The drugs, which are used to treat malaria, lupus, and rheumatoid arthritis, have been championed by President Donald Trump, who, at a White House briefing last week, said they had shown “very encouraging early results” and were a “game-changer” in the effort to combat the CCP (Chinese Communist Party) virus, commonly known as novel coronavirus.
The FDA has “issued an Emergency Use Authorization (EUA) to the Biomedical Advanced Research and Development Authority (BARDA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” the U.S Department of Health and Human Services (HHS) said in a statement.
HHS added that Sandoz had donated 30 million doses of hydroxychloroquine to the stockpile, and Bayer Pharmaceuticals had donated one million doses of chloroquine phosphate.
“President Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope,” said HHS Secretary Alex Azar.
“Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine. The President’s bold leadership and the hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response have succeeded in securing this large donation of medicine.
“We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective.”
Hydroxychloroquine and chloroquine, both of which are oral prescription drugs, have shown “activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19)” and that “anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients,” according to the statement.
However, it noted that clinical trials are needed to provide scientific evidence of their effectiveness and that there are currently no approved treatments for CCP virus.
A second French study of hydroxychloroquine, published late March 27, showed that the drug is effective in treating COVID-19 patients, with researchers at the IHU Méditerranée Infection Institute in Marseille calling it a “cost-effective therapeutic strategy, to both avoid the spread of the disease and treat patients as soon as possible before severe respiratory irreversible complications take hold.”
Currently, hydroxychloroquine is being prescribed by doctors in the United States, France, and Bahrain, while India has recommended it for health care workers.
Despite showing promising results, health officials have warned the public to remain cautious until larger clinical trials validate smaller studies, including Dr. Anthony Fauci, the United States’ leading infectious disease expert and a member of the White House Coronavirus Task Force.
Speaking at a White House news conference on March 20, Fauci said data on the drug so far “was not done in a controlled clinical trial. So you really can’t make any definitive statement about it,” and that only such studies would determine if the drug was truly safe and effective.