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

Milestones :: Perspectives :: Research

 

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

Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices’ Recommendation for an Additional Dose of an mRNA COVID-19 Vaccine in Moderately to Severely Immunocompromised People
August 13, 2021
Today, I signed CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation that endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series.

This official CDC recommendation — which follows FDA’s decision to amend the emergency use authorizations of the vaccines — is an important step in ensuring everyone, including those most vulnerable to COVID-19, can get as much protection as possible from COVID-19 vaccination.

Emerging data suggest some people with moderately to severely compromised immune systems do not always build the same level of immunity compared to people who are not immunocompromised. In addition, in small studiespdf icon, fully vaccinated immunocompromised people have accounted for a large proportion of hospitalized breakthrough cases (40-44%). Immunocompromised people who are infected with SARS CoV-2 are also more likely to transmit the viruspdf icon to household contacts.

While people who are immunocompromised make up about 3% of the U.S. adult population, they are especially vulnerable to COVID-19 because they are more at risk of serious, prolonged illness. Included in CDC’s recommendation are people with a range of conditions, such as recipients of organ or stem cell transplants, people with advanced or untreated HIV infection, active recipients of treatment for cancer, people who are taking some medications that weaken the immune system, and others.  A full list of conditions can be found on CDC’s website. The additional dose of an mRNA COVID-19 vaccine should be the same vaccine as the initial series and administered at least four weeks after completing a primary mRNA COVID-19 vaccine series.  While vaccination is likely to increase protection in this population, even after vaccination, people who are immunocompromised should continue follow current prevention measures (including wearing a mask, staying 6 feet apart from others they do not live with, and avoiding crowds and poorly ventilated indoor spaces) to protect themselves and those around them against COVID-19 until advised otherwise by their healthcare provider. CDC does not recommend additional doses or booster shots for any other population at this time…

CDC ACIP :: Meeting of August 13, 2021
Final Agenda – August 13, 2021pdf icon
Presentation Slides – August 13, 2021

New CDC Data: COVID-19 Vaccination Safe for Pregnant People
August 11,2021
CDC has released new data on the safety of the COVID-19 vaccines in pregnant people and is recommending all people 12 years of age and older get vaccinated against COVID-19.
“CDC encourages all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated to protect themselves from COVID-19,” said CDC Director Dr. Rochelle Walensky. “The vaccines are safe and effective, and it has never been more urgent to increase vaccinations as we face the highly transmissible Delta variant and see severe outcomes from COVID-19 among unvaccinated pregnant people.”…

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals – FDA
August 12,2021
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise…
“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”…

Vaccines and Related Biological Products Advisory Committee– FDA
:: No meetings scheduled

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Fact Sheet: Biden Administration Takes Steps to Address COVID-⁠19 in Rural America and Build Rural Health Back Better
August 13, 2021 • Statements and Releases

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
August 12, 2021 • Press Briefings

Readout of President Biden’s Meeting with Business, University and Health Care Leaders on COVID-⁠19 Vaccination Requirements
August 11, 2021 • Statements and Releases

Statement by President Joe Biden on COVID-⁠19 Vaccines for Service Members
August 09, 2021 • Statements and Releases