Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end.

The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the FDA after gathering the required amount of safety data.

On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

There was also solicited safety data from a random subset of around 8,000 patients aged 18 or above and unsolicited safety data from around 38,000 trial participants.

Pfizer said the companies are ready to distribute the vaccine candidate “within hours” after authorisation, which should occur within the next month or so.

The FDA this week authorised Eli Lilly’s baricitinib, just over a month after the company announced supportive phase 3 data in COVID-19.

While the regulator has not given guidance on how long the review will take, expect a similar, if not quicker, timeline given the importance of a working vaccine in the effort against the pandemic.

The companies have already begun rolling submissions across the globe including in Australia, Canada, Chile, Europe, Japan and the UK, and plan to submit applications immediately to other regulatory agencies around the world.

Based on current projections the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer and BioNTech are also working with governments and health ministries around the world to set up delivery arrangements for the vaccine, which must be stored at around -70C to maintain its integrity.

According to reports Pfizer has already designed “pizza box” storage cases for the vaccine to help with this and will likely distribute them from several hubs in each country.

The companies said they had already built up expertise after delivering the vaccine to more than 150 clinical trial sites across the US, as well as Europe, Latin America, and South Africa.

The phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, 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 or placebo as of 13 November, 2020.

It is one of 11 vaccines that are in phase 3 development, including contenders from Moderna, Novavax and AstraZeneca, according to the World Health Organization’s regularly updated tracker document.

Feature image courtesy of NIAID/Rocky Mountain Laboratories