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Separately, in order to be prepared for any potential future strain changes, Pfizer and BioNTech are in ongoing discussions with regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, regarding a registration-enabling clinical study to evaluate a variant-specific vaccine having a modified mRNA sequence. This study would use a new construct of the Pfizer-BioNTech vaccine based on the B.1.351 lineage, first identified in South Africa. This could position the Companies to update the current vaccine quickly if the need arises to protect against COVID-19 from circulating strains.
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“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.”
“Our proactive clinical development strategy aims to create the foundation today, that will enable us to address the challenges of tomorrow. We want to be prepared for different scenarios,” said Ugur Sahin, CEO and Co-founder of BioNTech. “Therefore, we will be evaluating a second booster in the current regimen as well as preparing for a potential rapid adaption of the vaccine to address new variants which might escape the current version of our mRNA-based vaccine. The flexibility of our proprietary mRNA vaccine platform allows us to technically develop booster vaccines within weeks, if needed.
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Covid-19 Vaccines Targeting Multiple Variants Are in the Works at Moderna, Novavax
Researchers are trying to get ahead of variants like those identified in the U.K., South Africa and Brazil
https://www.contagionlive.com/view/moderna-vaccine-offers-protection-against-new-covid-19-variants
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