The US Food and Drug Administration gave emergency use authorization Thursday night for a third dose in certain patients who are likely to have had a poor immune response to two doses of either Pfizer’s or Moderna’s vaccine. There’s not enough data to discuss the possibility for an extra dose of Johnson & Johnson’s one-shot Covid-19 vaccine, the FDA said.
That brought the question to the CDC and its Advisory Committee on Immunization Practices to decide whether to recommend that people actually get these extra doses.
Covid-19 vaccine booster doses for the general public are not yet recommended.
ACIP said it should be left up to the patients and doctors to decide who needs an extra dose and what the timing of that dose should be.
The committee did not recommend any tests to see if people have had a sufficient response to the vaccine. No test is FDA-authorized for checking immune response after getting a Covid vaccine.
ACIP members discussed whether it would be safe to recommend giving a third dose of vaccine to immunocompromised children as young as 12 and decided to recommend including children 12 and over — who are included in Pfizer’s EUA — in their recommendation. Moderna’s vaccine is authorized for use in people 18 and older.
“This EUA is intended to be for people with moderate to severe immunosuppression and not persons with chronic conditions for which there might be mild associated immunosuppression,” the CDC’s Dr. Amanda Cohn told the meeting.
“The intent of our clinical considerations is to allow for some flexibility for providers to assess their patients’ immunosuppression and individuals will need to kind of attest to their immunosuppression to get vaccine,” Cohn added.
“But the intent of this is to limit this to individuals for which, are considered under the EUA to be moderate or severe and so for example would not include long-term care facility residents or persons with diabetes, persons with heart disease — those types of chronic medical conditions are not the intent here.”
Based on an estimate by the CDC, about 9 million Americans are immunocompromised, either because of diseases they have or medications they take.
It has been known for months that Covid-19 vaccines might not work well for this group. The hope was that vaccination rates overall would be so high so that the “herd” would protect them. But it didn’t work out that way — about a third of eligible people in the US have not received even one dose of a Covid-19 vaccine.