“Many, many, many” hospitals in the South have already started giving third doses to their health workers amid an explosion of Covid cases linked to the Delta variant, said Helen Keipp Talbot, committee member and associate professor of medicine at Vanderbilt University.
“I think given that he was given with a date, many assumed he had received a blessing from the White House and that was the next step,” she said, adding that these providers have “now put themselves at risk” by immunizing people outside. FDA and CDC Recommendations.
Demetre Daskalakis, who was seconded to the CDC’s Covid response group, warned committee members that healthcare providers who do not follow federal guidelines on how vaccines should be administered may expose themselves liability when requesting reimbursement from the federal government.
CDC data shows 955,000 Americans have received additional doses of the vaccine, although it is not known how many of these have been technically cleared.
So far, the federal government has only authorized recalls for a small number of people with weakened immune systems, including solid organ transplant recipients. Pfizer and BioNTech, whose vaccine received full FDA approval last week, have asked the FDA for permission to offer recalls. The companies behind the other two vaccines in use in the United States – Moderna and Johnson & Johnson – have said they intend to seek approval for the recalls, but have yet to do so.
The Biden administration’s decision to announce that it would offer reminders to all adults has created a sticky situation for federal regulators, who must now chart the way forward despite limited, and sometimes confusing, data on the vaccine effectiveness over time.
A presentation by the CDC committee’s Covid Vaccine Working Group did not mention the Biden administration’s September schedule for recalls. He also avoided describing the booster injections as a done deal, stressing that it was “critical” to wait for more safety data and regulatory clearances before distributing them.
“As with the other recommendations for Covid vaccines, we will be reviewing the data in a systematic and transparent manner. The booster dose policy will be coordinated with the FDA for regulatory allocation,” said Sara Oliver of the CDC.
One of the main issues that independent CDC advisers must grapple with is what should be the goal of the U.S. Covid vaccination program – to prevent serious illness, hospitalizations, and death, or to tackle all of them. infections, even mild ones. Committee chair Grace Lee suggested the latter was impossible at this time, but the White House’s recall announcement avoided considering which populations might need recalls once those who were among the first. to be vaccinated – and were therefore more at risk – received additional doses.
“We’re not at the stage of the vaccination program in the United States or the world where… it seems to be achievable,” she said. While the United States has a steady supply of doses, and hundreds of millions more on order, many countries around the world are struggling to complete a first round of vaccinations.
The CDC’s Vaccine Task Force believes the top priority should be ensuring unvaccinated Americans are vaccinated, Oliver said. But on recalls, he emphasizes preventing serious illness in at-risk groups.
Oliver’s proposed risk-based recall approach would prioritize residents of long-term care facilities, healthcare workers, and people over the age of 65 or 75 years old. She noted that it is essential to prevent even mild cases of Covid among healthcare workers, as they may ‘not work if they are symptomatic.
Committee members called for clear guidelines on how to administer the boosters once they are approved by the FDA. The CDC panel is expected to meet again in mid-September to assess the latest data, ahead of any FDA decision on additional doses.
“We all have to go in the same direction to get everyone vaccinated, to protect everyone and to keep everyone protected, and not to waste this precious resource,” Fryhofer said.