Take this...... it works

[Leongsam]

FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19​

Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19

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The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus. Health care providers should review the Fact Sheet for detailed information about the use of REGEN-COV for post-exposure prophylaxis.
REGEN-COV also remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible. Learn more about FDA-authorized COVID-19 vaccines.
REGEN-COV may only be used as post-exposure prophylaxis for adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are:

• at high risk for progression to severe COVID-19, including hospitalization or death, and
• not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and
  • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or
  • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)

In general, people are considered fully vaccinated two weeks after their second dose in a two-dose series (the Pfizer or Moderna vaccines) or two weeks after a single-dose vaccine (the Janssen vaccine).
The CDC defines close contact as someone who has been within six feet of an infected person (laboratory-confirmed or a clinically compatible illness) for a cumulative total of 15 minutes or more over a 24-hour period.
People should talk to their health care provider about whether the use of REGEN-COV for post-exposure prophylaxis is appropriate for them.
The primary data supporting the EUA reissuance for post-exposure prophylaxis of COVID-19 are from a Phase 3 trial. The trial was a randomized, double-blind, placebo-controlled clinical trial studying a single dose of REGEN-COV for prevention of COVID-19 in household contacts of individuals infected with SARS-CoV-2. Cases were confirmed using real-time reverse transcription–polymerase chain reaction (RT-PCR), one of the most accurate laboratory methods for detecting, tracking, and studying COVID-19. An 81% reduction in confirmed symptomatic COVID-19 cases was observed with REGEN-COV compared to placebo at day 29 in cases who were RT-PCR negative and seronegative at baseline (the primary analysis population). In the overall trial population, there was a 62% reduction in RT-PCR confirmed symptomatic COVID-19 cases in the REGEN-COV group compared to placebo at day 29.
The most common side effects were injection site reactions. The signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were skin redness (erythema), an uncomfortable, irritating sensation that creates an urge to scratch (pruritus), and ecchymosis (discoloration of the skin resulting from bleeding underneath, caused by bruising). There were no cases of severe hypersensitivity reactions, or potentially life-threatening allergic reactions (such as anaphylaxis).
People who had a previous severe allergic reaction to REGEN-COV should not use it again. Other important information for these trials including other outcomes and side effect information is available in the health care provider fact sheet.
REGEN-COV consists of the monoclonal antibodies casirivimab and imdevimab, administered together. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens, such as viruses like SARS-CoV-2.
The authorized dose for REGEN-COV for both treatment and as post-exposure prophylaxis is 600 mg of casirivimab and 600 mg of imdevimab administered together.

• For treatment, intravenous infusion is strongly recommended; subcutaneous (under the skin) injection is authorized as an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment.
• For post-exposure prophylaxis, either intravenous infusion or subcutaneous injection is appropriate. For individuals who remain at high risk of exposure to another individual with SARS-CoV-2 for longer than 4 weeks, and who are not expected to mount an adequate immune response to full SARS-CoV-2 vaccination, following an initial dose of 600 mg of casirivimab and 600 mg of imdevimab, repeat doses of 300 mg of casirivimab and 300 mg of imdevimab once every 4 weeks are appropriate for the duration of ongoing exposure.

 

[Leongsam]

webmd.com

Monoclonal Antibodies vs. Vaccines vs. COVID-19: What to Know​

8-11 minutes

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Aug. 26, 2021 -- The FDA authorized monoclonal antibody drugs from the companies Regeneron and Eli Lilly in November 2020, but only recently have they attracted more attention as the Delta variant of the virus that causes COVID-19 surges across the U.S.

Clinical trials show that Regeneron’s monoclonal antibody treatment, a combination of two antibodies called casirivimab and imdevimab, reduces COVID-19-related hospitalization or deaths in high-risk patients by about 70%. And when given to an exposed person -- like someone living with an infected person -- monoclonal antibodies reduced their risk of developing an infection with symptoms by 80%.

“As hospitalizations go up nationwide, we have a therapy here that can mitigate that,” says William Fales, MD, medical director of the Michigan Department of Health and Human Services Division of EMS and Trauma. Getting monoclonal antibodies is one of “the best things you can do once you’re positive.”

Whether you’ve just tested positive or been exposed, monoclonal antibodies could help you and your loved ones stave off COVID-19. Here’s what you need to know.

How do they work?​

Monoclonal antibodies are like the antibodies your body makes to fight viruses and other bugs, but they are made in the labs of pharmaceutical companies, like Regeneron. They’re designed to target the coronavirus spike protein. When the antibodies bind to the spike protein, they block the virus from entering your body’s cells, says Lindsay Petty, MD, an infectious disease doctor at the University of Michigan. If the virus can’t enter cells, it can’t make copies of itself and continue spreading within the body.

If a person is already sick, that means monoclonal antibodies prevent them from having severe symptoms that require hospitalization. If someone has been exposed, monoclonal antibodies can fend off the virus to prevent them from becoming sick in the first place.

Monoclonal antibodies were first authorized as an IV and are most commonly given at infusion centers. But a recent study showed they can also be given as an shot into the belly when an IV isn’t as accessible.

As the coronavirus mutates, monoclonal antibodies targeted for the original form of the virus may become less helpful. The U.S. government stopped distribution of Lilly’s monoclonal antibodies, bamlanivimab and etesevimab, after evidence showed they weren’t as effective against new variants of the virus. But other monoclonal antibodies remain helpful.

“Consumers should know that Regeneron [does work] against the Delta variant,” says David Wohl, MD, an infectious disease expert at the University of North Carolina.

How is it different from a vaccine?​

A vaccine helps stimulate and prepare your immune system to respond if or when you are exposed to the virus, Petty says. “Your immune system is ready to create all these antibodies before they are needed.”

Monoclonal antibodies boost the immune system after you are already sick, speeding up your immune response to prevent COVID-19 from getting worse. “But a vaccine does this much easier and much better,” Petty says.

You can think of monoclonal antibodies as guided missiles that target and neutralize the virus, Fales says. But they don't stick around. While monoclonal antibodies are effective for about a month, they are long gone 6 months later, when a vaccine still offers significant protection.

When should you get them?​

Timing is critical with monoclonal antibodies, according to Petty. The earlier they are given, the more effective they are at treating or preventing COVID-19.

They are really most effective within the first 4 to 5 days of symptoms, according to Wohl.

The best thing you can do, Petty says, is get tested as soon as you notice any possible symptoms. And as soon as you test positive, get in touch with your doctor about your interest in monoclonal antibodies either for yourself or others you’ve been in contact with who are at high risk.

Monoclonal antibodies can’t be given after 10 days of symptoms, Petty says. So, “a delay [in testing or seeking out treatment] could mean there’s not a treatment available.”

Who’s eligible for monoclonal antibodies?​

There are two authorized uses for monoclonal antibodies: To treat or stop COVID-19’s progression in a high-risk person who tests positive, and to prevent COVID-19 in a high-risk person who’s been exposed.

To qualify for the treatment, a person must test positive for COVID-19, not be fully vaccinated, have had symptoms for fewer than 10 days, not be hospitalized or on oxygen because of COVID-19, and be at high risk for the disease to get worse.

The FDA has recently expanded what it means to be high-risk for severe COVID-19, Fales says. Many more people now may qualify for monoclonal antibodies, including those with high blood pressure, heart disease, a body mass index (BMI) higher than 30, an autoimmune disorder, people taking immunosuppressant drugs, and people who are pregnant.

The same groups of high-risk people can get monoclonal antibodies to prevent COVID-19 if they have been exposed. If you or a loved one is immunocompromised, based on CDC guidelines, and spent 15 minutes or longer within 6 feet of someone who tested positive, you likely qualify for a preventive monoclonal antibodies infusion.

As for vaccinated folks, there’s no evidence that the treatment doesn’t work or is harmful to them, Fales says. But vaccinated people have a lower risk of getting COVID-19 when exposed, and of developing severe COVID-19 if they do become infected, so they don’t generally qualify for monoclonal antibodies.

In certain cases, a vaccinated person may be eligible to get monoclonal antibodies, Fales says: If they are immunocompromised due to age or another condition and might not build a robust immune response to the vaccine that would protect them in case of exposure, or if they become infected with COVID-19 and their symptoms become significant.

How much does treatment cost?​

The U.S. government has bought doses of Regeneron’s monoclonal antibodies, which are free to patients who qualify. But depending on your insurance coverage, you may be charged for the cost of giving the treatment.

How do I get monoclonal antibodies?​

Since monoclonal antibodies are primarily given in infusion centers, not doctors’ offices, getting access isn’t always straightforward. And many doctors still aren’t very experienced with the treatment, Petty says.

Still, if you or a loved one has tested positive or been exposed and you think you might qualify for treatment, the first step is to contact your doctor. If they are familiar with monoclonal antibodies, they can help you get the treatment and bypass a lot of the work for you, Petty says.

If your doctor isn’t familiar with monoclonal antibodies, you should still talk to them about your interest in treatment. You can use websites from the Department of Health and Human Services and Infusion Centers of America to find a nearby treatment site.

Many of these sites require a referral from a doctor, Fales says. If you don’t have a referral, they often can help you get one if you call ahead, whether through your doctor, a doctor at the infusion center, a telehealth consultation, or a local urgent care clinic.

Can I help relatives in assisted living get it?​

If you believe that a relative in a residential facility -- like a nursing home, assisted living facility, long-term care home, or prison -- has COVID-19 or has been exposed, the first thing you should do is have a conversation with the medical leadership at the facility.

Fales has partnered Michigan-based paramedics with several nursing homes in the state to have monoclonal antibodies delivered to these facilities when there’s an outbreak. It’s also possible for long-term care pharmacies to get monoclonal antibodies to administer in-house. If the medical leadership doesn’t appear to be aware of the treatment, you can use the same websites to find the nearest infusion center and begin coordinating treatment with it.

It's a good idea, Fales says, to find out where monoclonal antibodies are offered in your area, and perhaps talk with your doctor or a high-risk loved one’s doctor about how to get them, to be prepared. The faster you can get the treatment, the more likely it will help.

 

[syed putra]

This probably cost a bomb. Ivermectin is way cheaper.

 

[Leongsam]

Japan turns to antibody cocktails as ‘new weapon’ in pandemic fight​

By

The Bharat Express News
-
August 24, 2021




Senior officials in Japan are increasingly hoping that a ‘cocktail of antibody’ treatment will serve as another mainstay in the country’s fight against COVID-19 after months of vaccine addiction, following the expansion of the scope of drug use beyond hospitalized patients.

The Suga administration relaxed the rules governing its use earlier this month when the health ministry informed municipalities that the cocktail – a combination of two antibodies – can now be used for patients isolated in converted hotels. ad hoc medical facilities. Previously, treatment was limited to hospitalized patients.
The question now is whether the therapy can be extended to outpatients or to those who are asked to self-isolate at home, a change in policy according to some medical experts is needed amid growing reports of people being turned away from the clinic. hospitalization dying at home.

A mixture of monoclonal antibodies casirivimab and imdevimab, intravenous therapy has been shown in clinical trials abroad to be very effective in preventing patients from developing severe symptoms of COVID-19. Its effectiveness in reducing the risk of hospitalization or death by around 70% has raised hopes that it could go a long way in preventing hospitals from being overwhelmed with patients requiring urgent medical attention.

Japan’s approval of the antibody drug, known as Ronapreve, also heralds the advent of a new dimension in its anti-virus strategy, which for months has relied on rapid deployment of the vaccine.

Currently, those eligible for treatment are those patients considered to be at high risk of complications from the virus, such as those aged 50 or older, smokers, and those with obesity, diabetes, and kidney and lung disease. chronic.

Antibody therapy – originally developed by US biotech company Regeneron Pharmaceuticals Inc. and licensed in Japan by Tokyo-based drugmaker Chugai Pharmaceutical Co. Yuriko Koike touted it as “a new weapon” in the industry. battle of the capital against the pandemic.

ALSO READ Suga denies impact of hosting Olympics on wave of virus

The Ministry of Health, however, is more cautious. Although it has allowed the drug to be used for patients in hotels, the ministry rejects any further expansion, citing the possibility of serious side effects which it says make the treatment too risky for patients who cannot. be placed under prolonged medical observation.

An intravenous bag used to deliver Ronapreve monoclonal antibody therapy at a clinic in Worcester, Massachusetts on August 13 | BLOOMBERG

Yet revised guidelines from the Ministry of Health have already prompted some municipalities to start implementing treatment in hotels accommodating COVID-19 patients with relatively mild symptoms.

This decision has been hailed by some as a more effective use of the treatment. Indeed, the antibody cocktail, which must be administered within a week of the onset of symptoms to have any effectiveness, is not necessarily suitable for hospitalized patients, many of whom are already seriously ill.

Local governments that have started applying antibody therapy to patients in hotels, or have expressed their intention to do so, include the prefectures of Tokyo, Fukuoka, Saitama and Osaka.

But none of these prefectures have been able to use the therapy for hotel patients in any meaningful way, with Tokyo, Fukuoka and Osaka each continuing treatment in just one of the many hotels they have opened to COVID patients. -19.

Behind the slow pace of deployment hides the difficulty of recruiting medical personnel capable of administering the treatment, as well as uncertainties about the supply of the drug.

“We were the second prefecture after Tokyo to start giving the cocktail treatment in hotels, but if more municipalities start doing the same, I expect the amount allocated to us will decrease,” Junko Baba said. , a leader of the Fukuoka Prefecture Coronavirus Task Force.

ALSO READ Japanese foreign minister plans talks with new Iranian president for Sunday

“It is not clear how long we will continue to be able to get the amount we want,” she said.

Suga, for his part, insists that the government has secured a “sufficient” amount of supply. He has reportedly purchased 70,000 doses of the drug, and about 200,000 are on their way by the end of this year.

A
mixture of the monoclonal antibodies casirivimab and imdevimab, Ronapreve has been shown in clinical trials abroad to be very effective in preventing patients from developing severe symptoms of COVID-19. | CHUGAI PHARMACEUTICAL CO. / VIA KYODO

Yet the amount available to the government is not infinite, an official from the Ministry of Health’s coronavirus task force stressed, declining to be named.

“We don’t want to have a situation where some local governments are asking too much assuming that the supply of the (antibody drug) is somehow unlimited, which leaves others without enough,” he said, citing lessons learned from procurement. shortages that have hampered the effort to deploy vaccines in some municipalities.

The effectiveness of the cocktail treatment has sparked calls for its use to be extended to newly diagnosed patients at home who are awaiting hospital approval, which the Department of Health takes a dim view at the moment. Despite the high hopes expressed by Suga and Koike on Ronapreve’s potential, the ministry remains generally cautious.

Antibody treatment “could be followed by quite serious reactions,” the health ministry official said. “Not to mention that this is a new drug whose effects on the Japanese are not yet fully understood. Data from clinical trials is also limited.”

A fact sheet released by the U.S. Food and Drug Administration notes that severe hypersensitivity, including anaphylaxis, and other reactions have been observed during and up to 24 hours after infusion of the drug.

ALSO READ With the Olympics over, Suga faces uncertain future over COVID-19 response

“Our position is that the treatment should be carried out under the supervision of doctors,” said the official, explaining the reason why patients treated in hotels, which are essentially a simplified version of hospitals, obtain the drug.

Critics, however, are not convinced. Some are calling for further relaxation of the rules so that outpatients can get treatment at local clinics or that healthcare professionals can be sent to administer the drug intravenously to those who are isolated at home.

“There is some logic in what the Department of Health is saying about the need to keep patients under observation long after the infusion, but I think the benefits of giving the antibody treatment to patients at home outweighs the risks of doing so, “said Tetsuya Matsumoto, professor of public health studies at the International University of Health and Welfare Graduate School, specializing in infectious diseases.

Mastumoto supports the idea of extending the use of the cocktail to patients invited to rest at home and to ambulatory patients. He said monitoring patients at home after the infusion is “difficult but not impossible,” saying it can be done by telling them to report any changes in their health or by asking family members to monitor them.

“My concern is that limiting the use of the cocktail due to undue concerns about side effects is undermining its availability and depriving those who really need it of the opportunity to use it,” he said.

 

[zhihau]

What happened to the cocktail churned out by Sinkie scientists?

 

[Loofydralb]

What happened to the cocktail churned out by Sinkie scientists?

What do you expect from a population that will never earn a Nobel prize?

Anyway is monoclonal treatment available in Sg?

 

[tobelightlight]

My immune system is still the best.. And if u want to take drug if u kanna covid, try invermectin. People reported healing from it. Those who kanna covid in the first place do not have the optimum immune system in the first place.

 

[Leongsam]

My immune system is still the best.. And if u want to take drug if u kanna covid, try invermectin. People reported healing from it. Those who kanna covid in the first place do not have the optimum immune system in the first place.

People die of Covid as a result of their immune systems being strong. Treatment involves suppressing the immune system.

 

[ginfreely]

I just realised I can’t find my posts last night. which bastard owner or moderator deleted my spam of Jeremy Quek @glockman clone @Cottonmouth posts last night while keeping all these spamming scamming posts by your fellow bastards slandering me a real virgin a fake virgin dirty whore? @nayr69sg? @zhihau? @Leongsam? My guess is @nayr69sgbecause he is the most free and sneaky manipulative bastard. Shame on you bastards.

 

[nayr69sg]

People die of Covid as a result of their immune systems being strong. Treatment involves suppressing the immune system.

You can see why regular people find it hard to understand this.

The whole cytokine storm.

Its just like me trying to understand rocket science when I dont have the relevant background knowledge and understanding.

But the funny thing is the medical profession demands that we listen to our patients and respect their views and autonomy to make decisions about their health.

It is like when i go on a spaceX flight as a customet and tell the company and pilots how they should execute the launce to space.

 

[ginfreely]

I just realised I can’t find my posts last night. which bastard owner or moderator deleted my spam of Jeremy Quek @glockman clone @Cottonmouth posts last night while keeping all these spamming scamming posts by your fellow bastards slandering me a real virgin a fake virgin dirty whore? @nayr69sg? @zhihau? @Leongsam? My guess is @nayr69sgbecause he is the most free and sneaky manipulative bastard. Shame on you bastards.

 

[glockman]

It is like when i go on a spaceX flight as a customet and tell the company and pilots how they should execute the launce to space.

OMG, you booked a ticket on a spaceX flight already? WOW!!!

 

[ginfreely]

You can see why regular people find it hard to understand this.

The whole cytokine storm.

Its just like me trying to understand rocket science when I dont have the relevant background knowledge and understanding.

But the funny thing is the medical profession demands that we listen to our patients and respect their views and autonomy to make decisions about their health.

It is like when i go on a spaceX flight as a customet and tell the company and pilots how they should execute the launce to space.

Why dare not answer? Looks like must be you serial liar opportunistic sneaky manipulative son of whore abusing your moderator power again. Answer me! Pui!

 

[tobelightlight]

People die of Covid as a result of their immune systems being strong. Treatment involves suppressing the immune system.

oh my goodness, i think i have to stop here with you.
There is one phrase that i would like to share with you

 

[ginfreely]

Why dare not answer? Looks like must be you serial liar opportunistic sneaky manipulative son of whore abusing your moderator power again. Answer me! Pui!

No answer from @nayr69sg means confirmed plus chop he is the one abusing his power to deal with my spam while he turned a blind eye to son of hooker @glockman aka @Cottonmouth Jeremy Quek spam of me a virgin as slut whore hooker everywhere.

 

[ginfreely]

No answer from @nayr69sg means confirmed plus chop he is the one abusing his power to deal with my spam while he turned a blind eye to son of hooker @glockman aka @Cottonmouth Jeremy Quek spam of me a virgin as slut whore hooker everywhere.

No wonder they are good friends all sons of hookers accusing a virgin aa hooker. Such unkind bastards better don’t be a doctor which is about saving lives.

 

[ginfreely]

oh my goodness, i think i have to stop here with you.
There is one phrase that i would like to share with you

View attachment 121424

You bastard tell that to your fellow bastard son of hooker @glockman ok?

 

[ginfreely]

You bastard tell that to your fellow bastard son of hooker @glockman ok?

The real fakes always think others are faking. A woman cannot be a virgin, must be fake virgin woh. Yet dare not swear if i am not a fake virgin then they be burnt to death. Pui!

 

[ginfreely]

No answer from @nayr69sg means confirmed plus chop he is the one abusing his power to deal with my spam while he turned a blind eye to son of hooker @glockman aka @Cottonmouth Jeremy Quek spam of me a virgin as slut whore hooker everywhere.

No answer from @nayr69sg the serial liar son of hooker the fake that apologized to me say will not be attacking me again but always attacking me in a sneaky way non stop using one opportunity or another. Pui!

 

[ginfreely]

No answer from @nayr69sg the serial liar son of hooker the fake that apologized to me say will not be attacking me again but always attacking me in a sneaky way non stop using one opportunity or another. Pui!

Oh ya @jw5 said he is 99.99% sure that @nayr69sg is a fake doctor and I believe he is a fake indeed.