Virus World

In a highly unusual decision, the C.D.C. director, Rochelle Walensky, reversed a move by agency advisers to endorse additional doses of the Pfizer-BioNTech vaccine for older Americans but not for health care workers or teachers.  The director of the Centers for Disease Control and Prevention on Friday overruled a recommendation by an agency advisory panel that had refused to endorse booster shots of the Pfizer-BioNTech Covid vaccine for frontline workers. It was a highly unusual move for the director, Dr. Rochelle Walensky, but aligned C.D.C. policy with the Food and Drug Administration’s endorsements over her own agency’s advisers. The C.D.C.’s Advisory Committee on Immunization Practices on Thursday recommended the boosters for a wide range of Americans, including tens of millions of older adults and younger people at high risk for the disease. But they excluded health care workers, teachers and others whose jobs put them at risk. That put their recommendations at odds with the F.D.A.’s authorization of booster shots for all adults with a high occupational risk. Dr. Walensky’s decision was a boost for President Biden’s campaign to give a broad swathe of Americans access to boosters. The White House had come under criticism for getting ahead of the regulatory process. The C.D.C.’s statement arrived well past midnight, a sign of the complicated and confusing decision-making surrounding the boosters. The C.D.C. advisers similarly spent two days debating who should get boosters and when, and could not agree on whether occupational risk should qualify as a criterion.

“I am surprised that Dr. Walensky overturned one of the four A.C.I.P. votes today, and I believe others will be as well,” said Dr. Yvonne Maldonado, an infectious disease expert at Stanford and the American Academy of Pediatrics liaison to the committee. But the vote on boosters for occupational risk “was close,” Dr. Maldonado said, and agreed with Dr. Walensky’s decision. “This addresses not only waning immunity but those at high risk of exposure,” Dr. Maldonado added. Minutes before Dr. Walensky’s statement, Dr. Amanda Cohn, who oversaw the two-day meeting of the panel, tried to prepare the advisers for the director’s decision. “Dr. Walensky is reversing the decision to not recommend use of a booster dose in persons at high risk for occupational or institutional exposure,” Dr. Cohn wrote in the email. “I am hoping to share this news with you before you see it in the press.” Dr. Walensky’s decision to go against her own agency’s advisers came as a surprise to at least some of her staff members: The C.D.C. director’s endorsement of the advisory committee’s recommendations is typically just a formality. Hours before her statement, agency insiders predicted she would stick with the usual protocol because doing otherwise would undermine the process and upset the advisers as well as her own staff.  But experts outside the C.D.C. said Dr. Walensky may have had no choice but to align herself with the F.D.A.’s decision. “There’s a complexity here, because Dr. Walensky was part of the White House announcement” on boosters, noted Dr. Ashish Jha, dean of the Brown University School of Public Health. Dr. Walensky said providing booster shots to health care workers and others who risk contracting the disease on the job would “best serve the nation’s public health needs.”

South Koreans are tested for COVID-19 in “drive-thru” spots. Patients go through a pre-screening booth where their symptoms are recorded and body temperature taken, then a nasal swab is taken. Results are received by text in 24h. If you have COVID-19 symptoms, the test is covered by the Government and you pay only 20% of the cost, about US$ 30. If you have no symptoms and you still wish to get tested, then you pay the entire amount, about US$ 150.

All South Koreans enjoy a universal “Medicare-type” insurance system provided by their government. Citizens pay a monthly tax in their paycheck. The cost varies depending on the income of the person. Cost is heavily biased, so wealthier individuals pay significantly more. A significant fraction of the population pays nothing at all. On average, South Koreans pay about US$ 100 per month (yes ! no typo, one hundred dollars).

The Government-based care usually covers most needs at 80%, and some at 100%. Citizens have the freedom to choose the hospitals and health facilities they visit. South Koreans can also access to corporate-based medical insurance if they wish. The South Korean government, as the major provider of health care, plays a major role in taken care of the prevention, surveillance and administration of therapies to its population. The differences with the US system are clear. Few people in South Korea complain about their health care system, which runs in the top 10% of the world’s health systems.

Next time you have to vote, think about the next pandemic, the choices you’ll have, and what your candidate plans to do with the dysfunctional insurance-bases health care system we have in the U.S.

A federal advisory committee to the Centers for Disease Control and Prevention voted Tuesday to recommend who should get COVID-19 vaccines first once one is authorized for use. The 14 voting members of the Advisory Committee on Immunization Practices, along with representatives from federal science agencies and the health care industry, voted during an emergency meeting online to recommend that the first COVID-19 vaccines should go to health care workers and residents of long-term care facilities, including nursing homes and assisted living. The CDC estimates that most people in these high-priority groups could be fully vaccinated by early next year if the Food and Drug Administration authorizes a vaccine by mid-December, as is currently anticipated. But because supplies will be short in the first few weeks after that authorization, individual health care and long-term care facilities will likely need to determine their own priority schedules for vaccination once they've obtained the vaccine. Long-term care facilities include nursing homes, assisted living and other residential facilities. The CDC estimates that 48 million doses will be needed to vaccinate these groups, which account for about 24 million people. It's anticipated that as many as 40 million doses could be available by the end of December, with 5 million to 10 million available each week afterward. The recommendations from the independent advisory committee now go to CDC Director Robert Redfield for final approval.

The issue of which risk groups should be prioritized for a COVID-19 vaccine has been a key topic at the group's regular public meetings over the past several months. The committee's goal is to use a COVID-19 vaccine to reduce severe illness and death from the disease and to lessen disruptions to society and the economy from the pandemic. In earlier meetings, the committee has considered four overlapping groups that might receive priority access to COVID-19 vaccines while immunizations are in short supply. The groups include health care workers and other essential workers who have a higher risk of exposure to the virus. Also included are people 65 and over and those with certain underlying medical conditions who are more likely to become severely ill if they contract COVID-19. Health care workers have long been considered to be first in line because they are exposed directly to COVID-19 through their work, and because protecting them and their patients from the virus would help reduce the spread of the coronavirus and keep the health system running. 

What's been more controversial is whether to add nursing home residents and other long-term care facility residents to the initial priority group. (Staffers at these facilities are considered health care workers.) At a public meeting last week, members of the committee agreed that the death toll in this population, a subgroup of the over-65 category, has been severe. Staff and residents at long-term care facilities represent just 6% of confirmed coronavirus cases but account for nearly 40% of COVID-19 deaths.  Still, some committee members raised concerns about giving newly authorized COVID-19 vaccines to nursing home residents. "This population is not a population that's been studied in the vaccine trials," said Dr. Robert Atmar, a professor of infectious diseases at Baylor College of Medicine, during last week's meeting. Older people who are participating in vaccine trials are generally in good health, while nursing home residents are often frail. "Coming back to the science of it, we really are not able to assess the balance of benefits and harms," he said. Another committee member worried that introducing COVID-19 vaccines first to nursing home residents could erode public confidence in the safety of the vaccines. Given the high mortality rate in long-term care facilities, it's likely that some nursing home patients who receive COVID-19 vaccines could die shortly after from other causes, said Dr. Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University Medical Center.  "I think you're going to have a very striking backlash of, 'My grandmother got the vaccine and she passed away.' They're not likely to be related, but that will become remembered," she said.

Before a COVID-19 vaccine is recommended for use among nursing home residents, Talbot suggested running a limited clinical trial in this population to gather data that would show the vaccine is safe for this group. Tuesday's vote comes in advance of a COVID-19 vaccine receiving FDA authorization. The CDC committee previously said it would wait for authorization before making vaccine recommendations. But in recent weeks, it has undergone pressure from the federal government to move faster. "We are not dependent on any delay from [the advisory committee] in terms of helping to advise states," Alex Azar, secretary of health and human services, said at a Nov. 24 press briefing, discussing his intent to move quickly with the vaccine distribution process. States will use the CDC guidance as they place orders for COVID-19 vaccine doses. Their first orders are due to the federal government Friday.