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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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CDC Data Shows Booster Shots Provide Effective Protection Against Omicron

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Public health experts have encouraged Americans to get boosted to protect themselves against the omicron variant, but less than 40% of fully vaccinated people who are eligible for their third shot have received it.


A First Glimpse of Official Data on Boosters and Omicron

COVID-19 booster shots are effective at preventing Americans from contracting omicron and protecting those who do become infected from severe illness, according to three reports from the Centers for Disease Control and Prevention (CDC) published Friday.

The reports mark the first real-world data regarding the highly infectious variant and how it has impacted the U.S.

One of the CDC reports, which studied data from 25 state and local health departments, found that there were 149 cases per 100,000 people among those had been boosted on average each week. 

In comparison, the figure was 255 cases per 100,000 people in Americans who had only received two shots.

Another study that looked at nearly 88,000 hospitalizations in 10 states found that the third doses were 90% effective at preventing hospitalization. 

By contrast, those who received just two shots were only 57% protected against hospitalization by the time they were eligible for a booster six months after their second dose.

Additionally, the same report also found that the boosters were 82% effective at preventing visits to emergency rooms and urgent care centers, a marked increase from the 38% efficacy for those who were six months out from their two-shot regime and had not yet received a third.

Low Booster Shot Vaccination Rates

Public health officials hope that the new data will urge more Americans to get their booster shots.

Since the emergence of omicron, experts and leading political figures have renewed their efforts to encourage people to get their third shots, arguing they are the best form of protection. 

The CDC currently recommends that everyone 12 and older get a booster shot five months after their second shot of Pfizer and Moderna or two months after receiving the single-dose Johnson & Johnson vaccine. Still, in the U.S., less than 40% of fully vaccinated individuals eligible for a third shot have gotten one.

While COVID cases in the country have begun to drop over the past several days from their peak of over 800,000 average daily infections, the figures are still nearly triple those seen in the largest previous surges.

Hospitalizations have also slowly begun to level out over the last week in places that were hit first, such as New York City and Boston, but medical resources still remain strained in many parts of the country that experienced later surges and have not yet seen cases slow.

Some experts predict that the U.S. will see a sharp decline in omicron cases, as experienced in South Africa and Britain. Still, they urge American’s to get boosted to ensure their continued protection from the variant, as well as other strains that will emerge.

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

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California Bill Would Allow Kids 12 and Up to Get Vaccinated Without Parental Consent

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Nearly one million California teens and preteens between the ages of 12 and 17 are not vaccinated against COVID-19. 


State Senator Proposes Legislation

Legislation proposed in California on Thursday would allow children age 12 and up to get vaccinated without parental consent. 

State Sen. Scott Wiener (D-San Francisco) introduced Bill 866 in the hope it could boost vaccination rates among teenagers. According to Wiener, nearly one million kids aged 12- to 17-years old remain unvaccinated against COVID-19 in the state of California. 

“Unvaccinated teens are at risk, put others at risk & make schools less safe,” Wiener tweeted. “They often can’t work, participate in sports, or go to friends’ homes.”

“Many want to get vaccinated but parents won’t let them or aren’t making the time to take them. Teens shouldn’t have to rely on parents’ views & availability to protect themselves from a deadly virus.”

Currently, teens in California can receive vaccines for human papillomavirus and hepatitis B without parental consent. They can also make other reproductive or mental healthcare choices without a guardian signing off. Wiener argues that their medical autonomy should expand to all vaccines, especially during a pandemic that has already killed roughly 78,000 Californians. 

Vaccine Consent Across the U.S.

“Teens shouldn’t have to plot, scheme or fight with their parents to get a vaccine,” he said. “They should simply be able to walk in & get vaccinated like anyone else.”

Bill 866 would allow any kids ages 12 and up to receive any vaccine approved or granted emergency use authorization by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention. Currently, Pfizer’s COVID vaccine has been fully approved by the FDA for those 16 and older. It has received emergency authorization for ages five through 15. 

Across the United States, vaccine consent ages vary. While the vast majority of states require parental approval for minors to be vaccinated against COVID-19, kids as young as 11 can get the jab on their own in Washington, D.C. In Alabama, kids can receive it without parental consent at 14, in Oregon at 15, and in Rhode Island and South Carolina at 16. According to the Kaiser Family Foundation, providers can waive consent in certain cases in Arkansas, Idaho, Washington, and Tennesee.

In October, California became the first state to announce plans to require that students receive the COVID-19 vaccine to attend class. The mandate has yet to take effect, but under the guidelines, students will be “required to be vaccinated for in person learning starting the term following FDA full approval of the vaccine for their grade span.” 

In other words, once the FDA gives a vaccine full approval for those aged 12 and up, it will be required the following session for kids in grades 7-12. Once it does so for kids as young as five, the same process will happen for children in kindergarten through sixth grade. There will also be room for exemptions from the mandate. 

The Fight to Vaccinate California

This week, a group of California state legislators formed a Vaccine Work Group in order to boost public health policies in the state. Wiener is among the several members who are “examining data, hearing from experts, and engaging stakeholders to determine the best approaches to promote vaccines that have been proven to reduce serious illness, hospitalization and death from COVID-19.”

“Vaccines protect not only individuals but also whole communities when almost everyone is vaccinated at schools, workplaces and businesses, and safe and effective COVID-19 vaccines have already prevented the deaths of hundreds of thousands of Americans,” Sen. Dr. Richard Pan (D-Sacramento) said in a press release. “Public safety is a paramount duty of government, and I am proud to join a talented group of legislators in the pro-science Vaccine Work Group who want to end this disastrous pandemic and protect Californians from death and disability by preventable diseases.”

While vaccine policies have been a divisive subject nationwide, including in California, state politicians and leaders are hopeful public health initiatives will prevail. 

“If we allow disinformation to drive our state policy making we will not only see more Americans needlessly suffer and die, but we will sacrifice the long term stability of our society having effectively abandoned the idea that we all must work together to protect each other in times of crisis.” Catherine Flores Martin, the Executive Director of the California Immunization Coalition, added. 

See what others are saying: (Los Angeles Times) (NBC News) (Sacramento Bee)

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Inmates Sue Jail for Giving Them Ivermectin to Treat COVID-19 Without Consent

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Four detainees who filed the suit allege that the jail’s doctor gave them “incredibly high doses” of the anti-parasite in a “cocktail of drugs” that he said were “‘vitamins’, ‘antibiotics,’ and/or ‘steroids.’”


Washington County Detention Center Lawsuit

Four inmates at an Arkansas jail have filed a federal lawsuit claiming that they were unknowingly given the anti-parasite drug ivermectin without their consent by the detention center’s doctor after contracting COVID-19.

The Food and Drug Administration, the Centers for Disease Control and Prevention, and countless other medical experts have said that ivermectin — commonly used for livestock — can be dangerous and should not be used to treat the coronavirus.

According to the lawsuit, after testing positive for COVID in August, the four men at the Washington County Detention Center (WCDC) were given a “cocktail of drugs” twice a day by the facility’s doctor, Robert Karas.

The inmates claim that Dr. Karas did not tell them that he was giving them ivermectin, but instead said the drugs consisted of “‘vitamins’, ‘antibiotics,’ and/or ‘steroids.’”

The complaint also alleges that the detainees were given “incredibly high doses” of the drug, causing some to experience “vision issues, diarrhea, bloody stools, and/or stomach cramps.”

Use on Other Inmates

The four plaintiffs were far from the only people to whom Karas gave ivermectin.

According to the lawsuit, the doctor began using the drug to treat COVID starting in November of 2020. In August, the Washington County sheriff confirmed at a local finance and budget committee meeting that the doctor had been prescribing the drug to inmates, prompting the Arkansas Medical Board to launch an investigation.

In response, Karas informed a Medical Board investigator in a letter from his attorney that 254 inmates at the facility had been treated with ivermectin.

In the letter, he confirmed that whether or not detainees were given information about ivermectin was dependent on who administered it, but paramedics were not required to discuss the drug with them.

He also admitted that after the practice got media coverage, he “adopted a more robust informed consent form to assuage any concern that any detainees were being misled or coerced into taking the medications, even though they weren’t.”

The American Civil Liberties Union of Arkansas, which filed the suit on behalf of the inmates, also claimed in a statement that after questions were raised about the practice, the jail attempted to make detainees sign forms saying that they retroactively agreed to the treatments. 

The WCDC has not issued a public response to the lawsuits, but Dr. Karas appeared to address the situation in a Facebook post where he defended his actions.

“Guess we made the news again this week; still with best record in the world at the jail with the same protocols,” he wrote. “Inmates aren’t dumb and I suspect in the future other inmates around the country will be suiing their facilities requesting same treatment we’re using at WCDC-including the Ivermectin.”

See what others are saying: (The New York Times) (CBS News) (NBC News)

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