[ad_1]
The Food and Drug Administration plans to authorize a third injection for the immunocompromised on Thursday, two sources familiar with the plans confirmed to ABC News.
If the FDA gives the green light for additional injections – first reported by NBC News – it is up to the Advisory Committee on Immunization Practices, the Centers for Disease Control’s expert advisory group, to make its own recommendation on who should get vaccinated and what factors they might want to consider. These recommendations are generally adopted by the CDC as national public health guidelines. ACIP is scheduled to meet on Friday, although it is not currently scheduled to vote.
MORE: CDC Advisory Board Expresses Support For Immunocompromised People Receiving Boosters
Many immunocompromised Americans have not had high immune responses to vaccines, leaving them vulnerable to the virus even after receiving an injection. The response has been poor, especially in transplant recipients, cancer patients, or people taking drugs that suppress their immune response.
Related Video: Doctors Push FDA To Speed Up Approval Of Childhood Vaccines
About 2.7% of American adults are considered immunocompromised.
Asked to comment on the plans, the FDA said it was “closely monitoring data as it becomes available from studies administering an additional dose of authorized COVID-19 vaccines to immunocompromised people.”
“The agency, along with the CDC, is evaluating potential options on this issue and will share information in the near future,” the FDA said in a statement.
At a meeting in July, ACIP members were overwhelmingly in favor of giving a third dose to immunocompromised people to boost their immunity and called on the FDA to act on the issue.
MORE: COVID-19 Live Updates: Mississippi Asks Biden Administration To Send Military Hospital Ship
Data presented at the meeting indicated that a booster could increase antibodies by up to 50% in an immunocompromised person.
Dr Sara Oliver, CDC epidemiologist who presented the results, also explained how immunocompromised people are a priority group for booster research, as they are at greater risk of serious consequences from COVID.
For example, in an American study, 44% of hospitalized rupture cases were immunocompromised. An Israeli study found it to be around 40%. The groundbreaking cases, which are expected, refer to people who test positive for COVID-19 while being fully vaccinated. Vaccines are very effective against serious illness and hospitalization, but people can develop mild or asymptomatic illness even when they are vaccinated.
The pressure continued to mount as other countries, including France and Israel, approved boosters for those who are immunosuppressed. Without official action, patients also took matters into their own hands.
The CDC has estimated that more than one million people who received the Moderna or Pfizer vaccine have returned for an unauthorized recall.
The estimated 1.1 million figure, included in an internal CDC backgrounder reviewed by ABC News, is likely an undercount because although it does include Moderna and Pfizer vaccine recipients, it ignores people who have. may have received the vaccine in one Johnson & Johnson injection but received another injection. .
MORE: At least 1 million people received an unauthorized recall
It is also not known whether people who received a third injection did so under the direction of a doctor. Florida is one of the states with the most people opting for a booster injection, followed by Ohio, California, Illinois and Tennessee.
For Phil Canuto, who remained immunocompromised after a kidney transplant 19 years ago, the news of the recalls on the horizon has thrilled him.
Canuto, from Akron, Ohio, had no immune response after two doses of the Pfizer vaccine. The increasing spread of the delta variant and data showing that even people who have been vaccinated can spread the virus have put him and his family members on high alert.
“I know a lot of transplant patients have tried to surreptitiously get additional injections, lying to contextual vaccination sites about their previous injections,” he said, adding that this news would give patients the opportunity to make medically informed decisions with their physicians. .
In an interview on Wednesday with ABC News’ Linsey Davis, Dr Anthony Fauci, the White House’s chief medical adviser, said he was not supporting anyone to receive a booster.
“What I am supporting are the people who are following the guidelines that will be published for those who are immunocompromised, as well as those who are now being followed in cohorts to be determined,” he said, “what an appropriate time to give to a reminder. “
Fauci said approval of boosters for immunocompromised Americans was a “very high priority” during a White House briefing in early August.
“It is extremely important for us to act so that these individuals receive their boosters. And we are working on it now, and we will make sure that it is implemented as quickly as possible. Because for us and for the individuals involved, it’s a very high priority, ”Fauci said.
MORE: CDC Strengthens Recommendation That Pregnant Women Get Vaccinated
Fauci also told governors privately on a call from the National Governor’s Association that immunocompromised people will be the first in line for recalls, and that the FDA is “working on a mechanism” to secure additional doses. for that group “as soon as possible,” according to a reading of the call obtained by ABC News.
He also said he expected the general population to follow suit eventually.
“I think we’ll all go in that direction eventually,” Fauci said, without specifying when.
Anne Flaherty of ABC News contributed to this report.
FDA to approve 3rd dose of vaccine for immunocompromised people: Sources originally appeared on abcnews.go.com
[ad_2]
Source link