Pfizer to seek emergency use authorisation for coronavirus vaccine from US FDA ‘within days’

Author: Adam Yanelli

2020/11/18

HOUSTON (ICIS)--US pharmaceutical major Pfizer and German partner immunotherapy specialist BioNTech, announced on Wednesday that a safety milestone has been reached for a coronavirus vaccine.

They will submit a request within days to the FDA for emergency use authorisation (EUA).

The companies previously announced that the phase 3 clinical study is at least 90% effective based on clinical trials. This will be welcome news for the global markets that have seen demand erode amid the pandemic.

US financial markets and global crude oil prices were higher midday on the news.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer chairman and CEO.

In the latest development, Pfizer's data showed a vaccine efficacy rate of 95% in participants without prior infections, which was the primary objective, and also in participants with and without prior infections, which was a second primary objective, with each case measured from seven days after the second dose.

The companies said efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.

To date, the data monitoring committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.

Based on current projections, the companies said they expect to produce up to 50m vaccine doses in 2020 and up to 1.3 bn doses by the end of 2021.

Four of Pfizer’s facilities are part of the manufacturing and supply chain, with three in the US and one in Puurs in Belgium. BioNTech’s German sites will also be leveraged for global supply.

Another vaccine trial also announced positive results from its phase 3 trials on Monday when US drug maker Moderna said its vaccine candidate showed 94.5% efficacy when tested among more than 30,000 participants in the US.

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