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Millions of Americans get their COVID-19 vaccines every day, but the United States will always need better treatments that can quell mild or moderate cases of COVID-19 before they get serious.
There are a number of reasons why people can still get sick after being vaccinated. There will be “revolutionary” cases, since COVID-19 vaccines are not 100% effective. Some people will not get the vaccine, which puts others at risk. And new variants or mutations of the virus could make vaccines less effective than they currently are.
In addition, people who have been vaccinated and who later undergo certain types of treatment, such as lymphoma, may have their antibody-producing B cells wiped out.
As of Thursday, more than 12% of the American population had been vaccinated, according to the Centers for Disease Control and Prevention. The United States is currently recording an average of 53,000 new cases per day – a rate which, although well below the January peak, remains high enough to worry public health officials.
“A lot of people have the impression that vaccination is going to solve the problem,” said Dr. John Brooks, a medical epidemiologist at the CDC. “But just look at the flu. We know that every year there are people who get infected with breakthroughs, and that is if they had the vaccine. “
For influenza, four treatments can be prescribed to patients, including GSK from GlaxoSmithKline,
ROG of Relenza and Roche Holdings AG,
Tamiflu, an oral antiviral approved by the Food and Drug Administration in 1999.
Having Tamiflu-type drugs ready to treat people with mild to moderate forms of COVID-19 and prevent them from getting so sick that they end up in the hospital or die could go a long way in slowing the rate of the virus and preventing them from getting so sick that they end up in hospital or die. advance the virus. The United States is returning to normalcy.
Preventing hospitalization and death from COVID-19 are two criteria that companies like Eli Lilly & Co.LLY,
and Regeneron Pharmaceuticals Inc. REGN,
focused on testing their monoclonal antibodies in clinical trials.
Lilly obtained her first emergency use authorization for stand-alone antibody therapy, bamlanivimab, then another for bamlanivimab and etesevimab together, while Regeneron’s cocktail of antibodies, called REGEN-COV, is allowed for adolescents and adults at high risk hospitalization.
Archives (October 2020): Regeneron CEO warns Trump results ‘unique case’ and coronavirus drug needs more testing
But there have been obstacles with regard to these therapies. They may not be as effective against variants like strain B.1.351, which was first identified in South Africa. And patients have had to go to infusion centers to receive these treatments because it is not scientifically possible to package monoclonal antibodies into the type of oral medication that can be purchased at a local pharmacy. (That part of the equation may soon change, with the White House announcing $ 150 million in funding on Wednesday to ensure more equitable access to these therapies.)
“The ideal therapy would be therapy that’s easy to take, easy to master, and inexpensive,” Brooks said. “Monoclonal is wonderful. They really seem to be helping people. But they do require an intravenous drip.
“ The mere existence of a vaccine is not enough ”
Monoclonal antibodies, which have been the only treatment options allowed for people with milder forms of COVID-19 during the pandemic, show great promise, both as treatments for patients who have tested positive for the disease. viruses and to prevent infections. (None of the antibody treatments have been approved to prevent COVID-19 for pre- or post-exposure cases at this time.)
Several drugmakers beyond Lilly and Regeneron are currently conducting clinical trials for antibody treatments, including Vir Biotechnology Inc. VIR,
in partnership with GSK and AstraZeneca AZN,
who announced on Tuesday that the United States had just purchased half a million doses of its still experimental antibody cocktail.
“The mere existence of a vaccine is not enough,” a Vir spokesperson said in an email. “It needs to be available, widely used and effective year after year, even against emerging variants. More than ever, we need active treatments for the variants of concern currently in circulation, as well as any new variants that emerge. “
But the executives of Lilly and Regeneron say they have seen limited use of their antibody treatments since the first authorizations were handed over in November.
A spokesperson for Lilly confirmed that only about one in seven qualified people with COVID-19 are prescribed antibody treatment. And a Regeneron executive said in February that the prescribing guidelines may have been drafted too narrowly to ensure widespread access to the company’s antibody treatment. (The National Institutes of Health and the Infectious Diseases Society of America both updated their guidelines this week to recommend the use of monoclonal antibody treatments.)
“As a country, we are not using these antibodies correctly,” said Dr David Weinrich, head of global clinical development at Regeneron. “In general, there are pockets where doctors have realized the value of these things, but it is not universal. And that, unfortunately, creates disproportionate access to the drug depending on where you are in the country and who your doctor is – it’s not a good scenario.
The intuition of analyst Bernstein Ronny Gal is that lower than expected use of these drugs has more to do with doctors’ expertise or lack thereof. “I suspect the main reason is that people diagnosed with mild cases have little overlap with doctors who often use infusions,” he said in an email.
Towards a Tamiflu for COVID-19
Then there are antivirals, which are the same type of medicine as existing flu treatments, but these options are limited at this time.
The Gilead Sciences Inc. GILD,
Veklury antiviral therapy is only indicated for people sick enough to be hospitalized, and clinical trials have been limited to testing the drug in people who are hospitalized.
It is not the only antiviral candidate to be tested, however. Ridgeback Biotherapeutics and Merck & Co. Inc. MRK,
have an investigational oral antiviral treatment, molnupiravir, which has reduced infection times in about 200 out-of-hospital COVID-19 patients, according to preliminary results from a Phase 2 clinical trial that were announced in March.
“This will be the combined approach of vaccines and antivirals,” said Dr. Bruce Polsky, an infectious disease physician at NYU Langone Hospital on Long Island. “Ideally, it would be an oral medication – an oral medication that you could give to a person when they have symptoms for the first time.”
Norbert Bischofberger – one of the inventors of Tamiflu, which generated nearly $ 3 billion in peak sales during the 2009 swine flu pandemic – is CEO of a biotech start-up called Kronos Bio Inc. KRON,
and had previously worked at Gilead when the company started developing Veklury, then called remdesivir, as an Ebola treatment. Bischofberger sees a parallel between how a drug like Tamiflu is used for influenza and what is needed for this coronavirus.
“In the past, during the winter season, I always traveled with Tamiflu in my luggage,” he says. “When you meet someone in the elevator or someone coughs and sneezes in their face, I go to my hotel room and take Tamiflu. It’s very, very effective.
‘Imagine’ tailor-made antibodies
It is not known at this time how many people are at risk of contracting the virus even after being vaccinated. And while public health experts applaud the arrival of COVID-19 vaccines, they don’t hesitate to advocate for more effective treatments, now and in the future.
The fact that we are already seeing variations that may reduce the effectiveness of vaccines and monoclonal antibodies is a primary reason for maintaining the focus on therapeutics alongside preventive products. Already, the United States is no longer allowing orders for bamlanivimab in Arizona, California and Nevada over concerns about its effectiveness against a new variant emerging there, Lilly confirmed Thursday.
Going forward, as new variants emerge, a set of personalized treatment options may be indicated, according to CDC’s Brooks. If a person’s test for the virus comes back positive, that sample can be sequenced to look for any variants of concern, and then specific antibody treatment effective against that variant would be prescribed medication.
Many of the groundbreaking therapies in the pharmaceutical industry over the past decade have done just that. Treatment for AstraZeneca Lynparza ovarian cancer requires testing for BRCA1 or BRCA2 gene mutations, while a prescription for Gilead’s Biktarvy depends on HIV-1 expression levels.
But so far, technology and medical practice have not caught up with the nervousness of this virus. Some areas are still experiencing delays in COVID-19 testing, genomic sequencing can take five or six days, and the antibody treatments we have are very new – and very underused.
“Imagine,” says Brooks. “I wish I could give the person the monoclonal antibody that I know will work – for two reasons: First, if they have resistance, I want to avoid a drug. But if they don’t, let me use the cheapest and most available drugs. It would be nice to be able to use direct therapy. At the moment, we are not there yet. “
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