October 15, 2021 by John Fernandez
Preventing or Treating COVID-19: What’s Approved and What Can Make You Seriously Ill
The battle between fact and misinformation when it comes to preventing or treating COVID-19 is not letting up. Even the normally restrained U.S. Food and Drug Administration (FDA) posted a Tweet recently that said: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The FDA was referring to widely circulating misinformation about Ivermectin, a drug often used in the U.S. to treat or prevent parasites in animals, including livestock and horses. The FDA had to reiterate that it has not approved Ivermectin for use in treating or preventing COVID-19 in humans. Ivermectin is not an anti-viral (a drug for treating viruses).
Nonetheless, prominent online personalities, or others with access to social media, are keeping Ivermectin in the unwelcome buzz of misinformation—or outright falsehoods — regarding COVID-19. To be clear, the FDA stated in a lengthy report: “Taking large doses of this drug is dangerous and can cause serious harm.” The FDA said it has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with Ivermectin intended for horses.
Treatments Should be Prescribed by Your Healthcare Provider
The U.S. Centers for Disease Control and Prevention (CDC) has also felt compelled to respond in the wake of reports of people getting sick from unprescribed self-treatments, which can include “vitamin cocktails” or other combinations of over-the-counter drugs or supplements.
“Treatments used for COVID-19 should be prescribed by your healthcare provider,” the CDC states. “People have been seriously harmed and even died after taking products not approved for COVID-19, even products approved or prescribed for other uses.”
Many people may not know that only one drug has been formally approved by the FDA to treat COVID-19 — Remdesivir. Other treatments — monoclonal antibodies and REGEN-COV (from Regeneron) — have been given emergency use authorization for certain COVID-19 patients or those who may have been exposed to the virus (see the list below).
Vaccines Offer Best Protection
The most effective — and proven — way of preventing infection from COVID-19, and especially serious illness or hospitalization, is by getting vaccinated. Three vaccines, the two-shots from Pfizer-BioNTech and Moderna, and the one shot from Johnson & Johnson, have received emergency use authorizations and have been proven to be up to 95 percent effective in preventing severe illness from COVID-19. Last month, Pfizer’s vaccine was the first to receive full approval from the FDA. Third doses, or booster shots, of the Pfizer and Moderna vaccines are already available for those with compromised immune systems. Within weeks, the FDA and CDC are expected to approve third doses, or booster shots, for everyone who has been fully vaccinated with the Pfizer or Moderna vaccines for at least eight months.
The vast majority of hospitalizations during the current Delta variant surge have been among the unvaccinated, said Sergio Segarra, M.D., chief medical officer at Baptist Hospital, part of Baptist Health South Florida. The only way to prevent severe illness or death from COVID-19 is by getting vaccinated, he says.
“We are having people who die in their 30s and 40s,” Dr. Segarra says in a Baptist Health Facebook post from Baptist Hospital’s COVID ICU (Intensive Care Unit). “We have people here as young as their late 20s and to their 80s. And the great, great majority of those who are intubated are unvaccinated. That is the common theme that we are seeing … that the vast majority are unvaccinated. We can’t play Russian roulette with our lives. We need to do everything possible to avoid this.”
Treatments Revoked or Modified by the FDA
Ongoing clinical studies have forced the FDA to revoke or modify emergency use authorization (EAU) over the past 15 months. The FDA revoked the emergency use authorization for hydroxychloroquine and chloroquine to treat COVID-19 in certain hospitalized patients. A large clinical trial in hospitalized patients found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery, the FDA said.
In the case of convalescent plasma, the FDA in February “revised the EUA to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients early in the disease course.”
Approved Treatments for COVID-19
Currently, there are three primary treatments either approved or granted EAUs by the FDA.
Derived from patients who have recovered from COVID-19, monoclonal antibodies must be administered in patients with mild to moderate COVID-19. The FDA has issued emergency use authorization to treat adults and pediatric patients (12 years of age or older weighing at least 80 pounds) with monoclonal antibodies. Before the FDA’s authorization, a clinical trial of patients with COVID-19 found that monoclonal antibodies — casirivimab and imdevimab — reduced COVID-19-related hospitalization or emergency room visits in patients at high risk within 28 days after treatment, the FDA say.
The biggest challenge is timing. For monoclonal antibodies to be effective, patients need to be treated when symptoms are still mild — and before they progress in severity. Since the discovery monoclonal antibodies in the 1970s, the FDA has approved this type of treatment for dozens of diseases, including some cancers and AIDS.
REGEN-COV (from Regeneron)
Manufactured by Regeneron Pharmaceuticals, REGen-COV contains two monoclonal antibodies — casirivimab and imdevimab. REGEN-COV may be used as post-exposure protection for adults and pediatric individuals (12 years of age and older weighing at least 88 pounds) who are at high risk for progression to severe COVID-19, including hospitalization or death, and not fully vaccinated, or those who are immunocompromised or taking immunosuppressive medications. Regeneron received initial emergency use authorization for REGEN-COV in November after researchers found that the treatment reduced the risk of symptomatic infection by 81 percent.
REGEN-COV’s authorization was expanded this year as a preventive measure in high-risk adults and adolescents. Initial approval last year was for treatment of mild-to-moderate COVID-19 in adults and pediatric patients who had tested positive and who were at high risk for progression to severe COVID-19. However, the FDA emphasizes that “prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19.”
The antiviral drug Remdesivir, made by Gilead Sciences under the brand Veklury, is the first and only drug to obtain approval — not just emergency use authorization – for the treatment of COVID-19 that requires hospitalization. After researchers found that it could stop COVID-19 from multiplying in cells, the drug was approved for use in adult and pediatric patients, 12 years of age and older and weighing at least 88 pounds.
The approval of Remdesivir came after the FDA’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. The median time to recovery from COVID-19 in study participant was 10 days for the Remdesivir group, compared to 15 days for the placebo group, a statistically significant difference, the FDA says. The agency in May issued an emergency authorization for Remdesivir’s use in critically ill patients who need supplemental oxygen.