President Donald Trump has admitted that a vaccine is unlikely to be available until after the November 3rd elections, calling the antibody cocktail drug he was given to treat the coronavirus a "cure".
In a video posted on Twitter, Trump addressed the concerns of the American people over a vaccine against the virus, which has killed more than 210,000 people and infected more than 7 million people in the United States alone. The President has repeatedly asked for a vaccine to be available before the election.
“We'll have a great vaccine very soon. I think we should have it before the elections, but honestly it involves politics and that's fine, "Trump said in the video that was filmed outside the White House.
A maskless Trump continued, “They want to play their games. It will be right after the election.
"The FDA acted faster than ever before in history," said Trump. "No president has ever pushed her like me, to be honest."
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President Donald Trump has admitted that a vaccine is unlikely to be available until after the November 3 elections and has falsely labeled the antibody cocktail drug he was given to treat the coronavirus a "cure".
In the same video, Trump mistakenly called the experimental Regeneron drug a "cure". Trump received the drug when he was treated for the virus by Walter Reed over the weekend.
Trump said hundreds of thousands of cans "are almost ready, I have an emergency permit set".
Regeneron, which is passing the experimental drug on to President Trump, has not announced a request for emergency approval for its drug with the Food and Drug Administration (FDA) and has not responded to Dailymail.com's request for comment at the time of publication.
Eli Lilly, who makes a similar competing antibody drug, has requested emergency approval from the FDA for its own combined antibody treatment.
“I think it was a blessing from God that I caught this. It was a blessing in disguise that I caught it because I heard about this drug and it was my suggestion that we try and it was amazing how it worked … and I want you to get it what I have, ”said Trump.
The president did not reveal details of how he intended to clear Regeneron's antibody cocktail, and there is no data to suggest the drug is a cure.
The presidents are also not authorized to approve medicinal products under regulatory law.
Earlier this week, the White House approved FDA rules making it nearly impossible for the agency to approve an emergency shot before Election Day.
Trump said an emergency approval for Regeneron's antibody drug (pictured left, in development) was "pending". The company has not applied for FDA approval. Eli Lilly is doing a similar therapeutic combination (right picture, in development) and applied for emergency approval on Wednesday. Trump was not treated with Lilly's drug
Talking about the Regeneron treatment he had received and his competitor's antibody treatment, Trump said, “We got these drugs from Eli Lilly and others that are so good that I think they are – remember them will say they are therapeutic Some people don't know how to define therapeutics – but I see it differently, for me it's a cure. & # 39;
Regeron published its first data from trials with its antibody cocktail REGN-COV2 last week.
REGN-COV2 is a "cocktail" of two laboratory-made versions of immune proteins that the body naturally develops to fight off COVID-19 once exposed.
Coronavirus patients who weren't sick enough to be hospitalized and treated with the drug saw their viral loads drop twice as much as those who received placebo.
WHAT TRUMPS HEALTH UPDATE SAYS – AND WHAT NOT
By Natalie Rahhal, US health editor
"HIS PHYSICAL TEST AND VITAL SIGNS, INCLUDING OXYGEN SATURATION AND BREATHING RATE, ARE ALL STABLE AND IN THE NORMAL RANGE"
Measured with a pulse oximeter, the normal oxygen saturation values are between 95 and 100 percent.
Trump had to be given oxygen twice after falling below 95 percent, including a dip below 94 percent.
A normal, healthy adult breathes around 12 to 16 breaths per minute.
But it's not clear what Trump's normal, dormant vital signs were before he tested positive for COVID-19, and he told White House doctor Dr. Sean Conley, not given permission to share a display of his stats since his diagnosis.
"NOW HE IS FEVER-FREE FOR MORE THAN 4 DAYS, SYMPTOM-FREE FOR MORE THAN 24 HOURS AND HAS NEEDED OR RECEIVED NO ADDITIONAL OXYGEN, SINCE THE FIRST HOSPITAL
Dr. Conley said late Friday morning that President Trump caused a "high fever". We don't know how high his fever got, what his normal resting body temperature is (it's usually between 97 and 99 ° F), or when exactly Dr. Conley has stopped thinking of it as "high".
During a press conference on Tuesday, Dr. Conley told reporters that Trump hadn't had any antipyretic medication in over 72 hours.
Noticeably, Wednesday's statement made no mention of drugs that could artificially keep the president's temperature below 100.4 ° F (the CDC definition of a fever).
Dr. Conley's statement outlines Trump's condition in terms that reflect the CDC's criteria for when a COVID-19 patient can be safely back with others – but not meet them:
- 10 days since symptoms first appeared and
- 24 hours without a fever and without antipyretic drugs
- Other symptoms of COVID-19 are improving
According to official White House statements, it has only been six days since Trump's first symptoms appeared. Fever or none, the CDC still sees him at risk of infecting countless others in the White House.
Dr. Conley had previously acknowledged that Trump's oxygen levels had suddenly dropped twice – which confused his statement that he hadn't needed oxygen since his first hospital stay.
& # 39; THE PRESIDENT'S LABS DEMONSTRATED DETECTABLE LEVELS OF SARS-CoV-2 IgG ANTIBODIES FROM LABS DRAWN ON MONDAY; Initial IgG antibodies … were undetectable. & # 39;
The body makes two categories of antibodies in response to pathogens, including the virus that causes COVID-19: IgM and IgG antibodies.
IgM antibodies emerge and fade faster and, by and large, offer very limited protection against re-infection.
IgG antibodies generally offer more sustained protection, although we don't know how long or how effective their protection is.
The vast majority of patients will develop antibodies of both types. It is normal for a patient to start developing IgM and IgG antibodies as early as the first week of infection.
IgG antibodies are usually generated about a week after infection, peak within about three weeks, and appear to last about three months – although studies are currently in progress.
However, Trump also received Regeneron's antibody cocktail drug on Thursday, which he used to artificially introduce antibodies into his body.
"Most standard tests for IgG would not differentiate (between) endogenous (homemade) antibodies and those provided by our therapy," Regeneron said in a statement to DailyMail.com.
"However, given the volume of IgG antibodies released in our therapy and the timing of these tests, it is likely that the second test will detect REGN-COV2 antibodies."
In other words, it is very likely that the antibodies detected in Trump have nothing to do with his own immune response, but are artificial immune cells from the experimental drug he was given.
Likewise, there is no way of knowing for sure whether the drug is working and is responsible for the anti-infection antibodies that would be detectable in any way in most patients at this point in the course of their illness – regardless of their prognosis.
People who received the antibody treatment recovered and in about half the time people who received the dummy treatment had less or no symptoms to reach this level of improvement.
None of the patients in the study – regardless of whether they received the antibody cocktail or a placebo – died. Therefore, it cannot be determined whether this will reduce the risk of someone dying from COVID-19.
Regeneron has not disclosed the results of tests for its drug in hospital patients.
Eli Lilly asked the FDA to approve the emergency use of its experimental antibody therapy against coronavirus, the company said on Wednesday.
Its use is based on early results from a study that indicated the drug reduced symptoms, virus levels, hospitalizations, and emergency room visits in patients with mild or moderate COVID-19.
Trump was not treated with Lilly's drug.
In addition to Regeneron's antibody cocktail, the president received Gilead's antiviral remdesivir and the steroid dexamethasone.
Remdesivir and dexamethasone have been shown in clinical studies to reduce mortality from COVID-19.
The FDA has issued an EUA for remdesivir used to treat COVID-19 patients. Dexamethasone did not receive this award although it is approved for other uses. Also, the steroid is only indicated for treating seriously ill patients and can actually harm people with milder cases.
"The president just got what is probably the best medical care anyone could see and which is available to almost no one else in the US," said Dr. Craig Bryan, a psychiatrist at Ohio State University, in a recent interview with DailyMail.com.
President Trump's free-run promise came shortly after he ordered the Departments of Defense and Veterans Affairs to investigate the links between pandemic and suicides.
"If I get sick, I will not get treatment or run into debt that could save my life and possibly the lives of my loved ones," said Dr. Bryan.
"All of these things would, in my opinion, be astronomically more effective for suicide prevention" than the plan to reduce the potential psychological consequences of the pandemic called for by the president over the next 45 days.
Now Trump claims he will make his bespoke treatment course available to everyone in the US for free.
"If you're in the hospital and you're feeling really bad, we're going to work on getting you to have them and get them off, especially if you're a senior, we're going to get you in there quickly," he said.
"I want everyone to get the same treatment as your president because I feel great and I feel perfect."
A five-day remdesivir treatment course costs an estimated $ 3,120.
According to the World Health Organization (WHO), about 20 percent of people who become infected with coronavirus seek some treatment.
On Tuesday, 43,562 new US cases of COVID-19 were reported in the United States, according to Johns Hopkins University.
Treating 20 percent of them with remdesivir would cost the U.S. government about $ 27.2 million – and that rough estimate is only for one day.
Dexamethasone costs only $ 6, but it's only used on seriously ill patients.
Neither Eli Lilly nor Regeneron have given possible price points for their experimental drugs, but while experts have predicted the development of antibodies as the most potentially effective, they have warned that they could be prohibitively expensive.
And all of this on the assumption that the drugs are approved.
Trump switched between praise and criticism of the FDA, the agency that has to issue the approvals he is now promising.
"The FDA has acted faster than ever in history, and there has never been a time (like this), and no president has ever pushed it like I pushed it, to be honest," he said.
His hints of a "cure" have also been accused of urging the FDA to approve the malaria drug, hydroxychloroquine, which Trump was also taking, in an emergency.
That approval had to be withdrawn after data showed that the drug did not offer patients any preventive or therapeutic benefit and, in some cases, may have increased the risk of mortality by causing heart problems.
Trump's rush to approve vaccines has also fueled suspicions about vaccines developed as part of Operation Warp Speed. Half of Americans say they aren't sure they'll get the first shot to prevent COVID-19.
FDA regulators yesterday received stricter coronavirus vaccine regulatory guidelines from the White House to rebuild that trust and put an end to Trump's hopes of approving a vaccine by the November 3rd election.
"They call it therapeutic," Trump said of treatments like Regeneron's antibody cocktail, "but I call it a cure."
“So we have to take them out and take them to the hospital, where people are doing badly. This is way more important than the vaccine, but in vaccines we have a lot of companies in the final stages of vaccines – Johnson & Johnson, Moderna, Pfizer – all big companies, and a lot of them are going to have a great vaccine soon.
"I think we should have it before the election but honestly the politics is involved, that's fine, they want to play their games, it will be right after the election but we did it, nobody else, nobody else it would have ever been able. & # 39;
The United States has not approved vaccines to prevent coronavirus. No shooter has compiled enough data to file an emergency clearance from the FDA.
Only two treatments have been given to EUAs: remdesivir, which offers a moderate reduction in the risk of death, and convalescent plasma, which may offer no benefit.
More than 7.5 million Americans have tested positive for COVID-19. This is seen as an underestimation.
Yesterday 705 Americans lost their lives to the virus. To date, at least 211,513 people have died from COVID-19, and the toll is expected to exceed 363.00 before the day of inauguration.
WHAT ARE THE DRUGS TRUMPF TREATED AND WHAT ARE THE SIDE EFFECTS?
President Trump has received at least three effective drugs since announcing he tested positive for COVID-19 Thursday night: Regeneron's cocktail of laboratory-made antibodies, the antiviral remdesivir, and the steroid dexamethasone.
Two of these drugs are still experimental for the treatment of COVID-19 and have received emergency approval from the Food and Drug Administration (FDA).
And the White House doctor, Dr. Sean Conley, admitted Monday he would not disclose every single drug the president is currently receiving (citing laws protecting the privacy of HIPAA patients, suggesting Trump himself is giving Dr. Conley permission has to disclose some of his drugs, but not all of them).
Remdesivir, dexamethasone, and the antibody cocktail are all in ongoing trials – but it's unclear whether anyone other than the U.S. Commander in Chief has ever been treated with all three.
These three drugs are "as far as we know (about the President's regimen) – but I found it all really confusing based on the reports," said Dr. Mark Poznansky, an infectious disease specialist at Massachusetts General Hospital, told DailyMail.com.
When asked if there was a precedent for treating a COVID-19 patient with all three drugs, Dr. Poznansky: "No."
"But the individual decisions are based on the individual patient and all bets are void when dealing with the President, the Commander in Chief," he added.
"The implication is that doctors believe the risk of using these is outweighed by the potential benefits."
And while we have some clarity about the possible side effects of each drug, it is a mystery how they might interact, "because they just haven't been used often enough … we don't know about the combination," Dr. Said Poznansky.
But even on their own, the side effects of these drugs could be of particular concern to the President as the steroid can cause mood swings, confusion, and aggression.
The drugs he's been treated with and their possible side effects are:
REGENERON'S EXPERIMENTAL ANTIBODY COCKTAIL MEDICINAL
IF HE HAS IT: Trump received a single dose of 8 grams of Regeneron's cocktail of laboratory-made antibodies on Friday.
WHAT IT DOES: REGN-COV2 is a combination of two laboratory-made versions of antibodies that prevent coronavirus from entering cells.
One of the antibodies in the "Cocktail" is based on an antibody that mice produce in response to the coronavirus, while the other is based on an antibody that was isolated from one of the first US COVID-19 patients.
The hope is that treatment will lower the viral load, prevent the body from overrun and mess up the immune system, and prevent the infection from getting serious.
WHAT THE DATA SAY: REGN-COV2 is still in the early stages of study, but initial data from its clinical trial showed that it drastically reduced viral loads within a week and increased recovery time in patients who were not sick enough to be hospitalized halved.
Regeneron has not yet studied the drug in seriously ill patients.
THE POSSIBLE SIDE EFFECTS: The main concern is that these types of treatment occasionally induce "antibody-dependent amplification," which means that the therapeutic intended will actually help the virus enter cells.
So far, the studies do not suggest that REGN-COV2 causes this phenomenon.
Antibody treatments can also cause allergic reactions such as anaphylaxis, as well as fever, chills, nausea, diarrhea, weakness, headache, and low blood pressure.
REMDESIVIR, GILEAD'S ANTIVIRAL MEDICINAL
IF HE HAS IT: President Trump received his first dose of a five-day treatment course Friday night after being transferred from the White House to Walter Reed National Medical Center.
He has since received his second and third doses of the drug.
WHAT IT DOES: Remdesivir is an antiviral therapy that was originally developed to treat Ebola.
Scientists aren't entirely sure why, but it helps prevent the coronavirus from making more copies of itself.
WHAT THE DATA SAY: Late clinical trials with remdesivir found that patients treated with the drug were more likely to recover within 11 days than those who did not receive the drug.
Their chances of survival were 40 percent better. In May, the drug was the first to receive emergency approval from the FDA for the treatment of critically ill patients. This approval has now been extended to all hospital patients.
THE POSSIBLE SIDE EFFECTS: It can cause nausea, vomiting, chills, sweating, or drowsiness. The drug can also affect liver function, which means patients must be closely monitored.
There was some evidence that Trump's liver and kidney function wasn't optimal last night, but Dr. Conley said Monday the president was just "dehydrated".
DEXAMETHASONE, THE $ 6 STEROID WITH COMMON PSYCHIATRIC SIDE EFFECTS
When he got it: The president received a dose of dexamethasone on Saturday after developing a high fever and twice his blood oxygen levels falling below 94 percent.
WHAT IT DOES: Dexamethasone is a cheap steroid that is known to suppress inflammation. It is already approved for use under other conditions in the United States.
WHAT THE DATA SAY: Although it hasn't received an emergency approval in the U.S., dexamethasone is the most promising treatment for coronavirus to date.
In a large UK study, the steroid reduced the risk of death for patients sick enough to need breathing equipment by 36 percent by 18 percent for patients who only need supplemental oxygen.
However, it appeared harmful in earlier stages or in milder cases of illness: 18 percent of drug users died versus 14 percent of usual caregivers.
Because of this, many doctors were alarmed that President Trump was being treated with the drug because its use indicated that he was either very ill or that doctors were taking a risk giving it to him early on.
THE POSSIBLE SIDE EFFECTS: The steroid is strong and can cause swelling, headache, stomach pain, nausea, weakness, dizziness, trouble sleeping, blurred vision, skin problems, severe allergic reactions including mood swings.
These mood swings include aggression, agitation, and confusion.
"Steroids are always very dangerous drugs," said Dr. Edward Jones-Lopez, an infectious disease specialist at the University of Southern California in Los Angeles, told Reuters.
& # 39; This is why it (dexamethasone) is used in severe to critical patients … There may be neuropsychiatric side effects. These are drugs that we use very, very carefully. & # 39;
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