Both vaccine candidates leverage advanced mRNA technologies for rapid development and manufacturing than traditional production methods
Moderna, Pfizer begin late-stage trials of Covid-19 vaccine candidates
Moderna, Pfizer and BioNTech, have separately begun late-stage clinical trials of their mRNA-based Covid-19 vaccine candidates, BNT162b2 and mRNA-1273, respectively.
The vaccine candidates under the late-stage studies are said to leverage advanced mRNA technologies for rapid development and manufacturing than traditional vaccine production methods.
Also, both the late-stage studies are designed to enrolling 30,000 participants to evaluate the safety of vaccines and determine their capability to prevent symptomatic Covid-19.
Pfizer and BioNTech selected BNT162b2 as a lead candidate from BNT162b programme
Pfizer and BioNTech have started a global Phase 2/3 safety and efficacy clinical study, excluding China, to evaluate the lead Covid-19 vaccine candidate BNT162b2, which has recently won US Food and Drug Administration (FDA) Fast Track designation.
The Phase 2/3 study is an event-driven trial, planned to enrol up to 30,000 participants, aged between 18 and 85 years, across 120 clinical sites around the world, including 39 states across the US and countries including Argentina, Brazil and Germany.
Pfizer and BioNTech said that BNT162b2 was selected as their lead vaccine candidate from BNT162 programme, following a thorough review of preclinical and clinical data from Phase 1/2 trials, and in consultation with the US FDA’s Centre for Biologics Evaluation and Research (CBER).
The preclinical and clinical studies in BNT162 programme showed BNT162b1 and BNT162b2 as strong candidates, with better safety and immune response, and based on the totality of existing data from preclinical and clinical studies, BNT162b2 has been selected as a lead vaccine candidate.
BNT162b2 is said to encode an optimised SARS-CoV-2 full-length spike glycoprotein (S), which serves as the target for body’s virus neutralising antibodies.
Pfizer senior vice president and vaccine research and development head Kathrin U Jansen said: “Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study is the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective Covid-19 RNA vaccine.
“The Phase 2/3 study protocol follows all the US Food and Drug Administration (FDA) guidance on clinical trial design for Covid-19 vaccine studies.
“The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing Covid-19 pandemic, and we look forward to generating additional data as the program progresses.”
Moderna started Phase 3 COVE study to evaluate its mRNA-1273
Moderna has started a Phase 3 clinical study of its mRNA vaccine candidate mRNA-1273 against Covid-19, dubbed called the coronavirus efficacy (COVE) study -19.
The Phase 3 COVE study is planned to enrol around 30,000 participants in the US. Prevention of symptomatic Covid-19 disease is the primary endpoint. Prevention of severe Covid-19 and prevention of infection by SARS-CoV-2 regardless of symptomology include the key secondary endpoints.
Moderna has previously received $483m from the US government, under Operation Warp Speed programme and recently revised its collaboration agreement with BARDA to receive additional $472m funding, making the total investment reach $1bn.
Moderna CEO Stephane Bancel said: “We are pleased to have started the Phase 3 COVE study. We are grateful to the efforts of so many inside and outside the company to get us to this important milestone.
“We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent Covid-19 so that we can defeat this pandemic.”