President Trump has repeatedly vowed that a vaccine for COVID-19 will be accessible to the general public by Nov. 3. This date should be familiar to most, as it is also the day of the 2020 presidential election. The CDC has been vocal with their professional opinion that a vaccine is unlikely to be FDA-approved until late 2020 at the earliest, leading many to believe that the Trump administration will “rubber-stamp a shot based on political calculations rather than scientific data.”
It is no secret that Trump’s poll numbers have been on the decline since the onset of the pandemic. His repeated assurance that there will be a vaccine “very soon” seems to be a last-ditch attempt to reacquire the faith of the American people. While this would be an effective strategy if rooted in fact, these claims are fictitious and unfeasible.
Trump has personally assembled a team of scientists to work on accelerating the vaccine process, calling their objective “Operation Warp Speed.” However, even the lead scientist assigned to the operation, Dr. Moncef Slaoui, has his doubts. In an NPR interview published on Sept. 3, Slaoui said “There is a very, very low chance the trials that are running as we speak could [be completed] before the end of October and therefore there could be if all other conditions required for an Emergency Use Authorization are met, an approval.”
There are two negative implications of this operation. The first lies within its title. According to a recent Forbes article, Dr. Anthony Fauci “told the New Yorker that he ‘never liked’ the name because it ‘suggests incorrectly… that you’re prematurely putting something out there that isn’t entirely safe.’” This echoes concerns he voiced in August that it “subliminally” suggests “reckless speed.”
The second is that even if a vaccine were to be streamlined, it would require the Emergency Use Authorization (EUA) by the FDA that Slaoui mentions above. An EUA gives an FDA commissioner license to “allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases.” The ongoing pandemic is certainly an emergency that would warrant an EUA, however allowing an unapproved vaccine to enter circulation is dangerous. It has not yet undergone the proper trial and revision processes.
There are six stages in the development process of a vaccine and another six stages in its approval process. It is possible that some stages are combined when considering an EUA. Top NIH officials such as Dr. Fauci have estimated the approval process will take 12 to 18 months. While there are currently over 150 COVID-19 vaccines in development across the world, it seems unclear whether or not any are approaching the final approval stages. What could possibly make Operation Warp Speed the exception?
Currently, the vaccine that is closest to being approved in America in partnership with Operation Warp Speed is called mRNA-1273. While China and Russia already have approved vaccines, mRNA-1273 has entered phase three of clinical trials. This means it is in the third phase of the third step of development in accordance with CDC guidelines and has not even reached the beginning step of the approval process. It is not expected to be completed or approved until Nov. 22, 2021.
Despite this, Trump still pushes for a vaccine later this year. This could mean several things, and none of them are positive. Vaccine veterans worry it has a strict political and nationalistic motive that puts the actual effectiveness of said vaccine and the welfare of the American people second to Trump’s pride. It is very possible that a hastily-released vaccine could be a placebo or negatively affect the health of those who use it. A weak vaccine could be worse than none, lulling the population into a false sense of security and causing them to let their guard down and return to normalcy before they should.
Considering these outcomes, it is imperative to stay away from any upcoming vaccines that are not FDA-approved. It is unlikely that an approved vaccine will be available by election day or even at the end of this year. A rushed vaccine has the potential to wreak havoc on our already-vulnerable nation. Under no circumstance should Trump be trusted on this matter.
