US Government Drug Agency Considering Stricter New Guidelines on Approval for COVID-19 Vaccine

Volunteers planted 20,000 miniature U.S. flags on the grounds of the Washington Monument in the nation’s capital Tuesday, the day the nation reached 200,000 COVID-19 deaths. Each flag represented 10 victims who have perished since the virus first arrived in the U.S. earlier this year.   During an interfaith religious service held at the Monument to mark the grim occasion, House Speaker Nancy Pelosi said the high death toll was “preventable” and urged the nation to embrace science to prevent any future losses.   In April, the top U.S. infectious disease expert, Dr. Anthony Fauci, said the death toll would be “more like 60,000,” while U.S. President Donald Trump, who early on minimized the coronavirus as something akin to seasonal flus, in May said the toll could be anywhere from 75,000 to 100,000.     Now, health analysts at the University of Washington say the death toll could reach 410,000 by the end of the year.  The United States has the highest death toll among all nations, but some countries in Europe and Latin America have recorded more deaths per capita.A “promotora” (health promoter) from CASA, a Hispanic advocacy group, tries to enroll Latinos as volunteers to test a potential COVID-19 vaccine, at a farmers market in Takoma Park, Md., on Sept. 9, 2020.In late April, more than 2,000 deaths a day were being recorded in the U.S. Now the figure is close to 800 deaths daily. Medical researchers are trying to develop a coronavirus vaccine and could have approval for a preventative in the coming months. Without one yet, though, and with seasonal colder weather arriving, experts say the daily death toll could increase again.   News outlets say the U.S. Food and Drug Administration is considering a set of stricter new guidelines for the emergency authorization of a potential COVID-19 vaccine.  The proposed new rules would require drug makers to observe participants in late-stage clinical trials for at least two months after they receive a second and final dose of an experimental vaccine.  The guidelines would also look for at least five severe cases of COVID-19 in volunteers who received a neutral version of the vaccine, known as a placebo.   Two pharmaceutical companies that are developing a coronavirus vaccine, Moderna and Pfizer, have only begun administering second doses to their volunteers. If the new rules are adopted, an authorization for a new vaccine would come well after the November 3 presidential election. President Donald Trump has been saying for several weeks that a coronavirus vaccine would be available either in October or right before Election Day.   The FDA and other federal scientific and regulatory agencies have seen their credibility diminished by constant administration efforts to revise their reports and guidelines to maintain Trump’s views about the nature of the pandemic. The United States is experiencing a surge of new coronavirus cases across more than 20 states, with many outbreaks reported at colleges and universities due to returning students failing to observe social distancing guidelines.  The outbreak has also caused chaos for local school districts across the country, with administrators and teachers struggling with either online learning or a combination of online and in-person instruction.  Members of the school board in Miami-Dade County, Florida, the fourth-largest school district in the United States, voted Tuesday to bring back students to the classroom in mid-October. The decision was reached after a non-stop 29-hour meeting that included 18 hours of public testimony from more than 750 people.   Under the plan laid out by Superintendent Alberto Carvalho, students in pre-kindergarten, kindergarten and first grade, plus those with special needs, would return to school on October 14, with the rest of the district’s students coming back on October 21. Miami-Dade’s online-only instruction has been plagued with problems since it began in August, including network outages, software glitches and a cyberattack carried out by a high school student. 

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