FDAReview.org

After a sluggish and error-prone beginning to a country-wide effort to vaccinate Americans against Covid-19, it seems things are quickly improving.

According to the Centers for Disease Control, as of March 18th, nearly 113 million Americans have received at least Covid-19 vaccination (two of the three available vaccines require two separate injections). The agency also reports that 12 percent of the US population is fully vaccinated and that about 2.4 million citizens are being vaccinated daily.

Nearly 13 months after the first confirmed Covid-19 infection in the US, President Biden held a memorial as the country surpassed 500,000 deaths attributed to the pandemic. Mourning a great tragedy, President Biden noted these casualties surpass the lives lost during WWI, WWII, and the Vietnam War combined.

While alarmingly high fatalities signify a time of immense suffering, recent developments suggest the worst of the pandemic may be behind us. Covid-19 fatalities, cases, and hospitalizations are decreasing. Many universities plan to offer more in-person instruction during this fall. Texas ended its lockdown and mask mandate.

In March 2019, an experimental drug designed to treat Alzheimer’s disease named aducanumab failed a futility test during the process for approval from the Food and Drug Administration. Facing seemingly little hope for success, aducanumab’s producers Biogen and Eisai strongly considered abandoning the project.

However, when the drugmakers conducted further analysis on a larger dataset, they found that aducanumab reversed Alzheimer’s symptoms in some patients. Other Alzheimer’s treatments can only (at best) delay symptoms.

President Biden seems comfortable using the executive branch’s power to push his agenda. As of February 2, 2021 (less than two weeks after taking office), he has signed 25 executive orders on issues ranging from environmental policy, racial equality, Covid-19 relief, and reinstating elements of the Affordable Care Act.

While passing an unprecedented amount of executive orders in record time, President Biden also placed a moratorium on all regulations enacted by the Trump administration set to go into effect this year. While freezing laws passed under previous administrations is common, preventing a regulation designed to provide less expensive life-saving drugs has generated widespread criticism.

In 1996, a vial of Humalog (roughly a month’s supply) cost patients about $25 per vial. By 2017, the anti-diabetes medication cost nearly $275. Insulin prices have only increased since then. A Business Insider article estimates that from 2017 to 2019 the average diabetic spent $300 to $400 for a month’s supply of insulin.

To afford their vital medication and make financial ends meet, many people with diabetes ration their insulin. One STAT article finds that 25 percent of diabetics rationed their insulin at least once a year due to financial difficulties. When rationing isn’t enough and times are desperate, some people turn to black markets.

In October, large portions of the United States began experiencing rapid increases in new COVID-19 cases. Many European countries have experienced a similar surge in cases, even after being devastated by severe COVID-19 outbreaks earlier this year.

Fearing the arrival of a second wave, several states reenacted various lockdown measures to curb spreading disease. Many European nations followed suit.

In a surprising memo released last month by Secretary of Health and Human Services Alex Azar, federal agencies under the umbrella of his department are now prohibited from passing additional regulations on food, medicines, medical devices, and vaccines without Azar’s approval. As stated in the memo, “Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded.”

Azar’s orders curtail the regulation-issuing authority of 8 agencies and 11 operating divisions. Among these agencies is the Food and Drug Administration, whose regulatory influence encompasses an estimated 20 percent of all consumer products as of 2008.

As Covid-19 began to spread through the United States in February, many feared hospitals would become overwhelmed with infected patients. To meet the demands a global pandemic places on our healthcare system, the U.S. Army Corps of Engineers began hiring private contractors to build field hospitals to treat patients when hospitals hit capacity.

The Corps effort was an incredible feat of engineering, sometimes erecting large-scale facilities within a few weeks. But building these emergency hospitals across the country came at a hefty price of over $660 million.

In the nearly eight months since Covid-19 arrived in the United States, the country has undergone extensive lockdowns, trying economic hardship, and prolonged social isolation.

Despite these sacrifices to battle the pandemic, the U.S. continues to lead the world in total confirmed Covid-19 cases and Covid-19 fatalities. As of September 9, the Coronavirus Resource Center at John Hopkins University estimates that nearly 6.4 million confirmed cases of Covid-19 with about 190,500 fatalities. With many universities, schools, and state governments trying to reopen, additional outbreaks are likely on the horizon.