Connect with us

U.S.

FDA Authorizes Portable Test Kit That Can Detect COVID-19 in 5 Minutes

Published

on

  • The FDA has approved the use of a new coronavirus test kit that can give positive results in as little as 5 minutes and negative results in 13, leaps faster than the hours and sometimes days laboratory tests normally take. 
  • The tests are run on a lightweight and small portable device that can be used in emergency rooms, urgent care clinics, and even outside hospital walls.
  • Abbott, the medical device company that makes the kits, plans to send out 50,000 tests a day starting next week.

New Test Approved

The U.S. Food and Drug Administration gave Emergency Use Authorization to the medical device company Abbott for a new coronavirus test kit that gives results within minutes.

Abbott announced the news in a Friday press release, saying it plans to start delivering 50,000 tests a day beginning next week. The tests run on the company’s ID NOW platform, a portable device about the size of a small toaster than weights only 6.6 pounds.

Its portability means it can be used directly in an emergency room or urgent care clinic and even, “outside the traditional four walls of a hospital in outbreak hotspots.”

The company called it “the fastest available molecular point-of-care test for the detection of novel coronavirus(COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.”

Second Rapid Test to Be Approved by FDA 

The approval from federal health officials means that regulators were satisfied with the test’s validation data and are confident that its benefits outweigh any risk, like false positives or negatives. 

The FDA’s approval marks the seconds time it has green-lit a fast working test that could accelerate testing across the country.  Last week, it approved a 45-minute rapid point of care test by the molecular diagnostics company Cepheid. However, that test is primarily intended for emergency rooms and hospitals, not doctors’ officers or urgent care clinics.  

Still, those turnaround times are leaps faster than the hours to days it takes most laboratory tests to bring results. 

Medical Shortages Still Cause Concern 

The approval of the Abbott test comes as cities across the nation battle with numbers of potential patients that surpass available tests and resources. Even with insufficient testing, the United States became the country with the largest number of reported cases of coronavirus on Thursday, exceeding China and Italy. By Friday, the U.S. hit more than 100,000 cases. 

Many fear that shortages of other critical medical equipment, like masks and swabs, could stifle the new rapid test’s impact. That’s because the kit requires a swab sample collected from patients, and many health care facilities are running desperately low on the tools needed to safely collect those samples.

The Center for Disease Control issued guidance Tuesday that allows some patients to collect their own nasal swabs in health care facilities, in an effort to reduce the amount of protective equipment needed for health care workers. 

On the opposite end, however, others note that fast and efficient testing can help medical professionals determine how much protective equipment they actually need to wear when interacting with a patient, as well as what kind of care to provide. Since this test can be done in a doctor’s office, it could even potentially help diagnose patients with mild or asymptomatic cases of the virus and help stop them from unknowingly spreading it. 

Experts also say drastically increasing testing capacity can help get the economy back on track sooner. With increased testing, measures like keeping everyone at home could be replaced with more targeted identification and isolation of those infected. 

See what others are saying: (The Hill) (CNBC) (CNN

U.S.

Amazon Backs GOP Bill to Legalize Marijuana in Effort to Ramp Up Lobbying

Published

on

The proposal is the first Republican-sponsored marijuana bill Amazon has backed since the company first began lobbying for legalization last summer.


Amazon Endorses States Reform Act

Amazon announced Tuesday that it is endorsing a Republican-backed proposal to legalize marijuana.

The move comes as the e-commerce giant has ramped up its efforts to legalize cannabis on the federal level since it came out in support of the idea last summer. Amazon argues that the move would remove hiring barriers — which disproportionately impact people of color — and, in turn, could increase the company’s application pool and boost employee retention.

The company has previously backed similar proposals by forward by Democrats, but Tuesday’s announcement marks the first time Amazon has put its support behind a Republican-sponsored bill aimed at addressing the issue.

The legislation, called the States Reform Act, was authored by Rep. Nancy Mace (R-S.C.). Among other measures, it would remove cannabis as a Schedule I substance, allow states to create their own laws, impose an excise tax, and regulate the drug in a similar fashion to alcohol.

While Mace’s bill is fundamentally very similar to others put forth by Democrats, by proposing it herself, the Republican hopes to rally other members of her party around the idea that legalization is pro-business, pro-state’s rights, and anti-big government.

The measure has already received support from the highly influential conservative group, American’s for Prosperity, which is funded by the Koch brothers.

Potential Momentum

Mace and Amazon have painted the company’s endorsement as a game-changer for garnering more support — both from other large corporations and politicians on either side of the aisle. Mace specifically told reporters she believes Amazon’s decision will push other companies to do the same. If more major corporations like Amazon back the effort, other Republicans may be more persuaded to jump on board.

That sentiment was echoed by Brian Huseman, Amazon’s vice president of public policy, who said in an interview with The Washington Post that the company was “particularly excited by Congresswoman Mace’s bill because it shows that there’s bipartisan support for this issue.”

Huseman also emphasized that, as part of its decision to back her bill, Amazon will use its powerful influence in Washington to try and drum up bipartisan support.

“We are talking with members of both parties, including Republicans, about why we think this is the right thing to do, especially from the standpoint of a major employer and what this means for our business and our employees and broadening the employee base,” he continued.

See what others are saying: (The Washington Post) (Forbes) (Marijuana Moment)

Continue Reading

U.S.

CDC Data Shows Booster Shots Provide Effective Protection Against Omicron

Published

on

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)

Continue Reading

U.S.

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

Published

on

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)

Continue Reading