Pfizer
The pair are planning for two separate studies: the first which involves participants from the Phase I study in the United States receiving a booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen, and the second evaluating a new variant-specific vaccine using a modified mRNA sequence.
For the second study, Pfizer and BioNTech are in talks with regulatory authorities,including the U.S Food and Drug Administration (F.D.A.) and the European Medicines Agency, to create a new vaccine to combat the new, highly transmissible variant first discovered in South Africa, known as B.1.351.
The companies hope that the two studies will help them be better prepared to modified their vaccine's mRNA technology as needed to protect against all currently circulating and possible future variants.
"While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine. This booster study is critical to understanding the safety of a third dose and immunity against circulating strains," said Pfizer CEO Albert Bourla in a statement.
"At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorization for an updated mRNA vaccine or booster if needed," Bourla added.
The companies are hoping to pursue easier authorization for their potential future modified mRNA vaccines with a shorter regulatory path, like the one for the annual flu vaccine update. Last Monday, the F.D.A. announced that it will not be requiring drugmakers to conduct lengthly safety and efficiency trials for modified versions of their coronavirus vaccines.
Moderna
