US COVID-19 vaccine boosters ready for September rollout, health officials say

In a joint statement released Wednesday, the nation’s top health officials said the U.S. is prepared to begin offering COVID-19 vaccine booster shots to Americans beginning Sept. 20, pending FDA review.

The shots would be offered to individuals whose second dose of a COVID-19 vaccine was eight months ago.

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"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 statement said, in part. "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."

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The statement, attributed to Centers for Disease Control and Prevention Director Dr. Rochelle Walensky, FDA Acting Commissioner Dr. Janet Woodcock, U.S. Surgeon General Dr. Vivek Murthy, NIH Director Dr. Francis Collins, President Biden's chief medical advisor Dr. Anthony Fauci and others, said currently available data indicates protection begins to wane over time, and "could diminish in the months ahead, especially among those who are higher risk or were vaccinated during the earlier phases of the vaccination rollout." 

"For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability," the statement continued. "We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence."

The officials said they are "prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual's second dose." 

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This group would likely include health care workers and nursing home residents who were targeted in the earliest phases of the rollout. 

Evaluations regarding Johnson & Johnson COVID-19 vaccine immunity is ongoing, the statement said, as the rollout for this shot did not begin until March. 

"Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape," the statement said. "We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it. We also want to emphasize the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world." 

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The officials said "nearly all the cases" of severe disease, hospitalizations and death are among unvaccinated individuals. 

"We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trust sources," the statement said. "We will also continue to expand our efforts to increase the supply of vaccines for other countries, building further on the more than 600 million doses we have already committed to donate globally."