Pfizer Covid Vaccine Trial Hasn’t Reached Analysis Milestone

(Bloomberg) --

Pfizer Inc.’s late-stage trial of an experimental coronavirus vaccine hasn’t yet reached a key milestone that will help researchers determine how well it protects people from Covid-19.

In a presentation included with its third-quarter earnings results Tuesday, the drugmaker said the data-monitoring board of scientists overseeing the trial hasn’t conducted an interim efficacy analysis. The first of four efficacy analyses is scheduled to be conducted when 32 cases of Covid-19 have occurred among the trial’s participants.

Pfizer’s is among a vanguard group of vaccines that also includes those of AstraZeneca Plc and Moderna Inc. On a conference call with investors, Chief Executive Officer Albert Bourla repeatedly refused to give give new details about exactly when the efficacy data will be analyzed. The data-monitoring board has not conducted any interim analysis of the trial data to date, he said.

“They haven’t seen any unblinded data yet and they haven’t performed any interim analysis yet,” Bourla said.

Patience Requested

Still, he affirmed the company’s earlier statement that it “may know” whether the vaccine is effective this month, a suggestion that an interim analysis is close. Yet even if the monitoring board were to see data this month showing clearly that the vaccine does or doesn’t work, it still could take several days for the results to be announced as Pfizer needs time -- as much as five to seven days -- to carefully go over the data, Bourla said.

“I just ask everybody to be a little bit patient,” he said. The company is “cautiously optimistic” that the vaccine will work based on the robust immune response it showed in early trials.

“You never know until you have a study readout,” he cautioned.

There is also the possibility that an interim analysis doesn’t show conclusive results. This could happen if the vaccine is partially but not totally effective, and the longer the trial continues without an efficacy result, the more modest the efficacy is likely to be.

Conclusive Results

In this case the trial would continue on to the next interim analysis -- there are four total in the trial, plus a scheduled final analysis. Bourla suggested in his opening remarks that Pfizer wouldn’t make an announcement if an interim analysis was inconclusive.

“After today’s earnings call, we do not intend to speak publicly about interim analyses until we have a conclusive readout from the data-monitoring committee,” he said on the call.

Pfizer is developing the vaccine with German partner BioNTech SE. The drugmaker has enrolled more than 42,000 patients in its Covid-19 vaccine trial. Almost 36,000 have received their second dose as of Oct. 26, the company said Tuesday.

Shares of Pfizer were little changed as of 12:39 p.m. in New York. Through the close on Monday, the stock had declined 3.2% so far this year.

Pfizer narrowed its profit forecast for the year, saying that it now expects adjusted earnings per share of $2.88 to $2.93, compared with $2.85 to $2.95 previously. In the third quarter, revenue fell 4.3% from a year earlier to $12.13 billion, as demand for some of its top drugs was reduced by Covid-19.

The company said that its third-quarter sales were reduced by $500 million, or 4%, due to Covid-19 related impacts, including reductions in wellness visits in the U.S. and lower demand for certain products in China. Sales in its Upjohn business, which sells many of its older drugs like cholesterol fighter Lipitor, were down 18% from a year earlier.

Sales of the smoking-cessation drug Chantix, down 19% in the U.S., were particularly impacted by the decline in wellness visits domestically, while in China there was lower demand for certain anti-infective products because of fewer elective surgeries and improved infection control compared to last year.

Partly offsetting the Covid-19 impact, some patients caught up on missed doses of the Prevnar-13 vaccine in third quarter.

©2020 Bloomberg L.P.