Pfizer CEO Albert Bourla’s recent open letter on the potential timing of his company’s COVID-19 vaccine candidate provides clarity where earlier unscripted comments sowed confusion. His previous statements to the media led some to believe he would push for approval of his company’s vaccine in October. New guidance on the safety data required by regulators has ruled out that timeline. In other words, there isn’t going to be a COVID-19 vaccine available to the public before the November election, as President Trump had hoped.
But that does not mean October won’t bring a vaccine surprise. As Bourla explains in his letter, event data from the vaccine’s Phase III trial might accumulate to a sufficient level to allow for an early reading on whether or not it works. Even without regulatory approval, an announcement this month by Pfizer and its German partner, BioNTech, that their vaccine candidate works well enough in preventing COVID-19 to satisfy the efficacy requirements would be major international news (Bourla says he feels obligated to announce the results of early looks at efficacy data soon after receiving them). It would then be a matter of weeks before sufficient time passed before regulators could reach some conclusions on the vaccine’s safety profile too.
Read Full Article »