Barefoot workers and cracked floors were found at a factory that made recalled eyedrops, FDA says
U.S. health inspectors found a host of sanitation and manufacturing problems at an Indian plant that recently recalled eyedrops sold in the U.S. The problems include cracked floors, barefoot workers and manipulated testing records.
FDA says it needs more research before deciding to approve nasal spray to treat dangerous allergies
The U.S. Food and Drug Administration declined to approve a nasal spray to treat severe allergic reactions, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen.
FDA warns consumers not to use off-brand versions of Ozempic, Wegovy
The U.S. Food and Drug Administration is warning consumers not to use versions of the popular weight-loss drug used in Ozempic and Wegovy and sold online because they might not contain the same ingredients as prescription products and may not be safe or effective.
Vermont governor signs shield bills aimed at protecting access to medicated abortion
Vermontโs Republican governor has signed abortion and gender affirming shield bills into law that include protecting access to a medication widely used in abortions even if the U.S. Food and Drug Administration withdraws its approval of the pill, mifepristone.
Vermont passes bills aimed at protecting abortion pills
The Vermont Legislature has passed reproductive and gender-affirming health care bills with a late addition aimed at protecting access to a medication widely used in abortions โ even if the U.S. Food and Drug Administration withdraws its approval of mifepristone.
Fauci: Likely those who received J&J vaccine will also be recommended for booster
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.
US expands use of Pfizerโs COVID-19 vaccine, paving way for children as young as 12 to get shots
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.
The Latest: Chinese, Russian vaccines to arrive in Mexico
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. โ 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. AdโIf we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries,โ 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.
University of Michigan professor joins FDA medical device security team
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 masterโs degree.
Congress, LA take divergent paths after COVID test warning
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 โ 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 wasnโt concerned that bad test results were contributing to the exponential spread of the virus in the county.
CDC green-lights Moderna COVID vaccine, distribution begins
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 Practicesโ recommendation for use of the second authorized #COVID19 vaccine. Current recommendations: https://t.co/cYJxH31I3F pic.twitter.com/qOQwyASpSG โ CDC (@CDCgov) December 20, 2020The CDC accepted the Advisory Committee on Immunization Practicesโ(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.
FDA advisory panelist in Michigan explains voting in favor of Moderna COVID-19 vaccine
ANN ARBOR, Mich. โ 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 โNoโ to recommend the Pfizer vaccine. However, she said she voted โYesโ this time for Moderna. It seemed like their study was set up to meet that at the minimum but it wasnโt set up to do a whole lot else,โ Fuller said.
FDA advisory panel votes yes on Moderna vaccine -- Whatโs next?
DETROIT โ 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 Pfizerโs 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 thereโs been two reactions to Pfizerโs 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 4โฒs Dr. Frank McGeorge.
Canada getting 168K Moderna vaccine doses before year end
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.
How you will know when itโs your turn to be vaccinated
DETROIT โ 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 itโs my turn to get the vaccine? Residency is not an issue, just make sure seniors are eligible for the vaccine in the state youโll 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 itโs best to delay your shingles vaccine a bit if it would conflict with your turn for the COVID vaccine.
Do all COVID patients receive the same treatment as the president? Which vaccine is best?
FDA reviewers noted four cases of Bellโs 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 Bellโs 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 Bellโs 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 MichiganโDo all hospitalized patients with COVID-19 receive the same care as the president did when he was hospitalized?โWith the exception of one medication, yes.
What concerns do you have about COVID vaccines?
After granting Pfizerโs emergency use authorization request for its coronavirus vaccine, the FDA addressed some of the publicโs 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 vaccineโs 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
Nightside Report Dec. 12, 2020: FDA officials address COVID vaccine concerns, Michigan Pfizer facility prepares to ship vaccines Sunday
DETROIT โ In a rare weekend press conference, the U.S. Food and Drug Administration (FDA) -- who is responsible for authorizing widespread use of Pfizerโs coronavirus vaccine on Friday -- discussed some of peopleโs 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.
White House threatens FDA chief's job over vaccine approval
The FDA granted emergency use for the vaccine produced by Pfizer Inc. and its German partner BioNTech. Fridayโs threat marked the latest attempt by the Trump administration to override government scientists working to combat the deadly pandemic. โGet the dam vaccines out NOW, Dr. Hahn,โ 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. โWeโre doing everything we can to cut down on the red tape, which I think is really important,โ Hahn told the AP.
The Latest: US gives go-ahead for Pfizer coronavirus vaccine
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 Pfizerโs 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. Michiganโs 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.
The Latest: Australia leader to go slow on Pfizer vaccine
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 โ 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 โ Hawaii expects to receive 80,000 doses of coronavirus vaccine in December for health care workers and residents of long-term care facilities.
The Latest: Hong Kong re-imposes restaurant dining bans
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 โ 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 โ as well as outside some health officialsโ homes โ were threatening public safety.
Hereโs a look at FDAโs COVID-19 vaccine review process
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). โThe safety profile of a vaccine thatโs going to be deployed in millions of people has to be incredibly clean,โ said Dr. Peter Marks, who directs CBER. โWe, as an agency, are one of the last agencies in the world that we still actually get the primary data. We donโt get summary data.โCBER receives raw data on all participants in a vaccine trial, in addition to volumes of information on every aspect of the vaccine.
The Latest: Hawaii imposes new COVID-19 travel restrictions
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 โ 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 โ Infection disease expert Dr. Anthony Fauci says he โwants to settleโ concerns about a coronavirus vaccine as he returns to the White House podium for the first time in months.
The Latest: S Korea begins stronger limits in some areas
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. โ Five Florida mayors are expressing concern about the rising number of coronavirus cases in the state, and are urging Gov. But the stateโs 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.
Testing timeline: Whatโs ahead for COVID-19 vaccines
The FDA was not involved in Pfizerโs decision to announce its early results and made no announcements of its own. Hereโs 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 โdata and safety monitoring board,โ 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.
Court orders FDA to assess environmental impact of GM salmon
NEW YORK โ A federal court judge ordered the U.S. Food and Drug Administration on Thursday to conduct an environmental assessment of genetically modified salmon that he said was required for the agencyโs approval of the fish. The ruling by U.S. District Court Judge Vince Chhabria in San Francisco centers on AquaBountyโs salmon, which are genetically modified to grow faster than normal salmon. In 2015, the fish became the first genetically modified animal approved for human consumption in the U.S. After clearing other regulatory hurdles. Aquabounty fish are Atlantic salmon injected with DNA from other fish species that makes them grow faster. The salmon already has been sold in limited quantities in Canada, where it doesnโt have to be labeled as genetically modified, the company has said.
Lilly antibody drug fails in a COVID-19 study; others go on
U.S. government officials are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalized with COVID-19 because it doesnโt seem to be helping them. Independent monitors had paused enrollment in the study two weeks ago because of a possible safety issue. In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness. The company also is continuing its own studies testing the drug, which is being developed with the Canadian company AbCellera. Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs for COVID-19 while late-stage studies continue.