The study involved participants who received two doses in a phase 1 study 6 to 12 months ago to evaluate the effectiveness of BNT162b2 (a vaccine), the companies said. It also includes testing how well their antibodies are able to neutralize “strains of interest” in the lab, companies said.
The facility reported that volunteers would receive a third dose 6 to 12 months after their previous two doses. The dosage would be the same as currently allowed, 30 micrograms.
“Although we have not seen any evidence that circulating variants lose the protection provided by the vaccine, we are taking several steps to act decisively and be prepared in case the strain becomes resistant to the protection provided by the vaccine. Booster vaccination is critical to understanding the safety and immunity of the third dose. against circulating positions, “he said Albert Bourla, Chairman and CEO, Pfizer.
He added: “At the same time, we are making the right investments and having appropriate discussions with regulators to help us potentially develop and apply for an authorization for an updated mRNA vaccine or booster vaccine if necessary.”
However, Bourla noted that companies have not yet seen convincing evidence of variant resistance to its vaccine, even though they are preparing for action.
Ugur SahinThe CEO and founder of BioNTech said: “The goal of our proactive clinical development strategy is to lay the foundation today to meet the challenges of the future. We want to be prepared for a variety of scenarios.”
The Pfizer-BioNTech COVID-19 vaccine has been approved for use in active immunization under the Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals. 16 years and older.
According to CNN, Pfizer and BioNTech are also in “ongoing discussions with regulators” about the possible testing of the vaccine has been modified to protect against variations in the Phase 1/2 study.
On Monday, the U.S. Food and Drug Administration (FDA) announced new guidelines that will streamline and expedite the updating of vaccines to target variations. An agency official estimates that this can affect several hundred people and take a few months.
Source: ANI
Source: The Nordic Page