Advertisement
Supported by
Long-Term-Care Residents and Health Workers Should Get Vaccine First, C.D.C. Panel Says
The C.D.C. director will decide by Wednesday whether to accept the recommendation. States aren’t required to follow it, but most are expected to.
By
WASHINGTON — An independent panel advising the Centers for Disease Control and Prevention voted Tuesday to recommend that residents and employees of nursing homes and similar facilities be the first people in the United States to receive coronavirus vaccines, along with health care workers who are especially at risk of being exposed to the virus.
The panel, the Advisory Committee on Immunization Practices, voted 13 to 1 during an emergency meeting to make the recommendation. The director of the C.D.C., Dr. Robert R. Redfield, is expected to decide by Wednesday whether to accept it as the agency’s formal guidance to states as they prepare to start giving people the shots as soon as two weeks from now.
“We are acting none too soon,” said Dr. Beth Bell, a panel member and global health expert at the University of Washington, noting that Covid-19 would kill about 120 Americans during the meeting alone.
States are not required to follow the panel’s recommendations, but they usually do. The final decision will rest with governors, who are consulting with their top health officials as they complete distribution plans.
The new recommendation is the first of several expected from the panel over the coming weeks, as vaccines developed by Pfizer and Moderna go through the federal approval process, on the thorny question of which Americans should be at the front of the long line to get vaccinated while supply is still scarce. The panel described it as an interim recommendation that could change as more is learned about how well the vaccines work in different age groups and how well the manufacturers keep up with demand.
The roughly three million people living in long-term care and those who care for them are a relatively clear target; 39 percent of deaths from the coronavirus have occurred in such facilities, according to an analysis by The New York Times. But states and health systems will ultimately have to decide which of the nation’s 21 million health care workers should qualify to receive the first doses, as there won’t be enough at first for everyone.
Pfizer and Moderna have estimated that they will have enough to vaccinate, at most, 22.5 million Americans by year’s end, with the required two doses, a few weeks apart. The C.D.C. will apportion the supply among the states, with the initial allocation proportional to the size of each state’s adult population.
The only member of the committee to vote against the recommendation was Dr. Helen Talbot, an infectious-disease specialist at Vanderbilt University, who expressed discomfort with putting long-term-care residents in the first priority group because the vaccines’ safety had not been studied in that particular population. “We enter this realm of ‘we hope it works and we hope it’s safe,’ and that concerns me on many levels,” she said before the vote.
But most panel members who offered opinions said they thought the high death rate among that group made it imperative to include it.
Dr. José Romero, the chairman of the panel, said that he felt strongly that its process had adhered to its core principles: “maximizing benefit and minimizing harm,” promoting justice and addressing health inequities. Dr. Beth Bell, the co-chair, acknowledged that all of the members would have liked more data from clinical trials but said that because of the pandemic emergency, “we need to act.”
The panel, whose 14 voting members have expertise in vaccinology, immunology, virology, public health and other relevant fields, has hinted that the next priority group it will recommend for vaccination — “Phase 1b” — will be so-called essential workers, a huge group numbering more than 85 million. A division of the Department of Homeland Security has come up with a list of workers states should consider counting in that group; it includes teachers and others who work in schools, emergency responders, police officers, grocery workers, corrections officers, public transit workers and others whose jobs make it hard or impossible to work from home.
After essential workers, the committee is leaning toward recommending vaccination of adults with medical conditions that put them at high risk of coronavirus infection, such as diabetes or obesity, and everyone over 65. But some states might diverge to an extent, possibly choosing, for example, to vaccinate residents over 75 and then some types of essential workers.
All other adults would follow the initial groups. The vaccine has not yet been thoroughly studied in children, so people under 18 would not be eligible yet.
For at least a month or two, there will not be nearly enough vaccine to cover everyone in the initial groups. Dr. Moncef Slaoui, who leads the Trump administration’s Operation Warp Speed, said Tuesday morning in an interview with The Washington Post that Pfizer and Moderna would be able to provide an additional 60 to 70 million doses in January “if all goes well.” Since each person gets two shots, that would only be enough for 55 million people at most through the end of January — about 22 percent of the nation’s roughly 255 million adults.
Production will continue to increase in February and March, Dr. Slaoui said, with the hope that two new vaccines, from AstraZeneca and Johnson & Johnson, will gain F.D.A. approval.
“So very quickly, we start having more than 150 million doses a month in March, April, May,” he added. He and other federal officials have said that the general public is likely to be able to be vaccinated by May or June.
The Road to a Coronavirus Vaccine
Words to Know About Vaccines
Confused by the all technical terms used to describe how vaccines work and are investigated? Let us help:
-
- Adverse event: A health problem that crops up in volunteers in a clinical trial of a vaccine or a drug. An adverse event isn’t always caused by the treatment tested in the trial.
- Antibody: A protein produced by the immune system that can attach to a pathogen such as the coronavirus and stop it from infecting cells.
- Approval, licensure and emergency use authorization: Drugs, vaccines and medical devices cannot be sold in the United States without gaining approval from the Food and Drug Administration, also known as licensure. After a company submits the results of clinical trials to the F.D.A. for consideration, the agency decides whether the product is safe and effective, a process that generally takes many months. If the country is facing an emergency — like a pandemic — a company may apply instead for an emergency use authorization, which can be granted considerably faster.
- Background rate: How often a health problem, known as an adverse event, arises in the general population. To determine if a vaccine or a drug is safe, researchers compare the rate of adverse events in a trial to the background rate.
- Efficacy: A measurement of how effective a treatment was in a clinical trial. To test a coronavirus vaccine, for instance, researchers compare how many people in the vaccinated and placebo groups get Covid-19. The real-world effectiveness of a vaccine may turn out to be different from its efficacy in a trial.
- Phase 1, 2, and 3 trials: Clinical trials typically take place in three stages. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. Phase 2 trials, involving hundreds of people, allow researchers to try out different doses and gather more measurements about the vaccine’s effects on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and efficacy of the vaccine or drug by waiting to see how many people are protected from the disease it’s designed to fight.
- Placebo: A substance that has no therapeutic effect, often used in a clinical trial. To see if a vaccine can prevent Covid-19, for example, researchers may inject the vaccine into half of their volunteers, while the other half get a placebo of salt water. They can then compare how many people in each group get infected.
- Post-market surveillance: The monitoring that takes place after a vaccine or drug has been approved and is regularly prescribed by doctors. This surveillance typically confirms that the treatment is safe. On rare occasions, it detects side effects in certain groups of people that were missed during clinical trials.
- Preclinical research: Studies that take place before the start of a clinical trial, typically involving experiments where a treatment is tested on cells or in animals.
- Viral vector vaccines: A type of vaccine that uses a harmless virus to chauffeur immune-system-stimulating ingredients into the human body. Viral vectors are used in several experimental Covid-19 vaccines, including those developed by AstraZeneca and Johnson & Johnson. Both of these companies are using a common cold virus called an adenovirus as their vector. The adenovirus carries coronavirus genes.
- Trial protocol: A series of procedures to be carried out during a clinical trial.
The C.D.C. panel was originally not supposed to vote on its recommendations until after the F.D.A. had approved a vaccine. But it bumped up the timing to give states more guidance as they complete their distribution plans, which must be submitted to the C.D.C. on Friday.
On Tuesday, the group specifically suggested that within the long-term-care population, residents of nursing homes, who tend to be the most frail and susceptible to Covid, should get the first vaccines in the event that there aren’t enough, along with staff members who have not had the virus within the last 90 days.
Within the much larger category of health care workers, the panel said that health systems should consider prioritizing those who have direct contact with patients and their families and those who handle infectious materials. Dr. Nancy Messonnier, who leads the C.D.C.’s National Center for Immunization and Respiratory Diseases, told the panel that based on her recent conversations with state health officials, most states and large cities “believe they can vaccinate all of their health care workers within three weeks.”
But whether they reach that goal depends on how much vaccine they get, and how quickly. Gov. Andy Beshear of Kentucky told reporters on Monday that his state had more than 200,000 health care workers but would receive only 38,000 doses in its first shipment and that it might not get another for two weeks.
Long-term-care facilities include nursing homes, with about 1.3 million residents; assisted-living facilities, with 800,000 residents; and residential care facilities, which tend to be small and cater to specific populations. The federal government has contracted with CVS and Walgreens to deliver vaccines to most such facilities nationwide, with teams of pharmacists making three visits to each to ensure that every staff member and resident gets both an initial shot and a booster shot several weeks later.
Several members of the panel urged that small community doctors’ offices not be left off the initial priority list. “Transmission dynamics suggest providers who care for patients earlier in their course of illness may be at higher risk,” said Dr. Jeffrey Duchin, a member of the panel who is in charge of public health in Seattle and King County, Wash.
Dr. Grace Lee, a panel member and a pediatrics professor at Stanford, said special attention should be paid to health care workers in lower-paying positions, such as nursing assistants, food workers and janitors, who may fear for their job security if they push to secure a spot toward the front of the vaccination line.
“I am very mindful of the equity concerns,” Dr. Lee said.
Jan Hoffman contributed reporting.
Advertisement
"term" - Google News
December 02, 2020 at 06:03AM
https://ift.tt/2VotMS7
Long-Term-Care Residents and Health Workers Should Get Vaccine First, C.D.C. Panel Says - The New York Times
"term" - Google News
https://ift.tt/35lXs52
https://ift.tt/2L1ho5r
Bagikan Berita Ini
0 Response to "Long-Term-Care Residents and Health Workers Should Get Vaccine First, C.D.C. Panel Says - The New York Times"
Post a Comment