Patience in ‘last mile’ of Covid-19 vaccine process

Pfizer’s chief executive has urged patience in the “last mile” of Covid-19 vaccine development, after the timeline for an early look at whether a late-stage trial shows its vaccine works was poised to slip into November.

Albert Bourla said on Tuesday that he was still “cautiously optimistic” about the vaccine, which could be the first submitted for US emergency approval. He noted that “stress levels” around the world were rising as the “worst fears” come true, with Covid-19 spreading in Europe, the US and around the globe.

But the trial — which has enrolled over 42,000 participants, with 36,000 having received their second dose — has not yet hit the threshold at which it is allowed to do an initial analysis on whether the vaccine works.

“Let’s all have the patience that is required for something so important for public health and the global economy,” Mr Bourla told analysts on Tuesday.

Once the independent advisers do see the data and examine whether the rates of Covid-19 infection were higher in the placebo group than the vaccinated participants, he said it would take five to seven days for it to be analysed and published. Previously, Mr Bourla has said Pfizer could see the data before the end of October.

Vamil Divan, senior biopharmaceuticals research analyst at Mizuho, said it looked unlikely that Pfizer would publish this data until next week or later. He said unless participants develop Covid-19 — either on the placebo or on the vaccine — there was no way to determine if it worked.

Currently, the trial had not yet reached the 32 infections required for the initial efficacy analysis, Mr Bourla said.

“It could be that the people who are in the trial are a little bit more attuned to the science and are trying to avoid getting Covid-19.  or maybe it is just the locations where the sites are,” Mr Divan said, adding that depending on what was causing the slowdown, it might affect other vaccine trials too.

Mr Bourla warned that it would be necessary to address concerns about politicisation of a Covid-19 vaccine. US President Donald Trump has in the past said he was hopeful that a vaccine could be approved by election day on November 3 or shortly thereafter, as he tries to clinch re-election in a tight race with Democratic challenger Joe Biden. Food and Drug Administration guidelines on safety, however, mean that is very unlikely to happen.

Mr Bourla called the coming US presidential election an “artificial milestone”.

Pfizer has also been trying to educate the public, including by creating content targeted at minority communities, which have been hit harder by the virus.

If Pfizer’s vaccine is shown to be effective, it will apply for an emergency approval after it collects the required safety data in the second half of November. The company said on Tuesday it would have doses for 15m people in the US by the end of the year.

But Pfizer did not include any impact from a potential Covid-19 vaccine in its 2020 financial forecasts. On Tuesday, it tightened its forecasts for the full year, predicting sales of between $48.8bn to $49.5bn. It expects adjusted earnings per share to be between $2.88 to $2.93. In the third quarter, Pfizer reported adjusted earnings per share of 72 cents and revenue of $12.1bn, broadly in line with expectations.