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Pfizer Says Its Vaccine Is 95% Effective, Will Seek FDA Approval

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  • Pfizer says new data for the COVID-19 vaccine it created with BioNtech shows it is 95% effective. Now, Pfizer plans on asking the FDA for authorization within the next few days, which will be followed by a review process.
  • If approved, it will be distributed to high-risk populations first. So far, data shows that the vaccine is effective across several demographics, including those over the age of 65, where the efficacy rate is 94%.
  • The biggest hurdle in the distribution process could potentially be getting proper funding to states. Many states have said they need more federal funding or are unsure if they have enough to adequately distribute it to their residents.
  • In other good coronavirus news, the FDA has approved its first at-home COVID-19 self-test. The test, which is approved to be used by those ages 14 and older who have received a prescription from their healthcare provider, can show results in 30 minutes or less.

Pfizer Releases New Vaccine Data

New data shows that Pfizer and BioNTech’s COVID-19 vaccine is 95% effective, Pfizer said in an announcement early Wednesday.

Last week, the company said preliminary data showed it was at least 90% effective. It’s not the only company making strides. On Monday, Moderna said it has developed its own vaccine that appears to be 94.5% effective.

Having two prominent companies with success in a vaccine is promising, and Pfizer’s new data only furthers that promise. The company said that of the 170 COVID-19 cases in their trial, 162 were in the placebo group and eight were in the vaccine group. A total of 44,000 people participated in the trial. 

According to a press release, the vaccine’s efficacy was consistent across age, gender, race, and ethnicity demographics, proving to be 94% effective for those over the age of 65. So far, data also shows no serious safety concerns, with the most severe effects found being fatigue in 3.8% of participants and a headache in 2%.

Steps Towards FDA Approval

Pfizer expects to produce up to 50 million doses of its vaccine in 2020 and 1.3 billion by the end of 2021. It also plans to submit the vaccine for review at the Food and Drug Administration within the next few days. As part of their review, FDA scientists will look over the data and evidence along with an external panel of independent experts. Those experts will also hold a public meeting to discuss the data, likely at some point in December. 

Once it is authorized, government and health authorities will offer it to high-risk populations first. This might include people like healthcare workers, essential workers, immunocompromised individuals, those in nursing homes, and public safety officials. However, the decision on who gets priority ultimately falls on the government.

Need for State Funding

While this is great news in the fight against the coronavirus, it does not come without its complications. Say the vaccine is approved to be given to people, states will have one big hurdle to face: getting enough funding to distribute it. 

At least one dozen states confirmed to ABC News that they need or are waiting for more funding, while others suggested they are still working out if they need more. Back in October, a group of local health officials sent a letter to Congress saying they would need $8.4 billion in COVID-19 vaccine funding. 

Trish Riley, the executive director of the National Academy for State Health Policy told ABC News she fears there could be a repeat of what happened at the start of the pandemic when states were competing for essential resources like personal protective equipment and ventilators.

“That’s the wake-up-at-night worry,” she told the outlet. “States can’t do this alone.”

While the CARES Act extended $200 million to states and more money is expected to come for vaccine distribution next month, states do not know how much they will get or how much will be enough. 

“It is essential that we get federal support, and that includes money,” New Jersey Governor Phil Murphy said during a Monday press conference. “As good as the distribution plan may be. We need the feds.”

Claire Hannan, the executive director of the Association of Immunization Managers, told ABC News that she is specifically worried about states not having enough money to hire and train nurses and other staff when the time comes.

“I do fear that the vaccine’s going to get shipped, we’re going to be able to plan out the logistics, but we’re not going to be able to have enough manpower for vaccinating and we’re not going to have robust community engagement,” she said. 

At Home Rapid Test Approved

While the nation waits for a vaccine and the potential to be immune to the coronavirus, other good news regarding the pandemic has also emerged.

On Tuesday night, the FDA authorized the first at-home COVID-19 self-test. That test, the Lucira COVID-19 All-In-One Test Kit, has been authorized for home use with a self-collected nasal swab by individuals ages 14 and older who are suspected to have COVID-19. The test will require a prescription and can be used by those younger than 14, but in those cases, it must be done by a healthcare provider. 

Those who take the test will swirl their self-collected sample in a vial that’s placed in the test unit and results will come in 30 minutes or less. Individuals who test positive are asked to isolate and seek guidance from their healthcare provider. Those who test negative are still encouraged to speak to their doctor, as the FDA says “negative results do not preclude an individual from SARS-CoV-2 infection.”

According to Lucira’s website, the test achieved a 94% positive percent agreement and a 98% negative percent agreement. Lucira says that if samples with very low levels of virus that could be past the point of activity are taken out of the picture, the test achieved a 100% positive percent agreement.

As far as cost, reports indicate that it will be $50 or less. It will initially be available in California and Florida, but will roll out to other states over time.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn said in a statement. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, also applauded the news. 

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” he said.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”

See what others are saying: (ABC News) (Associated Press) (NPR)

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Florida Cracks Down on “Vaccine Tourism”

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  • 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)

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Amanda Gorman Wows the Nation With “The Hill We Climb”

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  • 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)

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SAT Drops Subject Tests and Optional Essay Section

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  • 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. 

See what others are saying: (The Washington Post) (NPR) (The New York Times)

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