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Pfizer: Early Data Says COVID-19 Vaccine is Effective

Early Monday morning, Pfizer said its mRNA-based vaccine is more than 90% effective in preventing COVID-19 in trial participants without evidence of prior SARS-CoV-2 infection.

The pharmaceutical giant expects to file for Emergency Use Authorization (EUA) the third week of November—when it anticipates meeting the required safety milestone.

The first interim efficacy analysis, completed by an independent board Sunday, evaluated 94 confirmed cases of COVID-19 in over 43,000 trial volunteers. More than 90% of those cases occurred in participants who received a placebo, while less than 10% of infections were detected in those who were given the vaccine. According to Pfizer’s news release, the mRNA-based vaccine provided protection seven days after the second dose and 28 days after the initial dose.

The manufacturer was careful to caution that the final efficacy percentage could change as the study continues. The trial will conclude once it records 164 infections among all volunteers—a number Pfizer agreed upon with the FDA. The federal health agency has made it clear it expects any approved virus to be at least 50% effective across large, diverse populations. The current Phase 3 study meets those requirements with 43,538 enrolled global participants, 42% with racially and ethnically diverse backgrounds.

No serious illness or safety concerns have been observed thus far, although that will need to hold true for another two weeks if Pfizer wants to file for EUA. Last month, the FDA posted new guidance for manufacturers that said they need to provide at least two months of follow-up safety data after vaccinating volunteers before asking the federal health agency to consider an EUA. Pfizer will reach that milestone in the third week of November.

“Today is a great day for science and humanity,” said Albert Bourla, Pfizer Chairman and CEO. “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.”

For this trial, it’s important to note participants are/were only tested for COVID-19 if they developed symptoms, leaving questions as to whether vaccinated, seemingly healthy individuals can unknowingly spread the virus.

Pfizer also announced Monday that it has added a secondary endpoint to the current trial. The manufacturer will now also evaluate the vaccine’s potential to protect against COVID-19 in those who have had prior exposure to SARS-CoV-2, in addition to vaccine prevention against severe COVID-19.

If Pfizer’s BNT162b2 is approved, it will be the first mRNA-based vaccine ever approved by the FDA. Because mRNA is a naturally unstable molecule that is prone to degradation when exposed to dramatic temperature fluctuations, cold chain requirements for this vaccine are unprecedented. Anticipating the fact that ultra-low temperature freezers are not common, Pfizer designed temperature-controlled shipping packages that use dry ice to keep vaccine vials at -75˚C for 10 days. However, these suitcase-like containers are unproven, raising concerns about delivery, distribution and wastage. Based on current projections, Pfizer said it expects to produce worldwide up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Pfizer’s candidate is one of two mRNA-based vaccines in late-stage testing. In October, Moderna said more than 25,650 individuals had received their second dose of mRNA-1273, the company’s COVID-19 vaccine candidate, during a Phase 3 trial. As long as the current trend of safety continues, Moderna also intends to apply for EUA at the end of November, once the 2 months of safety follow-up have elapsed.

Photo: Researchers at the University of Maryland School of Medicine are supporting clinical trials for both Pfizer and Moderna's mRNA-based COVID-19 vaccine candidates.

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  • New York, NY, USA
  • Pfizer