CDC Director Issues Interim 3rd COVID-19 Vaccine Guidance

The 19th Director of the U.S. CDC, Rochelle P. Walensky, M.D., M.P.H., issued a statement today endorsing the Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in specific populations.

Dr. Walensky also recommended a booster dose for those in high-risk occupational and institutional settings.

The updated interim guidance from the CDC empowers millions of Americans at the highest risk for COVID-19 to receive a Pfizer-BioNTech COVID-19 booster shot to help increase their protection.

The booster dose would become a third immunization since the Pfizer-BioNTech COVID-19 vaccine has been administered as a two-dose regime.

The actions by the CDC were influenced by various studies reporting the Pfizer-BioNTech COVID-19 vaccine’s efficacy ‘wanes within months.’

The Food and Drug Administration (FDA) recent Authorization coincides with the CDC’s new guidance, which is as follows:

• People 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series,
• People aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their 2-dose Pfizer-BioNTech primary series,
• People aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
• People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

However, the new FDA and CDC guidance does not apply to the Authorized Moderna, Inc. or Johnson & Johnson COVID-19 vaccines.

With the Delta variant’s dominance as the circulating strain and cases of COVID-19 increasing significantly across the United States, a booster shot will help strengthen protection against severe disease in those populations at high risk for exposure to COVID-19 or the complications from severe disease, says the CDC.

The following is attributable to Dr. Walensky:

‘As CDC Director, it is my job to recognize where our actions can have the greatest impact. At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health.’ 

‘In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.’

‘I want to thank ACIP for their thoughtful discussion and scientific deliberation on the current data, which informed my recommendation.’

According to the CDC’s Interpretive Summary for September 24, 2021, the current 7-day moving average of daily new cases (121,533) decreased 17.1% compared with the previous 7-day moving average (146,684). And, the current 7-day daily average for September 15–September 21, 2021, was 9,636. This data reflects a 14.4% decrease from the prior 7-day average (11,255) from September 8–September 14, 2021.

Furthermore, the CDC confirmed about 212.6 million people, or 64% of the total U.S. population, have received at least one dose of a COVID-19 vaccine as of September 23, 2021.

The U.S. CDC works 24/7 protecting America’s health, safety and security. Whether disease starts at home or abroad, is curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

Notes: 

• The ACIP conducted a two-day digital meeting on Sept. 22 and 23rd. Most of the presentations are available for review at this CDC link. 
• The Pfizer-BioNTech COVID-19 vaccine is known globally as Comirnaty and is the same formulation but administered in 1,2, or 3 dose regimens.

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