The head of the U.S. Food and Drug Administration (F.D.A.), Dr. Stephen Hahn, over the weekend stated in an interview with the Financial Times that he will grant potential coronavirus vaccines an emergency use authorization before the conclusion of their late-stage, large-scale clinical trial--typically called Phase Three--if the benefits outweigh the risks. Yet, Hahn stressed that the agency's decision will not be put under political pressure, stating that "this is going to be science, medicine, data decisions."
"It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudications of their application," Hahn stated. "If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, will will make a determination."
Hahn's decision is likely to be one of the most important of its kind the in the history of United States public health, a burden that Hahn does not seem to take too lightly.
Yet, there are signs of political pressure towards speeding up the end result of the coronavirus pandemic throughout areas of the U.S. federal government. Recently, President Donald Trump tweeted: "The deep state, or whoever, over at the F.D.A. is making it very difficult for drug companies to get people in order to test the vaccine and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd," with the date referring to the upcoming U.S. presidential election.
Soon after that tweet, the F.D.A. had issued an emergency use authorization fo the use of convalescent plasma to treat hospitalized COVID-19 patients, a decision that was later criticized many health experts arguing that there is insufficient data on whether or not the treatment works for COVID-19.
Beyond the F.D.A., Trump has continued to push conspiratorial ideas surrounding the severity of the coronavirus pandemic within the United States. On Sunday, Trump had retweeted multiple tweets that claimed that the COVID-19 death toll in the U.S. grossly under the roughly 183,000 reported by the U.S. Centers for Disease Control and Prevention (C.D.C.).
In one tweet, which has since been removed by Twitter (NYSE: TWTR) for violating its coronavirus pandemic misinformation policies, the original poster claimed that only 6% of the total deaths in the U.S. were actually due to fatal coronavirus infection. The user argued that only 9,210 people in the U.S. have died for COVID-19, citing C.D.C. statistics that showed most fatal infections coincided with 2-3 other health conditions.
While the data citied by the user was correct, it is misleading to claim that those who died from multiple factors alongside COVID-19 infection did not die of COVID-19 infection. The new data shows who is more vulnerable to fatal COVID-19 infection: those with underlying health conditions like diabetes, hypertension, heart disease and obesity.
For the United States, new coronavirus infections seem to be steadying, if not falling in most of the country as social restrictions and masks mandates take effect in many states. But the fight against the virus is far from over, with the nation topping 6 million confirmed infections. According to recent trends, outbreaks are growing the the Midwest, with the states of Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, Ohio and North and South Dakota all seeing increases in their daily new infection seven-day averages. Similar trends were shown in shown by Arizona, Florida, and Texas before their major outbreaks.