FDA Revokes Hydroxychloroquine’s Emergency Authorization

The US Food and Drug Administration (FDA) issued a letter revoking the Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from the Strategic National Stockpile (SNS) previously issued on March 28, 2020. 

The FDA letter issued by Rear Admiral Denise M. Hinton, Chief Scientist, FDA, stated on June 15, 2020, ‘today’s request to revoke (the distribution) is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 disease and that the drug’s potential benefits for such use do not outweigh its known and potential risks.’

The basis for this FDA decision includes, but is not limited to the following statements:

We now believe that the suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to produce an antiviral effect.

Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomized controlled trial assessing the probability of negative conversion showed no difference between HCQ and standard of care alone.

Current U.S. treatment guidelines do not recommend the use of CQ or HCQ in hospitalized patients with COVID-19 outside of a clinical trial and the NIH guidelines now recommend against such use outside of a clinical trial.

Furthermore, recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ (Plaquenil)  treatment in hospitalized patients with COVID19.

RADM Hinton continued saying ‘While HCQ that has been distributed from SNS is no longer authorized under the EUA for the authorized use to treat hospitalized patients for COVID-19, FDA-approved HCQ can be distributed in interstate commerce.’ 

‘The CQ products covered by the EUA are not approved by the FDA for any indication and therefore cannot be legally introduced into interstate commerce.’ 

In addition, ‘under section 564(f)(2) of the Act, HCQ and CQ that were distributed from the SNS under this EUA remain authorized for emergency use to continue to treat any hospitalized patient to whom the authorized product has already been administered during the COVID-19 public health emergency, to the extent found necessary by such patient’s attending physician.’

Since early 2020, the US Centers for Disease Control and Prevention (CDC) has closely monitored the worldwide outbreak of a novel coronavirus known as SARS-CoV-2, which is causing the COVID-19 disease in humans.

The CDC announced on March 3, 2020, that a significant portion of individuals infected with the SARS-CoV-2 coronavirus lack symptoms (“asymptomatic”) and that even those who eventually develop symptoms (“pre-symptomatic”) can transmit the virus to others for several days before showing symptoms. 

This means that the virus can spread between people interacting in close proximity—for example, speaking, coughing, or sneezing—even if those people are not exhibiting symptoms. 

Furthermore, recent studies suggest that recovery from one SARS-CoV-2 infection might not protect a person against a second infection.

Precision Vaccinations publishes COVID-19 disease treatment news.