Antony J. Blinken, Secretary of State
On behalf of the Government and people of the United States of America, I extend my warmest congratulations to the people of Belize on the momentous occasion of the 40th anniversary of your independence.
The United States joins the people of Belize in celebrating the accomplishments your country has achieved over the past four decades of independence. Our nations are bound by a strong friendship and partnership, safeguarded by our mutual commitment to democracy, security, and joint prosperity. We continue to stand with Belize in facing shared challenges such as the COVID-19 pandemic, transnational organized crime, and the climate crisis.
As you celebrate your 40th Independence Day, may the bond between our nations continue to be an example of what is possible through partnership between vibrant democracies with shared values and common goals.
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Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021 As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna's and Pfizer/BioNTech's vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Technology readiness. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events. Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS's accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including: Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS's Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities. Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production. Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. 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. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or email@example.com or firstname.lastname@example.org.[Read More…]
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The average amount Education awarded per school was about $1.3 million, while amounts schools received ranged from less than $2,000 to more than $27 million, with half of schools receiving awards of $422,000 or less. Education data show that, as of November 2020, schools had drawn down about 90 percent—or $5.6 billion—of their HEERF student aid funds. About 70 percent of schools had drawn down all of their student aid funds, and an additional 24 percent of schools had drawn down at least half. Department of Education’s Higher Education Emergency Relief Fund (HEERF) Awards to Schools for Emergency Student Aid under the CARES Act, by School Sector Notes: Schools of less than 2 years are included in the 2-year school categories above. The Department of Education also awarded about $24 million to 2-year private, nonprofit schools and about $1.7 million to the Commonwealth of Puerto Rico Department of Education. Sector-level figures do not add up to $6.19 billion because of rounding. Schools used a variety of approaches to determine student eligibility and distribute funds to students. According to GAO’s analysis of a sample of school websites and data from Education, schools had distributed approximately 85 percent of all emergency student aid funds by fall 2020, with an average amount per student of about $830. Determining student eligibility. Approximately half of schools reported that they required a completed Free Application for Federal Student Aid (FAFSA)—the form used to apply for federal financial aid—to determine student eligibility for HEERF student aid. For example, one school reported requiring students who did not have a FAFSA on file to complete one by June 2020 to be eligible for student aid. Other schools did not require a FAFSA to establish eligibility, according to their websites, but reported using alternative methods. For example, a 4-year public school reported that graduate students applying for emergency aid had the option of submitting a school-provided affidavit certifying they were eligible to receive federal financial aid, an option described in Education’s interim final rule on student eligibility. Awarding funds to students. Schools reported using two main methods for awarding HEERF emergency student aid to students: requiring students to complete a school-developed application or using existing school records. Approximately 18 percent of schools used a combination of both methods. For example, a 4-year nonprofit school reported on its website that it awarded $300 to $500 to eligible students in its first round of funding based on existing student financial aid records, and then allowed students who had more expenses related to COVID-19 to apply for additional funding. Determining award amounts. Schools reported using various factors to determine award amounts for HEERF-eligible students. Over half of schools reported on their websites that amounts were based on individual circumstances, such as students’ general financial need, access to essential items such as food or housing, or a combination of these factors. About 20 percent of schools also reported using full-time or part-time status to determine aid amounts. For example, a 4-year public school reported that it distributed grants, ranging from $150 to $1,000, to all eligible students based on their enrollment status and financial need based on students’ FAFSA information. Why GAO Did This Study In June 2020, GAO issued the first of a series of reports on federal efforts to address the pandemic, which included a discussion of HEERF student aid grants to schools. At that time, limited information on how schools distributed HEERF funds to students was available. This report provides additional information and examines (1) how HEERF emergency student aid funds were provided to schools under the CARES Act, and (2) how schools distributed emergency student aid to eligible students. GAO analyzed Education’s obligation data as of November 2020, after Education had obligated most of the HEERF emergency student aid funds. GAO also analyzed information about HEERF student aid that Education requires schools to report on their websites by selecting a generalizable random sample of 203 schools for website reviews. These schools were representative of the more than 4,500 schools that received HEERF student aid funds as of August 2020. GAO also collected non-generalizable narrative details about how schools distributed funds to eligible students.[Read More…]
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