answering questions about efficacy of COVID-19 vaccineNot surprisingly, many wanted to get this vaccine Tuesday. How will I know when it’s my turn to get the vaccine? Residency is not an issue, just make sure seniors are eligible for the vaccine in the state you’ll be in when the second dose is due and that it will be available. It was not tested along with any other vaccines and the COVID vaccine itself can trigger a day or two of side effects, so it’s best to delay your shingles vaccine a bit if it would conflict with your turn for the COVID vaccine.

FDA reviewers noted four cases of Bell’s palsy -- a temporary weakening of muscles in the face -- among those that received the vaccine. It is still unknown if this is related to the vaccine or not and -- as of Dec. 16, 2020 -- a prior history of Bell’s palsy is not a contraindication to the vaccine. READ: Answering questions about efficacy of COVID-19 vaccineThe FDA is monitoring closely for more potential cases of Bell’s palsy as more people get the vaccine. Although both vaccines are MRNA vaccines, there are differences in the genetic sequences used and the coating used to get the MRNA into our cells. READ: Answering questions about COVID-19 vaccine efforts in Michigan“Do all hospitalized patients with COVID-19 receive the same care as the president did when he was hospitalized?”With the exception of one medication, yes.

After granting Pfizer’s emergency use authorization request for its coronavirus vaccine, the FDA addressed some of the public’s major concerns regarding the vaccine during a news conference Saturday. We want to know: What concerns or reservations do you have about coronavirus vaccines? Following the Pfizer vaccine’s authorization on Dec. 11, Michigan officials have outlined how the vaccine will be distributed in the state in the coming months. Due to limited quantities of and high demand for a COVID-19 vaccine, states are planning to administer the vaccinations in multiple phases, prioritizing individuals who are at greater risk. Read more: Michigan officials: COVID vaccine to be distributed in 4 phases, prioritize frontline workersRelated news

DETROIT – In a rare weekend press conference, the U.S. Food and Drug Administration (FDA) -- who is responsible for authorizing widespread use of Pfizer’s coronavirus vaccine on Friday -- discussed some of people’s biggest concerns about the vaccine. Following a rapid development and review process, many people still have questions about who is safe to receive the COVID-19 vaccine. Touching on topics of allergic reactions, age and pregnant and breastfeeding women, FDA officials say they are confident in the safety of the vaccine, but encourage some individuals to consult with their physician before receiving the shots. WATCH Local 4 News at 11Metro Detroit weather: Going from mild to chilly, Saturday eveningAfter highs in the 50s, temperatures plummet through Saturday night. It will be mostly cloudy and colder, with overnight lows in the low 30s.

The FDA granted emergency use for the vaccine produced by Pfizer Inc. and its German partner BioNTech. Friday’s threat marked the latest attempt by the Trump administration to override government scientists working to combat the deadly pandemic. “Get the dam vaccines out NOW, Dr. Hahn,” Trump tweeted Friday. Hahn told The Associated Press earlier this week that his agency had already teed up authorization by prefilling all the necessary legal paperwork. “We’re doing everything we can to cut down on the red tape, which I think is really important,” Hahn told the AP.

This October 2020 photo provided by Pfizer shows freezers set up in a warehouse in Kalamzoo, Mich., in preparation for distribution of the company's coronavirus vaccine. ___THE VIRUS OUTBREAK:The White House is pressuring the FDA chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of the day. Andrew Cuomo has reinstated indoor dining restrictions indefinitely in New York City in an effort to limit the increase in coronavirus cases and hospitalizations. Michigan’s health department argues the teaching restriction is necessary to control the spread of the coronavirus, especially after Thanksgiving gatherings. State Health Department officials on Friday confirmed 513 new cases of the coronavirus.

If approved, shots could begin within days for health care workers and people in nursing homes. Shots would then begin for health care workers and nursing home residents. ___CANBERRA, Australia — Australian researchers say they have abandoned development of a potential coronavirus vaccine because it produced false positive results on HIV tests. A health ministry statement says the government will first vaccinate health care workers, particularly those who deal with COVID-19 cases. ___HONOLULU — Hawaii expects to receive 80,000 doses of coronavirus vaccine in December for health care workers and residents of long-term care facilities.

Hong Kong on Wednesday reported an additional 100 cases, bringing its two-week total to 1,274. Hong Kong has reported a total of 7,075 confirmed cases since the start of the pandemic, with 112 deaths. The Texas Department of State Health Services also said 9,028 people were hospitalized across the state. Since late November, the new daily cases have soared past 10,000 on several days, with 15,103 new cases reported Tuesday, according to state health officials. ___BOISE, Idaho — Idaho public health officials abruptly ended a meeting Tuesday evening after the Boise mayor and chief of police said intense anti-mask protests outside the health department building — as well as outside some health officials’ homes — were threatening public safety.

Scientists with the U.S. Food and Drug Administration (FDA) are working to review two COVID-19 vaccines submitted by drug companies Pfizer and Moderna. Pfizer submitted its application on Nov. 20 for an emergency use authorization to the FDA Center for Biologics Evaluation and Research (CBER). “The safety profile of a vaccine that’s going to be deployed in millions of people has to be incredibly clean,” said Dr. Peter Marks, who directs CBER. “We, as an agency, are one of the last agencies in the world that we still actually get the primary data. We don’t get summary data.”CBER receives raw data on all participants in a vaccine trial, in addition to volumes of information on every aspect of the vaccine.

There were 1,225 new confirmed COVID-19 cases increasing the state total to 60,873. ___WASHINGTON -- Pharmaceutical companies Pfizer and BioNTech will seek emergency government approval for their coronavirus vaccine, as the U.S. aims to begin administering doses by the end of the year. ___LOUISVILLE, Kentucky — Kentucky reported a new daily record of 3,649 coronavirus cases Thursday amid warnings by Gov. He and public health experts are warily watching the number of patients hospitalized with the COVID-19 disease caused by the coronavirus. ___WASHINGTON — Infection disease expert Dr. Anthony Fauci says he “wants to settle” concerns about a coronavirus vaccine as he returns to the White House podium for the first time in months.

In September, the district reported about 13 new coronavirus cases weekly, mostly involving teachers and staff, when it first opened early childhood education classes. ___ST. PETERSBURG, Fla. — Five Florida mayors are expressing concern about the rising number of coronavirus cases in the state, and are urging Gov. But the state’s rolling seven-day average for new coronavirus cases was more than nine times higher Wednesday than it was than when her first order took effect. Officials began instituting local shutdowns in neighborhoods where coronavirus cases were rapidly rising. There were 5,102 cases reported in Minnesota on Wednesday, along with 67 deaths.

The FDA was not involved in Pfizer’s decision to announce its early results and made no announcements of its own. Here’s a look at the process:HOW THE STUDIES WORKPfizer and its German partner BioNTech have enrolled nearly 44,000 people in final testing of their vaccine. Late-stage testing of other vaccine candidates is similar, varying slightly in the number of volunteers and timing. HOW TO TELL SHOTS WORKEvery vaccine study is overseen by an independent “data and safety monitoring board,” or DSMB. The more COVID-19 cases occur in the trial, the better idea scientists will have of just how protective the shots really are.