Federal Government Changes Course Again on COVID-19 Vaccine Policy
After the leaders of the NIH, FDA, and HHS made an announcement stating that both pregnant women and children were going to be taken off the COVID-19 immunization schedule, they decided to offer a new designation for the latter group making it a shared decision between providers and patients.
Last week, the leaders of the National Institutes of Health, Health and Human Services, and FDA, announced the removal of the COVID-19 vaccine from the CDC immunization schedule for pregnant women and healthy children in a video social media post.
"I couldn't be more pleased to announce that, as of today, the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said in the video.
However, since that post, and during the same week, the federal government has yet again changed its stance on the vaccine and healthy children. In fact, on the CDC's Child and Adolescent Immunization Schedule by Age, the COVID-19 vaccines will be available to the pediatric population under what is called shared clinical decision-making in the guidance.1
This addresses children who ages 6 months through 17 years, and who are not moderately or severely immunocompromised. It says the following: "Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," the CDC says on the website.
The way the federal health agencies are operating is very different from the past, offers William Schaffner, MD, professor of Medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine.
"So the Food and Drug Administration regarding COVID vaccines has become very assertive in indicating which populations ought to be vaccinated going forward this fall. Well, that to the minds of many of us, has the FDA getting into the CDC territory. You know, the FDA looks at the effectiveness of the vaccine and its safety and then licenses it, and traditionally, then that vaccine has been left to the CDC advisory committee to make recommendations as to which populations ought to receive the vaccine. But here, just recently, the FDA seems to be, if you will, poaching on CDC territory,” Schaffner said. “People are uncertain,” Schaffner said. “The mechanism that I've described, first the FDA and then the CDC, has stood in good stead for over 60 years. In the minds of many people, it ain't broke. Why do we have to fix it?”
With this changing guidance, it can leave the general public and clinicians confused about who is eligible for the vaccines. Additionally, there is no updated guidance for pregnant women since the announcement was made that this population was ineligible for COVID-19 vaccines.
In terms of these ongoing, shifting vaccine policies, Schaffner says we will have to wait and see.
“I think the vaccine community is looking forward to, shall we say, how these new policies actually are implemented. They're a little bit different than in the past, and changes always raise questions. There's that old saying, the devil is in the details. And so as these new policies come forward and are implemented, everybody will be looking at them very, very carefully,” he said.
To view the CDC’s immunization schedule, interested parties can go here.
