Humboldt Has Monoclonal Antibody Infusions For Some COVID-19 Infected, but Inoculation and Prevention Are Better, Says Dr. Hoffman
We asked Providence St. Joseph Hospital’s Press Communications Director Christian Hill about the availability of this potentially game-changing treatment. In the midst of vaccine mandates and burgeoning emergency rooms across the region and the state, a therapy that could lessen the impact of hospital capacity is a welcome tool in the arsenal. The hype around the experimental treatment has been building for months, beginning with former President Donald Trump receiving the treatment after falling ill with COVID-19 last year.
We are informed by Hill that at St. Joes, “Regeneron, a monoclonal antibody is being provided to select patients.” Indicating there is not a great deal of the antibodies to go around, Hill assured us that more will be coming soon. “There is an international shortage of Tocilizumab, a monoclonal antibody that may have a role in therapy.”
He confirmed for us that St. Joseph Hospital has been using this locally, saying, “We have given this to some patients, more has been ordered, however there is limited availability.” Hill assured us, “[T]he manufacturer is working on increasing supply.”
According to St Joseph Hospital, the plan would be to offer the therapy to more people soon. “In order to expand access, we are setting up an Outpatient Monoclonal Antibody Infusion Program for people diagnosed with COVID-19 who are at risk of progression.” We are told the hospital anticipates this new infusion program to open as soon as this week.
Well before any vaccine was made available, Chief Scientific Officer, George Yoncopoulos was vying for emergency use of the monoclonal antibody made by Regeneron and Biontech. In September of 2020 he explained, “[Y]es people’s immune systems most of the time can do a great job fighting the virus, by making antibodies against the virus- but then we showed that with most people it’s a race against the virus and their immune system most people win this race by rapidly making more antibodies, however, some people make antibodies more slowly, and this delayed response can put them at risk of losing this race to the virus.”
The Regeneron Scientific Officer spoke with unmitigated confidence about the treatment before it had received the FDA’s go-ahead and Emergency Use Authorization during the pandemic. He added, “[W]e can turn losers into winners by giving them their own immune system in a vial.”
Humboldt County’s Health Officer also expressed hope that this treatment could be helpful locally. Hoffman told our reporter during a virtual Press conference Thursday morning, he was hopeful that it would be more widely available soon, but was cautious in placing a bet on this as therapy as the winning game changer, preferring the vaccine in the long run. Hoffman explained that while monoclonal antibodies are a handy tool in the battle against COVID-19, they may not be for everyone.
“When we talk about cost-benefit ratio here, this is a very labor intensive treatment and it is not something that is going to easily, be widely available,” he said. “So one of the reasons it’s been difficult to implement is because this requires dedicated space where a person can sit for several hours while getting this infusion of the antibody. It requires nursing staff – which we just already talked about was extraordinarily short on in our county and everywhere [and] it requires oversight by physician staff…”
Currently the Federal Drug Administration has approved the Regeneron Monoclonal Antibodies for Emergency Use Authorization. “The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for REGEN-COV™ (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age and older with positive results SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.”
The treatment is described by the FDA as ”Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.”
Patrizia Cavazzoni MD, director of the FDA’s Center for Drug Evaluation and Research is quoted in the FDA’s press release of May 26, 2021 saying, “With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital.”
According to Regeneron Pharmaceuticals, it is reaching fewer than 30 percent of eligible patients, up from fewer than 5 percent a month ago. In a May 2021 interview, Chief Scientific Officer of Regeneron Pharmaceuticals, Inc, George Yoncopoulos discussed the antibody treatment and why it may be an important new tool in the arsonal as doctors and health officers across the nation grapple with surging COVID cases.
“Obviously we’re all hoping that vaccines are being broadly enough used to generate what’s called ‘herd immunity’. What is that? The vaccine makes individuals make their own antibodies against the virus – antibodies that will bind to and kill the virus and provide protection against them,” said Yoncopoulos.
The scientist explained the method behind the production, explaining, “[W]hat we were able to do was essentially clone out the very antibody – the best of the antibodies that bind and block to the coronavirus – we grow them up in these big bioreactors and then we highly purify them and we concentrate them, and we can give it back to individuals as an injection.”
“The cocktail is still retaining its effectiveness against all the variants of concern that have been identified to date… if you’re already infected… This can decrease your risk of progressing to severe disease, hospitalization or death. It can also shut down your production of the virus, so making you less infectious, so if it was used widely enough, it would actually decrease the spread.”
The antibody infusion is an intravenous therapy that needs to be done in an outpatient or hospital. The process is not simple, and is likely to be followed by a short time of observation by the staff on duty. It is recommended that a patient get the treatment as soon as possible following a positive COVID-19 test result, and within 10 days of symptoms.
Dr. Hoffman placed his proverbial bet on the inoculation, as the “winner” in the fight against the virus. He said, “[Y]ou know, the highest, really bang for our buck, it’s vaccination. Those folks who are highest risk for for needing monoclonal antibodies would also reduce their risk just as much if not more actually by getting vaccinated, and so those same people who are unvaccinated, if they would go out and get vaccinated right now would actually have a better impact on on this pandemic. It’s safer. I would say, you know, vaccination is much safer than the monoclonal antibody treatment and it lasts much longer. We know that the monoclonal antibodies probably only give protection for maybe a few months – possibly only a few weeks – it’s really geared to preventing the disease right in that moment, whereas vaccination is a long-term, much longer term solution.”
In regard to possibly having this treatment administered in other ways, Regeneron’s Yoncopoulos noted, “Our most recent phase three study was actually done testing a subcutaneous – that’s a simple injection right under the skin – that can be done at home or in a doctor’s office or anywhere, does not require an infusion center. It appeared that when given that way, the cocktail was very effective, and so we are talking with the FDA about having them authorize subcutaneous administration for both treatment of already infected people as well as for prevention, and we will see what the FDA thinks about that data.”
The therapy is not authorized for use in patients “who are hospitalized due to COVID-19, who require oxygen therapy due to COVID-19, who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.”
Breaking down the difference between the monoclonal antibody treatment and the effects of getting vaccinated, Humboldt’s Public Health Officer Dr, Hoffman had this to say. “Monoclonal antibodies are really designed to kind of go in quickly for someone who’s either been infected, or at super high risk for infection based on a high risk exposure, to prevent them from getting really sick in that couple week time period that they would get sick in, but it doesn’t last long. It doesn’t stimulate the body’s response to prevent disease in the future, whereas a vaccine stimulates your own body to produce those antibodies for a long time, and you know, the real difference is that long-lasting immunity versus that just, short time period.”
Doubling down on his professional opinion that the vaccine won in both unofficial categories of efficiency and longevity when up against the antibody infusion, Hoffman said, “[A]gain, we’re talking about a very labor intensive, high cost, high barrier treatment, that will help people stay out of the hospital – but it’s not going to last for very long, versus a very easy to administer, we can do it in 15 minutes, we can do a lot of people in a day, and it’s going to last for a really long time, the cost is way less…”
People who do want to receive anti-SARS-CoV-2 monoclonal antibodies are advised to put off vaccination at least 90 days, according to the FDA, as a precautionary measure,because the treatment may “interfere with vaccine-induced immune responses”. The FDA also noted, “people who develop COVID-19 after receiving SARS-CoV-2 vaccination, prior vaccination should not affect treatment decisions, including the use of and timing of treatment with monoclonal antibodies. A fact sheet for providers (and inquiring minds) can be found here.