INSIDER
Panel: Trump staffers pushed unproven COVID treatment at FDA
Read full article: Panel: Trump staffers pushed unproven COVID treatment at FDAA special House panel looking into the government's coronavirus response says the Trump White House tried to pressure U.S. health experts into reauthorizing the drug hydroxychloroquine that had been discredited as a COVID-19 treatment.
FDA allows use of over-the-counter home test for COVID-19
Read full article: FDA allows use of over-the-counter home test for COVID-19This undated photo provided by Ellume shows a self-administered rapid coronavirus at home test kit developed by Australian manufacturer Ellume. U.S. regulators on Tuesday, Dec. 15, 2020, allowed emergency use of the first rapid coronavirus test that consumers can buy without a prescription to test themselves entirely at home. (Ellume via AP)WASHINGTON โ The first home test for COVID-19 that doesn't require a prescription will soon be on U.S. store shelves. U.S. officials Tuesday authorized the rapid coronavirus test which can be done entirely at home. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.
Residents cheer on historic shipment of COVID vaccine from outside Michigan Pfizer plant
Read full article: Residents cheer on historic shipment of COVID vaccine from outside Michigan Pfizer plantPORTAGE, Mich. โ The eyes of the nation are on Portage, a city on Michiganโs west side in Kalamazoo County, just west of Battle Creek. The monumental effort to create a COVID-19 vaccine came together Sunday as the first batches were shipped nationwide. It is the biggest vaccination effort in American history. From Portage, the doses of the vaccine will be kept in temperature safe packages and transported with GPS trackers and U.S. RELATED: What it takes to safely transport Pfizerโs COVID vaccine to hospitalsThe vaccine will be shipped to those on the front lines of the health care industry and nursing home patients.
FDA addresses COVID vaccine concerns in news briefing: What to know
Read full article: FDA addresses COVID vaccine concerns in news briefing: What to knowIn 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. Amid two recent cases of allergic reactions to Pfizerโs coronavirus vaccine in the U.K., FDA officials addressed concerns about individuals with a history of allergic reactions receiving the vaccine. FDA officials said Saturday that theyโve followed that process when reviewing Pfizerโs vaccine, and they feel confident that it is safe for this age group to receive the shots. During Saturdayโs news briefing, officials made it clear that pressure from the White House did not force the FDA to authorize use of the vaccine too early. More: Report: White House to FDA chief: Approve Pfizer vaccine Friday or quitโWeโre going to maintain the integrity of the scientific process,โ Hahn added.
US allows emergency COVID-19 vaccine in bid to end pandemic
Read full article: US allows emergency COVID-19 vaccine in bid to end pandemicThe U.S. is considering a second vaccine, made by Moderna Inc., that could roll out in another week. Friday, Sanofi and GSK announced a months-long delay after early tests showed their vaccine didnโt work well enough in older adults. About 3 million doses of the Pfizer-BioNTech vaccine are expected in the first shipments around the country, according to officials with Operation Warp Speed, the Trump administrationโs vaccine development program. Expected to follow health workers and nursing homes are other essential workers, older adults and people at high risk because of other health problems. If emergency use of Modernaโs vaccine also is authorized, the U.S. expects to vaccinate 20 million people by the end of December.
States will start getting COVID-19 vaccine Monday, US says
Read full article: States will start getting COVID-19 vaccine Monday, US saysTrucks will roll out Sunday morning as shipping companies UPS and FedEx begin delivering Pfizerโs vaccine to nearly 150 distribution centers across the states, said Army Gen. Gustave Perna of Operation Warp Speed, the Trump administrationโs vaccine development program. Initially, about 3 million doses were expected to be shipped nationwide. Perna compared the vaccine distribution effort to D-Day, the U.S.-led military offensive that turned the tide in World War II. The vaccine was timed to arrive Monday so health workers could receive the shots and begin giving them, Perna said. The announcement came after revelations that the White House opted not to lock in an additional 100 million doses of Pfizerโs vaccine for delivery in the second quarter of 2021.
White House threatens FDA chief's job over vaccine approval
Read full article: White House threatens FDA chief's job over vaccine approvalThe 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.
Report: White House to FDA chief: Approve Pfizer vaccine Friday or quit
Read full article: Report: White House to FDA chief: Approve Pfizer vaccine Friday or quitThe Trump administration has ordered the head of the FDA to approve the Pfizer COVID-19 vaccine on Friday -- or to submit his resignation, according to a report from the Washington Post. WaPo reports White House Chief of Staff Mark Meadows on Friday told Stephen Hahn, the commissioner of the Food and Drug Administration, to submit his resignation if the agency does not clear the nationโs first coronavirus vaccine by dayโs end. On Thursday, an FDA advisory panel endorsed widespread use of Pfizerโs coronavirus vaccine, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans. Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committeeโs recommendation. In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and over.
Viral spread: Americans paying the price for Thanksgiving
Read full article: Viral spread: Americans paying the price for ThanksgivingWith some Americans now paying the price for what they did over Thanksgiving, health officials are warning people begging them, even not to make the same mistake during the Christmas and New Year's season. Zana Cooper, a 60-year-old cancer survivor in Murrieta, California, tested positive for COVID-19 after attending a Thanksgiving dinner with her sonโs girlfriendโs family. Cooper learned the following Sunday that he tested positive. Her family started developing symptoms, and seven members tested positive, said Dr. Thomas Farley, Philadelphia's health commissioner. Harry and Ashley Neidig, of Shepherdstown, West Virginia, tested positive for COVID-19 last week.
The Latest: US gives go-ahead for Pfizer coronavirus vaccine
Read full article: The Latest: US gives go-ahead for Pfizer coronavirus vaccineThis 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
Read full article: The Latest: Australia leader to go slow on Pfizer vaccineIf 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.
EXPLAINER: Final steps in US review of COVID-19 vaccine
Read full article: EXPLAINER: Final steps in US review of COVID-19 vaccineWASHINGTON โ Pfizerโs COVID-19 vaccine is entering the final phase of review before the U.S. government decides whether to allow millions to get the shots. The Food and Drug Administration posted a positive review of the Pfizer vaccine on Tuesday and will hold a public hearing on Thursday. A look at the process:FDA REVIEWThe agency's scientific review is a key step โ not just for the U.S. โ but for countries around the world weighing whether to begin using a vaccine. There is no deadline for a ruling, but FDA's Marks said he hoped a decision on the Pfizer vaccine could come by the following week. ___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Instituteโs Department of Science Education.
Pushed to rush, FDA head says feds will get vaccine 'right'
Read full article: Pushed to rush, FDA head says feds will get vaccine 'right'Hahn remains FDA Commissioner.โHahn said the FDA will thoroughly review each vaccine before making it available to the public. The White House did not respond to requests for comment about the meeting with Hahn and his future at the agency. But more recently, Hahn has resisted White House pressure, including for hasty vaccine approval. In October, Hahn published strict FDA safety guidelines that effectively closed the door on Trumpโs goal of delivering a vaccine by Election Day. Meanwhile, the administration has invited leading vaccine manufacturers, distributors and others to a โvaccine summitโ next week.
FDA publishes vaccine guidelines opposed by White House
Read full article: FDA publishes vaccine guidelines opposed by White HouseIn the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines. On Monday Trump said vaccines are coming โmomentarily,โ in a video recorded after he returned to the White House. The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.
Health officials testify science, integrity will guide COVID-19 vaccine process
Read full article: Health officials testify science, integrity will guide COVID-19 vaccine processRELATED: Whatโs a realistic timeline for a COVID-19 vaccine? โThe FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families,โ said FDA commissioner Stephen Hahn. Hahn went on to say that the decision to approve a vaccine or treatment will be made by the FDA after a thorough review process. โWe believe very much that asymptomatic transmission is an important part of the transmission cycle of this virus,โ Redfield said. RELATED: Why did CDC director say masks are more of a guarantee against COVID-19 than a vaccine?
US experts vow โno cutting cornersโ as vaccine tests expand
Read full article: US experts vow โno cutting cornersโ as vaccine tests expandPresident Donald Trump is pushing for a faster timeline, which many experts say is risky and may not allow for adequate testing. FDA Commissioner Stephen Hahn pledged that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly stated standards that it works and is safe. In one of the largest studies yet, Johnson & Johnson aims to enroll 60,000 volunteers to test its single-dose approach in the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. J&Jโs vaccine is made with slightly different technology than others in late-stage testing, modeled on an Ebola vaccine the company created. Going forward, โwe need uniformity throughout the country.โIn a testy exchange, Sen. Rand Paul of Kentucky insisted public health officials were wrong that a lockdown could change the course of the pandemic.
White House faces skepticism over prospects for a vaccine
Read full article: White House faces skepticism over prospects for a vaccine(AP Photo/Hans Pennink, File)Could the U.S. really see a coronavirus vaccine before Election Day? White House spokeswoman Kayleigh McEnany gave assurances Thursday that Trump will not in any way sacrifice safety" when it comes to a vaccine. Still, to some public health experts, the timing smacked of a political stunt by a president facing a tough re-election. I think its almost a certainty, said Ashish Jha, dean of the Brown University School of Public Health. I think its very irresponsible how people are trying to politicize notions of delivering a vaccine to the American people, he told CBS.
Spike in COVID-19 cases reported at colleges in 36 states
Read full article: Spike in COVID-19 cases reported at colleges in 36 statesTens of thousands of coronavirus (COVID-19) cases have been reported on college campuses across the country. Some leaders are pushing testing as an answer, since a safe and effective vaccine is still months away. Three potential vaccines are in phase 3 of human trials in the United States. READ: University of Michigan to carry out phase 3 of COVID-19 vaccine trialThe Food and Drug Administration (FDA) suggests one could be approved before the trials are over. The White House Coronavirus Task Force just warned Iowa that it has the highest rate of cases in the nation.
Second Trump appointee out at FDA amid credibility concerns
Read full article: Second Trump appointee out at FDA amid credibility concernsAn FDA spokesperson confirmed Wednesday that John Wolf Wagner, a political appointee installed by the White House earlier this summer, is no longer heading the agencys office of external affairs. Instead, Heidi Rebello, a longtime FDA career official, has stepped into the position on an acting basis, overseeing all FDA public communications. Miller served just 11 days on the job and helped coordinate the agencys announcement that it had allowed the emergency use of convalescent plasma for COVID-19 patients. During her few days as chief spokeswoman, she defended her credentials, sparred with some reporters on Twitter and pushed back against claims that the FDAs convalescent plasma announcement was influenced by politics. FDA communications adviser Michael Felberbaum stepped into the vacant role Wednesday on an acting basis, according to FDA's statement.
Health agencies' credibility at risk after week of blunders
Read full article: Health agencies' credibility at risk after week of blundersThe credibility of two top public health agencies is on the line after controversial decisions that outside experts say suggest political pressure from the Trump administration. Trump's own factual misstatements about COVID-19 are well documented, but the back-to-back messaging blunders by public health officials could create new damage, eroding public trust in front-line agencies. He also denied political pressure played any role in FDAs decision on convalescent plasma. Events surrounding the FDAs plasma decision resembled the agencys March authorization of hydroxychloroquine, the anti-malaria drug vigorously promoted by Trump. ___Follow Matthew Perrone on Twitter: @AP_FDAwriter___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education.
FDA commissioner says he overstated effects of virus therapy
Read full article: FDA commissioner says he overstated effects of virus therapy(AP Photo/Alex Brandon)WASHINGTON Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma. I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The comparison was not between the number of patients who received plasma and those who got none at all. Lurie said Hahns performance at the press conference undermined his credibility, particularly among FDA staff. On Monday, House Speaker Nancy Pelosi, a Democrat, called Hahn a disappointment and said House committees were looking into FDA actions.
Trump announces plasma treatment authorized for COVID-19
Read full article: Trump announces plasma treatment authorized for COVID-19President Donald Trump speaks, accompanied by Food and Drug Administration Commissioner Dr. Stephen Hahn, center, during a media briefing in the James Brady Briefing Room of the White House, Sunday, Aug. 23, 2020, in Washington. (AP Photo/Alex Brandon)
Johnson & Johnson COVID-19 vaccine effective in animal trials
Read full article: Johnson & Johnson COVID-19 vaccine effective in animal trialsDETROIT โ Another coronavirus vaccine is reporting encouraging results, this time itโs the shot being developed by Johnson & Johnson. Early research published in the journal โNatureโ found it protected primates from COVID-19 with a single dose. The pharmaceutical company said a single dose triggered a strong immune response in the six primates who received it. Johnson & Johnson has already begun phase one and two trials in humans in the United States and Belgium. If a single dose is effective, it would double the number of people who could receive the vaccine.
Mike Pence to visit Raleigh in push for schools to reopen
Read full article: Mike Pence to visit Raleigh in push for schools to reopenVice President Mike Pence, center, gestures as he speaks during a news conference with Food and Drug Administration Commissioner Dr. Stephen Hahn, left, and Florida Gov. Pence was in Florida to mark the beginning of Phase III trials for a coronavirus vaccine. (AP Photo/Wilfredo Lee)RALEIGH, N.C. Vice President Mike Pence will travel to Raleigh on Wednesday morning in a push to encourage more K-12 schools to reopen with entirely in-person instruction. According to an announcement from his office, Pence will join a roundtable discussion highlighting how a private school has worked to safely resume classes. After his visit to Thales Academy, Pence will remain in the Raleigh area to tour NCBiotech, which is conducting Phase 3 clinical trails for a coronavirus vaccine.
Trump still confident in virus test despite false negatives
Read full article: Trump still confident in virus test despite false negativesAbbott is a great test; its a very quick test, Trump said at a Rose Garden event to highlight his administration's efforts to develop a vaccine for the virus. Trump has praised the Abbott test as very quick, very good" and alluded to the tests helping keep him safe. Still, she said, They take any indication of false negatives very seriously," adding that anyone who tests negative but still presents symptoms should consider being tested again. The agency said physicians may need to confirm the results of a negative Abbott test if patients have symptoms of the virus. The Department of Heath and Human Services also paid more than $27.3 million last month for the problematic Abbott tests.