A 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.

The former head of the Food and Drug Administration says there is a strong case for restructuring the agency to shield it from outside pressure.

This 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 – 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.

PORTAGE, Mich. – The eyes of the nation are on Portage, a city on Michigan’s 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 Pfizer’s COVID vaccine to hospitalsThe vaccine will be shipped to those on the front lines of the health care industry and nursing home patients.

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. Amid two recent cases of allergic reactions to Pfizer’s 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 they’ve followed that process when reviewing Pfizer’s vaccine, and they feel confident that it is safe for this age group to receive the shots. During Saturday’s 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 quit“We’re going to maintain the integrity of the scientific process,” Hahn added.

The 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 didn’t 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 administration’s 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 Moderna’s vaccine also is authorized, the U.S. expects to vaccinate 20 million people by the end of December.

Trucks will roll out Sunday morning as shipping companies UPS and FedEx begin delivering Pfizer’s vaccine to nearly 150 distribution centers across the states, said Army Gen. Gustave Perna of Operation Warp Speed, the Trump administration’s 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 Pfizer’s vaccine for delivery in the second quarter of 2021.

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.

The 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 nation’s first coronavirus vaccine by day’s end. On Thursday, an FDA advisory panel endorsed widespread use of Pfizer’s 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 committee’s 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.

With 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 son’s girlfriend’s 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.

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.

WASHINGTON – Pfizer’s 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 — not just for the U.S. — 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 Institute’s Department of Science Education.

Hahn remains FDA Commissioner.”Hahn 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 Trump’s goal of delivering a vaccine by Election Day. Meanwhile, the administration has invited leading vaccine manufacturers, distributors and others to a “vaccine summit” next week.

In 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 “momentarily,” 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.

RELATED: What’s a realistic timeline for a COVID-19 vaccine? “The FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families,” 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. “We believe very much that asymptomatic transmission is an important part of the transmission cycle of this virus,” Redfield said. RELATED: Why did CDC director say masks are more of a guarantee against COVID-19 than a vaccine?

President 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&J’s vaccine is made with slightly different technology than others in late-stage testing, modeled on an Ebola vaccine the company created. Going forward, “we need uniformity throughout the country.”In a testy exchange, Sen. Rand Paul of Kentucky insisted public health officials were wrong that a lockdown could change the course of the pandemic.

(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.

Tens 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.

An 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.

The 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.

(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.

President 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)

DETROIT – Another coronavirus vaccine is reporting encouraging results, this time it’s the shot being developed by Johnson & Johnson. Early research published in the journal “Nature” 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.

Vice 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.

Abbott 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.