A report released yesterday by the US Government Accountability Office (GAO) says supply chain issues could interfere with a smooth rollout of a COVID-19 vaccine and that the Food and Drug Administration (FDA) should disclose scientific review of vaccine and drug efficacy and safety data when issuing emergency use authorizations (EUAs). However, GAO investigators said they are cautiously optimistic about the future of vaccine distribution under the Biden administration. GAO remains deeply troubled by the lack of sufficient federal action on critical gaps identified and by the lack of clear plans to address these gaps. However, the companies have not publicly published peer-reviewed data on the final stage clinical trial research and been criticized for a lack of transparency. The chairman of the Committee on Homeland Security, a key leader in the pandemic response plan, took the release of the GAO report as an opportunity to criticize the Trump administration. Researchers in Britain are studying a possible combination of Pfizer-BioNTech and the AstraZeneca vaccine. The GAO report highlights an issue that has dogged Gilead over the past year, as the company raked in profits for remdesivir, sold under the brand name Veklury. Beijing has yet to approve any foreign vaccines for use in mainland China. Daunte Wright: Night of peaceful protests ends in fence breach, arrest. Chinese vaccines' effectiveness low: Report; Chinese vaccines’ effectiveness low: Report Chinese vaccines “don’t have very high protection rates,” said the director of the China Centers for Disease Control, Gao Fu, at a conference Saturday in the southwestern city of Chengdu. WASHINGTON, Feb. 2 (UPI) -- The federal government has "critical gaps" in its COVID-19 vaccine distribution and vulnerabilities in the nation's supply chain are "deeply troubling," according to a recent Government Accountability Office report. In today’s report, we reiterate some of our previous recommendations, while also making 13 new ones that focus on improving vaccine distribution, creating a national testing strategy, improving data for tracking COVID cases and the impacts on communities, and … The report found that only four of the 31 recommendations it requested of the Trump administration were implemented. But when it comes to manufacturing enough vaccines to meet the need, timelines can’t be compressed, especially when manufacturing facilities and supplies are limited. Chinese state media and popular health and science blogs also questioned the safety and effectiveness of the Pfizer-BioNTech vaccine, though large-scale trials and the rollout of the vaccines in the U.S. have established its safety. He was quoted by the official Xinhua News Agency as saying in December he couldn’t rule out negative side effects because they were being used for the first time on healthy people, saying “there is a safety concern.”. Chilly air, which has gripped the central United States all week, will be reinforced by another shot of cold weather early next week, forecasters said Saturday. End-to-end supply chain data and strategy In a rare admission of the weakness of Chinese coronavirus vaccines, Gao the country's top disease control official says their effectiveness is low and the government is considering mixing them to give them a boost. April 17 (UPI) -- Indianapolis police have identified the eight victims of Thursday night's FedEx shooting. A healthcare professional prepares syringes to deliver COVID-19 vaccinations in New York City. This report examines, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA’s use of EUAs for COVID- 19 therapeutics and vaccines, among other objectives. Police identify 8 people killed in Indianapolis FedEx shooting. In the report released Thursday, the GAO… GAO highlights key steps the Biden Administration has taken to help improve vaccine distribution. Gao Fu, CDC head, told a conference on Saturday that the agency was “considering how to solve the problem that the efficacy of existing vaccines is not high”, according to local media. In February, we released an online dashboard that provides an interactive view of vaccine development data. But another CDC official said Chinese developers are working on mRNA-based vaccines. On his first day in office, President Joe Biden signed an executive order calling for the evaluation of the nation's emergency supply inventory. HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is not high and may require improvements. China currently has five vaccines in use in its mass immunization campaign, three inactivated-virus vaccines from Sinovac and Sinopharm, a one-shot vaccine from CanSino, and the last from Gao’s team in partnership with Anhui Zhifei Longcom. Sinovac’s vaccine, for example, raised concerns when it was found to have different efficacy rates from each of the trials it conducted in different countries, ranging from around 50% to over 83%. The Sinovac spokesman, Liu, said studies find protection “may be better” if time between vaccinations is longer than the current 14 days but gave no indication that might be made standard practice. Global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to an urgent race to develop a vaccine. Gao Fu, director of the China Centers for Disease Control, speaks at the National Vaccines and Health conference in Chengdu in southwest China's Sichuan province Saturday, April 10, 2021. He also praised the benefits of mRNA vaccines, the technology behind the two vaccines seen as the most effective, Pfizer-BioNTech and Moderna, months after questioning whether the then-unproven method was safe. Copyright © 2021 United Press International, Inc. All Rights Reserved. The shot from Gao’s team, was given emergency use approval a month ago, and has not publicly disclosed data yet about its efficacy. He directed the AP to an interview he did with the state-owned Global Times, which has published several articles raising doubts about the safety of Pfizer’s mRNA vaccine. Gao Fu, the director of China's Centers for Disease Control, said the COVID-19 vaccines developed in the country 'don't have very high protection rates.' The GAO report said the Department of Veterans Affairs should resume inspections of more than 150 state veterans’ homes that house 20,000 veterans. As of January, 27 of GAO’s … This report examines, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID-19 therapeutics and vaccines, among other objectives. Chinese COVID-19 vaccine effectiveness 'not high,' government exploring options: officials CDC director Gao Fu urged China to explore mRNA treatments In the report released Thursday, the GAO, a nonpartisan investigative arm of Congress, provided an additional 13 requests to optimize the pandemic response plan in the upcoming months, specifically focusing on increasing public transparency and consistent communication between Congress and state and local stakeholders. Sales of the drug reached $1.9 billion in the fourth quarter alone, and Gilead estimates about half of all patients hospitalized with COVID-19 are treated with it. Gao was quoted by the outlet Sunday as saying he was misunderstood and merely talking in general terms about improving vaccine efficacy. China has distributed hundreds of millions of doses of domestically made vaccines abroad and is relying on them for its own mass immunization campaign. Although the media continue to praise Biden for his development and deployment of the COVID-19 vaccine, Levin cited a Government Accountability Office (GAO) report that suggested otherwise, giving former President Donald Trump's Operation Warp Speed a "sterling review." “The mRNA vaccines developed in our country have also entered the clinical trial stage,” said the official, Wang Huaqing. For example: GAO’s report states: “On January 26, 2021, the White House announced that the federal government would begin providing states, Tribes, and territories with reliable vaccine allocation estimates 3 weeks in advance – instead of the one-week look-ahead they had been receiving – to give state and … Stakeholders GAO interviewed identified challenges with initial COVID-19 vaccine implementation. The US Government Accountability Office (GAO) yesterday published a report calling for actions such as increasing transparency in COVID-19 vaccine and treatment development and meeting states' needs for scarce medical supplies. “Before the COVID-19 pandemic, most existing vaccine manufacturing capacity was already in use,” according to the GAO report. “We must follow it carefully and not ignore it just because we already have several types of vaccines already.”, Gao previously questioned the safety of mRNA vaccines. Still, they add, "GAO is pleased that the Consolidated Appropriations Act, 2021—enacted in December of 2020—requires a number of actions that are consistent with several of GAO's prior recommendations, including those related to the medical supply chain, vaccines and therapeutics, and COVID-19 testing." Biden has not yet announced a nominee for HHS assistant security of preparedness and response, a division of the Department of Health and Human Services that plays a critical role in pandemic response. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. He gave no timeline for possible use. "Its inaction to address critical weaknesses that GAO previously identified, including developing clear and comprehensive plans for testing and vaccine distribution, likely cost lives and created an even bigger mess for the new administration," Rep. Benny Thompson, D-Miss., said in a written statement. GAO reviewed federal laws and agency documents, including HHS and DOD information on vaccine and therapeutic development and EUAs as of November 2020. Globally, public health experts have said that any vaccine that is 50% effective would be useful, and many governments have been eager to use Chinese vaccines as rich countries around the world have snapped up shots from Pfizer and Moderna. However, GAO investigators said they are cautiously optimistic about the future of vaccine distribution under the Biden administration. We released a report that looks at how the vaccine companies accelerated and combined some steps in the development process to meet unprecedented timeframes. The effectiveness of the vaccines range from just over 50% to 79%, based on what the companies have said. A convoy received a new shipment of anti-COVID-19 vaccine containing 200,000 doses of the Sinovac vaccine provided by the People's Republic of China as a gift to the Republic of Tunisia, as part of the decades-long health cooperation between the two countries at Tunis Carthage International Airport, Tunis, Tunisia, March 25, 2021. (Chinatopix Via AP), Connect with the definitive source for global and local news. https://www.factcheck.org/2021/02/bidens-misleading-vaccine-boasts "It's now under formal consideration whether we should use different vaccines from different technical lines of the immunization process," … While recent actions have brought glimpses of hope, officials and experts still express concerns about transparency and public confidence in the vaccine process. April 17 (UPI) -- The Department of Justice filed a lawsuit Friday against political strategist Roger Stone for almost $2 million in unpaid taxes. GAO analyzed the readiness of each company’s vaccine technology. China is “formally considering” options to change its vaccines to “solve the problem that the efficacy of the existing vaccines is not high,” Gao said at a conference in Chengdu. WHO Director General Tedros Adhanom Ghebreysus said Friday that while one in four people in rich countries had received a vaccine, only one in 500 people in poorer countries had gotten a dose. "None of this is able to be done by one entity," Denigan-Macauley said. A Government Accountability Office (GAO) review of COVID-19 vaccine development efforts found that vaccine producers are facing significant manufacturing hurdles as they scale up operations. As the new Congress and administration establish their policies and priorities for the federal government’s COVID-19 response, GAO urges swift action on these 13 recommendations, as well as the 27 of the agency’s 31 prior recommendations that have not been implemented from our June, September, and November 2020 CARES Act reports, and our November 2020 report on vaccines and therapeutics. The president also announced last week that the number of overall vaccine doses distributed weekly to states, tribes and territories will increase from 8.6 million to at least 10 million. "This is going to allow millions of more Americans to get vaccinated sooner than previously anticipated. GAO was asked to review OWS vaccine development efforts. CDC Director denies reports claiming that the director "admitted" Chinese COVID-19 vaccines have a low protection rate. “Everyone should consider the benefits mRNA vaccines can bring for humanity,” Gao said. Finally, GAO will review actions federal agencies have taken in response to the American Rescue Plan of 2021 in future reporting. April 17 (UPI) -- The U.S. Consumer Product Safety Commission warned users with small children and pets Saturday to stop using Peloton Tread+ devices after a child death and injuries. In a message to The Associated Press, Gao said late Sunday night he was speaking about the effectiveness rates for “vaccines in the world, not particularly for China.” He did not respond to further questions about which vaccines he was referring to. Gilead Sciences' antiviral remdesivir quickly rose to the top of treatment guidelines as the pandemic spiraled out of control last year. COVID-19 continues surge in Mich., Colo.; Schools cited in Maine outbreaks. West Point expels 8 cadets, holds more than 50 back a year in cheating scandal. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. States also will be given an estimate of the number of incoming vaccine doses three weeks in advance rather than one week. This story has been corrected to show that Chinese vaccines were donated or exported to several dozen countries, not 22, and that Sinovac is a private company, not state-owned. The vaccines "don't have very high protection rates," Gao reportedly said Saturday at a conference in Chengdu. Forecasters: Central U.S. will plunge back into winter next week. Gao concluded his presentation Saturday with praise for mRNA vaccines and called for innovation in research. So that when it comes down to where we have an extreme hesitancy in the vaccine uptake, that will improve," Denigan-Macauley said. April 17 (UPI) -- The U.S. Coast Guard said it's recovered four bodies from a commercial vessel that capsized off the Louisiana coast earlier this week, but nine remain missing. BEIJING (AP) — China’s top disease control official, in a rare acknowledgement, said current vaccines offer low protection against the coronavirus and mixing them is among strategies being considered to boost their effectiveness. GAO’s prior work has found that timely, clear, and consistent communication about vaccine availability is essential to ensure public confidence and trust, especially as initial vaccine implementation did not match expectations. The report found that only four out of the 31 recommendations it requested of the Trump administration were implemented. But the director of the Chinese Center for Disease Control and Prevention, Gao Fu, said at a conference Saturday their efficacy rates needed improving. And we feel it's critically important that was disclosed and we hope that the new administration will take that seriously," Mary Denigan-Macauley, director of healthcare at the GAO, said. April 17 (UPI) -- The sixth night of demonstrations over the fatal police shooting of Daunte Wright near Minneapolis was peaceful until protesters breached security fences, prompting arrests, officers said. GAO is also examining the federal government’s COVID-19 vaccine efforts, which will be the focus of an upcoming report. Biden administration walks back refugee cap plans after blowback. "These sites need to have clear and predictable supply schedules," Yadav said. “It’s now under consideration whether we should use different vaccines from different technical lines for the immunization process.”. Experts say mixing vaccines, or sequential immunization, might boost effectiveness. Experts say mixing vaccines, or sequential immunization, might boost effectiveness. This action is "simple, but very powerful," said Prashant Yadav, a lecturer on global health and social medicine at Harvard University. For example, a clear and comprehensive vaccine distribution plan remains a work in progress. April 17 (UPI) -- West Point has expelled eight cadets and held back more than 50 for a year after completing its investigation into cheating on a remote learning May calculus exam. Death toll increases to 4 in capsized boat near Louisiana; 9 missing. Beijing earlier tried to promote doubt about the effectiveness of the Pfizer-BioNTech vaccine, which uses genetic code called messenger RNA, or mRNA, to prime the immune system. The coronavirus pandemic, which was first detected in central China in late 2019, marks the first time the Chinese drug industry has played a role in responding to a global health emergency. Gao's remarks are a rare public admission from the country's top health official that the efficacy of China's coronavirus vaccines is not ideal -- and improvements are needed to boost protection. "In our mind, it's not sufficient. “We will solve the issue that current vaccines don’t have very high protection rates,” Gao said in a presentation on Chinese COVID-19 vaccines and immunization strategies at a conference in the southwestern city of Chengdu. Chinese Centers for Disease Control and Prevention Director Gao Fu is walking back comments he made about the country's COVID-19 vaccines. The report found that only four of the 31 recommendations it requested of the Trump administration were implemented. Gao also rejected claims by some media reports that he said Chinese COVID-19 vaccines have a low protection rate, telling Global Times that it was “a … Those inspections were halted in March. After the evaluation, appropriate federal action will be taken to fill any gaps in the stockpile, including possible use of the Defense Production Act, he said. As of April 2, some 34 million people in China have received the full two doses of Chinese vaccines and about 65 million received one, according to Gao. A Sinovac spokesman, Liu Peicheng, acknowledged varying levels of effectiveness have been found but said that can be due to the age of people in a study, the strain of virus and other factors. Health officials at a news conference Sunday didn’t respond directly to questions about Gao’s comment or about possible changes in official plans. April 17 (UPI) -- Coronavirus case counts continued to spike in Michigan and Colorado Friday and Maine health officials said schools account for nearly 70% of the state's active COVID-19 outbreaks. Researchers in Britain are studying a possible combination of Pfizer-BioNTech and the AstraZeneca vaccine. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. The Department of Health and Human Services also expanded the number of healthcare officials authorized to administer the vaccine. The GAO emphasized that executing an efficient and effective vaccine distribution plan will require cooperation across many federal and local agencies. Pfizer and Moderna’s vaccines, which are primarily being used in developed countries, have both been shown to be about 95% in protecting against COVID-19 in studies. He said it will build confidence in the officials at individual vaccine sites. U.S. safety group warns users with small children to stop using Peloton Tread+. GAO was asked to review OWS vaccine development efforts. Photo by John Angelillo/UPI |, DOJ lawsuit claims Roger Stone owes $2M in back taxes. Vaccines made by Sinovac, a private company, and Sinopharm, a state-owned firm, have made up the majority of Chinese vaccines distributed to several dozen countries including Mexico, Turkey, Indonesia, Hungary, Brazil and Turkey. April 16 (UPI) -- The Biden administration backtracked Friday after initially saying it planned to maintain the existing cap of 15,000 on refugee admissions. Israel sends shipment of COVID-19 vaccines to Palestinian Authority, U.S. reaches 31 million vaccine doses administered, Pentagon halts plan to vaccinate Guantanamo Bay detainees. "Being transparent about every aspect of this pandemic response is key in having faith in the federal government. We got a long way to go, though," Biden said last week. Gao et al. Demonstrators protest police violence in Portland, Ore., Oakland, Calif. April 17 (UPI) -- Residents and business owners in Portland, Ore., and Oakland, Calif., were assessing damages Saturday after protests against police misconduct turned violent in the two cities. Gao Fu, head of the Chinese Centres for Disease Control and Prevention, on Saturday said at a conference the current vaccines "don't have very high rates of protection". Gao concluded his presentation Saturday with praise for mRNA vaccines and called for innovation in research. Prince Philip laid to rest in St. George's Chapel, Iran names suspect in Natanz facility blast, issues arrest warrant. 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