FDA approves second COVID-19 vaccine booster dose for older and immunocompromised people

The U.S. Food and Drug Administration on Tuesday gave the green light for a second booster of either the Pfizer-BioNTech or Moderna COVID-19 vaccines for people age 50 and older and certain immunocompromised individuals.

Shortly after the FDA’s regulatory action Tuesday, the federal Centers for Disease Control and Prevention followed suit with a recommendations to allow a second booster for immunocompromised individuals and people over the age of 50 who had received an initial mRNA booster dose at least four months earlier.

The CDC also said that newly published data shows that adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least four months ago can now get a second booster dose using an mRNA COVID-19 vaccine.

Dr. Sundari Mase, Sonoma County’s health officer, said Tuesday the local public health agency is waiting for guidance from the California Department of Public Health and the Western States Scientific Safety Review Workgroup before making any changes to the county’s public health policy on boosters. The scientific work group is made up of nationally acclaimed scientists with expertise in immunization and public health.

The FDA and CDC approvals make a second booster dose available to some populations at higher risk of severe disease, hospitalization and death.

Previously, the FDA authorized a single booster dose for certain immunocompromised people following the completion of a three-dose primary vaccination series. Immunocompromised individuals require three inoculations to be considered fully vaccinated.

“Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns,” the FDA said in a news release Tuesday.

The agency said:

• A second booster dose of the Pfizer or Moderna COVID-19 vaccines may be administered to people 50 years of age and older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
• A second booster dose of the Pfizer vaccine may be administered to certain immunocompromised individuals 12 years of age and older at least three months after receipt of a first booster dose of any approved COVID-19 vaccine. These are people who have undergone solid organ transplants or who are living with conditions that are considered to be equivalently immunocompromised.
• A second booster dose of the Moderna COVID-19 vaccine may be administered at least four months after the first booster dose of any authorized or approved COVID-19 vaccine to certain immunocompromised individuals 18 years of age and older.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the news release that current evidence suggests vaccine protection wanes over time against serious outcomes from COVID-19 in older and immunocompromised individuals.

“Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Marks said.

“Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so,” he added.

You can reach Staff Writer Martin Espinoza at 707-521-5213 or martin.espinoza@pressdemocrat.com. On Twitter @pressreno.