Early Phase III data from Pfizer and BioNTech

BNT162b2 is the experimental mRNA-based vaccine candidate from Pfizer and BioNTech’s in Phase III study.

Since June, 43,538 participants have been enrolled to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8.

On Monday, November 9th, the company announced that the BNT162b2 vaccine candidate was more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.

Currently, it’s unclear exactly how many of the trial’s 43,000 participants, who received either two doses of the vaccine or the placebo, have contracted COVID-19, the interim analysis includes 94 confirmed cases. Among these 94, roughly 10 percent had been given the vaccine, while the other 90 percent had been given a placebo.

This vaccination will consist of a two-dose schedule and, based on the drugmakers the protection is achieved 28 days after the initiation of the vaccination. No serious safety concerns have been reported and a key safety milestone is expected in the third week of November.

All subject participants will continue to be monitored for long-term protection and safety for an additional two years after the second dose.

 

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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