(WPRI) — Nearly 3% of Americans considered to be immunocompromised will be able to get another chance to boost their immunity against COVID-19.
Late Thursday night, the U.S. Food & Drug Administration (FDA) announced it had amended the emergency use authorization documents for both Pfizer and Moderna‘s two-dose COVID-19 vaccines.
The FDA states the authorizations for both Pfizer and Moderna’s vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine.
In letters from the FDA’s chief scientist to both Pfizer and Moderna, Rear Adm. Denise Hinton stated revising the emergency use authorization of both vaccines is “appropriate to protect the public health or safety under section 564(g)(2) of the Act.”
No announcement was made pertaining to those who got the single-dose Johnson & Johnson shot. However, Alison Hunt, a press officer with the FDA, told 12 News “the vast majority of the immune compromised population impacted by this have received either Pfizer or Moderna.”
“Since members of this population were some of the first eligible for vaccination, many were vaccinated before J&J was even authorized. We believe it is a very tiny number of immunocompromised individuals who would have received J&J as their vaccination, and those individuals should talk to their doctor,” Hunt said in a statement to 12 News.
Hunt said information used in the FDA’s decision for Pfizer and Moderna was not available for the Janssen vaccine.
The move from one of the nation’s leading federal health entities comes as the highly contagious Delta variant continues to cause a spike in COVID-19 cases across the country, even among those who are considered fully vaccinated.
Some immunocompromised Americans have not had high immune responses to the vaccines, leaving them vulnerable to the virus even after becoming fully vaccinated. The FDA’s decision only pertains to those who are immunocompromised.
According to the U.S. Centers for Disease Control and Prevention (CDC), those who are considered immunocompromised would include, but are not limited to, “people with HIV infection or other immunocompromising conditions or people who take immunosuppressive medications or therapies.”
The CDC also considers someone immunocompromised if they are “receiving chemotherapy for cancer, people with hematologic cancers such as chronic lymphocytic leukemia, people receiving stem cells or organ transplants, people receiving hemodialysis, and people using certain medications that might blunt the immune response to vaccination.”
“Other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,” Acting Commissioner Dr. Janet Woodcock said. “The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”
During a state COVID-19 press conference on Tuesday, 12 news asked Tom McCarthy, head of Rhode Island’s COVID-19 Response Team, if the state was prepared to launch a booster campaign.
“We have several plans already prepared based on whatever guidance we might get from the FDA,” McCarthy said. “We’ve been watching what they have been doing internationally and say we’re prepared to administer a booster if it’s decided that it’s needed, to every single Rhode Islander.”
In early March, the R.I. Department of Health expanded vaccine eligibility to an estimate of more than 160,000 Rhode Islanders ages 60 and older and those with certain health conditions that may result in a weakened immune system, including:
- People who get chemotherapy or radiation
- People who have had a transplant or are waiting for a transplant
- Sickle cell disease
- People who have a disease that weakens the immune system
- People who take medicine that weakens the immune system
Following the FDA’s green light, a CDC advisory committee convened to make its own recommendation on who should get the shot and what factors they might want to consider.
The CDC’s advisory committee met Friday to discuss and vote on “clinical considerations for use of an additional doses of mRNA COVID-19,” according to the committee’s finalized agenda.
After a nearly three hour discussion, the panel unanimously approved recommending an additional dose of Pfizer’s vaccine in immunocompromised people 12 and older, as well as a third dose of Moderna’s vaccine for immunocompromised people 18 and older.
Following the CDC panel’s meeting, Gov. Dan McKee’s office, along with the R.I. Department of Health, issued a joint statement calling the announcements from the FDA and CDC “great news.”
“The COVID-19 vaccine already provides excellent protection against COVID-19-associated hospitalizations and fatalities, and this additional dose will give even more immunity to people who may be a little more vulnerable,” the joint statement said in part.
McKee’s office and RIDOH said they are reviewing the new recommendations from federal partners and are aiming to make third doses available for eligible populations in Rhode Island by early next week.
More information will be made available to healthcare providers and the public in the coming days, including information on who is eligible, according to McKee’s office and RIDOH.
“Ample vaccine supply exists in Rhode Island to meet this new demand and we have the infrastructure in place to move swiftly. For any eligible Rhode Islanders who have not yet gotten their first vaccine – it is time,” the joint statement added.
Dr. Sara Oliver, an epidemiologist with the CDC, presented data in an Advisory Committee on Immunization Practices (ACIP) meeting in July that indicated a booster shot could increase antibodies in an immunocompromised person anywhere from 33 to 50%.
Oliver also told the panel immunocompromised people are a priority group for booster research because they’re at higher risk of severe COVID-related consequences, like prolonged infection and viral shedding.
She told the panel immunocompromised people are more likely to transmit the virus to household contacts, as well as have breakthrough infections, which refer to people who test positive for COVID-19 while fully vaccinated.
Oliver said a U.S. study found 44% of hospitalized breakthrough cases involved immunocompromised people, while an Israeli study found 40% of hospitalized breakthrough cases comprised of immunocompromised people.
The committee also heard an update on emerging SARS-CoV-2 variants and COVID-19 vaccines, as well as discussed considerations for booster doses of COVID-19 vaccines.
Action from federal regulators will also trigger a meeting of the R.I. COVID-19 Vaccine Subcommittee.
The subcommittee has moved from semi-regular meetings to only convening amid new vaccine milestones, such as booster shots, in addition to full approval of a COVID-19 vaccine from the FDA or a decision on vaccines for children younger than 12.