Put An End To Publication By Proclamation For Covid Vaccines

(Posted on Monday, November 30, 2020)

Covid-19 has dealt a blow to many Americans, physically, mentally, and economically. But even the heaviest of hearts is likely to have been lifted by recent promises from Covid-19 drugmakers about the effectiveness and safety of their vaccines. As hopeful as these promises may be, we have still not seen the full data from any of the Phase III clinical trials. So if the FDA approves one of these vaccines in the coming weeks, we will soon have to decide whether we trust the drug manufacturers and agree to the vaccine or whether we hold off until we can examine the data.

This dilemma becomes even more profound for our medical workers, who are likely to be first in line for any approved vaccine. Many are hesitating to commit to taking the vaccine until more data are released. A reasonable request in my opinion, but a sign of how difficult it may be to convince average Americans to accept the vaccine. If the doctors won’t take it, why would we, as patients?

Generally, questions around the safety or efficacy of these vaccines has had less to do with any single concern about the drugs themselves and more to do with how data about the drugs has been released. Since the launch of Operation Warp Speed, data on vaccines has been released first by the drugmakers themselves, by proclamation or by press release. Only later, and sometimes after much criticism, is the full data published and able to be examined.

Meanwhile, executives at these drug companies have made significant amounts of money off their early announcements of success. Since the launch of Operation Warp Speed, reports suggest that executives at five of the companies receiving COVID vaccine funding made stock transactions that increased the size of their personal pocketbooks by nearly $150 million US. That figure includes stock sales up until the end of August and excludes more recent sell-offs, like the one by Pfizer CEO Albert Bourla earlier this month. Pfizer announced that their Covid vaccine was 90% effective on the very same day that the CEO was scheduled to sell 60% of his company stock. He earned $5.6 million from the sale that day.

I am no lawyer, but as a vaccine maker and former CEO of a drug company myself, I can tell you that what these drug companies are doing is absolutely verboten. Had I done in the past what these drug companies are doing today, I would have had the U.S. Securities and Exchange Commission and the Board of my company on me immediately. But the SEC has remained largely silent on the moves made by drugmakers this year, despite calls by watchdog groups and some lawmakers for an investigation.

Self-interest colors credibility. No drug company should be allowed to announce premature trial results without providing the full data to back up their claims. The move may have a positive effect on company stock prices, the wealth of drug company executives, and the value of the entire market. But our concern is not with the billions that businesses stand to make with each new announcement. It lies with the many millions of lives at stake if doubts about a vaccine prevent the vast majority from taking it.

Recent polling suggests that forty-two percent of Americans would say no to a vaccine, if offered one today. With those numbers, even if a vaccine is approved and available to all, we would still not be able to end the pandemic. To build trust in a vaccine, we must end the trend of publication by proclamation. Drug companies should release the data so we can make an informed decision about what we each do next.

This article originally appeared in Forbes, originally published on November 30, 2020.