Covid Vaccine will be the “October Surprise” one way or the other
[Thursday, July 16, 2020]

With the announcement of positive results from a small clinical trial for its experimental Covid vaccine this week, Moderna set the stage for what to expect in the next 2-3 months. Moderna may be in the news more than others, but others are not behind. Oxford-Astra Zeneca announced the start of a 10,000 patient multi-national Phase 3 trial for its vaccine which they project will be completed by September, and Pfizer announce positive results, very similar to those from Moderna, earlier this month with plans to launch a Phase 3 trial next month. There are at least 4 vaccines in Phase 3, not including Moderna, with another 11 in Phase 2 and Phase 3 world-wide, all trying to be ready by the Fall-Winter time. And all developers are rushing their programs to be the first in mass use because whoever gets their first will reap the most financial benefits. A unique blend of regulatory involvement, exceptional science, outstanding talent, and tumultuous politics guarantees an interesting Fall for Covid vaccines, and not just because there is a Presidential election in early November in the US. So far, the pandemic has defied all predictions and conventional wisdom.  We still have it spread in peak summer, the physical distancing and mask-wearing have done little to stem the spread (in the US), and it seems to come back in waves. And efforts to find a vaccine have been unprecedented as well. Way back, in April (less than 3 months ago) it was being projected that an effective vaccine could take 12-18 months. The projections were then revised to the end of the year, and now a vaccine in Sep-Oct seems a possibility, right before the US elections. This would mean a never done before 6 months from the start of the Phase 1 trials to patients. It would be interesting to see how the FDA deals with the data from several competing products developed with public and private funds. FDA announced a threshold for vaccine approval but also claimed the flexibility to approve a vaccines it “likes” with suboptimal data, the way it did with Remdesevir and Chloroquine. FDA may have several good options to pick from to approve for the masses. It would be highly detrimental for FDA’s reputation to rush to approval before the US elections. FDA is intrinsically involved in developing the vaccines funded by the US government with private partners creating a conflict of interest for the FDA. The review and approval of FDA/NIH supported vaccines should be unquestionably transparent and unambiguous. It is not going to be easy for the reviewers to buck the pressure to make quick decisions, but they need to be clearly impartial to whichever product they finally approve. We will see a lot of doubts raised for the FDA process, no matter what the decision, a politicization like never before. It is FDA’s responsibility that the politics of the vaccine does not discredit the “good” vaccine. In the past FDA has bent to public pressure creating unhealthy precedence. Let us hope it does not do it again. The October surprise may help influence an election, but after the election season is over, the politicization of this FDA decision, if any, could tarnish FDA forever.