CDC advisors recommend a third shot of either the Pfizer or Moderna vaccine for people with compromised immune systems. The vote follows the approval of such use by the FDA. Patrick T. Fallon / AFP via Getty Images Hide caption
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Patrick T. Fallon / AFP via Getty Images
CDC advisors recommend a third shot of either the Pfizer or Moderna vaccine for people with compromised immune systems. The vote follows the approval of such use by the FDA.
Patrick T. Fallon / AFP via Getty Images
Advisors to the Centers for Disease Control and Prevention have unanimously voted to recommend people with compromised immune systems receive a third vaccination with either the Pfizer BioNTech or Moderna vaccine.
The vote follows the approval of such use by the Food and Drug Administration on Thursday evening.
The CDC is expected to approve the committee’s actions later on Friday. Vendors generally await a CDC recommendation on vaccine use, even if the FDA has approved or approved a vaccine.
Immunocompromised people make up about 2.7% of US adults, or about 7 million people. They are more likely to get sick with COVID-19 and have a higher risk of prolonged coronavirus infection and transmission. They also have a lower antibody response to the initial vaccination schedule and are more likely to spread the virus to household contacts, according to the studies CDC officials presented to the committee.
People with conditions that weaken the immune system or who are taking treatments that suppress immunity are also much more likely to have a breakthrough infection than people of normal health. A US study shows that 40% to 44% of breakthrough hospital admissions occur in immunocompromised people.
Studies have also shown that the vaccine is less effective in these people, ranging between 59% and 72%. This compares to 90-94% in people without serious immunodeficiency. People who have received a solid organ transplant have the lowest immunity on the standard vaccination schedule.
The CDC will further clarify the terms on which the recommendation is made once the agency formally accepts the committee’s advice.
Some of the situations presented to the committee for consideration that are likely to be officially recommended by the CDC include:
- Active or recent treatment of solid tumors and haematological malignancies
- Receiving solid organ transplants or new haematopoietic stem cells
- Severe primary immunodeficiency
- Advanced or untreated HIV infection
- Chronic diseases such as asplenia and chronic kidney disease, which can be associated with varying degrees of immunodeficiency.
- Receiving a CAR-T cell or haematopoietic stem cell transplant (within 2 years of transplant or taking immunosuppressive therapy)
- Moderate or severe primary immunodeficiency (e.g. DiGeorge, Wiskott-Aldrich syndrome)
- Active treatment with high-dose corticosteroids (ie ≥20 mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressants, cancer chemotherapeutic agents classified as severely immunosuppressive, TNF blockers and other biological agents that are immunosuppressive or immunomodulatory
The recommendation for the Moderna vaccine is limited to adults aged 18 and over, as this vaccine has not yet been approved for adolescents. This approval is expected by the FDA in the next few weeks. The Pfizer vaccine is approved for adolescents 12 years and older and adults.
People with other medical conditions are not advised to receive an additional dose at this time. “This would not include residents of long-term care facilities, people with diabetes, people with heart disease – these types of chronic conditions are not the intent here,” said Dr. Amanda Cohn from the CDC. Additional studies of how long immunity lasts in healthy people are underway and will determine the timing of additional doses for the general population, officials from the FDA and CDC say.
The CDC said attempts should be made to match the type of additional dose that was used in the original shots someone receives. However, if this is not possible, an additional dose with the other vaccine is allowed. According to the data reviewed by the committee, the additional dose should be administered at least 28 days after the end of the primary series.
On Thursday, the FDA said the agency could not extend approval for an additional dose of the Johnson & Johnson vaccine due to insufficient data. Representatives from both agencies said they were “actively involved” in determining the best course of action for recipients of the Johnson & Johnson vaccine.
In a presentation to the committee, Dr. Kathleen Dooling, of the CDC, advised immunocompromised people, including those receiving an extra dose, should continue to follow preventive measures, including wearing a mask, keeping 6 feet away from others they don’t live with, and avoiding crowds and bad ventilated interiors until otherwise advised by your doctor.
Close contacts of immunocompromised people should be strongly encouraged to get vaccinated against COVID-19, she said.
Separately, the CDC says about 1.1 million people who aren’t necessarily immune system dysfunction have already received one or more extra doses of the Moderna or Pfizer vaccines. About 91,000 have received one or more extra doses of the Johnson & Johnson vaccine.
The action of the committee comes during an intense new climb powered by the Delta variant. Since July 1, the number of confirmed cases has increased by 700%, according to the CDC.
According to the CDC, new experimental and observational data in adults suggest that an additional dose of COVID-19 vaccine with the Moderna or Pfizer vaccine may increase the antibody response and increase the proportion of immunocompromised patients who respond to the vaccine.
In her review of the evidence, Dooling said that small studies with an additional dose of the Pfizer or Moderna vaccine did not reveal any serious side effects. However, the standard dose of these vaccines has been associated with rare but serious side effects, including anaphylaxis and myocarditis and pericarditis in young adults. The effects of immune-compromising diseases on these rare events are unknown, she said.
Several committee members expressed concerns that there are currently no safety studies on an additional dose of Pfizer or Moderna in adolescents with immune system disease.
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