The first Pfizer-BioNTech vaccine supplies are already preparing for distribution in the US. y prioridad will be a personal physician who treats Covid-19 patients

The first shipments of the Pfizer-BioNTech vaccine is already preparing to be shipped from the company’s site in Kalamazoo, Michigan, to the rest of the US, the company announced today.

Supplies will be distributed by the US Department of Defense UU. in partnership with agencies within the Department of Health and Human Services (HHS) to government-designed facilities across the country, signaled by Pfizer after an advisory panel from the U.S. Centers for Disease Control and Prevention. UU. approve the first Covid-19 vaccine.

Yesterday, the US Centers for Disease Control and Prevention (CDC) Immunization Practice Advisory Committee. UU. (ACIP) voted to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in 16-year-olds or below the Emergency Use Authorization (US) issued by the US Food and Drug Administration. UU. (FDA).

The ACIP vote follows the recommendation of 1 December 2020 for an implementation of Phase 1, where the first priority of Covid-19 vaccines it is provided to health care staff who treat patients and residents in nursing homes and other long-term care centers.

Emergency use of this product is only permitted as long as you maintain the statement that there are circumstances that justifies the authorization of the emergency use of the medical device.

Albert Bourla, President and CEO of Pfizer He stated that “Pfizer’s purpose is to change the lives of patients, and in our 171-year history it has never had a more urgent need for progress than it does today, with hundreds of miles of people still suffering. of Covid- 19 ”.

Bourla added that the news “is a great source of pride and joy because Pfizer has overcome the challenge of developing a vaccine that had the potential to help end this devastating pandemic. We have worked tirelessly to make the impossible possible, stand firm in our belief that science will prevail. ”

The FDA based its decision on all of the scientific evidence shared by companies, including data from a fundamental phase 3 clinical study announced last month and published this week in The New England Journal of Medicine.

Phase 3 data demonstrated a 95% vaccine efficacy rate in participants without prior SARS-CoV-2 infection (first primary endpoint) and also in participants with and without prior SARS-CoV-2 infection. (second primary objective), in each case measured from 7 days after the second dose.

The study’s Data Monitoring Committee did not report any serious safety issues related to the vaccine. Efficacy was constant across age, gender, race, and ethnicity. All follow-up participants will continue to monitor to assess long-term protection and safety for an additional two years after their second dose.

In the study Pfizer and BioNTech have participated approximately 44,000 test volunteers.

In July 2020, Pfizer and BioNTech announced an agreement to meet the program’s goal Warp Operation Speed of the US government. UU. to administer doses of a vaccine for Covid-19. With the vaccine authorized for emergency use in the U.S., companies will begin delivering the first doses in the US UU. immediately, and expects delivery to be completed by 2021.

To ensure product quality, companies have developed specially designed and temperature-controlled vaccine conveyors, which can be maintained recommended storage conditions (-70 ° C ± 10 ° C) for extended periods with dry ice.

The sender can keep the temperature for 10 days unopened, allowing transportation to markets around the world. Once opened, a vaccination center can use specially designed shippers as a temporary storage solution to maintain the Recommended storage conditions (-70 ° C ± 10 ° C) up to 30 days with re-freezing every five days according to handling instructions. Once thawed, the vaccine vial can be safely stored for up to five days under refrigerated conditions (2-8 ° C).