Pfzier, BioNTech Select mRNA COVID-19 Vaccine Candidate

Pfizer and BioNTech recently announced the start of a global (excluding China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA COVID-19 vaccine candidate.

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The late-stage global study will enroll nearly 30,000 participants aged 18 to 85 and will evaluate vaccine candidate, BNT162b2, from the company’s BNT162 mRNA-based vaccine program, which was established back in March. 

The trial regions will include areas with significant expected SARS-CoV-2 transmission to evaluate if the candidate is effective in highly infected areas.

The decision to advance the vaccine candidate into the Phase 2/3 study was based on review of preclinical and clinical data from Phase 1/2 clinical trials.

“We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in the announcement. 

“This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio. Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”

Pfizer and BioNTech have been successful in their mRNA vaccine program for COVID-19 thus far. 

Back in May, Pfizer and BioNTech announced that the first participants were dosed in the Phase 1/2 clinical trial, which aimed to uncover the safety, immunogenicity, and necessary dose level of four mRNA vaccine candidates

Last month, the companies announced that the Phase 1/2 clinical trial found that one of the vaccine candidates, BNT162b1, could be administered in a dose that was well tolerated and generated dose dependent immunogenicity.

The highest amount of antibodies present was found seven days after the second dose of 10µg or 30µg on Day 28 after vaccination. The neutralizing geometric mean concentration (GMC), or average antibody concentration, were 168 and 267 for the 10µg and 30µg dose levels, respectively.

At Day 21 after a single injection, the 12 subjects who received 100 µg had an RBD-binding IgG GMC of 1,778 units and a neutralizing GMT of 33.

At the 10µg and 30µg dose levels, adverse reactions included low grade fever and were more common after the second dose than the first.

Pfizer and NTech were also granted FDA Fast Track designation for two of the companies’ four investigational COVID-19 vaccine candidates from their vaccine program in mid-July.

The two candidates, BNT162b1 and BNT162b3 are the two most advanced candidates from the program.

More recently, the companies made an agreement with HHS and the Department of Defense (DoD) for large-scale production and nationwide delivery of 100 million doses of its BNT-162.

Under the agreement, the government will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses. 

Kathrin U. Jansen, PhD, senior vice president and head of vaccine research & development at Pfizer noted that the selection of the BNT162b2 vaccine candidate for the Phase 2/3 study is from the extensive, collaborative, and unprecedented R&D program between Pfizer, BioNTech, clinical investigators. 

“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,” Jansen concluded.