12-15-2020, 10:21 AM
Yes, Donald Trump does get credit for the speed of approval. In order to show efficacy of the vaccines, enough volunteers needed to get COVID-19 to make it possible to see a difference between placebo and vaccinated groups. Were it not for the surge in cases this fall, we would probably still be waiting for cases to accrue.
Seriously, though, the viral genome was available in January. The first patient was dosed with the Moderna vaccine March 16, 63 days from sequencing to phase 1 dosing. The phase 1 results were available in July, four months from the first patient being dosed; the first patient in the phase 2 trial was dosed in May (before the final phase 1 results were available). I can't find when the first phase 3 patient was enrolled in the trial, but the trial had accrued all 30,000 patients by October 22. The first interim result was announced Nov. 16, and the EUA will likely be granted this week.
I don't think people appreciate just how quickly that was done. Just to give you an idea, a typical FDA review takes six months from submission of the complete package of data, which itself takes about 6 months to generate from the end of a phase 3 trial. The fastest that a vaccine was developed from identification of the virus to approval before COVID-19 was 4 years (mumps). The general consensus (and I endorsed this consensus) was that the fastest it could be done, if everything broke correctly, was 12 - 18 months (with 18 being more realistic than 12). The combination of effort, luck, and yes, support from the administration, allowed this to happen in less than 11 months from sequence to EUA. Maybe he offered no value of a replacement President, and this was such a no-brainer that even Ted Cruz or Hillary Clinton, had either of them won in 2016, would have gotten us to a vaccine as fast or faster. Alas, neither of them are President, so we don't get to find out (but if they had been president and pursued the policies and gotten us the vaccine this fast, I would be offering them credit).
BC
Seriously, though, the viral genome was available in January. The first patient was dosed with the Moderna vaccine March 16, 63 days from sequencing to phase 1 dosing. The phase 1 results were available in July, four months from the first patient being dosed; the first patient in the phase 2 trial was dosed in May (before the final phase 1 results were available). I can't find when the first phase 3 patient was enrolled in the trial, but the trial had accrued all 30,000 patients by October 22. The first interim result was announced Nov. 16, and the EUA will likely be granted this week.
I don't think people appreciate just how quickly that was done. Just to give you an idea, a typical FDA review takes six months from submission of the complete package of data, which itself takes about 6 months to generate from the end of a phase 3 trial. The fastest that a vaccine was developed from identification of the virus to approval before COVID-19 was 4 years (mumps). The general consensus (and I endorsed this consensus) was that the fastest it could be done, if everything broke correctly, was 12 - 18 months (with 18 being more realistic than 12). The combination of effort, luck, and yes, support from the administration, allowed this to happen in less than 11 months from sequence to EUA. Maybe he offered no value of a replacement President, and this was such a no-brainer that even Ted Cruz or Hillary Clinton, had either of them won in 2016, would have gotten us to a vaccine as fast or faster. Alas, neither of them are President, so we don't get to find out (but if they had been president and pursued the policies and gotten us the vaccine this fast, I would be offering them credit).
BC