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Pfizer’s top executives are standing by their expectation that the pharmaceutical giant will know conclusively by the end of October whether its coronavirus vaccine candidate works.
The $205 billion drugmaker is leading one of the few vaccine programs in the final stage of clinical trials. Pfizer started a phase-three study in July. While several vaccine candidates are now in phase-three trials, including Moderna and AstraZeneca, Pfizer has been alone in voicing confidence of getting efficacy data in October.
Read more: There are 176 coronavirus vaccines in the works. Here’s how top drugmakers see the race for a cure playing out in 2020 and 2021 and when the first shots might be available.
Company CEO Albert Bourla and head of vaccine research Kathrin Jansen both reiterated the October timeline Tuesday as part of a two-day investor presentation and on a press call.
Data by October requires perfection
A lot will have to go not just right, but perfectly, for Pfizer to achieve that speedy timeline. Overall, Pfizer is banking on an interim analysis of the study to show conclusive effectiveness. That means the group of study volunteers randomly receiving the experimental vaccine registered far less COVID-19 disease than a placebo group.
The FDA has said any coronavirus vaccine has to be at least 50% effective at preventing disease. An independent group of scientists who regularly monitor Pfizer’s study will need to examine the data and conclude there is a statistically meaningful difference between the group getting the real vaccine and the placebo.
Pfizer will have to show its vaccine is safe in data from thousands of trial participants for emergency authorization
Even if that data shows the vaccine works, Jansen said Tuesday the US Food and Drug Administration will require safety data from at least 6,000 people — 3,000 participants receiving Pfizer’s vaccine and 3,000 receiving a placebo. She did not specify how long the follow-up time must be for that safety data.
Safety is widely seen as the top priority for any vaccine, since the shots are given to otherwise healthy people. AstraZeneca’s trials were recently halted, as the company investigated a suspected serious adverse event reaction. While the UK-based study has since resumed, other global trials, including one in the US, remain on pause.
The FDA has not issued formal guidance on what it will take to issue an emergency approval for a vaccine — something the regulatory agency has never done before in its history with a previously unapproved vaccine. But top vaccine experts in the US government have said most side effects from vaccines are seen within a month and half of receiving the doses.
Some basic back-of-the-envelope math shows how extraordinarily tight Pfizer’s October timeline is shaping up to be. But it also shows it’s theoretically possible for Pfizer to land a Halloween surprise with enough data to support an emergency use authorization.
This chart shows how quickly Pfizer’s study has enrolled volunteers. The study reached 6,000 volunteers sometime around August 15. The vaccine is given as a two-dose regimen, with the shots …read more
Source:: Business Insider