As this issue was going to press, global news feeds started buzzing when Pfizer and BioNTech released interim results from their COVID vaccine trial. The vaccine, called BNT162b2, was reported to have an “efficacy rate above 90%.”

The efficacy against COVID-19 was in participants without prior evidence of SARS-CoV-2 infection, based on interim efficacy analysis by an independent Data Monitoring Committee (DMC) from the Phase III trial. After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the case count reached 94 and the DMC performed its first analysis on all cases.

According to the companies, the case split between vaccinated individuals and those who received the placebo indicated a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in a statement.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”

While the news injected some much-needed optimism into peoples’ lives, particularly amid what has to be the most chaotic presidential election cycle we as a nation have ever witnessed here in the U.S., the key moving forward is in the “additional efficacy and safety data” that will be released in the coming weeks.

Just because interim results say the vaccine is 90% efficacious in trials, doesn’t mean it will be 90% effective in the real world. As mentioned, the results of the interim analysis is for 94 participants—they need 164 to complete the trial. Safe vaccines with efficacy above 50% are expected to be approved for COVID-19.

So the path may be looking clearer, but we’re not out of the woods yet. Once a vaccine is approved and receives emergency use authorization (EUA) by FDA, which could come by the end of the year, they still have to make it and distribute it across the globe. No small feat.

While the R&D effort for a vaccine so far has been impressive by any measurement, the manufacturing, quality control and logistics side of the broader pharmaceutical industry must begin zeroing in and catching up, according to the authors of this month’s COVID-19 feature story, “Inspecting the Unexpected.” Andrea Sardella and Raffaele Pace from Stevanato Group say one step in particular could be a COVID vaccine choke point: inspection, which has long exemplified the push-pull between speed and quality. Turn to page 34 to hear what they have to say about preparing quality control processes for COVID-19 vaccine candidates.

Tim Wright, Editor
twright@rodmanmedia.com