- Dr. Anthony Fauci said Wednesday that a recent study into remdesivir had shown positive results in decreasing the time to recovery in COVID-19 patients, though he also noted that it hadn’t shown an ability to decrease the mortality rate.
- Following the release of this information, it’s now being reported that the Food and Drug Administration will likely grant emergency use of the drug.
- Still, health officials are warning that remdesivir is not a miracle drug, though they are optimistic that it can eventually be used in combination with other drugs to create even more efficacious treatments.
FDA Likely To Approve Remdesivir for Emergency Use
White House health advisor Dr. Anthony Fauci announced Wednesday that a clinical trial of the antiviral drug remdesivir showed a “clear-cut positive effect in diminishing time to recovery” for coronavirus patients.
Speaking from the oval office, Fauci said a trial conducted by the National Institutes of Health showed that patients recovered in an average of 11 days if they were on the drug. By contrast, he said it took 15 days for those in the placebo group to recover.
It is also being reported that the Food and Drug Administration is now likely to grant emergency use authorization for remdesivir, which is manufactured by Gilead Sciences.
“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in… discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” FDA spokesperson Michael Felberbaum said in statement.
Though the drug has not yet shown statistically significant decreases in the mortality rate for COVID-19 patients, results from the NIH do suggest survival benefits. According to the NIH, people receiving the drug also saw a mortality rate of 8% as opposed to 11.6% in the placebo group.
As such, health officials aren’t calling remdesivir a miracle treatment; however, it is a hopeful sign that patients might not have to spend as long in the hospital. As Fauci noted, it will also become a standard of care and will guide clinicians in their approach on how to best treat COVID-19, especially since no other treatments have been approved for the disease.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is very important proof of concept,” Fauci said. “What it has proven is that a drug can block this virus.”
Specifically, remdesivir works by blocking enzymes that the SARS-CoV-2 virus needs to be able to replicate. Because of that, future treatments could include a combination of remdesivir and another drug. In fact, the NIH is already moving forward on testing remdesivir with anti-inflammatory drugs.
Fauci called the study “the first truly high-powered randomized placebo controlled trial” and said about 1,090 participated in it internationally.
During his announcement, Fauci noted that the final analyses for this trial have not yet been completed. While he said he would usually hold off on releasing results of such a trial for several more days, he emphasized the importance of shifting placebo groups to the actual drug as quickly as possible.
“Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know so that they can have access,” Fauci said.
The trial was launched in February after the U.S. evacuated and recruited an American patient from the Diamond Princess cruise ship docked in Japan. From there, the NIH expanded the trial by recruiting other COVID-19 patients. For each of those patients, the process involved giving them either the drug or a placebo for five to 10 days.
WHO Says It’s Too Early to Comment on Remdesivir
The World Health Organization seemed to restrain some of the expectations of remdesivir’s success on Wednesday.
“Typically, you don’t have one study that will come out that will be a game changer,” said Dr. Maria Van Kerkhove, the WHO’s technical lead for the coronavirus response.
Kerkhove then explained that the WHO will generally look at multiple studies before reviewing evidence on a drug’s effectiveness.
“It can sometimes take a number of publications to determine (what) the ultimate impact of a drug is,” Dr. Mike Ryan, executive director of the WHO’s health emergencies program, said.
Other researchers have echoed similar explanations that more research will still need to be conducted with remdesivir as well as other drugs.
“We have work to do. We are looking for other therapies. This trial is going to continue,” said Dr. Andre Kalil told CNN.
Still, Kalli noted that even with that, remdesivir’s currently known benefits are quite significant, especially if patients need a ventilator.
“Four days (fewer) in a hospital is, for me as a clinician—as a clinical practitioner—it is not only significant but very meaningful,” he said.
According to The Washington Post, Eric Topol, director of the Scripps Research Translational Institute, said remdesivir “isn’t a breakthrough drug” and that it has offered a mix of good and bad results that paints a “confusing picture.” Still, he noted that it is a “good start,” calling it efficacious and safe.
Gilead’s Smaller Trial
Also on Wednesday, Gilead released the results of its own study of remdesivir. In it, the company said patients who took remdisivir for five days did just as well as those who took it for 10 days.
Notably, if found to be accurate, that would mean people would not need to receive as much of the drug, making more of it available to a wider group of patients.
“The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” Merdad Parsey, Gilead’s chief medical officer, said. “This is particularly important in the setting of a pandemic, to help hospitals and health care workers treat more patients in urgent need of care. ”
Gilead’s study, however, was much smaller than the NIH trial as it looked at 397 patients all with “severe” cases of COVID-19. It also didn’t use a control group, a criticism that several international studies into the potential vaccines chloroquine and hydroxychloroquine have also faced.
According to Gilead, the company actively prioritized remdesivir’s manufacturing over that of a placebo early in the pandemic.
“Our goal with these studies was to answer the question of treatment duration, comparing safety and efficacy with five or 10 days of remdesivir treatment,” the company said in a statement. “A placebo control was not necessary to answer this question. The open-label study design was necessary to understand whether shortening the duration of therapy can lead to earlier discharge from the hospital.”
Gilead said it has now expanded its study to be conducted at 180 locations internationally.
See what others are saying: (CNN) (CNBC) (The Washington Post)
Florida Cracks Down on “Vaccine Tourism”
- Florida is now requiring that people show proof of either full-time or part-time residency in the state in order to get vaccinated against COVID-19.
- The state has been hit with “vaccine tourism” as many people, predominantly wealthy individuals, fly to the state from other parts of the U.S. and abroad just to get the shot.
- So far, nearly 41,000 of the 1.3 million doses administered in Florida went to out-of-staters, though it is unclear if all those people were tourists or if this figure includes some part-time residents.
Florida Requires Proof of Residency
Florida is cracking down on “vaccine tourism” and requiring that people show proof of either full-time or part-time residency in the state in order to get a COVID-19 shot.
Previously the state was allowing anyone 65 and older, including non-residents, to get the vaccine. This resulted in people flying to the Sunshine State from across the U.S. and abroad just for the purpose of receiving it.
According to state data, nearly 41,000 of the 1.3 million doses Florida has administered have gone to out-of-staters. It is unclear if all these out-of-staters are tourists or if this figure includes some part-time residents.
Now, people must show a form of identification like a driver’s license or mortgage payment to receive it. Exceptions will be made for healthcare workers.
Vaccine Supply Continues to Be Limited
Wealthy people in particular were quick to schedule travel plans to Florida for this reason. According to the Wall Street Journal, there was an influx of Canadians booking private jets to Florida. Some were looking to book flights there and back on the same day, leaving just enough time for them to get vaccinated against the coronavirus.
Meanwhile, people in Florida and across the country are waiting in long lines and struggling to book appointments on glitching websites to get their shots. Vaccine supply continues to be incredibly limited and not everyone in high-risk groups have received them.
Florida Governor Ron DeSantis said this rule is not made to impact snowbirds, people who live in Florida during the winter to escape cold weather up north.
“They go to doctors here or whatever, that’s fine, DeSantis said, according to CNN. “What we don’t want is tourists, foreigners. We want to put seniors first, but we obviously want to put people that live here first in line.”
See what others are saying: (Wall Street Journal) (CNN) (Travel + Leisure)
Amanda Gorman Wows the Nation With “The Hill We Climb”
- Amanda Gorman, a 22-year-old poet, impressed the nation when she read “The Hill We Climb” at President Biden’s inauguration, making her the youngest inaugural poet in the nation’s history.
- Gorman’s said the Jan. 6 attack on the nation’s Capitol inspired her to focus on a message of hope, community, and healing in her poem.
- Big names like Oprah Winfrey, Anderson Cooper, Barack Obama, and Lin-Manuel Miranda have all praised her work.
Amanda Gorman Becomes Youngest Inaugural Poet
Inaugural poet Amanda Gorman wowed the nation on Wednesday as she spoke of healing, unity, hope, and what it means to be American while reading her poem, “The Hill We Climb.”
At 22-years-old Gorman is the youngest inaugural poet in the nation’s history. Born and raised in Los Angeles, she was the youth poet laureate of Los Angeles in 2014 at the age of 16. She then became the first national youth poet laureate in 2017.
Now, her books are topping Amazon’s Best Sellers list and they are not even scheduled to be released until the fall.
First Lady Dr. Jill Biden became a fan of Gorman after watching her give a reading at the Library of Congress. She then suggested that Gorman be a part of the ceremony.
“Let the globe, if nothing else, say this is true: That even as we grieved, we grew. That even as we hurt, we hoped That even as we tired, we tried,” Gorman recited during inauguration. “That we’ll forever be tied together, victorious. Not because we will never again know defeat but because we will never again sow division.”
Like President Biden, Gorman has struggled with a speech impediment and has been open about her experience overcoming it. She actually used poetry as a tool to correct it. First, she used it as a way of expressing herself without having to speak. Then she used it to bring her poems to life.
“Once I arrived at the point in my life in high school, where I said, ‘you know what? Writing my poems on the page isn’t enough for me,” she told CBS News. “I have to give them breath, and life, I have to perform them as I am.’ That was the moment that I was able to grow past my speech impediment.”
What Inspired “The Hill We Climb”
Gorman said the inaugural committee gave her freedom and flexibility when it came to choosing what to write about. She was well on her way before the Jan. 6 attack on the U.S. Capitol. Those events then influenced her writing.
“It energized me even more to believe that much more firmly in a message of hope, community and healing. I felt like that was the type of poem that I needed to write and it was the type of poem that the country and the world needed to hear,” she told CNN’s Anderson Cooper.
That message came across clearly and the insurrection was depicted in part of “The Hill We Climb.”
“It’s because being American is more than a pride we inherit. It’s the past we step into and how we repair it. We’ve seen a force that would shatter our nation rather than share it, would destroy our country if it meant delaying democracy and this effort very nearly succeeded,” she said. “But while democracy can be periodically delayed it can never be permanently defeated. In this truth, in this faith we trust. For while we have our eyes on the future history has its eyes on us.”
Nation Impressed by Gorman
“Wow…Wow, I just, wow you’re awesome,” Cooper said when closing his interview with her. “I am so transfixed.”
Lin-Manuel Miranda also cheered Gorman on. “The Hill We Climb” notably references a line of scripture that appears in a “Hamilton” song. Gorman also said she used to sing the song “Aaron Burr, Sir” to help her say her R sounds and correct her speech impediment.
“I have never been prouder to see another young woman rise!” Oprah Winfrey wrote. “Brava Brava Amanda Gorman! Maya Angelou is cheering—and so am I.”
Winfrey also gave Gorman a ring with a caged bird on it—a reference to the famous Angelou poem— which Gorman wore during the inauguration.
Actor Mark Ruffalo joined the onslaught of praise, saying that her words will lead the nation.
Former President Barack Obama echoed that idea as well, and former Secretary of State Hillary Clinton said Gorman promised to run for president one day.
See what others are saying: (CBS News) (New York Times) (Los Angeles Times)
SAT Drops Subject Tests and Optional Essay Section
- The College Board will discontinue SAT subject tests effective immediately and will scrap the optional essay section in June.
- The organization cited the coronavirus pandemic as part of the reason for accelerating these changes.
- Regarding subject tests, the College Board said the other half of the decision rested on the fact that Advanced Placement tests are now more accessible to low-income students and students of color, making subject tests unnecessary.
- It also said it plans to launch a digital version of the SAT in the near future, despite failing to implement such a plan last year after a previous announcement.
College Board Ends Subject Tests and Optional Essay
College Board announced Tuesday that it will scrap the SAT’s optional essay section, as well as subject tests.
Officials at the organization cited the COVID-19 pandemic as part of the reason for these changes, saying is has “accelerated a process already underway at the College Board to simplify our work and reduce demands on students.”
The decision was also made in part because Advanced Placement tests, which College Board also administers, are now available to more low-income students and students of color. Thus, College Board has said this makes SAT subject tests unnecessary.
While subject tests will be phased out for international students, they have been discontinued effective immediately in the U.S.
Regarding the optional essay, College Board said high school students are now able to express their writing skills in a variety of ways, a factor which has made the essay section less necessary.
With several exceptions, it will be discontinued in June.
The Board Will Implement an Online SAT Test
In its announcement, College Board also said it plans to launch a revised version of the SAT that’s aimed at making it “more flexible” and “streamlined” for students to take the test online.
In April 2020, College Board announced it would be launching a digital SAT test in the fall if schools didn’t reopen. The College Board then backtracked on its plans for a digital test in June, before many schools even decided they would remain closed.
According to College Board, technological challenges led to the decision to postpone that plan.
For now, no other details about the current plan have been released, though more are expected to be revealed in April.