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CDC, FDA Authorize Pfizer-BioNTech Booster

 

October 6, 2021 | View PDF



Lincoln – On Thursday, September 23, 2021, Center for Disease Control and Prevention (CDC) issued a recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in populations who are at highest risk for COVID-19. The CDC announcement follows the Food and Drug Administration (FDA) authorization of the use of Pfizer-BioNTech’s COVID-19 Vaccine on September 22, 2021. Vaccine booster doses are to be administered at least 6 months after completion of the primary Pfizer vaccine series. 

The FDA authorization and the CDC guidance will allow many Nebraskans who received the Pfizer vaccine their initial vaccine early in the vaccination program to benefit from additional protection. Although no vaccine offers foolproof protection against the virus, with the Delta variant’s dominance as the circulating strain and cases of COVID-19 are increasing across the United States, booster shots will help strengthen protection against severe disease in those populations who are at high-risk for exposure to COVID-19 or the complications from severe disease. 

The FDA has authorized and the CDC recommended the booster shot for people who received the Pfizer vaccine in the following categories: 

People aged 65 years and older

Long-term care residents

People aged 50-64 years with underlying medical conditions

The CDC made additional announcements:

People 18-49 years, including pregnant women, with underlying medical conditions are recommended to weigh their individual benefits and risks.

People who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting, including frontline workers, such as teachers and healthcare workers. CDC plans to issue additional guidance for occupational exposure. 

The State of Nebraska’s guidance encourages individuals to have a conversation with their doctor about the vaccine booster. 

CDC is currently assessing whether immunocompromised individuals who received an additional vaccine dose (three doses total) will need a booster (bringing them to four doses). More information will be provided by the time immunocompromised individuals would need to receive their booster shots (not until February 2022 at the earliest). 

At this time, self-attestation is sufficient for an individual to get a booster shot; no documentation is necessary.

Guidance for Moderna and Johnson & Johnson Vaccines to Be Addressed 

Pfizer was the first vaccine to be authorized for use, so data on its ongoing effectiveness were also available first. In the coming weeks, CDC plans to evaluate available data and make additional recommendations for people who received the Moderna or Johnson & Johnson vaccines. CDC Director Dr. Rochelle P. Walensky commented, “Today, ACIP only reviewed data for the Pfizer-BioNTech vaccine. We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available.” 

Vaccine Effectiveness 

Vaccines have been shown to be effective in reducing risk of severe disease, hospitalization, and death, including against the Delta variant. A small percentage of people who are fully vaccinated will still get COVID-19 if they are exposed to the virus that causes it. These are called vaccine breakthrough cases. 

Data obtained from State Health Information Exchange and Nebraska State Immunization Information System (NESIIS) show that Nebraskans who are not fully vaccinated are 6 times more likely to be hospitalized with COVID-19. 

 

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