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

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11 months ago

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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 School Says Students Vaccinated Against COVID-19 Must Stay Home for 30 Days

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17 mins ago

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October 18, 2021

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The school falsely claimed that people who have just been vaccinated risk “shedding” the coronavirus and could infect others.

Centner Academy Vaccination Policy

A private school in Florida is now requiring all students who get vaccinated against COVID-19 to quarantine for 30 days before returning to class.

According to the local Miami outlet WSVN, Centner Academy wrote a letter to parents last week describing COVID vaccines as “experimental” and citing anti-vaccine misinformation.

“If you are considering the vaccine for your Centner Academy student(s), we ask that you hold off until the Summer when there will be time for the potential transmission or shedding onto others to decrease,” the letter reportedly stated.

“Because of the potential impact on other students and our school community, vaccinated students will need to stay at home for 30 days post-vaccination for each dose and booster they receive and may return to school after 30 days as long as the student is healthy and symptom-free.”

The Centers for Disease Control and Prevention (CDC) has debunked the false claim that those newly vaccinated against COVID-19 can “shed” the virus.

According to the agency’s COVID myths page, vaccine shedding “can only occur when a vaccine contains a weakened version of the virus,” but “none of the authorized COVID-19 vaccines in the United States contain the live virus that causes COVID-19. This means that a COVID-19 vaccine cannot make you sick with COVID-19.”

In fact, early research has suggested that vaccinated people are less likely to spread the virus than unvaccinated people.

Beyond that, unvaccinated people are more likely to spread COVID in general because they are much more likely to get the virus than vaccinated people. According to recently published CDC data, as of August, unvaccinated people were six times more likely to get COVID than vaccinated people and 11 times more likely to die from the virus.

Centner Academy Continues Spread of Misinformation

In a statement to The Washington Post Monday, Centner Academy co-founder David Centner doubled down on the school’s new policy, which he described as a “precautionary measure” based on “numerous anecdotal cases that have been in circulation.”

“The school is not opining as to whether unexplained phenomena have a basis in fact, however we prefer to err on the side of caution when making decisions that impact the health of the school community,” he added.

The new rule echoes similar efforts Centner Academy has made that run counter to public health guidance and scientific knowledge.

In April, the school made headlines when its leadership told vaccinated school employees that they were not allowed to be in contact with any students “until more information is known” and encouraged employees to wait until summer to get the jab.

According to The New York Times, the following week, a math and science teacher allegedly told students not to hug their vaccinated parents for more than five seconds.

The outlet also reported that the school’s other co-founder, Leila Centner, discouraged masking, but when state health officials came for routine inspections, teachers said they were directed in a WhatsApp group to put masks on.

See what others are saying: (WSVN) (The Washington Post) (Business Insider)

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Katie Couric Says She Edited Ruth Bader Ginsburg Quote About Athletes Kneeling During National Anthem

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4 days ago

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October 14, 2021

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Couric said she omitted part of a 2016 interview in order to “protect” the justice.

Kate Couric Edited Quote From Justice Ginsburg

In her upcoming book, journalist Katie Couric admitted to editing a quote from Supreme Court Justice Ruth Bader Ginsberg in 2016 in order to “protect” Ginsberg from potential criticism. 

Couric interviewed the late justice for an article in Yahoo News. During their discussion, she asked Ginsburg about her thoughts on athletes like Colin Kaepernick kneeling for the national anthem to protest racial inequality.

“I think it’s really dumb of them,” Ginsburg is quoted saying in the piece. “Would I arrest them for doing it? No. I think it’s dumb and disrespectful. I would have the same answer if you asked me about flag burning. I think it’s a terrible thing to do, but I wouldn’t lock a person up for doing it. I would point out how ridiculous it seems to me to do such an act.”

According to The Daily Mail and The New York Post, which obtained advance copies of Couric’s book “Going There,” there was more to Ginsburg’s response. Couric wrote that she omitted a portion where Ginsburg said the form of protest showed a “contempt for a government that has made it possible for their parents and grandparents to live a decent life…Which they probably could not have lived in the places they came from.“

Couric Says She Lost Sleep Making Choice

“As they became older they realize that this was youthful folly,” Ginsberg reportedly continued. “And that’s why education is important.“

According to The Daily Mail, Couric wrote that the Supreme Court’s head of public affairs sent an email asking to remove comments about kneeling because Ginsburg had misspoken. Couric reportedly added that she felt a need to “protect” the justice, thinking she may not have understood the question. Couric reached out to her friend, New York Times reporter David Brooks, regarding the matter and he allegedly likewise believed she may have been confused by the subject. 

Couric also wrote that she was a “big RBG fan” and felt her comments were “unworthy of a crusader for equality.” Because she knew the remarks could land Ginsburg in hot water, she said she “lost a lot of sleep” and felt “conflicted” about whether or not to edit them out. 

Couric was trending on Twitter Wednesday and Thursday as people questioned the ethics behind her choice to ultimately cut part of the quote. Some thought the move showed a lack of journalistic integrity while others thought revealing the story now harmed Ginsburg’s legacy.

See what others are saying: (New York Post) (The Daily Mail) (Insider)

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Biden Administration Orders ICE To Halt Workplace Raids

Published

5 days ago

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October 13, 2021

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The Department of Homeland Security will now focus on targeting employers who exploit undocumented workers, instead of carrying out raids that dissuade those workers from reporting labor violations.

DHS Reverses Worksite Raid Policy

The Biden administration announced Tuesday that it was ordering Immigration and Customs Enforcement (ICE) to stop workplace raids.

The move marks a reversal from Trump administration policies that have been strongly criticized by immigration activists who argue the efforts created fear in immigrant communities and dissuaded them from reporting labor violations or exploitative employment practices.

In addition to stopping the raids, Department of Homeland Security (DHS) Secretary Alejandro Mayorkas said in a memo that the administration will refocus enforcement efforts to instead target “employers who exploit unauthorized workers, conduct illegal activities or impose unsafe working conditions.” 

Mayorkas added that the immigration agencies housed in DHS will have the next 60 days to identify harmful existing policies and come up with new ones that provide better deportation protections for workers who report their employers.

In the Tuesday memo, the secretary argued that shift of focus will “reduce the demand for illegal employment by delivering more severe consequences to exploitative employers” and “increase the willingness of workers to report violations of law by exploitative employers and cooperate in employment and labor standards investigation.”

Labor Market Implications

The new policy comes at a time when the U.S. is experiencing a critical labor shortage, including in many sectors that rely on immigrant labor.

Some companies that use undocumented workers pay them wages that are far below the market rate, which is not only exploitative but also undercuts competitors.

According to Mayorkas, the pivot to employer-based enforcement will help protect American businesses.

“By exploiting undocumented workers and paying them substandard wages, the unscrupulous employers create an unfair labor market,” he said in the memo. “They also unfairly drive down their costs and disadvantage their business competitors who abide by the law.”

It is currently unclear how effective the new efforts will be, but historical precedent does not paint an optimistic picture.

The Biden administration’s efforts closely mirror a similar move by the Obama administration, which attempted to reverse workplace raids authorized under President George W. Bush by targetting those who employ undocumented workers rather than the workers themselves.

That effort, however, still led to thousands of undocumented workers being fired.

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

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