On May 19, the U.S. Food and Drug Administration (FDA) authorizes longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine.
Based on evidence from clinical trials, the Pfizer-BioNTech vaccine was 95% effective at preventing laboratory-confirmed COVID-19 illness in people without evidence of previous infection. “From the GRADE evidence assessment, the level of certainty for the benefits of the Pfizer-BioNTech COVID-19 vaccine was type 1 (high certainty) for the prevention of symptomatic COVID-19. Evidence was type 3 (low certainty) for the estimate of prevention of COVID-19–associated hospitalization and type 4 (very low certainty) for the estimate of prevention of death. Regarding potential harms after vaccination, evidence was type 2 (moderate certainty) for serious adverse events and type 1 (high certainty) for reactogenicity,” – Pfizer said.
U.S. Vaccination Data
The Centers for Disease Control and Prevention said about 159.2 million people have received at least one dose of a Covid-19 vaccine, including about 125.5 million people who have been fully vaccinated by Johnson & Johnson’s single-dose vaccine or the two-dose series made by Pfizer-BioNTech and Moderna.
More than 60 percent of adults have received at least one shot. President Biden set a goal on May 4 of reaching 70 percent of adults by July 4. Providers are administering about 1.8 million doses per day on average, about a 47 percent decrease from the peak of 3.38 million reported on April 13.
“Some experts have estimated that 70 to 90 percent of the total population — adults and children — needs to acquire resistance to the coronavirus to reach herd immunity, when transmission of the virus substantially slows because enough people have been protected through infection or vaccination. A number of factors will determine how quickly this threshold is met, especially the pace at which newly vaccinated people join those who are immune after past infections. But the presence of more transmissible virus variants could complicate that progress. And children, who aren’t yet eligible, may be key to reaching herd immunity, experts say,” – The New York Times report.
Changing in EUA for Pfizer-BioNTech Vaccine
Based on a review of recent data submitted by Pfizer Inc., the U.S. Food and Drug Administration is authorizing undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month. Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to 5 days.
Pfizer Inc. submitted data to the FDA to demonstrate that undiluted, thawed vials of its COVID-19 vaccine are stable at refrigerator temperatures for up to 1 month. The updated Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) is intended to help frontline workers understand the revised storage time.
“Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end. Pfizer Inc. submitted data to the FDA to support storage of undiluted, thawed vials of its COVID-19 vaccine for up to one month at refrigerator temperatures. This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store and administer the vaccine,” – said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.