Millions of Americans get their COVID-19 shots every day, but the US will still need better treatments that can smother mild or moderate cases of COVID-19 before they become serious.
There are a number of reasons why people may still get sick after vaccination. There will be "breakthrough" cases as the COVID-19 vaccines are not 100% effective. Some people are not vaccinated, others are at risk. And new variants or mutations of the virus could make vaccines less effective than they are now.
Also, people who have been vaccinated and later undergo certain types of treatments, such as lymphoma, may see their antibody-producing B cells being eradicated.
As of Thursday, more than 12% of the US population had been vaccinated, according to the Centers for Disease Control and Prevention. The US is currently reporting an average of 53,000 new cases per day – a rate well below its January peak but still high enough to worry health officials.
"Many people feel that vaccination will solve the problem," said Dr. John Brooks, a medical epidemiologist at the CDC. “But just look at the influenza. We know that every year there are people who have breakthrough infections and that's when they had the vaccine. "
When it comes to the flu, there are four treatments that patients can be prescribed including that from GlaxoSmithKline
Relenza and Roche Holdings AG
Tamiflu, an oral antiviral drug approved by the Food and Drug Administration in 1999.
If Tamiflu-like drugs are ready to treat people with mild to moderate forms of COVID-19 and keep them from getting so sick that they end up in hospital or die, it could slow the pace of the virus and let the virus in Movement set US back to normal.
Preventing hospital stays and death from COVID-19 are two endpoints that companies like Eli Lilly & Co.
and Regeneron Pharmaceuticals Inc.
have focused on this when testing their monoclonal antibodies in clinical trials.
Lilly received his first emergency approval for a stand-alone antibody treatment, bamlanivimab, and then another for bamlanivimab and eesevimab combined, while Regeneron's antibody cocktail called REGEN-COV is approved for high-risk adolescents and adults at high-risk hospitalization.
From the archives (October 2020): Regeneron's CEO warns Trump's findings are "a case of one" and the coronavirus drug needs more testing
But there were bumps in these therapies. They may not be as effective against variants as the B.1.351 strain, which was first identified in South Africa. And patients have had to go to infusion centers to receive these treatments because it is scientifically not possible to package monoclonal antibodies into the type of oral medication that can be picked up at a local pharmacy. (That part of the equation could change soon as the White House announced on Wednesday $ 150 million in funding to ensure fairer access to these therapies.)
"The ideal therapy would be one that is easy to take, easy to get, and inexpensive," said Brooks. “Monoclonals are wonderful. You really seem to be helping people. But they do require an intravenous infusion. "
"The mere existence of a vaccine is not enough"
Monoclonal antibodies, which have been the only approved treatment options for people with milder forms of COVID-19 as the pandemic progressed, show promise, both as a treatment for patients who test positive for the virus and to prevent infections. (None of the antibody treatments at this point were approved for COVID-19 prevention for pre- or post-exposure cases.)
Several drug companies outside of Lilly and Regeneron are currently conducting clinical trials for antibody-based treatments, including Vir Biotechnology Inc.
in partnership with GSK and AstraZeneca
It was announced on Tuesday that the US had just bought half a million cans of its still experimental antibody cocktail.
"The mere existence of a vaccine is not enough," a Vir spokesman said in an email. “It has to be available year after year, widespread and effective, even against newly emerging variants. More than ever, we need treatments that are effective against the worrying variants currently in circulation as well as any emerging variants. "
However, Lilly and Regeneron executives say they have had limited use of their antibody treatments since the first approvals were granted in November.
A Lilly spokesperson confirmed that only about one in seven qualified people with COVID-19 will be prescribed antibody treatment. And a Regeneron executive said in February that prescribing guidelines may have been too narrow to allow broad access to the company's antibody therapy. (The National Institutes of Health and the Infectious Diseases Society of America updated their guidelines this week to recommend the use of the monoclonal antibody treatments.)
"We as a country are not using these antibodies properly," said Dr. David Weinrich, Regeneron's director of global clinical development. "In general, there are pockets in which doctors have recognized the value of these things, but it is not universal. And that unfortunately leads to disproportionate access to the drug depending on where you are in the country and who your doctor is – that's not a good scenario. "
Bernstein analyst Ronny Gal's suggestion is that the unexpectedly low use of these drugs has more to do with medical expertise or its lack. "I suspect the main reason is that people diagnosed with mild cases have little overlap with doctors who use IVs frequently," he said in an email.
On the way to a Tamiflu for COVID-19
Then there are antiviral drugs, which are the same type of drug as existing flu treatments, but these options are currently limited.
Gilead Sciences Inc.
Veklury antiviral treatment is only indicated for people sick enough to be hospitalized, and clinical studies have been limited to testing the drug on people who have been hospitalized.
However, it isn't the only antiviral candidate being tested. Ridgeback Biotherapeutics and Merck & Co. Inc.
have an experimental oral antiviral treatment, molnupiravir, which is reducing infection times in approximately 200 out-of-hospital COVID-19 patients. This is based on the preliminary results of a phase 2 clinical trial that was announced in March.
"It will be the combined approach of vaccines and antivirals," said Dr. Bruce Polsky, an infectious disease doctor at NYU Langone Hospital on Long Island. "Ideally, it would be an oral medicine – an oral medicine that you can give someone the first time they show you symptoms."
Norbert Bischofberger – one of the inventors of Tamiflu, which had peak sales of nearly $ 3 billion during the 2009 swine flu pandemic – is CEO of a biotech startup called Kronos Bio Inc.
and had previously worked at Gilead when the company started developing Veklury, then called Remdesivir, as a treatment for Ebola. Bischofberger sees a parallel between the use of a drug such as Tamiflu against the flu and what is needed for this coronavirus.
"In the past, during the winter season, I always traveled with Tamiflu in my luggage," he said. “If you run into someone in the elevator or someone coughs and sneezes in your face, I'll go to my hotel room and take Tamiflu. It's very, very effective. "
Imagine customized antibodies
It is currently unknown how many people are at risk of contracting the virus after vaccination. And even if public health experts welcome the introduction of COVID-19 vaccines, they are not shy about advocating more effective treatments now and in the future.
The fact that we are already seeing variants that can reduce the effectiveness of vaccines and monoclonal antibodies is a main reason to continue to focus on therapeutic products in addition to preventive ones. The US is already no longer allowing orders for Bamlanivimab in Arizona, California and Nevada due to concerns about its effectiveness against a newly emerging variant, Lilly confirmed on Thursday.
Looking ahead, when new variants emerge, a number of personalized treatment options could be presented to the CDC, according to Brooks. If a person tests positive for the virus, that sample can be sequenced to look for variants of concern. A specific antibody treatment that is effective against this variant is the drug prescribed.
Many of the pharmaceutical industry's breakthrough therapies over the past decade have done just that. AstraZeneca's treatment for Lynparza ovarian cancer requires testing for the BRCA1 or BRCA2 gene mutations, while a prescription for Gilead's Biktarvy is based on HIV-1 expression levels.
But at the moment, technology and medical practice have not caught up with the irregularity of this virus. There are still delays in COVID-19 testing in some regions, genome sequencing can take five or six days, and the antibody treatments we are doing are very new – and underused.
"Introduce yourself," said Brooks. "I want to be able to 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. If they don't, let me do that using the cheapest and most available drugs. It would be nice to be able to use direct therapy. At the moment we are not there. "