WASHINGTON – Pfizer and BioNTech announced that they will seek regulatory authorisation for a third dose of their Covid-19 vaccine yesterday.
This comes after initial data from a trial showed a third shot pushed antibody levels five to 10 times higher against the original strain and the Beta variant compared with the first two doses alone, according to a statement.
“The companies expect to publish more definitive data soon, as well as in a peer-reviewed journal, and plan to submit the data to the Food and Drug Administration, European Medicines Agency and other regulatory authorities in the coming weeks.”
In addition, the companies expect that a third dose will perform similarly well against the highly transmissible Delta strain, which is quickly becoming globally dominant.
Out of caution, they are also developing a Delta-specific vaccine, the first batch of which has been manufactured at BioNTech’s facility in Mainz, Germany.
The companies anticipate the clinical studies will begin next month, subject to regulatory approvals.
Based on drop-offs in efficacy seen in Israel after six months, they believe that a third dose may be needed within six to 12 months after full vaccination, said the statement.
“While protection against severe disease remains high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected.” – AFP, July 9, 2021
