U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

CDC [ACIP]

CDC Statement on ACIP Booster Recommendations

Friday, September 24, 2021

Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings. The Food and Drug Administration’s (FDA) authorization and CDC’s guidance for use are important steps forward as we work to stay ahead of the virus and keep Americans safe.

This updated interim guidance from CDC allows for millions of Americans who are at highest risk for COVID-19 to receive a Pfizer-BioNTech COVID-19 booster shot to help increase their protection.

CDC recommends:

  • 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 6 months after their Pfizer-BioNTech primary series,
  • people aged 50–64 years with underlying medical conditionsshould receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • people aged 18–49 years with underlying medical conditionsmay receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 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 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

Many of the people who are now eligible to receive a booster shot received their initial vaccine early in the vaccination program and will benefit from additional protection. 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 who are at high-risk for exposure to COVID-19 or the complications from severe disease.

CDC will continue to monitor the safety and effectiveness of COVID-19 vaccines to ensure appropriate recommendations to keep all Americans safe. We will also evaluate with similar urgency available data in the coming weeks to swiftly make additional recommendations for other populations or people who got the Moderna or Johnson & Johnson vaccines.

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 believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19. This aligns with the FDA’s booster authorization and makes these groups eligible for a booster shot. 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.

While today’s action was an initial step related to booster shots, it will not distract from our most important focus of primary vaccination in the United States and around the world. I want to thank ACIP for their thoughtful discussion and scientific deliberation on the current data which informed my recommendation.

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Changes in booster shot guidance lead to confusion for doctors, patients

Washington Post, 9/25/2021

The muddle came to a head with this week’s showdown between the CDC’s advisers and its director. Health care providers are now trying to get answers to patients’ questions — and their own.

By Carissa Wolf, Frances Stead Sellers, Ashley Cusick and Kim Mueller

…Confusion over boosters, which has been brewing for months, heightened over the past week as government regulators and advisers met to hash out the pros and cons of administering third doses.

Hours of meetings culminated in a showdown Thursday: The Centers for Disease Control and Prevention’s advisory group narrowed the Food and Drug Administration’s recommendation for who should get a third Pfizer shot, only to be overruled in a late-night announcement by the CDC director: Along with Americans 65 and older, nursing home residents and people ages 50 to 64 with underlying medical conditions, who the advisory panel had suggested should get shots, Rochelle Walensky added the people in high-risk jobs.

“It’s a communications crisis,” said Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, who said he received worried calls Thursday evening from health-care workers who thought they would not be eligible for the shots, followed by messages Friday from colleagues wondering when and where to get them…

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Vaccines and Related Biological Products Advisory Committee- FDA

 

Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting Announcement

Agenda
Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER).

Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.

YouTube recording: https://youtu.be/VeknygU5MKM

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
September 24, 2021 • Press Briefings

Global COVID-⁠19 Summit: Ending the Pandemic and Building Back Better
September 24, 2021 • Statements and Releases
Editor’s Note:
This statement provides the U.S. narrative on the “Virtual Global COVID-19 Summit” as further detailed by the speeches, statement and releases below. It includes quotations attributable to and a list of “more than 100 governments and other partners” which participated and the “more than 100 International Organizations, non-governmental organizations, private sector, and philanthropies” which participated. We recognize the limited alignment between this statement and the tone and detail of the COVAX partners announcement on the Biden Summit above.

Remarks by President Biden on the COVID-⁠19 Response and the Vaccination Program
September 24, 2021 • Speeches and Remarks

Remarks by Vice President Harris At Virtual Global COVID-⁠19 Summit
September 22, 2021 • Speeches and Remarks

Remarks by President Biden at Virtual Global COVID-⁠19 Summit
September 22, 2021 • Speeches and Remarks

A U.S.-EU Agenda for Beating the Global Pandemic Vaccinating the World, Saving Lives Now, and Building Back Better Health Security
September 22, 2021 • Statements and Releases

United States–European Commission Joint Statement
September 22, 2021 • Statements and Releases
Editor’s Note:
This statement provides details on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce first announced in June. This week, the Taskforce met in Washington, D.C., to finalize the Mission Statement of this Taskforce, which will focus on the following three priority “work strands” including: [1] Monitor global supply chains for COVID-19 vaccines and therapeutics through assessment of global demand and supply of these items and their production and ancillary supplies, and through identification of supply chain bottlenecks; [2] Address critical supply chain bottlenecks and other disruptive factors for global COVID-19 vaccine and therapeutics production, and [3] Coordinate initiatives to boost global production of COVID-19 vaccines, therapeutics, and their production and ancillary supplies.

FACT SHEET: President Biden’s Global COVID-⁠19 Summit: Ending the Pandemic and Building Back Better
September 22, 2021 • Statements and Releases

FACT SHEET: Targets for Global COVID-⁠19 Summit
September 22, 2021 • Statements and Releases
[See Milestones above for detail]