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Pfizer and BioNTech have started a new trial to determine the efficacy of the third dose of their Covid-19 vaccine (BNT162b2) against emerging variants of SARS-CoV-2.
The new study will enroll up to 144 phase I study participants in the US in two age cohorts 18 to 55 and 65 to 85 years.
According to the trial, a 30 µg booster of the current vaccine will be given to participants who received the initial two-dose regimen about six to 12 months ago.
The study will evaluate the safety and immune response of the third dose of BNT162b2.
All participants will be monitored after receiving the third dose, and then a week and a month later. They will be monitored for up to two years as originally planned.
The Pfizer-BioNTech vaccine has been licensed for emergency use by the US Food and Drug Administration for use in persons 16 years of age and older.
The first interim efficacy analysis data from the BNT162b2 trial found the vaccine to be more than 90% effective in preventing Covid-19.
Separately, Pfizer and BioNTech are in discussions with regulatory authorities to undertake a registry-enabling clinical study to evaluate a variant-specific vaccine that has a modified mRNA sequence.
The study plans to use a Pfizer-BioNTech vaccine construct based on the B.1.351 lineage, which was first identified in South Africa. This will support companies’ preparations to address potential voltage changes in the future.
Pfizer Chairman and CEO Albert Bourla said: “While we have not seen any evidence that circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be prepared in the event of a strain becoming resistant to the protection provided by the vaccine.
“This booster study is critical to understanding the safety of a third dose and immunity against circulating strains.
“At the same time, we are making the appropriate investments and participating in the appropriate conversations with regulators to help position ourselves to develop and seek authorization for an updated mRNA vaccine or a booster if needed.”
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