When will a COVID-19 vaccine be ready in the USA?

There are a bunch of vaccines being developed against COVID-19. Focusing on the US-based vaccines, the one leading the race at this time is Moderna. There is also Astrozeneca (AZD1222) but they are not registered on clinicaltrials.gov and are being pretty shady about their US clinical trial, and so I will ignore them for now.

So how soon might the Moderna vaccine be available, if everything goes well?

According to FDA guidelines, for a vaccine to be deemed safe and effective, the vaccine must first be observed to not have "Serious and other medically attended adverse events in all study participants for at least 6 months after completion of all study vaccinations. Longer safety monitoring may be warranted for certain vaccine platforms (e.g., those that include novel adjuvants)."

So basically, the Moderna vaccine will have to wait at least 6 months after the last of the 30,000 shots are administered before the FDA will approve it as "safe and effective." As of July 31, 2020, the vaccine clinical trial was still recruiting participants. According to the CEO of Moderna, it will be challenging to recruit the 30,000 patients necessary. Therefore, optimistically, the Moderna vaccine could be ready for commercialization as early as March 1, 2021 (assuming that all 30,000 patients were recruited as of Aug 1, 2020), but realistically it will be much later than that. I will be keeping an eye on the clinical trial, to see when the status switches from "recruiting" to "active, not recruiting" to know when to start the six month clock.

The FDA is an arm of Human Health Services, which is an arm of the Executive Branch of the US Federal Government. Therefore, I believe there will be immense pressure on Moderna and other companies to "release the vaccine" before the clinical trials have completed the six-month safety study, or perhaps there will be large-scale misinformation about when they will be ready. For example, Dr. Fauci has suggested that "We may be able to at least know whether we are dealing with a safe and effective vaccine by the early winter, late winter, beginning of 2021." That is bullshit, the earliest a Moderna vaccine would be deemed "safe and effective" by the FDA would be March 2021. I think Dr. Fauci is muddying the waters by confusing "FDA approved" with "we may be able to at least know", which is some undefined standard of vaccine goodness. I think this type of imprecision may lead to large-scale repercussions such as the White House trying to over-rule the FDA and get a vaccine released earlier, specifically before the upcoming US Presidential election. If Dr. Fauci thinks a vaccine will be ready in 2020, he should tell us which vaccine he is talking about and when the 30,000 patient recruitment was completed.

Note: other countries may have lower standards for safety than the US and therefore release a vaccine much sooner.