The United States started Covid-19 vaccinations on Monday after Robert Redfield, the director of the Centers for Disease Control and Prevention or CDC, gave the approval for Pfizer- BioNTech’s COVID-19 vaccine.
The CDC Director accepted the recommendation by CDC’s Advisory Committee on Immunization Practices or ACIP for vaccination with Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older. The recommendation follows the Emergency Use Authorization or EUA issued by the U.S. Food and Drug Administration for the vaccine on last Friday.
Redfield said, “As COVID-19 cases continue to surge throughout the U.S., CDC’s recommendation comes at a critical time.”
The Pfizer Vaccine is authorized for use under EUA for active immunization to prevent covid-19 caused by severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 in individuals 16 years of age and older.
The ACIP recommendation is based on the scientific evidence supporting the COVID-19 vaccine, including data from a Phase 3 clinical study announced last month, as well as on interim guidance that ACIP made on December 1, 2020 regarding the allocation of initial vaccine doses.
The ACIP on December 1 had recommended for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities.
CNN reported that the first freight trucks carrying around 184,275 vials of the vaccine departed Pfizer’s facility in Kalamazoo, Michigan, on Sunday.
The vaccines will be distributed by the U.S. Department of Defense in partnership with agencies within the Department of Health and Human Services, including the CDC, to government-designated facilities across the country.
Earlier, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, noted that Pfizer would move vaccine from its manufacturing facility to the UPS and FedEx hubs, and then it would go out to already identified 636 locations nationwide.
According to Perna, the estimate is that 145 sites across all the states would have receive vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday in the initial delivery of the Pfizer orders for vaccine.
Pfizer and Germany’s BioNTech earlier said they now gather additional data and prepare to file a planned Biologics License Application or BLA with the FDA for a possible full regulatory approval in 2021.
Source: Read Full Article