Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 is 95% effective, new and final analysis of a phase 3 trial shows.
In a final analysis of the phase 3 study of the mRNA-based COVID-19 vaccine, BNT162b2 was found to have an efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).
The company added that the efficacy rate was consistent across age, gender, race and ethnicity, with the observed efficacy in adults over 65 years of age coming in at over 94%.
There were also ten severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the vaccinated group.
Pfizer said in a statement that it will submit a request ‘within days’ to the US Food and Drug Administration (FDA) for an emergency use authorisation (EUA) based on the final safety and efficacy data.
Pfizer has initiated a pilot delivery programme for BNT162b2 amid concerns over potential distribution issues relating to the vaccine, which must be stored at ultra-low temperatures if it is to remain stable.
The vaccine candidate needs to be both distributed and stored at -70˚C (minus 94°F), which is well below the typical vaccine storage temperature of +2˚C to +8˚C.
The pilot programme is being conducted in four states in the US and will aim to improve understanding for accurate planning, deployment and administration of BNT162b2.
For inclusion in the pilot, Pfizer selected Rhode Island, Texas, New Mexico and Tennessee based on the differences in each states’ overall size, diversity of populations and immunisation infrastructures, as well as the states’ need to reach individuals in varied urban and rural settings.
“This pilot programme and our collaboration with US and state officials will help us prepare for broader vaccine deployment in the near future, subject to authorisation or approval, as we work to address this urgent public health need,” said Angela Hwang, group president, Pfizer Biopharmaceuticals Group.
“We are hopeful that results from this vaccine delivery pilot will serve as the model for other US states and international governments, as they prepare to implement effective COVID-19 vaccine programmes,” she added.
According to the WSJ, Pfizer has designed a ‘new reusable container’ that ensures the vaccine can be kept at the ultra-low temperatures required for up to ten days while it is being transported. These containers can hold between 1,000 and 5,000 doses, according to WSJ.
Another mRNA-based vaccine candidate, developed by German biotech CureVac, seems to have overcome the temperature obstacle, reporting earlier this week that its vaccine remains stable for at least three months when stored at a standard refrigerator temperature.
The stability of CVnCoV was tested at the anticipated storage concentration and also stored at +5°C (+41°F) as well as below -60°C (-76°F), with the vaccine fulfilling all set release specifications at both temperatures after three months.