Tag: fda

What Is Naloxone? Where To Get Narcan And How To Reverse Overdoses

The overdose crisis continues to worsen in the U.S., and overdose deaths reached an all-time high in 2021. Experts say that a simple drug — naloxone — is a key tool in preventing more deaths. But not enough people know about it, have access to it or actually carry it with them.

“Naloxone is a miracle drug,” Dr. Kimberly Sue, medical director for the National Harm Reduction Coalition and associate professor of medicine at Yale School of Medicine, told TODAY. “It’s literally a Lazarus drug that prevents people from dying of an opioid overdose.”

And in the midst of the overdose crisis, which claimed nearly 108,000 lives just last year, getting naloxone to those who need it is vitally important. Here, experts discuss what naloxone is, how to get it and how it can save lives.

How does naloxone work?

Naloxone, also referred to by the brand name Narcan, is what experts call an opioid antagonist, Dr. Sarah Wakeman, medical director for the Massachusetts General Hospital Substance Use Disorder Initiative, told TODAY. Narcan is not the only branded naloxone product; a high-dose nasal spray called Kloxxado works similarly, according to the FDA.

That means it “binds to the opioid receptors in the brain — the same receptors that opioid drugs or medications like oxycodone or heroin or fentanyl bind to — and then blocks those receptors,” Wakeman explained. In the event of an opioid overdose, naloxone “can actually kick off the opioid from the receptor, reverse the acute effects of an opioid overdose and save someone’s life.”

A standard dose of naloxone is effective against even fentanyl, Wakeman said. If they’ve taken an opioid and something else, or if they took something like cocaine that was tainted with illicit fentanyl, naloxone will still work against the opioid in their system.

“And naloxone won’t be harmful to someone who doesn’t have an opioid in their body,” Wakeman said. “So if there’s a possibility that you think someone is having an overdose … then it is always a good idea to give naloxone.”

When should naloxone be given?

Before using naloxone, check to see if someone has the telltale signs of an overdose, Dr. Ayana Jordan, an addiction expert and associate professor of psychiatry at NYU Grossman School of Medicine, told TODAY. She pointed to the Center for Disease Control and Prevention‘s tips to learn about the signs of an overdose.

According to the CDC, someone having an overdose may have:

  • Loss of consciousness.
  • Weak, slow or no breathing.
  • Small or constricted pupils.
  • Choking or gurgling sounds.
  • Limp body.
  • Clammy or cold skin.
  • Blue or discolored skin, especially around the lips. (However, Jordan notes that this may not apply to people with darker skin.)

In general, someone who is in the midst of an overdose will “have slowed and very shallow breathing to the point that, ultimately, they’ll stop breathing,” Wakeman said. “So they may look blue or cold and not be responsive.”

Giving someone naloxone

Once you’ve identified that someone might be having an overdose, you should call 911, the CDC says. Even if you’re able to reverse the overdose, they will likely still need emergency services. (Some states, but not all, have Good Samaritan laws, which protect people calling for medical help from some drug-related charges, Sue explained.)

From there, the right way to use naloxone depends on the specific formulation you’re using. For most people, that will likely be the nasal spray called Narcan, Wakeman said. In the hospital, naloxone may be given through an IV or as an injection into the muscle, she added.

After administering naloxone, the person should wake up within seconds to minutes, Wakeman said. And you should always start with as low a dose as possible. If someone is a regular opioid user and you give them a massive dose of naloxone all at once, “they’re going to immediately go into withdrawal,” Wakeman explained. While that isn’t necessarily harmful, it is pretty unpleasant and uncomfortable.

After giving someone naloxone, you should stay with them if you can until emergency medical help arrives. “Naloxone works very quickly, but it also wears off very quickly,” Wakeman said. In fact, the effects of naloxone can wear off within 30 minutes. And if someone still has the other opioid in their system, they may fall back into an overdose after the naloxone has worn off.

Where to get naloxone

If you use drugs, your doctor may give you a naloxone prescription as a regular part of their practice. “I make sure that everyone that sees me gets prescribed naloxone and that they understand how to use it,” Jordan said.

Depending on the state, you may be able to get naloxone at a local pharmacy without a prescription through the use of a standing order, Wakeman noted. (Standing orders allow pharmacies to give out prescription medications, like the annual flu vaccine, without requiring each individual person to have their own prescription.)

Another option is to connect with local harm reduction groups in your area, which frequently hand out naloxone kits, Wakeman said. These community-based organizations may also offer in-person or virtual trainings on how to use naloxone. Jordan noted that her research group also does large virtual naloxone training sessions for people who participate in their studies looking at drug use.

If you live in a state without a standing order and want to get naloxone to use on someone else, you can likely get a third-party prescription through a doctor, Sue said. She recommended looking at the local health department’s website for more information about where to get naloxone in your area.

It’s most important for people who use drugs to have access to naloxone. But if you know someone who uses drugs, you should consider carrying naloxone, too, the experts said. “Carrying naloxone is no different than carrying an epi-pen,” Jordan said.

And even though there are several ways to get naloxone now, there are still barriers to actually accessing and using it, Sue explained. She recalled a story of pharmacy staff being simply unaware of the standing order for naloxone, for instance, and noted that harm reduction groups are experiencing an ongoing naloxone shortage.

Additionally, naloxone is something that, by definition, people can’t use on themselves in the event of an overdose, Sue said. (If you are going to use by yourself, Sue recommended calling the Never Use Alone hotline so there is someone who can notify emergency services if you lose consciousness.)

Naloxone is a crucial tool in reducing overdose deaths, experts say

“Really, no one should die from an opioid overdose,” Wakeman said. “Not only do we know how to prevent overdoses and how to treat people who have an opioid use disorder, but we also have this life-saving, immediately-acting medication that will quickly reverse the effects of an opioid overdose.” 

The challenge for experts now is to make naloxone more accessible to those who need it. “There’s no moral or medical reason to keep this life-saving medication behind the counter,” Dr. Bobby Mikkamula, chair of the American Medicine Association’s Substance Use and Pain Care Task Force, told TODAY.

Earlier this year, AMA urged the Biden administration to remove naloxone’s prescription status, which would make it available over-the-counter. “It’s not the kind of thing that needs to be protected or that people need to be protected from,” Mikkamula said. “This saves their lives, and the fewer barriers we have to getting this into their hands and into their medicine cabinets, the better.”

For Jordan, the importance of naloxone comes down to one simple truth: “I can’t help people who are dead,” she said.

By Sarah Jacoby

Source: What Is Naloxone? Where To Get Narcan And How To Reverse Overdoses

Related links:

Overdose Deaths Behind Bars Rise as Drug Crisis Swells The Good Men Project

Report details Alaska demographics hurt most by 2021 spike in drug–overdose deaths Alaska Public Media

Devastated family of young mum found dead on Belfast bench from drug overdose in plea to MLAs Belfast Telegraph
11:37 Sun, 31 Jul
Rotten Big Apple: New York City drug busts decline while overdose deaths soar New York Post
19:26 Sat, 30 Jul
Toronto harm reduction workers call for robust safer supply program to prevent deaths Toronto Sun
02:58 Sat, 30 JulToronto Public Health Opioid Crisis Canada
Coming wave of opioid overdoses ‘will be worse than ever before’ Social Care Today
13:02 Fri, 29 JulOpioid Crisis Fentanyl
Drug overdose deaths in the U.S. Are increasing more in Black and indigenous populations Smithsonian Magazine
15:34 Mon, 25 JulNative Americans Pandemic Racism
CDC study reveals overdose death rates surged among minorities in 2020 CBS News
01:14 Thu, 21 JulNative Americans CDC Alaska
‘Too many tragedies’ Dundee politicians react to latest drug death stats Daily Record
17:49 Thu, 28 JulDundee Scotland
Pandemic restrictions led to more black Americans overdosing The Daily Caller
20:06 Wed, 20 JulDrug Overdoses (World) CDC Pandemic
Israel pharmaceutical firm proposes $4.35bn settlement for role in US opioid epidemic Middle East Monitor
21:10 Wed, 27 JulIsrael Opioid Crisis Israeli Settlements
U.S. Drug Policy disconnect: Starting harm reduction at home, deep into ‘Drug war’ abroad The Washington Office on Latin America
21:28 Wed, 27 JulDrug Overdoses (World) Joe Biden Latin America
Fentanyl, death by the dose The Washington Times
23:33 Mon, 25 JulFentanyl Joe Biden Drug Overdoses (World)
Federal grants will fund rural Treatment centers to address psychostimulant overdoses Daily Yonder
14:37 Mon, 01 AugDrug Overdoses (World) HHS Opioid Crisis
More Remote Working Apps:

https://quintexcapital.com/?ref=arminham     Quintex Capital

https://www.genesis-mining.com/a/2535466   Genesis Mining

 http://www.bevtraders.com/?ref=arminham   BevTraders

https://www.litefinance.com/?uid=929237543  LiteTrading

https://alpariforex.org/fa/registration/?cpa_partner_id=13687690   Alpari Forex Trading

https://dealcheck.io?fp_ref=armin16   Dealcheck Real Estate Evaluator

https://jvz8.com/c/202927/369164  prime stocks

 https://jvz1.com/c/202927/373449  forrk   

https://jvz3.com/c/202927/194909  keysearch  

 https://jvz4.com/c/202927/296191  gluten free   

https://jvz1.com/c/202927/286851  diet fitness diabetes  

https://jvz8.com/c/202927/213027  writing job  

 https://jvz6.com/c/202927/108695  postradamus

https://jvz1.com/c/202927/372094  stoodaio

 https://jvz4.com/c/202927/358049  profile mate  

 https://jvz6.com/c/202927/279944  senuke  

 https://jvz8.com/c/202927/54245   asin   

https://jvz8.com/c/202927/370227  appimize

 https://jvz8.com/c/202927/376524  super backdrop

 https://jvz6.com/c/202927/302715  audiencetoolkit

 https://jvz1.com/c/202927/375487  4brandcommercial

https://jvz2.com/c/202927/375358  talkingfaces

 https://jvz6.com/c/202927/375706  socifeed

 https://jvz2.com/c/202927/184902  gaming jobs

 https://jvz6.com/c/202927/88118   backlinkindexer

 https://jvz1.com/c/202927/376361  powrsuite  

https://jvz3.com/c/202927/370472  tubeserp  

https://jvz4.com/c/202927/343405  PR Rage  

https://jvz6.com/c/202927/371547  design beast  

https://jvz3.com/c/202927/376879  commission smasher

 https://jvz2.com/c/202927/376925  MT4Code System

https://jvz6.com/c/202927/375959  viral dash

https://jvz1.com/c/202927/376527  coursova

 https://jvz4.com/c/202927/144349  fanpage

https://jvz1.com/c/202927/376877  forex expert  

https://jvz6.com/c/202927/374258  appointomatic

https://jvz2.com/c/202927/377003  woocommerce

https://jvz6.com/c/202927/377005  domainname

 https://jvz8.com/c/202927/376842  maxslides

https://jvz8.com/c/202927/376381  ada leadz

https://jvz2.com/c/202927/333637  eyeslick

https://jvz1.com/c/202927/376986  creaitecontentcreator

https://jvz4.com/c/202927/376095  vidcentric

https://jvz1.com/c/202927/374965  studioninja

https://jvz6.com/c/202927/374934  marketingblocks

https://jvz3.com/c/202927/372682  clipsreel  

https://jvz2.com/c/202927/372916  VideoEnginePro

https://jvz1.com/c/202927/144577  BarclaysForexExpert

https://jvz8.com/c/202927/370806  Clientfinda

https://jvz3.com/c/202927/375550  Talkingfaces

https://jvz1.com/c/202927/370769  IMSyndicator

https://jvz6.com/c/202927/283867  SqribbleEbook

https://jvz8.com/c/202927/376524  superbackdrop

https://jvz8.com/c/202927/376849  VirtualReel

https://jvz2.com/c/202927/369837  MarketPresso

https://jvz1.com/c/202927/342854  voiceBuddy

https://jvz6.com/c/202927/377211  tubeTargeter

https://jvz6.com/c/202927/377557  InstantWebsiteBundle

https://jvz6.com/c/202927/368736  soronity

https://jvz2.com/c/202927/337292  DFY Suite 3.0 Agency+ information

https://jvz8.com/c/202927/291061  VideoRobot Enterprise

https://jvz8.com/c/202927/327447  Klippyo Kreators

https://jvz8.com/c/202927/324615  ChatterPal Commercial

https://jvz8.com/c/202927/299907  WP GDPR Fix Elite Unltd Sites

https://jvz8.com/c/202927/328172  EngagerMate

https://jvz3.com/c/202927/342585  VidSnatcher Commercial

https://jvz3.com/c/202927/292919  myMailIt

https://jvz3.com/c/202927/320972  Storymate Luxury Edition

https://jvz2.com/c/202927/320466  iTraffic X – Platinum Edition

https://jvz2.com/c/202927/330783  Content Gorilla One-time

https://jvz2.com/c/202927/301402  Push Button Traffic 3.0 – Brand New

https://jvz2.com/c/202927/321987  SociCake Commercial

https://jvz2.com/c/202927/289944  The Internet Marketing

 https://jvz2.com/c/202927/297271  Designa Suite License

https://jvz2.com/c/202927/310335  XFUNNELS FE Commercial 

https://jvz2.com/c/202927/291955  ShopABot

https://jvz2.com/c/202927/312692  Inboxr

https://jvz2.com/c/202927/343635  MediaCloudPro 2.0 – Agency

 https://jvz2.com/c/202927/353558  MyTrafficJacker 2.0 Pro+

https://jvz2.com/c/202927/365061  AIWA Commercial

https://jvz2.com/c/202927/357201  Toon Video Maker Premium

https://jvz2.com/c/202927/351754  Steven Alvey’s Signature Series

https://jvz2.com/c/202927/344541  Fade To Black

https://jvz2.com/c/202927/290487  Adsense Machine

https://jvz2.com/c/202927/315596  Diddly Pay’s DLCM DFY Club

https://jvz2.com/c/202927/355249  CourseReel Professional

https://jvz2.com/c/202927/309649  SociJam System

https://jvz2.com/c/202927/263380  360Apps Certification

 https://jvz2.com/c/202927/359468  LocalAgencyBox

https://jvz2.com/c/202927/377557  Instant Website Bundle                                        

https://jvz2.com/c/202927/377194  GMB Magic Content

https://jvz2.com/c/202927/376962  PlayerNeos VR

https://jvz8.com/c/202927/381812/  BrandElevate Bundle information

https://jvz4.com/c/202927/381807/ BrandElevate Ultimate

https://jvz2.com/c/202927/381556/ WowBackgraounds Plus

https://jvz4.com/c/202927/381689/  Your3DPal Ultimate

https://jvz2.com/c/202927/380877/  BigAudio Club Fast Pass

https://jvz3.com/c/202927/379998/ Podcast Masterclass

https://jvz3.com/c/202927/366537/  VideoGameSuite Exclusive

https://jvz8.com/c/202927/381148/ AffiliateMatic

https://jvzoo.com/c/202927/381179  YTSuite Advanced

https://jvz1.com/c/202927/381749/  Xinemax 2.0 Commercial

https://jvzoo.com/c/202927/382455  Living An Intentional Life

https://jvzoo.com/c/202927/381812  BrandElevate Bundle

https://jvzoo.com/c/202927/381935 Ezy MultiStores

https://jvz2.com/c/202927/381194/  DFY Suite 4.0 Agency

https://jvzoo.com/c/202927/381761  ReVideo

https://jvz4.com/c/202927/381976/  AppOwls Bundle

https://jvz8.com/c/202927/381950/  TrafficForU

https://jvz3.com/c/202927/381615/  WOW Backgrounds 2.0

https://jvz4.com/c/202927/381560   ALL-in-One HD Stock Bundle

https://jvz6.com/c/202927/382326/   Viddeyo Bundle

https://jvz8.com/c/202927/381617/  The Forex Joustar

https://jvz3.com/c/202927/383751/ ADA Web Accessibility Compliance 

https://jvz3.com/c/202927/383942/  10 Bold Actions In Positive Life & Work

https://jvz3.com/c/202927/383706/  Adtivate Agency

https://jvz1.com/c/202927/384099/   My Passive Income Blueprints

https://jvz3.com/c/202927/329145/  Content Tool Kit

https://jvz6.com/c/202927/382663/    ReviewReel

https://jvz3.com/c/202927/383865/     QR Verse Bundle

https://jvz4.com/c/202927/379307/    VIADZ Ad Template

https://jvz2.com/c/202927/383051/    EngageYard Ad Creator

https://jvz4.com/c/202927/381011/   Videevolve

https://jvz4.com/c/202927/383751/  Local Leader Bundle

https://jvz8.com/c/202927/383119/   Tonai Voice Content

https://jvz2.com/c/202927/383848/   Vocalic Commercial

https://jvz3.com/c/202927/383483/  Dropshiply Store Creator

https://jvz6.com/c/202927/384025/  Levidio Royal Podcasting

https://jvz6.com/c/202927/383094/  Develop Self Empowerment

https://jvz1.com/c/202927/379223/   Hostley Domain Creator

https://jvz6.com/c/202927/383447/   Mech Forex Robot

https://jvz4.com/c/202927/383177/   Motion Kingdom Studio

https://jvz8.com/c/202927/144577/   Forex Blizz Trading

https://jvz3.com/c/202927/382851/  AdRaven

https://jvz2.com/c/202927/383307/   Animaxime V2

https://jvz8.com/c/202927/375692/  Promovidz Promotion Videos

https://jvz3.com/c/202927/381148/  AffiliateMatic

https://jvz4.com/c/202927/379051/  CanvaKitz Business Templates

https://jvz1.com/c/202927/383113/  Agencyscale Business Agency

https://jvz3.com/c/202927/347847/  Pitchdeck Professional Presentations

https://jvz2.com/c/202927/381179/   YTSuite YouTube Ads Campaigns

https://jvz8.com/c/202927/382455/     Living an International Life

https://jvz1.com/c/202927/188236/    Galactic Dimension backgrounds

https://jvz6.com/c/202927/381749/    Xinemax Hollywood Creator

https://jvz3.com/c/202927/381194/   DFY Suite 4.0 Agency

https://jvz4.com/c/202927/381231/    Appowls Mobile Apps

https://jvz1.com/c/202927/381935/   Ezy Multi Stores

https://jvz3.com/c/202927/381950/  TrafficForU

https://jvz2.com/c/202927/381556/  WOW Backgrounds

https://jvz2.com/c/202927/381685/   Your 3DPal

https://jvz6.com/c/202927/381617/   Forex Joustar

https://jvz2.com/c/202927/381129/   Ultrafunnels A.I

https://jvz3.com/c/202927/128215/   DUX Forex Signals

https://jvz3.com/c/202927/381003/   Trendio Keyword Content

https://jvz1.com/c/202927/381439/  FX Goldminer

https://jvz2.com/c/202927/380937/  Linkomatic

https://jvz2.com/c/202927/378775/  Pixal 2.022

https://jvz1.com/c/202927/379983/   VidVoicer

https://jvz6.com/c/202927/380087/   Big Audio Club

https://jvz1.com/c/202927/379995/  Podcast Advantage

https://jvz8.com/c/202927/380159/  Reputor

https://jvz6.com/c/202927/379863/  TubePal

https://jvz4.com/c/202927/380543/  Local Sites

https://jvz1.com/c/202927/369500/   PodKastr Commercial

https://jvz6.com/c/202927/351606/ Insta Keyword

https://jvz1.com/c/202927/376325/   Facedrip

https://jvz8.com/c/202927/374505/  7 Minutes Kit

https://jvz6.com/c/202927/383057/  Aweber Crash Course

https://jvz3.com/c/202927/46987/   WP Simulator

https://jvz8.com/c/202927/379995/  Podcast Advantage

https://jvz2.com/c/202927/380692/  Boost Optimism

https://jvz1.com/c/202927/36517/   Superior Muscle Growth

https://jvz6.com/c/202927/379480/  TV Boss Fire

https://jvz1.com/c/202927/379455/  Webprimo Website Builder

https://jvz2.com/c/202927/379339/  LocalCentric

https://jvz4.com/c/202927/378683/  WebCop

https://jvz3.com/c/202927/384619/  Agency Client Finder

https://jvz8.com/c/202927/384625/  Power Reviews

https://jvz8.com/c/202927/380933/   Survai

CDC Approves COVID-19 Vaccines For Children Under 5

U.S. health advisers on Saturday recommended COVID-19 vaccines for infants, toddlers and preschoolers — the last group without the shots.The advisers to the Centers for Disease Control and Prevention unanimously decided that coronavirus vaccines should be opened to children as young as 6 months. On Saturday afternoon, CDC Director Rochelle Walensky signed off on the panel’s recommendation.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against COVID-19,” Walensky said in a statement. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can. I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”

HHS Secretary Xavier Becerra released a statement calling the CDC’s move a “major milestone.”

“Thanks to the FDA and CDC’s rigorous, comprehensive, and independent review of the data, and their strict commitment to following the science, we are reaching another major milestone in our efforts to protect more children, their families, and our communities as we work to end the pandemic,” Becerra said. “We are following the data and science as we make sure all Americans are eligible and have access to COVID-19 vaccines and boosters to prevent severe disease and save lives. Based on CDC and FDA actions, we now know that vaccination for our children 6 months through 5 years old is safe and effective and we are ready to get millions of children vaccinated.”

The White House also weighed in on the decision in a statement calling the CDC’s decision a “monumental step forward in our nation’s fight against the virus.””For parents all over the country, this is a day of relief and celebration,” President Biden said in the statemente. “As the first country to protect our youngest children with COVID-19 vaccines, my Administration has been planning and preparing for this moment for months, effectively securing doses and offering safe and highly effective mRNA vaccines for all children as young as six months old.

“While the Food and Drug Administration OKs vaccines, it’s the CDC that decides who should get them. The government has been gearing up for the start of the shots early next week, with millions of doses ordered for distribution to doctors, hospitals and community health clinics around the country. Roughly 18 million kids will be eligible, but it remains to be seen how many will ultimately get the vaccines. Less than a third of children ages 5 to 11 have done so since vaccination opened up to them last November.

Two brands — Pfizer and Moderna — got the green light Friday from the FDA. The vaccines use the same technology but are being offered at different dose sizes and number of shots for the youngest kids.

Ticker Security Last Change Change %
PFD FLAHERTY & CRUMRINE PREFERRED INC 12.30 -0.07 -0.57%
MRNA MODERNA INC. 128.03 +6.95 +5.74%

Pfizer’s vaccine is for 6 months through 4 years. The dose is one-tenth of the adult dose, and three shots are needed. The first two are given three weeks apart, and the last at least two months later. Moderna’s is two shots, each a quarter of its adult dose, given about four weeks apart for kids 6 months through 5. The FDA also approved a third dose, at least a month after the second shot, for kids with immune conditions that make them more vulnerable to serious illness.

Two doses of Moderna appeared to be only about 40% effective at preventing milder infections at a time when the omicron variant was causing most COVID-19 illnesses. Pfizer presented study information suggesting the company saw 80% with its three shots. But the Pfizer data was so limited — and based on such a small number of cases — that experts and federal officials say they don’t feel there is a reliable estimate yet.

Hospitalizations surged during the omicron wave. Since the start of the pandemic, about 480 children under age 5 are counted among the nation’s more than 1 million COVID-19 deaths, federal data show. “It is worth vaccinating, even though the number of deaths are relatively rare, because these deaths are preventable through vaccination,” said Dr. Matthew Daley, a Kaiser Permanente Colorado researcher who sits on the advisory committee.

U.S. officials expect most shots to take place at pediatricians’ offices. Many parents may be more comfortable getting the vaccine for their kids at their regular doctor, White House COVID-19 coordinator Dr. Ashish Jha said. He predicted the pace of vaccination to be far slower than it was for older populations.

Pediatricians, other primary care physicians and children’s hospitals are planning to provide the vaccines. Limited drugstores will offer them for at least some of the under-5 group. U.S. officials expect most shots to take place at pediatricians’ offices. Many parents may be more comfortable getting the vaccine for their kids at their regular doctor, White House COVID-19 coordinator Dr. Ashish Jha said. He predicted the pace of vaccination to be far slower than it was for older populations.

“We’re going see vaccinations ramp up over weeks and even potentially over a couple of months,” Jha said. It’s common for little kids to get more than one vaccine during a doctor’s visit. In studies of the Moderna and Pfizer shots in infants and toddlers, other vaccinations were not given at the same time so there is no data on potential side effects when that happens. But problems have not been identified in older children or adults when COVID-19 shots and other vaccinations were given together, and the CDC is advising that it’s safe for younger children as well.

About three-quarters of children of all ages are estimated to have been infected at some point. For older ages, the CDC has recommended vaccination anyway to lower the chances of reinfection.Experts have noted re-infections among previously infected people and say the highest levels of protection occur in those who were both vaccinated and previously infected. The CDC has said people may consider waiting about three months after an infection to be vaccinated.

By

Source: CDC approves COVID-19 vaccines for children under 5 | Fox Business

Related contents:

As Medication Abortion Becomes Dominant, Red States Restrict Pills

The abortion drug mifepristone was approved by the FDA more than 20 years ago. The FDA recently relaxed some of the rules for dispensing the drug. Now, some legislatures are trying to restrict access.

For most of the almost 50 years since the Roe v Wade Supreme Court decision legalized abortion nationwide, clinics have been the focus of the battle over abortion rights.

Protesters gather outside on sidewalks. And Republican state lawmakers try to regulate what happens inside — through laws restricting which healthcare providers can perform abortions, the kind of counseling required and which procedures are allowed.

But now, more than half of abortions are taking place with pills.

“For a lot of people, having the option of having an abortion in the privacy and comfort of their own home is appealing,” said Rachel K. Jones, a research scientist with the Guttmacher Institute, which supports abortion rights.

According to data released by Guttmacher earlier this year, abortion pills – not surgical procedures – accounted for 54 percent of abortions in 2020. That makes medication abortion the dominant choice in the United States for the first time since the Food and Drug Administration approved an abortion pill, mifepristone, more than 20 years ago. It’s part of a two-drug protocol approved to terminate pregnancies up to 10 weeks gestation. That protocol also is prescribed to manage some miscarriages.

During the pandemic, the FDA relaxed rules so that the tightly regulated drug mifepristone could be obtained through telehealth appointments and mail-order pharmacies, rather than in person. That made it easier for patients in some states to get a medication abortion at home. The Biden administration recently made those changes permanent.

Now, Republican lawmakers in several states are pushing back. In South Dakota, Gov. Kristi Noem recently signed legislation designed to restrict access to the drugs.

Already, more than a dozen states restrict limit the use of telemedicine to provide abortion pills. And this year, Planned Parenthood says new restrictions have been introduced in two dozen states, some of which would ban the pills altogether if Roe v Wade is overturned.

In Georgia, Republican state Sen. Bruce Thompson sponsored SB 456, a bill banning abortion pill delivery by mail and requiring doctors to examine patients in person before prescribing them. During floor debate, Thompson said his bill was intended “to protect the cherished doctor-patient relationship.”

But that position is at odds with that of major medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, who’ve long supported easing access to the pills and called for lifting the in-person dispensing requirement.

Thompson opposes abortion rights, but he claims this bill is all about patient safety.

“Why would we not do everything within our power to protect women’s health and safety during this difficult time in their lives?” he said.

But opponents say the bill would make patients less safe. Several lawmakers noted that Georgia is among the states with the highest rates of maternal mortality – and that those death rates are dramatically higher for Black women.

State Sen. Kim Jackson, a Democrat, noted that many people, particularly in rural areas, lack access to pregnancy care.

“What’s really cruel about this bill is that those who are already the most vulnerable are the ones who are most likely to be burned by this injustice,” Jackson said. “People who are poor, people who live in rural communities. People with disabilities, and people of color.”

The bill passed Georgia’s state senate on March 1 and is awaiting a vote in the House.

“As soon as the FDA made medication abortion more accessible, Georgia pretty much turned around and was like, ‘No, we actually want to make it really difficult for people to get one,'” said K. Agbebiyi, a Georgia-based advocate with the reproductive rights group URGE, which is fighting the bill.

Agbebiyi said medication abortion could become the only option for a growing number of people in states where clinics are few and far between because of abortion restrictions.

“We know, and our opponents know, that medication abortion is going to grow in popularity if Roe is overturned,” Agbebiyi said. “And that’s precisely why they’re trying to put as many barriers in place as possible.”

It’s more difficult to put up barriers on the internet, where abortion pills are available through mail-order pharmacies and other groups.

Ushma Upadhyay, a reproductive health researcher at the University of California, San Francisco, warned that if states try to block access to abortion pills, patients will find them online without a doctor’s help.

“That is what I’m concerned about,” she said. “It is extremely safe, but all patients should have the access to clinical support if they need it, if they have questions about how to take it, or whether what’s happening is normal.”

Meanwhile, some states are trying to make access to medication abortion easier. A bill moving forward in Delaware would allow a wider array of healthcare providers to prescribe the pills to their patients.

By:

Source: Republican state lawmakers are working to restrict access to abortion pills. : NPR

.

Critics:

By: Shefali Luthra

“Medication abortion is the existential threat of the anti-abortion movement,” said Greer Donley, an assistant professor at the University of Pittsburgh Law School who specializes in laws surrounding medication abortion access. “When they’re on the precipice of getting the Supreme Court to overturn Roe v. Wade, there’s a technological advance that has made it impossible to control abortions.” 

Texas, which is so far the only state that has ended access to abortions after six weeks of pregnancy, provides some insight. The number of Texans receiving abortions has only fallen somewhat — a far larger number of people are now making journeys out of state or ordering medication abortion pills online from the European nonprofit Aid Access, which operates outside the U.S. health care system but has worked to provide Americans with telemedicine-based medication abortions since 2018.

In a post-Roe world, the options would likely look different. With more states banning or severely restricting abortion access, travel likely poses a greater burden, especially for people who live where neighboring states also have legislatures that have restricted access. But health care providers in states where abortion rights are protected could, under the new FDA guidance, could potentially prescribe pills through a phone call or video-chat and mail them to people in other states.

There are accessibility questions. Not everyone has sufficient internet access to find a virtual provider, noted Abigail Aiken, an associate professor at the University of Texas at Austin who has studied the Texas law’s impact on medication abortion requests. And not everyone knows about services like Aid Access or other ways to navigate the health care system and find an out-of-state provider.

.

The Coronavirus Crisis

More Patients Seek Abortion Pills Online During Pandemic, But Face Restrictions

Consider This from NPR

The New Texas Abortion Law Is Putting Some Patients In Danger

National

With Abortion Restrictions On The Rise, Some Women Induce Their Own

More Remote Working Apps:

https://quintexcapital.com/?ref=arminham     Quintex Capital

https://www.genesis-mining.com/a/2535466   Genesis Mining

http://www.bevtraders.com/?ref=arminham   BevTraders

https://jvz8.com/c/202927/369164  prime stocks

https://jvz3.com/c/202927/361015  content gorilla

https://jvz8.com/c/202927/366443  stock rush

https://jvz1.com/c/202927/373449  forrk

https://jvz3.com/c/202927/194909  keysearch

https://jvz4.com/c/202927/296191  gluten free

https://jvz1.com/c/202927/286851  diet fitness diabetes

https://jvz8.com/c/202927/213027  writing job

https://jvz6.com/c/202927/108695  postradamus

https://jvz1.com/c/202927/372094  stoodaio

https://jvz4.com/c/202927/358049  profile mate

https://jvz6.com/c/202927/279944  senuke

https://jvz8.com/c/202927/54245   asin

https://jvz8.com/c/202927/370227  appimize

https://jvz8.com/c/202927/376524  super backdrop

https://jvz6.com/c/202927/302715  audiencetoolkit

https://jvz1.com/c/202927/375487  4brandcommercial

https://jvz2.com/c/202927/375358  talkingfaces

https://jvz6.com/c/202927/375706  socifeed

https://jvz2.com/c/202927/184902  gaming jobs

https://jvz6.com/c/202927/88118   backlink indexer

https://jvz1.com/c/202927/376361  powrsuite

https://jvz3.com/c/202927/370472  tubeserp

https://jvz4.com/c/202927/343405  PR Rage

https://jvz6.com/c/202927/371547  design beast

https://jvz3.com/c/202927/376879  commission smasher

https://jvz2.com/c/202927/376925  MT4Code System

https://jvz6.com/c/202927/375959  viral dash

https://jvz1.com/c/202927/376527  coursova

https://jvz4.com/c/202927/144349  fanpage

https://jvz1.com/c/202927/376877  forex expert

https://jvz6.com/c/202927/374258  appointomatic

https://jvz2.com/c/202927/377003  woocommerce

https://jvz6.com/c/202927/377005  domainname marketing 

https://jvz8.com/c/202927/376842  maxslides

https://jvz8.com/c/202927/376381  ada leadz

https://jvz2.com/c/202927/333637  eyeslick

https://jvz1.com/c/202927/376986  creaite contentcreator

https://jvz4.com/c/202927/376095  vidcentric

https://jvz1.com/c/202927/374965  studioninja

https://jvz6.com/c/202927/374934  marketingblocks

https://jvz3.com/c/202927/372682  clipsreel

https://jvz2.com/c/202927/372916  VideoEnginePro

https://jvz1.com/c/202927/144577  BarclaysForexExpert

https://jvz8.com/c/202927/370806  Clientfinda

https://jvz3.com/c/202927/375550  Talkingfaces

https://jvz1.com/c/202927/370769  IMSyndicator

https://jvz6.com/c/202927/283867  SqribbleEbook

https://jvz8.com/c/202927/376524  superbackdrop

https://jvz8.com/c/202927/376849  VirtualReel

https://jvz2.com/c/202927/369837  MarketPresso

https://jvz1.com/c/202927/342854  voiceBuddy

https://jvz6.com/c/202927/377211  tubeTargeter

https://jvz6.com/c/202927/377557  InstantWebsiteBundle

https://jvz6.com/c/202927/368736  soronity

https://jvz2.com/c/202927/337292  DFY Suite 3.0 Agency+ information

https://jvz8.com/c/202927/291061  VideoRobot Enterprise

https://jvz8.com/c/202927/327447  Klippyo Kreators

https://jvz8.com/c/202927/324615  ChatterPal Commercial

https://jvz8.com/c/202927/299907  WP GDPR Fix Elite Unltd Sites

https://jvz8.com/c/202927/328172  EngagerMate

https://jvz3.com/c/202927/342585  VidSnatcher Commercial

https://jvz3.com/c/202927/292919  myMailIt

https://jvz3.com/c/202927/320972  Storymate Luxury Edition

https://jvz2.com/c/202927/320466  iTraffic X – Platinum Edition

https://jvz2.com/c/202927/330783  Content Gorilla One-time

https://jvz2.com/c/202927/301402  Push Button Traffic 3.0 – Brand New

https://jvz2.com/c/202927/321987  SociCake Commercial

https://jvz2.com/c/202927/289944  The Internet Marketing Newsletter PLR Monthly Membership

https://jvz2.com/c/202927/297271  Designa Suite License

https://jvz2.com/c/202927/310335  XFUNNELS FE Commercial Drag-n-Drop Page Editor

https://jvz2.com/c/202927/291955  ShopABot

https://jvz2.com/c/202927/312692  Inboxr

https://jvz2.com/c/202927/343635  MediaCloudPro 2.0 – Agency Rights

https://jvz2.com/c/202927/353558  MyTrafficJacker 2.0 Pro+

https://jvz2.com/c/202927/365061  AIWA Commercial

https://jvz2.com/c/202927/357201  Toon Video Maker Premium

https://jvz2.com/c/202927/351754  Steven Alvey’s Signature Series 3rd Installment

https://jvz2.com/c/202927/344541  Fade To Black

https://jvz2.com/c/202927/290487  Adsense Machine

https://jvz2.com/c/202927/315596  Diddly Pay’s DLCM DFY Club

https://jvz2.com/c/202927/355249  CourseReel Professional

https://jvz2.com/c/202927/309649  SociJam System

https://jvz2.com/c/202927/263380  360Apps Certification Masterclass

https://jvz2.com/c/202927/359468  LocalAgencyBox

https://jvz2.com/c/202927/377557  Instant Website Bundle

https://jvz2.com/c/202927/377194  GMB Magic Content

https://jvz2.com/c/202927/376962  PlayerNeos VR

Hydrogel Injected Into Fat Stores Fights Obesity From Within

Next-generation therapies that fight obesity could come in many forms, but one example from Nanyang Technological University that uses a unique combination of light and metabolic function to break down fat has some unique advantages.

The team’s solution consists of a hydrogel that can be injected into fat deposits and subjected to near-infrared light, with obese mice showing up to a 54-percent fat reduction following treatment.

The function of this new technology hinges on a protein called TRPV1, which plays an important role in our metabolism. This protein can trigger the conversion of white fat, the type that stores excess calories in beer bellies and love handles, into brown fat.

This is the type of fat that the body readily burns for energy and warmth, and as such a lot of anti-obesity research focuses on therapies that can initiate this conversion.

TRPV1 activity also promotes the breaking down of fat droplets into fatty acids that can be used by the converted brown fat to burn calories, or be broken down in the bloodstream through a process called lipolysis. Further, the protein stimulates the secretion of a hormone that improves metabolism of glucose and lipids in the liver and muscles, while also improving insulin sensitivity.

Setting out to develop a therapy that targets TRPV1, the researchers created a hydrogel containing copper sulphide nanoparticles that activates the protein in response to light, and a drug approved by the FDA that can stimulate browning of fat tissues.

A biocompatible polymer was also added to keep the hydrogel in a gel-like state after injection, slowly releasing its contents over several days. Obese mice with hallmarks of metabolic disease had the hydrogel injected into their subcutaneous fat, with near-infrared light then shone onto the site of the injection for five minutes.

This took place each day for three days, followed by four days of rest, for a two-week period, leading to a 5.5-percent reduction in the animals’ body weight, compared to a 9.5-percent increase seen among a control group.  The treated mice also showed a 40-percent reduction in subcutaneous fat, a 54-percent drop in visceral fat, a 54-percent reduction in cholesterol and 65-percent drop in insulin resistance.

“Through lab experiments, we found that this approach not only resulted in 40 to 54 per cent fat reduction in obese mice, but also significantly improved their metabolism, which is key to reducing the risk of metabolic conditions such as heart disease, stroke and type 2 diabetes,” said study author Chen Peng.

“Though this method makes use of heat converted from near infrared light to burn subcutaneous fat, we found no thermal injury to the skin.” The scientists still have much to do to convert these promising results into therapies to tackle obesity and metabolic dysfunction in humans.

However, the early signs indicate that it could come to fill a gap in existing treatments for these conditions that carry a risk of side effects or are prohibitively expensive. “All FDA-approved medications for obesity indirectly act on the brain to suppress appetite or on the digestive system to reduce fat absorption,” said Peng.

Most of them have been withdrawn from the market due to their serious side effects. Procedures performed in clinics to remove fat in targeted areas have shown to be effective, but they come with risks and high cost, and do not improve body metabolism. In contrast, our therapeutic approach focuses on remodeling white fat tissue, which is the root of the evil.”

Nick Lavars
Nick Lavars

Nick has been writing and editing at New Atlas for over six years, where he has covered everything from distant space probes to self-driving cars to oddball animal science. He previously spent time at The Conversation, Mashable and The Santiago Times, earning a Masters degree in communications from Melbourne’s RMIT University along the way

Source: Hydrogel injected into fat stores fights obesity from within

.

More contents:

Requirement and Development of Hydrogel Micromotors towards Biomedical Applications

Xinyi Lin et al., Research, 2020

Dynamic Colloidal Photonic Crystal Hydrogels with Self-Recovery and Injectability

Yue Ma et al., Research, 2021

Connecting Dots

GenomeWeb, 2012

Put the power of 24/7 digital addiction therapy into patient’s hands with reSET and reSET-O

reSET and reSET-O are brought to you by Pear Therapeutics

Adding reSET-O to outpatient therapy is proven to significantly improve the rates of patients continuing with their addiction treatment

reSET and reSET-O are brought to you by Pear Therapeutics

reSET is a 12-week Prescription Digital Therapeutic that is proven to retain patients in addiction treament longer than treatment as usual

Bizarre radio signal repeating every 18 minutes discovered in Milky Way

James Webb Space Telescope reaches deep-space destination

The electric XC40. For a clear monthly fee. Subscribe online now.Care by Volvo

Pfizer Says Its Vaccine is 90.7% Effective Against Symptomatic Covid-19 In Children Ages 5 To 11

Bridgette Melo, 5, holds the hand of her father, Jim Melo, during her inoculation of one of two reduced 10 ug doses of the Pfizer BioNtech COVID-19 vaccine during a trial at Duke University in Durham, North Carolina September 28, 2021 in a still image from video. Video taken September 28, 2021. Shawn Rocco/Duke University/Handout via REUTERS NO RESALES. NO ARCHIVES. THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY.

In a new document posted ahead of a key meeting of the US Food and Drug Administration’s vaccine advisers, Pfizer says its vaccine is safe and 90.7% effective against symptomatic Covid-19 in children ages 5 to 11.

In the trial, which included around 2,000 children, there were three Covid-19 cases among the group that received the vaccine and 16 cases in the placebo group. In the trial, twice as many children received the vaccine as the placebo.

Pfizer/BioNTech are seeking FDA emergency use authorization of a two-dose regimen of their 10-microgram dose for children ages 5 to 11. The two doses would be administered three weeks apart. Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and generated a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11.

Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet October 26 to discuss whether to recommend the vaccine for authorization for those ages 5 to 11.

If authorized, this would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.

The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.

This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.

By:

Source: Pfizer says its vaccine is 90.7% effective against symptomatic Covid-19 in children ages 5 to 11 – ABC17NEWS

.

Other Sources:

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com

or by calling 1-800-438-1985.

Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age)

Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection (PDF). Regulation 174 (Report). Medicines and Healthcare products Regulatory Agency (MHRA). 15 December 2020. Archived (PDF) from the original on 16 December 2020. Retrieved 23 April 2021. Burger L (15 March 2020). “BioNTech in China alliance with Fosun over coronavirus vaccine candidate”. Reuters. Archived

%d bloggers like this: