Should we vaccinate now? @StevenSalzberg1 @Forbes

1) To be clear: No one is recommending skipping phase 3 trials. Those must be completed. Question is should a parallel pathway be available to people willing to take the risk & volunteer for early access https://www.google.com/amp/s/www.forbes.com/sites/stevensalzberg/2020/08/02/start-vaccinating-now/amp/

2) In ordinary times & with ordinary infections we would never think of an accelerated pathway before phase 3 trials. But these are not ordinary times. COVID is no ordinary virus. We have lost over 150,000 lives. It is worse than cancer in immediate threat to life without warning

3) I’m a firm believer in phase 3 trials. I’ve lead 10 of them for cancer. But in oncology we often have new drugs approved that are far more toxic and far less effective than vaccines with very small uncontrolled trials while we wait for phase 3 trials to complete in parallel.

4) I support what the @SerumInstIndia is planning to do: manufacture hundreds of millions of doses now. Countless lives will be lost waiting for months to see results of phase 3 to start manufacturing.

@StevenSalzberg1 argues we should consider having volunteer path: I agree.

5) It’s a risk benefit judgment call: What is likely to claim more lives and drive more people to financial ruin? Vaccines (specifically Oxford vaccine and Moderna vaccine) which seem safe and immunogenic on phase 2? Or COVID?

6) A vaccine is extraordinarily unlikely to be more dangerous than COVID. Almost impossible given the known mortality rate of COVID. To me the greater problem with a vaccine is the chance it won’t work or won’t work well. But that’s a risk worth taking.

7) A vaccine doesn’t need to totally prevent COVID; it just needs to make it milder. It needs to only make immune system aware of the virus, and so when we are exposed to COVID the immune system is not caught totally unaware. We know these vaccines are immunogenic.

8) Early vaccine use can be monitored for safety and efficacy just as we do in phase III trials. The data can be informative. Early access should be voluntary and have restrictions on eligibility to ensure safety.

This is something I’ve written about since April.

9) In fact another alternative would be do just expand the phase 3 dramatically in hotspots. Solves both problems. Ultimately having more people immune(without risking the mortality risk associated with natural infection) is how we get back to normal. We cannot shelter for ever.

Well if anything, the article has started a risk/benefit discussion. This will not be a static process. Everyday as new data emerges the risk benefit equation will shift. Everyone will have their own threshold for making a call.

People should recognize this is just a discussion. We don’t have the power to make this call. Just because someone writes an article or a tweet people are not going to get vaccinated. The vaccine is not available for anyone to take (unlike off-label use of an approved drug).

The decision on the vaccine and expansion etc will be made by the FDA. Not us.

This is overall not an easy call.

We lost 5000 lives yesterday i the world to COVID. 1100 in the US. Multiply by 6 months. That’s what’s at stake in whatever risk benefit decision we make.

Once again: This thread is a commentary on a published article which generated a lot of interest. As I stated with the first tweet I’m not recommending skipping Ph 3s. Or minimizing the absolute necessity of phase 3s. This is a discussion of pros & cons. Please take it like that

There are 50000 people who got COVID yesterday in the US. In one day. Millions go to work daily taking on risk of actual COVID. I advocated 1) having a alternative pathway to current 30000 person Ph 3: Greatly expanding Ph 3 in hotspots, to volunteers meeting eligibility criteria

2) Suporting the decision of companies worldwide to manufacture now to avoid delays, especially commenting on the @nytimes report on @SerumInstIndia decision to manufacture now.