Pfizer and BioNTech SE have announced their mRNA-based COVID-19 vaccine candidate has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of infection.
The findings of the efficacy of Pfizer and BioNTech’s COVID-19 vaccine candidate – BNT162b2 – are based on the first interim efficacy analysis conducted on 8 November 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase III clinical study.
The UK Government has claimed the country will be at the “front of the pack” for the vaccine. A government spokesperson said: “The results from Pfizer/BioNTech are very promising and we have procured 40 million doses of their vaccine.”
Based on current projections, Pfizer and BioNTech SE say up to 50 million vaccine doses can be expected to be produced in 2020 and up to 1.3 billion doses in 2021.
Positive results for an effective vaccine
Pfizer has commented that the positive results show that the mRNA-based vaccine can help to prevent a COVID-19 infection in the majority of people who receive it.
Following discussions with the FDA, the two companies dropped the 32-case interim analysis and conducted the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.
The case split between vaccinated individuals and those who received the placebo indicates an efficacy rate above 90% at seven days after the second dose, meaning that protection from a COVID-19 infection is achieved 28 days after the initiation of the vaccination which is administered on a two-dose schedule.
The trial has enrolled 43,538 participants since 27 July 2020, 38,955 of whom have received a second dose of the vaccine candidate as of 8 November 2020, and approximately 42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds.
Dr Albert Bourla, Pfizer Chairman and CEO, said: “Today is a great day for science and humanity. The first set of results from our Phase III COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development programme at a time when the world needs it most with infection rates setting new records, hospitals nearing over capacity, and economies struggling to reopen.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavour. We could not have come this far without the tremendous commitment of everyone involved.”
The trial is continuing to enrol and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. It will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to the virus, as well as prevention against severe COVID-19. The final vaccine efficacy percentage may vary as the study continues.
Safety of the vaccine
There have been no safety concerns about the vaccine reported, and both companies are continuing to accumulate safety data – estimating that a median of two months of safety data, as specified by FDA guidance, following the second (and final) dose of the vaccine candidate, will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
“The first interim analysis of our global Phase III study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Professor Ugur Sahin, BioNTech co-founder and CEO.
“When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enrol for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
The Government spokesperson added: “While we are optimistic of a breakthrough, we must remember that there are no guarantees. We will know whether the vaccine meets robust standards of safety and effectiveness once the safety data have been published, and only then can the medicines regulator consider whether it can be made available to the public.
“Once approved, the NHS stands ready to begin a vaccination programme for those most at risk, as currently recommended by the independent Joint Committee on Vaccination and Immunisation (JCVI), before being rolled out more widely.”
The companies are also working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine produced.
Pfizer and BioNTech plan to submit data from the full Phase III trial for scientific peer-review publication.