After months of deliberation and debate, on Tuesday a panel of independent experts advising the Centers for Disease Control and Prevention will decide which Americans will recommend getting the coronavirus vaccine first while supplies are scarce.
The body, the Advisory Committee on Vaccination Practices, will vote in a public meeting on Tuesday afternoon. Health workers are expected to come first along with residents of nursing homes and other long-term care facilities. When the C.D.C. The director, Dr. Robert R. Redfield, approves the recommendations. They will be passed on to states preparing to receive their first vaccine shipments as early as mid-December when the Food and Drug Administration develops an application for emergency use of an approved vaccine from Pfizer.
States must comply with the recommendations of the C.D.C. don't follow, but most likely will, said Dr. Marcus Plescia, the chief physician of the Association of State and Territorial Health Officials, which represents state health authorities. The committee will meet again soon to vote on which groups should be given priority next.
Here are answers to some common questions about the vaccine and its distribution.
Who will get the vaccine first?
Based on its recent discussions, the C.D.C. The committee will almost certainly recommend that the country's 21 million healthcare workers come out ahead of any other, along with three million mostly elderly people living in nursing homes and other long-term care facilities.
According to the committee, a staggering 39 percent of deaths from the coronavirus occurred in long-term care facilities. But initially there won't be enough doses to vaccinate everyone in these groups. Pfizer and Moderna, the two companies closest to getting their vaccines approved, have estimated that by January they will have enough to vaccinate no more than 22.5 million Americans. So each state has to decide which health care workers go first.
You can choose to prioritize critical care physicians and nurses, respiratory therapists, and other hospital workers, including cleaners, who are most likely to be exposed to the coronavirus. Or they may first offer the vaccine to older healthcare workers or nursing homes who are at higher risk of contracting the virus. Kentucky Governor Andy Beshear said Monday that most of his state's initial allocation would go to residents and employees of long-term care facilities, while a smaller amount would go to hospital workers.
It's important to remember that anyone who gets a vaccine from Pfizer or Moderna needs a second shot – three weeks later for Pfizer, four weeks for Moderna.
Who will get it next?
The C.D.C. The committee indicated last week that it would recommend that important workers take turns. Approximately 87 million Americans work in the food and agriculture, manufacturing, law enforcement, education, transportation, corrections, emergency response, and other sectors. They are at an increased risk of exposure to the virus because their job makes them unable to work from home. And these workers are disproportionately black and Spanish, population groups that are particularly badly affected by the virus.
Individual states can decide to include employees from industries particularly affected by the virus into this group. Arkansas, for example, has proposed adding workers to its large poultry industry, while Colorado is looking to include ski workers who live in meetinghouses.
After essential workers, the priority groups likely to be determined by the C.D.C. The committee is made up of adults with conditions that are at high risk of coronavirus infection and people over 65. However, some states may vary to some extent, such as choosing to vaccinate residents over 75 in front of certain types of workers . All other adults would follow. The vaccine has not yet been thoroughly studied in children so they would not be considered yet.
Who will make decisions at the country level on priority groups?
Each state has a working group, mostly made up of public health officials, that has been planning and making decisions about vaccination campaigns for months. The chief health officer and governor of each state will likely sign the final plans.
How long will states focus on one priority group before moving on to the next in line?
According to C.D.C. States do not need to reach all members of a priority group before moving on to the next. Advisory Committee. However, further federal guidelines on this matter are expected.
When are the first doses of a vaccine sent and where do they go?
Federal officials have announced that the first 6.4 million doses will be delivered within 24 hours of the F.D.A. authorizes a vaccine, and the number each state receives is based on a formula that takes into account its adult population. Pfizer delivers special coolers, each with a minimum of 1,000 cans, direct to locations determined by the governor of each state. First of all, likely almost all of these locations will be hospitals that have confirmed that they can store shipments at minus 94 degrees Fahrenheit, as the Pfizer vaccine requires, or use them quickly.
The road to a coronavirus vaccine
Interesting facts about vaccines
Confused by all of the technical terms used to describe how vaccines work and study? Let us help:
- Adverse event: A health problem that occurs in volunteers in a clinical trial with a vaccine or drug. An adverse event is not always caused by the treatment tested in the study.
- Antibody: A protein produced by the immune system that can attach itself to a pathogen such as the coronavirus and prevent it from infecting cells.
- Approval, licensing and approval for emergency use: Medicines, vaccines and medical devices cannot be sold in the US for no profit approval by the Food and Drug Administration, also known as Licensing. After a company has submitted the results of clinical studies to the F.D.A. For testing purposes, the agency decides whether the product is safe and effective. This process usually takes many months. If the country faces an emergency – like a pandemic – a company can file an application instead Emergency approvalthat can be granted much faster.
- Background rate: How often does the general population experience a health problem called an Adverse Event? To determine whether a vaccine or drug is safe, the researchers compare the rate of adverse events in one study to the background rate.
- Effectiveness: A measure of the effectiveness of a treatment in a clinical trial. For example, to test a coronavirus vaccine, the researchers compare how many people in the vaccinated group and the placebo group receive Covid-19. The actual effectiveness of a vaccine may differ from its effectiveness in a study.
- Phases 1, 2 and 3 studies: Clinical trials typically take place in three phases. Phase 1 studies typically involve a few dozen people to determine whether a vaccine or drug is safe. In Phase 2 trials, involving hundreds of people, researchers can try different doses and take more measurements of the vaccine's effects on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of the vaccine or drug by waiting to see how many people are protected from the disease it is supposed to be fighting.
- Placebo: A substance with no therapeutic effect that is widely used in clinical trials. For example, to see if a vaccine can prevent Covid-19, researchers can inject the vaccine into half of their volunteers while the other half are given a placebo with salt water. You can then compare how many people are infected in each group.
- Post-market surveillance: The surveillance that occurs after a vaccine or drug has been approved and regularly prescribed by doctors. This monitoring usually confirms that the treatment is safe. Rarely, side effects are noted in certain groups of people that were overlooked during clinical trials.
- Preclinical Research: Studies that take place prior to the start of a clinical trial typically include experiments that test a treatment on cells or animals.
- Viral vector vaccines: A type of vaccine that uses a harmless virus to deliver immune-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 companies use a cold virus called adenovirus as a vector. The adenovirus carries coronavirus genes.
- Test protocol: A series of procedures that must be performed during a clinical trial.
When will a vaccine be available to the general public and where will people get it?
Federal officials have repeatedly suggested that people who are not in the priority groups – healthy adults under 65 who do not work in health care or are otherwise considered essential workers – should have access to the vaccine by May or June as there will be enough delivery by the time there. But a lot has to be right for that. One factor is whether or when vaccines other than Pfizer and Moderna are approved.
Can employers like hospitals or grocery stores require their employees to be vaccinated?
Employers have the right to force their workers to vaccinate. For example, many hospital systems require annual flu vaccinations. However, employees can request exceptions for medical or religious reasons. In such cases, employers should make “reasonable accommodation”; With a coronavirus vaccine, a worker may be able to wear a mask to the office or work from home instead.
Three companies have released preliminary data suggesting their vaccines are effective, and there are dozens of other candidates in clinical trials. Can I choose which vaccine to get?
This will depend on a number of factors including the supply in your area at the time of vaccination and whether certain vaccines are used in certain population groups, e.g. B. in older adults, are more effective. For now, the Pfizer vaccine may be the only choice, provided it is approved. Moderna asked the F.D.A. for emergency approval on Monday; If approved, it will most likely be available within weeks of Pfizers.
Are there any side effects from taking it?
Some participants in the Pfizer and Moderna studies reported having symptoms such as fever, muscle pain, severe headache, and fatigue after receiving the shots, but the side effects generally lasted no more than a day. However, preliminary data suggests that the coronavirus vaccinations have a slightly higher rate of such reactions compared to most flu vaccines. These are almost always normal signs that the body's immune response is starting. At the meeting of the C.D.C. In last week's advisory committee, some members said it was important that doctors warn their patients about possible side effects and ensure that the vaccines are safe.
How do I know it's safe?
Application of each company to the F.D.A. Includes two months of follow-up safety data from phase 3 clinical trials conducted by universities and other independent bodies. At this stage, tens of thousands of volunteers are given a vaccine and wait to see if they get infected compared to others given a placebo. As of September, the Pfizer study had 44,000 participants. No serious security concerns were reported.
The F.D.A. will also review the dates for any vaccine seeking approval and share them with its advisory committee, which – in the case of the Pfizer vaccine – will meet publicly on December 10 to ask questions and make a recommendation to the agency. The F.D.A. will then decide whether the emergency vaccine should be approved.
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