Nature

Many say they don’t know if, when to get a second callback

But this time around, the federal government has offered little detailed guidance on who should get the extra dose and when. Instead, the Centers for Disease Control and Prevention said on Tuesday that immunocompromised and older Americans could getting the fourth vaccine while stopping short of recommending it – a change from some previous decisions about coronavirus vaccines. CDC Director Rochelle Walensky said those most likely to benefit fall into two categories: people 65 and older, or anyone 50 and older with underlying medical conditions that are at higher risk of serious illness from covid-19.

“It feels like we’re a bit of an afterthought,” Patel, a primary care physician at Mary’s Center, a community health center, said of the doctors, noting that she didn’t receive any intervention. CDC or other federal agencies. “We are understaffed, under-resourced and asked to demonstrate clinical nuance when we don’t have the tools to do so.”

Some doctors and experts shared that view, arguing that the agency’s meager advice left them responsible for complicated clinical decisions in a landscape with unclear and ever-changing data. They also said federal agencies had offered little warning that new guidelines for second recalls were to come, leaving them unprepared and confused by the change in policy.

Others said they agreed with the Food and Drug Administration and CDC’s decision, saying federal officials could not risk delaying second reminders for those most vulnerable since the sub- omicron BA variant. 2, which is already fueling infection spikes in Europe and Asia, could cause a surge here. These experts noted that older Americans are more likely to have weaker immune systems, and people over 50 are more likely to have underlying health risks.

They also said the risk varies greatly from person to person, and doctors and patients should be given the opportunity to make individual choices about fourth injections based on a multitude of factors, including their age. , their state of health, the level of infection where they live and the number of months since their last shot.

The new guidelines come amid a series of confusing and conflicting messages about booster shots since last summer, when federal officials and outside experts fiercely debated whether they were needed. At the start of the omicron wave, federal officials strongly recommended them and relied on boosters as an essential tool to protect people.

But booster uptake was lower than desired, including among older Americans at increased risk of serious illness. Doctors said they are still struggling to get people to get their first booster, let alone start conversations for about a second.

“There have unfortunately been a series of guidelines and statements made by various departments and agencies, FDA and CDC included, throughout the pandemic and most of them have not been very clear or easily interpreted,” said James Lawler, an infectious disease physician and co-director of the Global Center for Health Security at the University of Nebraska Medical Center. “And this one is the same.”

“There also needs to be a lot more guidance provided to doctors and providers. It is a complicated landscape. There’s a lot of data, the data is potentially ubiquitous, and it’s very difficult even for infectious disease doctors to keep up with all the latest data,” Lawler said.

Adding to the confusion, new CDC guidelines on booster shots for those who received the Johnson & Johnson vaccine. The agency released data showing that the nearly 17 million Americans who received the single-shot coronavirus vaccine are less protected against serious illness and hospitalization than those who received the Pfizer-BioNTech and Moderna vaccines. . He gave the go-ahead for a second booster, either Pfizer-BioNTech or Moderna injections, for the 1.3 million people who received the Johnson & Johnson vaccine and a Johnson & Johnson booster at least four months ago .

For Patel, who works at a clinic that primarily treats Medicaid patients, many of whom received the Johnson & Johnson vaccine, that advice was particularly puzzling. The CDC’s language was so confusing, she said, that it was unclear which Johnson & Johnson recipients should receive mRNA boosters and how many doses those patients should receive.

“The Johnson & Johnson language was completely confusing,” Patel said. “I had to call my friends and I was like, explain this to me.”

Some experts said the agencies made the best call possible amid limited data, much of it from Israel, an evolving virus and BA’s steady growth. 2 cases in the United States.

“I think it’s the right decision because there’s little downside to getting a booster and they seem to be safe,” said Albert Ko, an infectious disease physician and epidemiologist at the Yale School of Public Health. “Much of the risk will have to be decided by individual people given the lack of evidence and the uncertainty. And having individuals make that decision at this point is the right way to go.

The issue of additional boosters four months after the last dose had sparked days of discussion among Biden administration health officials and extensive debate among the wider scientific community. In addition to the sparse data, administration officials have wrestled with uncertainty about whether the highly transmissible subvariant of omicron BA. 2 represents a major threat and a political environment in which much of the American population is ambivalent – ​​or, in some cases, hostile – towards vaccines and public health recommendations.

Although the data shows the vaccines are safe and there are few downsides to getting another shot, Biden officials did not consider the data to be strong enough to tell all eligible people that they should receive a second booster shot.

Outside experts have debated the age at which second boosters should be available – and the broader question of whether and when all eligible adults will need a fourth dose of mRNA vaccines. This will be discussed on April 6 by the FDA’s external vaccine experts, who will also consider whether vaccines need to be adjusted to more effectively combat potential variants.

Many scientists who support a fourth dose for some older people see little evidence that people under 60 or even 65 would clearly benefit. Federal officials said they were expanding eligibility at a lower age to avoid confusion and because underlying health risks were relatively common in people over 50.

“I don’t think we have good clarity,” said Jason Goldman, a Florida physician who is also a liaison member of the CDC’s vaccine expert group, the Advisory Committee on Immunization Practices.

“I wish I had more specifics,” Goldman said “… [the CDC] might say, “we don’t have the data to give a definitive recommendation, but you can consider it in these scenarios.”

Like other clinicians, Goldman said he was bombarded with questions from colleagues and patients seeking more information. A colleague wanted to know what to advise a healthy patient in their 60s who has been fully vaccinated and boosted and who has also been infected with covid-19. Another asked about a patient in his 80s who had no risk factors.

Goldman said he has directed questions to CDC staff and hopes the agency can provide more clarity by updating its website in the coming days.

At the same time, he said evidence supporting a fourth dose is limited and mixed, based largely on data from Israel. But it’s hard to compare the United States to Israel, Goldman said, because of that country’s high vaccination rate and relative homogeneity.

Doctors say one of their biggest challenges in trying to help their patients make decisions about fourth shots will be time. They usually have about 15 minutes with each patient, and it’s impractical to expect them to be able to go through a patient’s medical history and figure out if the fourth shot makes sense for them.

The advice can’t cover every individual case, but if that advice clearly states… those are the things you should consider, it makes it easier for a primary care physician to make those decisions,” Lawler said. “They don’t have three hours with each patient to dig through the literature to decide with each patient.”


Washington

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