American Liver Foundation Applauds Full FDA Approval of COVID-19 Vaccine, Recent CDC Announcements

Pfizer-BioNTech Vaccine Reaches Key Milestone at a Critical Time

The American Liver Foundation (ALF) applauds the announcement of the Food and Drug Administration (FDA) granting full approval of the first Coronavirus vaccine. The Pfizer vaccine, previously known as the Pfizer-BioNTech COVID-19 Vaccine, will now be known as Comirnaty and is authorized for those 16 and older, with emergency use authorization for children 12-15 years old, as well as for those receiving a third booster dose. Read the full statement here.

ALF appreciates the FDA’s urgency in the situation while acknowledging the rigorous process and scientific review necessary to make the decision. We are hopeful that the approval inspires additional confidence in the public about the safety of the vaccines, and encourages those who are hesitant to reconsider getting it.

The announcement comes as we enter another wave of the COVID-19 pandemic with the rise of the Delta variant. It also comes at the same time as a number of important recent recommendations and guidelines for vaccine usage issued by the CDC, including suggested vaccination for all people over 12, who are pregnant, booster shots for immunocompromised individuals, and upcoming booster shots for those who’ve had the Moderna and Pfizer vaccines for over eight months.

Pregnant people and those who were recently pregnant have a slightly higher risk of severe illness from COVID-19. A growing body of data suggests that the benefits of vaccination outweigh the risk, and there has been no information to suggest that they are connected to any fertility issues in either men or women. Read more about this recommendation here.

Also, the CDC now recommends that certain immunocompromised individuals receive an additional booster dose of an mRNA COVID-19 Vaccine at least 28 days after the completion of the initial mRNA COVID-19 Vaccine series (Pfizer-BioNTech or Moderna). The FDA has authorized an additional vaccine dose for these immunocompromised individuals. The immunocompromised groups include those that have received a solid-organ transplantation or have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

If you are considered immunocompromised, please speak to your doctor about an additional dose of the mRNA COVID-19 Vaccine (Pfizer-BioNTech or Moderna).

Finally, the CDC announced this week in a joint statement with HHS that they recommended booster doses for all Pfizer and Moderna recipients. While still extremely effective, protection has been observed to diminish over time. Therefore, shots will be start to be offered the week of September 20^th, 2021 for those who’ve had the vaccine for at least eight months. You can read the statement here.

The American Liver Foundation joins the Global Hepatology Society in strongly recommending that all patients with liver disease undergo any authorized immunization when they are able to do so. Please read the full statement here.

Thank you for your continued vigilance. We will continue to provide additional updates on new developments in the days and weeks ahead. For additional information, please visit the ALF COVID-19 Information Center or CDC website: https:/www.cdc.gov/ and remember to give our helpline a call if you have questions about liver health and disease at 1-800-GO-LIVER.