Поиск информации о COVID-19 здесь
На основе текущих тенденций COVID-19 Министерство здравоохранения и социальных служб (HHS) планирует, чтобы федеральное Публичное здравоохранение (PHE) по COVID-19, объявленное на основе раздела 319 Закона о государственной службе по здравоохранению (PHS), истекло в конце дня 11 мая 2023 года.
С тех пор, как министр здравоохранения и социальных служб Савьер Бесерра написал свое письмо от 9 февраля 2023 года губернаторам о планируемом завершении PHE по COVID-19, Министерство сотрудничает с партнерами — включая губернаторов; агентства штатов, местных органов власти, индейские племена и территории; промышленность; и защитников — чтобы обеспечить системную переориентацию от COVID-19 PHE.
На сегодняшний день HHS публикует информационный бюллетень с обновленной информацией о текущих гибкостях, предоставленных временным положением по COVID-19, и как они будут затронуты завершением COVID-19 PHE 11 мая.
Достижения:
При приближении к завершению COVID-19 PHE:
Мы знаем, что многие люди по-прежнему сталкиваются с последствиями COVID-19, особенно пожилые люди, люди с нарушениями иммунной системы и люди с инвалидностью. Поэтому наш ответ на распространение SARS-CoV-2, вируса, вызывающего COVID-19, остается приоритетом общественного здравоохранения. Для обеспечения системной переориентации мы работали месяцами, чтобы продолжать удовлетворять потребности тех, кого затронул COVID-19.
Даже после завершения COVID-19 PHE мы продолжим работать над защитой американцев от вируса и его худших последствий, поддерживая доступ к вакцинам, лечениям и тестированию COVID-19, включая тех, у кого нет медицинской страховки. Мы будем продолжать продвигать исследования новых, инновационных вакцин и лечений через инвестиции в $5 миллиардов в программу NextGen, посвященную ускорению и сокращению сроков разработки следующего поколения вакцин и лечений, включая инвестиции в исследования, разработку и производственные мощности и продвижение критической науки. Мы также продолжаем инвестировать в улучшение понимания и борьбу с долговременными последствиями COVID и помощь в их смягчении.
Что не изменится после завершения COVID-19 PHE:
Доступ к вакцинации и определенным лечениям COVID-19, таким как Паксловид и Лагеврио, в целом не будет затронут. Для обеспечения безопасности сообществ от COVID-19 HHS продолжает обязываться обеспечивать максимальный доступ к вакцинам и лечениям COVID-19.
После завершения COVID-19 PHE 11 мая американцы смогут продолжать пользоваться вакцинами COVID-19 бесплатно, также, как они делали во время COVID-19 PHE, благодаря требованиям Соглашения о поставках по программе вакцинации от COVID-19 Центром по контролю и предотвращению заболеваний. Люди также смогут продолжать получать доступ к лечению COVID-19 так же, как они делали во время COVID-19 PHE.
Перевод вакцин и лечений от COVID-19 на традиционный рынок здравоохранения
Изменения, касающиеся оформления исключений и освобождений в рамках программ Medicare и Medicaid после COVID-19
Ответ FDA на нехватку медицинских изделий в связи с COVID-19
Paxlovid is an antiviral therapy that consists of two separate medications packaged together. When you take your three-pill dose, two of those pills will be nirmatrelvir, which inhibits a key enzyme that the COVID virus requires in order to make functional virus particles. After nirmatrelvir treatment, the COVID virus that is released from the cells is no longer able to enter uninfected cells in the body, which, in turn, stops the infection. The other is ritonavir, a drug that was once used to treat HIV/AIDS but is now used to boost levels of antiviral medicines.
As a COVID-19 treatment, ritonavir essentially shuts down nirmatrelvir’s metabolism in the liver, so that it doesn’t move out of your body as quickly, which means it can work longer—giving it a boost to help fight the infection.
When should I take Paxlovid?
You have to take Paxlovid within five days of developing symptoms.
Like all antivirals, Paxlovid works best early in the course of an illness—in this case, within the first five days of symptom onset, says Jeffrey Topal, MD, a Yale Medicine infectious diseases specialist who is involved in determining COVID-19 treatment protocols for Yale New Haven Hospital patients.
How often do I take Paxlovid?
The standard dose is three Paxlovid pills twice daily for five days for a full course that adds up to 30 pills. It helps that the pills are packaged in a “dose card,” basically a medication blister pack that allows you to punch out the pills as needed. There is also a reduced dose (two pills instead of three) for people with moderate renal impairment.
Is Paxlovid similar to Tamiflu?
“I think it’s a good comparison,” says Dr. Roberts. Tamiflu is an antiviral drug that reduces flu symptoms. Both are prescription-only oral antiviral pills given early in illness.
Tamiflu is taken twice a day for five days, and it must be started within 48 hours of flu onset. “When you give a patient Tamiflu beyond that, it doesn’t really change the course of their flu,” Dr. Roberts says.
But there are also differences between the two, starting with the way they were studied, Dr. Topal adds. Researchers showed that Paxlovid can prevent hospitalization and death. But since influenza causes fewer severe cases, clinical trials focused on whether Tamiflu could shorten the length of flu illness—which it did, he says.
Can anyone get a Paxlovid prescription?
In order to qualify for a prescription, you must be at high risk for developing severe COVID-19. That means you must either be 50 or older (age remains the strongest factor for severe COVID-19 outcomes, according to the FDA), although, the agency still authorizes Paxlovid for adolescents and teenagers ages 12 and older who weigh at least 88 pounds. You also qualify if you have certain underlying conditions (including cancer, diabetes, obesity, or others). The more underlying medical conditions a person has, the higher their risk for developing a severe case of COVID-19, according to the CDC.
Determining whether a patient is at high risk for progression to severe COVID-19, including hospitalization or death, is based on the provider’s assessment of the individual patient and that patient’s medical history, according to the FDA. If you are pregnant or breastfeeding, the FDA recommends discussing your options and specific situation with your health care provider, since there is no experience using the drug in these populations. If you could become pregnant, it’s recommended that you use effective barrier contraception or do not have sexual activity while taking Paxlovid.
How well does Paxlovid work?
The FDA’s approval of Paxlovid for adults in 2023 was based on the totality of scientific evidence submitted by Pfizer, including efficacy data from a Phase 2/3 study showing an 86% reduction in risk of COVID-19-related hospitalization or death from any cause in patients who took Paxlovid within five days of symptom onset.
When it applied for FDA authorization in 2021, Pfizer presented data from a clinical trial conducted between mid-July and early December 2021. That data showed that participants, who were given Paxlovid were 89% less likely to develop severe illness and death compared to trial participants who received a placebo. All of the trial participants were unvaccinated and they took the drug within three days of symptom onset.
In November 2022, the CDC reported on a real-world study that showed adults who took Paxlovid within five days of a COVID-19 diagnosis had a 51% lower hospitalization rate within the next 30 days than those who were not given the drug. The study included people who had been vaccinated or had a previous infection, which the CDC said implied the drug should be offered to people who are eligible regardless of their vaccination status.
What do we know about how Paxlovid works in kids?
Pfizer launched a clinical trial in March 2022 to study the safety and efficacy of Paxlovid in children and teenagers ages 6 to 17 who have COVID-19 symptoms and test positive for the virus, and who are neither hospitalized nor at risk for severe disease.
While Paxlovid is authorized for use in adolescents and teenagers ages 12 and up, and weighing at least 88 pounds, that age group wasn’t tested in the original clinical trial. But because many children reach 88 pounds—considered to be an adult weight—the FDA has allowed extensions of EUAs for medications such as monoclonal antibodies and remdesivir in younger age groups, adds Dr. Topal.
“Based on the pharmacokinetics of the drugs in Paxlovid, the differences in metabolism and excretion—liver and kidney function specifically—of these drugs in this age group are thought to be similar to that of adults,” Dr. Topal says.
Do antiviral treatments such as Paxlovid work against Omicron subvariant JN.1?
The CDC says antiviral treatments work well against JN.1, which is currently the dominant strain in the U.S..
What are the side effects from Paxlovid?
The most common side effects of taking Paxlovid include impaired sense of taste (for example, a metallic taste in the mouth) and diarrhea, according to the FDA. Most people who take Paxlovid should not experience serious side effects, explains Dr. Roberts. “Paxlovid is usually very well-tolerated,” he says.
Other possible side effects include:
Since Paxlovid is cleared by the kidneys, dose adjustments may be required for patients with mild-to-moderate kidney disease, explains Dr. Topal. “For patients with severe kidney disease—or who are on dialysis—or those with severe liver disease, Paxlovid is not recommended; the levels of the drug can become too high and could cause increased side effects,” he says.
The FDA says that anyone who takes Paxlovid should contact their health provider right away if they have any signs and symptoms of liver problems: loss of appetite, yellowing of the skin and whites of the eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach-area (abdominal) pain.
It’s worth noting that because Paxlovid is still being monitored in the real world, it is possible that all of the risks are not yet known. (The FDA has provided a fact sheet on Paxlovid with a full list of known side effects.)
Can I take Paxlovid if I’m taking other medications?
There is a long list of medications Paxlovid may interact with, and in some cases, doctors may not prescribe Paxlovid because these interactions may cause serious complications.
The list of drugs that Paxlovid interacts with includes some organ anti-rejection drugs that transplant patients take, as well as more common drugs like some used to treat heart arrhythmias. Paxlovid also decreases the metabolism of anticoagulants, or blood thinners, that many older adults depend on, driving up levels of those medications in the body to a point where they are unsafe, Dr. Topal explains.
Anyone who has Human Immunodeficiency Virus 1 (HIV-1) infection should talk to their health care provider before taking Paxlovid, since it may lead to some HIV-1 medicines not working as well in the future.
What is the rebound effect of Paxlovid?
There have been reports of a “rebound” of COVID-19 symptoms in some people within 2 to 8 days after completing the five-day course of Paxlovid; in those cases, some have tested positive again but have no symptoms; others have a recurrence of symptoms. Pfizer had said that in the clinical trial for Paxlovid, several participants appeared to have a rebound in virus levels, although this also occurred in some people who were given a placebo.
When it approved Paxlovid in May, the FDA said there not a clear association between Paxlovid treatment and COVID-19 rebound based on available data, and rebound rates in clinical trials were similar among participants who took Paxlovid and those who took a placebo.
However, scientists are still studying the Paxlovid rebound. The CDC says a rebound does not mean a person was resistant to Paxlovid, nor does it mean they were reinfected with the virus. In June, the CDC released guidance for clinicians, saying a brief return of symptoms may be part of the natural history of SARS-CoV-2 infection in some people, independent of treatment with Paxlovid, adding that there is no evidence additional treatment is needed. A CDC study reported that rebound symptoms tended to be unlikely to require hospitalization and milder than symptoms experienced during the primary infection.
“The hypothesis is that the immune system didn’t have a chance to see the full extent of the virus, since Paxlovid suppressed replication early in disease,” Dr. Roberts says. Scientists are studying the effects of longer treatment durations, longer periods of isolation, and other ways of managing the problem, he adds.
For anyone who experiences a rebound, Pfizer recommends reporting it to them on its portal for adverse events associated with Paxlovid.
If I’m not eligible for Paxlovid, is there something else I can take?
There are other therapies for COVID-19, and anyone who cannot take Paxlovid—perhaps because it would interact with another medication—should talk to their doctor about the best approach for their situation.
Do I still need to be ‘up to date’ on vaccination if Paxlovid is available?
Vaccination, testing, and mitigation efforts such as masking, remain a key part of prevention, even as more drugs become available, says Dr. Topal.
“Early testing is key to making these drugs work,” he says. “It’s always been the Achilles’ heel of these antiviral drugs that most people don’t get tested—or they don’t have access to testing.”
He encourages taking a test even if you think you only have a cold or allergies—and if you can get one. “Home testing is a huge part of the way to really ‘operationalize’ these medications,” he says, adding that while home tests may not be as highly sensitive as the laboratory-based polymerase chain reaction (PCR) tests, they are still very helpful in making a diagnosis.
Dr. Topal says people also should remember that Paxlovid, even with its high efficacy, is not perfect, and even if it were, viruses can mutate and develop resistance to antiviral medications. “Will some people still be hospitalized? Yes—no medication is perfect,” he says. “But for many high-risk patients, this medication can really reduce that risk.”
If you are experiencing symptoms of COVID-19 and think you are eligible for a treatment, you can visit the government Test-to-Treat Locater. You can use the site to search for the places near you where you can fill a COVID-19 prescription, or identify sites that provide testing, medical care, and COVID-19 medications.
For answers to more Paxlovid-related questions, read the Paxlovid FAQ provided by the FDA.
Information provided in Yale Medicine articles is for general informational purposes only. No content in the articles should ever be used as a substitute for medical advice from your doctor or other qualified clinician. Always seek the individual advice of your health care provider with any questions you have regarding a medical condition.
COVID-19 is a respiratory disease that can cause severe illness. COVID-19 spreads easily from person to person when someone who is sick breathes out droplets and very small particles with the virus. These droplets and particles can be breathed in by other people or land on their eyes, noses, or mouth and make them sick.
With widespread access to vaccines, testing, and treatment options, we have more tools than ever before to prevent severe disease.
Information on COVID-19
Learn how to protect yourself and others from serious illness and find the support you need to stay healthy.
See basic information on COVID-19 testing, including when to get a test, how to get a test, and what to expect.
Get the latest statistics, learn how our data is collected, and more.
Download COVID-19 educational resources—from posters and signs to fact sheets and videos—in multiple languages.
Why get vaccinated against COVID-19?
The emergency phase of COVID-19 is over, but the virus continues to spread and endanger people’s lives, particularly those who are older, have chronic diseases, are immunocompromised or pregnant.
Safe and effective vaccines help ensure that COVID-19 does not result in severe disease and death. In 2021 alone, COVID-19 vaccines saved an estimated 14.4 million lives worldwide. Vaccination also reduces the likelihood of new variants from emerging.
Check your COVID-19 vaccination status and consult with your healthcare provider for any needed doses.
COVID-19 vaccines are safe.
Strict precautions are in place to help ensure the safety of all COVID-19 vaccines.
Before receiving validation from WHO and national regulatory agencies, COVID-19 vaccines were subject to rigorous testing in clinical trials to prove that they meet internationally agreed benchmarks for safety and efficacy.
Unprecedented scientific collaborations, extensive prior research and substantial public funding enabled swift COVID-19 vaccine development to be completed in record time – while maintaining high safety standards. New versions of the vaccine are being developed as the COVID-19 virus continues to circulate and change.
Who should get vaccinated and boosted?
In November 2023, WHO’s Strategic Advisory Group on Immunization (SAGE) updated the recommendations on COVID-19 vaccination in the context of extensive population immunity resulting from vaccination and/or infection.
The table below outlines the updated recommendations based on a person’s (1) vaccination history and (2) age and health condition.
Getting vaccinated: Specific advice
What to expect after getting vaccinated
COVID-19 Vaccines
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Most respiratory infections are caused by a virus, like flu viruses, RS virus or coronavirus. They can make some people very ill. For instance, RS virus can be dangerous for very young children. And people with underlying health issues and the elderly have a higher risk of becoming severely ill from coronavirus or the flu. But a viral infection can also cause prolonged symptoms in people without underlying health issues. This is the case with post-COVID-19 syndrome (long COVID), for example.
That’s why you should try to minimise the chance of passing on a respiratory virus.
Symptoms of a respiratory infection
The most common symptoms of a respiratory infection are coughing, sneezing, a sore throat and a runny or stuffy nose. Other symptoms include fever, muscle ache, headache and fatigue.
The following rules apply to everyone
Vaccines are available against some viruses that cause respiratory infections, including flu viruses and coronavirus. These vaccines help protect against severe illness.
More information about influenza and the flu vaccine is available on the RIVM website.
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