Along with 40-some thousand other people around the world, I’m enrolled in the clinical trials for the Pfizer COVID vaccine. All has gone well for me, and I’ve had no side effects. Of course, I’ve followed closely the progress of the trials, and I occasionally receive updates from Pfizer.
Pfizer announced yesterday that its early review suggests that the vaccine is astonishingly effective – over 90%. The FDA has previously said that it will approve a safe vaccine that exceeds 50% efficacy.
These early Pfizer results are based on 94 COVID cases that have been identified in the tens of thousands of trial patients. The company’s 90% efficacy determination suggests that all or nearly all those cases occurred in the 50% of the patients who received the placebo, and hardly any or perhaps none at all occurred in the other 50% who received the actual vaccine.
Pfizer plans to manufacture over a billion doses in 2021. A dozen other companies are also in final testing of vaccines. Scientists say the Pfizer results bode well for the other vaccines.
The end of the pandemic is in sight. The stock market soared and scientists rightly congratulated themselves.
President Trump predicted over the summer that we’d have results before the end of October. Pfizer itself said that was entirely possible. They initially planned to release early results on the basis of 32 patients. According to the company, that number was increased to 62 due to “discussions” with the FDA. Then the number was inexplicably increased to 94.
Of course, a higher number of cases produces a more precise efficacy determination. But also, a higher number of cases requires more time to accumulate those cases.
Pfizer acknowledged in an open letter to me and other patients last month that the timing of its work implicated politics. They emphasized that political considerations would not rush their release of data. Interestingly, they did not emphasize that political considerations would not delay that release.
It is well documented that some Democrats have seen the pandemic as a God-send. They’ve actively rooted for the virus and rooted against treatments, and second-guessed every containment strategy without offering much in alternative strategies.
Their vice presidential candidate explicitly stated that she would not trust a vaccine developed while Trump is in office. A governor expressed regret that Pfizer’s vaccine has proved successful before his party can assume the office of the president. The Biden campaign specifically admitted that it met with the vaccine developers before the election.
Pfizer has tried to explain away its delay with this statement: “You know, from the time that the data comes in, before the committee meets, some people need to prepare for each case a very big and accurate narrative. And the physician should sign it. So there’s a lot of work that needs to be done. But we did it with the speed of light.”
As the man who apparently won the presidential election that occurred between Pfizer’s accumulation of the data and its public release might say, if the shoe were in the other mouth, C’mon man!
A glance at the data would have shown hardly any of the COVID cases were amongst the vaccine patients, and nearly all were amongst the placebo patients.
Moreover, Pfizer could have released the data in pieces. For example, they could have released the first 32 cases along with a cautionary note that the number is still fairly small but would be supplemented with more in a week or two. What could possibly justify withholding from the public what should be public information about the public solution to a public health crisis?
Politics, that’s what.
Postscript: I still don’t know whether I received the actual vaccine or a placebo. If I received the placebo, will my trouble and risk be rewarded by moving me toward the front of the line for the real vaccine, or is the front of the line reserved for people of some favored identity group?