Washington, DC—Pharmacists have a little time to prepare for an onslaught of people who have received two doses of COVID-19 vaccines and now are ready for their third.

A statement from the Department of Health and Human Services advises that administration of the booster shots will begin the week of September 20 and should be at least 8 months after the person’s second dose.

“At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster,” according to a statement attributed to a variety of public health and medical experts.

“We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.”

The booster shot program will involve a lot of people. As of August 10, the CDC and reported that nearly 91 million Americans had received the Pfizer-BioNTech COVID-19 vaccine, while another 64 million had been administered the Moderna shot.

“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant,” the group states. “Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long-lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maximize this protection. The available data makes very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease.”

The group says they determined that current protection against severe disease, hospitalization, and death could lessen in coming months, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout, adding, “For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

The HHS says the plan is to begin offering these booster shots this fall. The schedule is contingent, however, on the FDA’s independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines. The CDC’s Advisory Committee on Immunization Practices must also issue booster-dose recommendations based on an in-depth analysis of the evidence.

The initial booster shot roll-out only is related to the two-dose mRNA vaccines, according to the HHS announcement, which adds, “We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

The group of experts adds that in an environment of a “constantly changing virus and epidemiologic landscape,” the plan could be modified based on new scientific data.

HHS says the statement is attributable to Rochelle Walensky, MD, CDC Director, Janet Woodcock, Acting Commissioner, FDA; Vivek Murthy, MD, MBA, U.S. Surgeon General; Francis Collins, MD PhD, Director of the National Institutes of Health; Anthony Fauci, MD, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases; Rachel Levine, MD, Assistant Secretary for Health; David Kessler, MD, Chief Science Officer for the COVID-19 Response; and Marcella Nunez-Smith, MD, MHS, Chair of the COVID-19 Health Equity Task Force.

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