Announcement

Collapse
No announcement yet.

FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

    FDA NEWS RELEASE
    Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

    Other fully vaccinated individuals do not need an additional vaccine dose right nowFor Immediate Release: August 12, 2021

    Espaņol

    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 Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals. Today’s action does not apply to people who are not immunocompromised.

    “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.”

    People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19. The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines in these individuals and determined that the administration of third vaccine doses may increase protection in this population. These patients should be counseled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection to their loved ones.

    It is recommended that immunocompromised individuals discuss monoclonal antibody treatment options with their health care provider should they contract or be exposed to COVID-19. The FDA has authorized monoclonal antibody treatments for emergency use during this public health emergency for adults and pediatric patients (ages 12 and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. One authorized product includes use for preventative (prophylaxis) treatment after being exposed to SARS-CoV-2; however, this product is not a substitute for vaccination.

    The Pfizer-BioNTech COVID-19 Vaccine is currently authorized for emergency use in individuals ages 12 and older, and the Moderna COVID-19 Vaccine is authorized for emergency use in individuals ages 18 and older. Both vaccines are administered as a series of two shots: the Pfizer-BioNTech COVID-19 Vaccine is administered three weeks apart, and the Moderna COVID-19 Vaccine is administered one month apart. The authorizations for these vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine to individuals 18 years of age or older (ages 12 or older for Pfizer-BioNTech) who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

    The EUA amendments for the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine were issued to Pfizer Inc. and ModernaTX Inc., respectively.

    Related Information
    ###
    Dave Bexfield
    ActiveMSers

  • #2
    The CDC Panel has given it full backing.
    The CDC, in a presentation to the panel, detailed for the first timewhich patients should consider the extra shots. They include individuals undergoing treatment for tumors or cancers of the blood; organ transplant patients, including those have gotten a stem cell transplant within the last two years, and those whohave diseases that damage the immune system. Also on the list arepeople with advanced or untreated HIV infection, those being treated with high-dose steroids, and those who have chronic medical conditions that can weaken immune response, such as chronic kidney disease. The CDC hasestimated that about 2.7 percent of U.S. adults are immunocompromised, or about 7 million people.
    https://www.washingtonpost.com/healt...nocompromised/
    Article from The Washington Post:
    https://www.washingtonpost.com/healt...t-coronavirus/

    Article from The New York Times:
    https://www.nytimes.com/live/2021/08...pfizer-moderna
    Dave Bexfield
    ActiveMSers

    Comment


    • #3
      I was just turned away from one of the county vaccination sites today on the grounds that until the FDA gives them an exact list of who is eligible, they can't give a third dose to anyone. (It is not clear to me that the FDA is actually going to release an exact list of who is eligible.)

      My recommendation is to call before you go to find out if the site is actually giving third doses to immunocompromised people.

      Comment


      • #4
        Thanks for the update. I figured Saturday would be iffy until most pharmacies get a grip on the new directive. Please post here when you are successful, Bethany!
        Dave Bexfield
        ActiveMSers

        Comment


        • #5
          I got it from Walgreens on Monday. I didn't have an antibody response after the first two shots, so fingers crossed!

          Comment


          • #6
            Here are the MS Society's recommendations and MS-specific advice about booster doses of the vaccine:

            https://www.nationalmssociety.org/Ab...WSg8LM.twitter
            Dave Bexfield
            ActiveMSers

            Comment


            • #7
              Canada has updated its policy on boosters as well.

              TORONTO — Ontario is updating eligibility for the COVID-19 vaccine to protect individuals most at risk of serious illness from the virus, as well as children and youth to minimize disruptions from COVID-19 heading into the fall.

              A complete two-dose COVID-19 vaccine series provides strong protection against COVID-19 infection and severe outcomes, including against the Delta variant, in the general population. However, for some populations, a third dose may be required to provide sufficient protection based on a suboptimal or waning immune response to vaccines and increased risk of COVID-19 infection.

              Based on the recommendation of the Chief Medical Officer of Health and health experts, the province will begin offering third doses of a COVID-19 vaccine to select vulnerable populations:
              • Transplant recipients (including solid organ transplant and hematopoietic stem cell transplants)
              • Patients with hematological cancers (examples include lymphoma, myeloma, leukemia) on active treatment (chemotherapy, targeted therapies, immunotherapy) for malignant hematologic disorders
              • Recipients of an anti-CD20 agent (e.g. rituximab, ocrelizumab, ofatumumab)
              • Residents of high-risk congregate settings including long-term care homes, higher-risk licensed retirement homes and First Nations elder care lodges
              https://news.ontario.ca/en/backgroun...on-eligibility
              Dave Bexfield
              ActiveMSers

              Comment


              • #8
                I'm pleased to report that I had an antibody response following my third dose of Moderna! (I am on fingolimod.)

                Comment


                • #9
                  Fantastic news, Bethany! Thank you for the update.
                  Dave Bexfield
                  ActiveMSers

                  Comment

                  Working...
                  X