Pfizer CEO says don't expect COVID-19 vaccine EUA until after election

Pfizer's CEO Albert Bourla has published a statement on the pharmaceutical company's efforts on developing a COVID-19 vaccine, stating that he wants to 'speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic.' Bourla details Pfizer's vaccine development timelines, offering greater transparency on the company's efforts.

A COVID-19 vaccine is a long-awaited solution to the global pandemic. Efforts to develop such a vaccine have been ongoing for several months by this point, but many signs point toward the general availability of a COVID-19 not arriving until around next summer — and some experts say that timeline is optimistic.

In his newly published statement, Pfizer's CEO points out that there are several hurdles that must be overcome to bring a vaccine to market, including proving that it is both effective and safe. Bourla states, "To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas."

According to Bourla, Pfizer may be able to determine by the end of this month whether its COVID-19 vaccine is effective, which is only the first of three different milestones the company's vaccine must pass. Once the vaccine is determined to be effective, it must then be demonstrated as safe — the FDA will require at least two months of safety data as part of its decision to grant an Emergency Use Authorization (EUA).

Assuming everything continues to progress along its current path, Bourla says that Pfizer anticipates it will hit the safety data milestone in the third week of November — which is, of course, after the upcoming presidential election.

The company will also need to prove that it has a high-quality vaccine manufacturing process that will result in consistent quality. Once all of these milestones are reached, Bourla says that Pfizer will apply for the FDA's EUA in the US, which is expected to happen in the third week of November. These are the 'best estimates' for when the vaccine program milestones will be achieved, however, with Bourla noting that things could change.