November 18, 2020 -- Pfizer and BioNTech have passed another milestone in their effort to deliver a vaccine for the SARS-CoV-2 virus. The companies on November 18 reported that their BNT162b2 vaccine candidate has met safety milestones and that they plan to apply for an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the product in the coming days.
BNT162b2 has met the safety milestones that are required by the FDA for an EUA to be issued, according to the company. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the safety and efficacy data collected to date, as well as manufacturing data related to the quality and consistency of the vaccine.
This announcement regarding the intent to submit an EUA comes just one week after the companies announced the interim results of the phase III trial.
More results from the phase III clinical trial
The data indicate a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection, measured seven days after participants received a second dose. The primary objective was based on 170 cases of COVID-19, as specified in the study protocol, where 162 of the cases were observed in the placebo group and only eight cases were in the BNT162b2 group.
The phase III trial began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13. Importantly, the company found that efficacy was consistent across age, gender, race, and ethnicity demographics. The observed efficacy for the vaccine in individuals over 65 years of age was 94%. There were 10 cases of severe COVID-19 in the trial, nine of which occurred in the placebo group.
The independent monitoring committee for the study has not reported any serious safety concerns related to the vaccine and the vaccine seems to be well-tolerated. The committee reported only rare cases of fatigue (3.8%) or headache (2%).
The companies plan to submit the vaccine data to other regulatory agencies around the world.
Pfizer and BioNTech expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer's facilities are part of the manufacturing and supply chain, including facilities in St. Louis, MO; Andover, MA; Kalamazoo, MI; and Puurs, Belgium. BioNTech's German sites will also be leveraged for global supply.
Pfizer will leverage its experience in cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers that utilize dry ice to maintain temperature conditions of -70°C. The containers can be used as temporary storage units for 15 days by refilling them with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across preset routes leveraging Pfizer's distribution network.
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