From The Wall Street Journal:
We have heard so much about vaccines in the past 18 months that we may not welcome still more. But “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” is well worth looking at closely. Albert Bourla, Pfizer’s chief executive, boasts of saving millions of lives while restoring the otherwise tarnished image of the pharmaceutical industry. Yet his victory lap races by a hard truth: Covid-19 continues to cause disruption and challenge our confidence in science.
To be fair, the number of new cases did decline by 85% during the first few months after the vaccines hit the market in December 2020. But when cases hit a low point, in February 2021, only about 5% of the U.S. population had been vaccinated. Although it is easy to blame recent surges on the people who decided not to get vaccinated, current data show that states with the highest vaccination rates also have the most cases, hospitalizations and deaths. (Because hot spots move around, such statistical profiles change from month to month.) The current wave of new cases is hitting the unvaccinated, vaccinated and boosted alike. This is not to say that vaccines don’t work. They do reduce the severity of infection, but they haven’t delivered the promised herd immunity that would end the pandemic.
Pfizer’s ability to develop, test and distribute a vaccine in less than a year is, without doubt, a stunning accomplishment, and Mr. Bourla is right to feel proud. But he overdoes it, dropping the names of the presidents, prime ministers and world leaders who have sought his counsel. At times, he praises his colleagues and advisers, yet often in a context that shows them being subservient to the CEO. He quotes Benjamin Netanyahu, Israel’s former prime minister, who relays a long-ago comment from his brother (who led the 1976 Entebbe Raid and was killed in action): “There are not good or bad soldiers. There are only good or bad commanders.” Mr. Bourla seems to take this maxim to heart.
Mr. Bourla stresses the importance—for Pfizer and, in general, for the battle against Covid—of high ethical standards, complete transparency and trust in science. Yet “Moonshot” shows, sometimes inadvertently, the difficulty of meeting these admirable goals. Well into the pandemic, in March 2021, Mr. Bourla canceled a trip to advise Israeli researchers. Why? Because Israel denied entry to anyone who was not one week beyond his second Covid jab. That’s right, one of the most prominent vaccine promoters in the world wasn’t fully vaccinated at the time. “Getting vaccinated had created a crisis of confidence for me,” Mr. Bourla writes. “I chose to wait until my vaccination might be used to encourage those with vaccine hesitancy later on.” Does this claim meet a high ethical standard? Mr. Bourla thinks so; others might not. An aghast Mr. Netanyahu said to him: “My wife, who is sitting next to me, is asking when you plan to vaccinate yourself. What shall I tell her?”
How transparent has Pfizer been? In the book’s more than 200 pages, one topic is not explored in any real depth—side effects. Although the vaccine is generally regarded as safe, side effects do appear to be more common—and perhaps more severe—than for other widely used vaccines. In the 2020 clinical trial that provided the basis for FDA emergency-use authorization, more than 83% of 18- to 55-year-old participants (in comparison with 14% of those injected with a placebo) reported arm pain after their first shot, and approximately a third had a fever in reaction to their second (in contrast to less than 1% for a placebo). More serious side effects, like myocarditis, are rare, but they happen slightly more often following vaccination. Mr. Bourla might have paused to address the concerns of those who worry about side effects, if only to put the matter in proper perspective.
Mr. Bourla asserts that, ultimately, “science will win.” Who could argue with that? The problem is that science is a process that works best when research findings are peer-reviewed and when calculations are verified by independent scientists with no vested interest in a commercial product. Pfizer skipped this step. Instead it used internally controlled trials and first made the results public through highly curated press releases that showed its evidence in the best light. “In the past,” Mr. Bourla explains, “politicians and governments would pressure us to share data and learnings more quickly than we were comfortable.” This time, he says, Pfizer held off on sharing data lest it fuel a counternarrative. Even now, Pfizer has not released data that would allow independent scientists to verify its analyses. If the evidence is in the public interest, shouldn’t the data be in the public domain?
At a Dec. 10, 2020, hearing on emergency-use authorization, conducted by the Food and Drug Administration, several of the presentations and a number of comments from the general public raised concerns about how long vaccine protection would last. But the one clinical trial used to justify the authorization followed participants for only two months, and Pfizer was so confident of the vaccine’s durable benefit that it vaccinated the placebo group, calling the decision the only “ethical” option. By June 2021, however, Pfizer understood that protection against infection declines after only a few months. When it acknowledged this fact, Mr. Bourla says, officials at the Center for Disease Control and Prevention and at the FDA feared that the disclosure would provoke more vaccine hesitancy. Perhaps it did. But it also helped Pfizer gain the authorization and public financing for a third dose.
Link to the rest at The Wall Street Journal