Pfizer’s News Raised Political Questions. We Have Answers.

(Bloomberg Opinion) -- Max Nisen, who covers the pharmaceutical industry for Bloomberg Opinion, answered questions about Monday’s vaccine announcement by Pfizer. The conversation has been edited and condensed.

On Monday, Pfizer won the most-watched race in the world, announcing that its Covid-19 vaccine was more than 90% effective in a large trial. But some critics are saying the company was too slow, delaying the news in order to hurt President Trump on Election Day. Was there anything off about the timing of Pfizer’s announcement? 

Max Nisen: Based on what we’ve heard from Pfizer and BioNTech's press release and executive interviews, I don't think so.

What did Pfizer say?

Max Nisen: In an interview with Axios, Pfizer's CEO Albert Bourla said that the independent board monitoring the trials only began receiving data on the trial last Thursday or Friday, convened to discuss it Sunday, and that he received the information on the positive results later that day. They weren't sitting on the data. If there's any possible point of controversy, it's in a recent change in the decision of when to start looking at trial results. That requires a bit more explanation, but I think it was wholly justified and not politically motivated. Bourla says that if data were available pre-election, the company would have released it.

Why exactly did the results come now?

Max Nisen: Vaccine trials like this one are "event-based." They compare the number of confirmed Covid cases among those who get the vaccine to those that take an inactive placebo. Pfizer planned early looks at the data to see if it was working after 32 confirmed cases, 62, 92, and 120 cases before conducting a final analysis at 164. That plan was controversial, because it was more aggressive and included a much earlier peek at the data than protocols put forward by other companies.

At some point -- the companies haven't disclosed precisely when or even if it was pre- or post-election -- the developers had discussions with the FDA and decided to skip the first analysis. By the time they finished those discussions and looked at the data, there were 94 cases. It's not clear if the analysis would have arrived before the election even without the change. What’s clear is that the company hadn't hit the threshold as of Pfizer's earnings call Oct. 27 – and recording cases and analyzing them takes time. Either way, waiting for more cases is a good scientific decision. Small sample sizes bring statistical bias, so a 90% plus efficacy rate after 94 cases is far more convincing than the same figure after just 32. On top of that, because of FDA safety requirements, announcing the results earlier almost certainly wouldn't have led to an earlier authorization. 

What’s Bourla’s reputation among investors and the scientific community?

Max Nisen: It's fairly solid, he's a long-time Pfizer executive who took over as CEO in January 2019. His sometimes aggressive messaging about the vaccine may have caused something of a hit to his reputation. But after pressure from public health experts, he clarified the company's position in a very useful way. President Donald Trump's repeated calls for a pre-election vaccine release introduced some concern that Pfizer’s process might be politicized or rushed.

Bourla then said explicitly that his company would abide by the FDA's request for at least two months of safety follow up for most trial volunteers before submitting a vaccine for authorization, even though the White House questioned the necessity of that requirement. The scientists have it right here: the two month requirement is a reasonable compromise between ensuring safety and making the vaccine available quickly.  With that, he essentially ended the possibility of pre-election vaccine release (if not the disclosure of data) because that safety information won't be available until later in the month. It was an important stand that came as a relief to many in the scientific community.

Are Pfizer and other pharma companies known for any particular political leanings?

Max Nisen: Big pharma generally tends to favor the Republican Party, which has traditionally been more supportive of free market policies that let drugmakers price medicines aggressively. Democrats, on the other hand, want more government intervention in the market to reduce costs. Industry donations tend to lean Republican. 

It is worth noting that President Trump has been more aggressive on regulating drug prices than other Republicans, though he hasn't accomplished much.

Biden's plans are much more distasteful to the industry, though he would have trouble passing them without Senate control.

Pfizer faced questions about its announcement beyond its timing, right?

Max Nisen: Yes. The other bit of controversy was the role of the U.S. government's Operation Warp Speed. Vice President Mike Pence appeared to claim some credit on Twitter but Pfizer took pains to distance itself from the program and note that it didn't take government money to fund its vaccine. That's true for the U.S., though the company's partner BioNTech got a significant amount of funding from Germany. The truth is somewhere in the middle. The company didn't take up-front money from Warp Speed, unlike other companies, but has a big guaranteed contract to purchase doses at a set price on FDA authorization, and it is likely to benefit in other ways from the program's effort to accelerate vaccines.

Do you think that Pfizer could have done a better job in managing expectations of an announcement like this in order to avoid any backlash?

Max Nisen: Absolutely. In previous months, the company repeatedly suggested that it may have data in October. The better strategy would have been to say throughout that timing was highly uncertain, which is the truth given how trials of this type work, and that any announcement would be guided by science. 

This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

Bloomberg Opinion provides commentary on business, economics, politics, technology and markets.

©2020 Bloomberg L.P.