Drafted by the ASTS COVID Strikeforce & Endorsed/Approved by the ASTS Council
ASTS applauds the FDA for its decision to authorize an additional COVID-19 vaccine dose for transplant recipients and other immunocompromised patients, and we fully support this approval for the treatment of our patients.
On Thursday, August 12, the U.S. Food and Drug Administration (FDA) announced it had 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 solid organ transplant recipients and certain other immunocompromised individuals who diagnoses leave them immunocompromised to a similar extent as transplant recipients.
Explaining the rationale behind the decision, the FDA cited certain immunocompromised individuals’ reduced ability to fight infections and other diseases, including COVID-19. It evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines in this population and determined the administration of third vaccine doses may increase protection for these individuals. The FDA additionally recommended these patients be counseled to maintain physical precautions to prevent them from contracting COVID-19 addition and said close contacts of immunocompromised persons should get vaccinated. The ASTS has an additional concern that fully vaccinated recipients from an adenoviral vector vaccine (J&J in the US) may also benefit from an additional vaccine dose. While other countries have mixed types/platforms to boost vaccine antibody response, we encourage that the FDA and CDC urgently address this recipient population and mitigate their suboptimal vaccine response as well.
Since the COVID-19 vaccine became available, ASTS has supported surgeons, physicians and staff receive the vaccine in order to prevent respiratory disease and infection among the community and in particular, our patients. Early on, there was evidence that showed transplant recipients do not get the same benefit of protection as non-immunocompromised individuals. Therefore, ASTS is in full support of the FDA’s decision to approve a third dose of the COVID-19 vaccine to immunocompromised patients, strongly encourages this approach with patients.
Additionally, ASTS recommends that, pending approval from the FDA, such patients receive a third dose of an mRNA vaccine, as there is strong evidence to show this elicits a stronger antibody response and better protection from serious infection. Though the data are not definitive, there is enough experience globally to show that this practice is both safe and effective, as seen in literature from both Israel and France.
ASTS continues to monitor the SARS-CoV-2 pandemic and variants, and resources can be found at on our website.
Read the full FDA announcement here.