The US has officially adopted recommendations for the updated Covid vaccines, the US Department of Health and Human Services (HHS) announced on Monday – paving the way to offer Covid vaccines to more than half of children in the US who were unable to access them while the recommendations were in limbo.
Yet the delays, and the announcement itself, compound misinformation and persistent access issues, providers and experts say.
The Advisory Committee on Immunization Practices (ACIP) voted on 19 September to recommend Covid vaccines to anyone over the age of six months with shared provider decision-making. The ACIP vote on Covid vaccines was itself delayed from June to mid-September.
Jim O’Neill, acting director of the US Centers for Disease Control and Prevention (CDC), officially signed off on the recommendation last week, according to an HHS press release – though the CDC webpage on ACIP recommendations has not yet been updated with these details.
The CDC also officially removed the recommendation for the combined MMR and varicella (chickenpox) vaccine, the statement said. This vaccine is preferred by one in six parents.
O’Neill said providers were previously deterred from counseling patients on the benefits and risks of Covid vaccines.
“Informed consent is back,” O’Neill said in the statement. “CDC’s 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent.”
There were no limitations on such discussions, which are common between patients and providers.
“Unless people mime their vaccine request, there’s always some discussion before a vaccine is given,” said Dorit Reiss, a professor focused on vaccines at UC Law San Francisco .
When patients go to a pharmacy or a doctor’s office for vaccines, they are already undergoing shared decision-making, Reiss said. “Unless the goal is to only have the conversation to deter people, what does this do?”
It is also beyond the ACIP’s purview to require discussions.
Thomas Nguyen, a pediatrician and associate professor of pediatrics at Ohio University Medical School, notes “the problem is they aren’t allowed to do this”.
Federal law allows the CDC to update its Vaccine Information Statement (VIS), which providers must offer to every vaccine recipient or their caregiver. But “they have no basis to require a discussion”, he said, and informed consent is already the standard for vaccination.
“Every pediatric Covid vaccine we have given, I have offered to discuss the risks and benefits with the family and every single one has declined,” Nguyen said.
The families who are getting Covid vaccines already know they want it, he continued. “The people who want to get a Covid vaccine for their kids are the ones who are really committed to it, who have done their research and feel like it’s a good idea for their kids.”
But the delays in recommending the vaccines have created obstacles for families who want them.
The Vaccines for Children (VFC) program covers 52% of children in the US: anyone under the age of 19 who is under-insured or uninsured, eligible for or enrolled in Medicaid, or Native American or Alaska Native.
Vaccines are included in the program only when they’re recommended by the CDC, so children who would normally receive Covid vaccines through VFC have not been able to get them.
Every visit this fall has been the same, said Elias Kass, a naturopathic physician in Washington state specializing in pediatric primary care. Families asked about seasonal vaccines, and he told them about the annual flu shot.
“Then they say: ‘And Covid?’” Each time, he answered: “Nope. We don’t have Covid vaccines.”
Washington is one of 12 states and territories, along with the city of Houston, with a universal VFC program, which means they offer vaccines for free to all children (and, in some places, all adults). In universal states, providers order all vaccines through the VFC program – but they couldn’t order any Covid vaccines at all without the CDC recommendation.
“We still don’t have doses in hand,” Kass said.
The timing was critical, as flu vaccination campaigns have already gotten under way for the fall.
“We are missing a really crucial window to vaccinate kids. We have been giving flu vaccines for a couple of weeks,” Kass said. “It’s a huge lost opportunity. I don’t know if we’ll get those families to come back.”
In addition to limiting boosters for young children, the delay has “created this huge gap for our infants”, Kass said, “who are at very high risk of complicated Covid”.
Covid vaccines have been plagued by persistent access issues and misinformation, resulting in already low vaccination rates among children.
“Approximately 10,000 six-month-olds become eligible to receive Covid-19 vaccines every day, but parents continue to struggle to find access to that vaccine,” said Michelle Fiscus, a pediatrician and chief medical officer of the Association of Immunization Managers.
Yet the stakes are high. Children under two, especially infants, are at high risk for hospitalization and death, second only to people aged 75 and older.
Children may also suffer from long Covid, particularly after repeat infections, and unknown complications could arise long after infection – as sometimes happens with viruses like measles, human papillomavirus (HPV), hepatitis B, Epstein-Barr, and cytomegalovirus.
The delay caused “huge” equity issues, Kass said, especially among children who have been marginalized within the health system because of socioeconomic status or racism.
There were already significant access issues plaguing pediatric vaccines across the country, with some providers declining to stock the vaccines due to a perceived lack of interest and misinformation.
“The argument that I often hear from pediatricians is that they don’t stock Covid vaccines because there’s low demand,” said Fiscus. “But the reality is that parents do call and ask for the vaccine, but are told that it’s not being stocked. So to an extent, that’s a self-fulfilling prophecy.”
Some providers offer outdated reasons for not stocking the vaccines, like previous needs for ultra-cold storage or multi-dose vials, Kass said. “They’re justifying not stocking it with reasons that are no longer relevant, but they’re assuming nobody wants it anyway.”
The HHS press release also highlighted “vaccine safety signals” and “unintended side effects during routine immunization”, even though the Covid vaccines are extremely safe and effective.
That’s “the biggest problem” among Nguyen’s patients, he said. Certain health officials and Republican politicians have been very vocal about the purported risks of Covid vaccines “to the point that almost nobody wants them”, he said. This fall, he has given out 325 flu shots and only 16 Covid shots.
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