Pfizer Inc. (NYSE: PFE) and its partner BioNTech SE (NASDAQ: BNTX) announced the completion of the Phase 3 clinical trial of their COVID-19 vaccine candidate BNT162b2, after meeting all primary efficacy endpoints and achieving an efficacy rate of 95%.
The data was based on the evaluation of 170 confirmed cases of COVID-19, with 162 in the placebo group and 8 in the vaccine group. The results showed consistent efficacy across all demographics with 94% efficacy in adults above the age of 65.
The Phase 3 trial, which commenced towards the end of July, has enrolled over 43,000 participants to date, out of which over 41,000 participants have received a second dose of the vaccine as of November 13.
The companies have achieved all the safety milestones needed for Emergency Use Authorization (EUA) as mandated by the US FDA and will apply for the same within days. They will also submit the data to other global regulatory agencies.
mRNA technology
Pfizer’s vaccine uses gene-based technology called messenger RNA which triggers the growth of spike proteins, similar to those seen on the SARS-CoV-2 coronavirus, on human cells. The immune system mounts a defense by removing these spike proteins thereby developing the capability to recognize and remove spike proteins from the coronavirus in the event of infection.
Storage and manufacturing
Pfizer believes its current cold-chain infrastructure will be adequate for the global distribution of the vaccine. The companies stated that they will use specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperatures of minus 70°C, which can be used as temporary storage units for 15 days by refilling with dry ice.
Pfizer expects to produce up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021. Pfizer and BioNTech have already entered into an agreement with the US government under which the latter will first receive 100 million doses of the vaccine for $1.95 billion once it is approved.
Supply agreements
Last week, Pfizer and BioNTech reached an agreement with the European Commission to supply 200 million doses of their COVID-19 vaccine, with the option for an additional 100 million doses. If approved, deliveries could start by the end of this year.
In July, the companies entered into an agreement with Japan to supply 120 million doses of the vaccine in the first half of 2021 after approval. The companies also have a supply agreement in place with Canada for the COVID-19 vaccine.
Shares of Pfizer were up over 2% in morning hours on Wednesday.