Q. What is an Emergency Use Authorization (EUA)?
A. Under Section 564 of the Federal Food, Drug & Cosmetic Act, after a statement by the Secretary of HHS based on one of four types of determinations, the FDA may authorize an unapproved product or unapproved uses. of a product approved for emergency use. When issuing an EUA, the FDA must determine, among other things, that, based on all of the scientific evidence available to the agency, including data from adequate and well-controlled clinical trials, the case where applicable, it is reasonable to believe that the product may be effective in diagnosing, treating or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological or nuclear agent; that the known and potential benefits of the product, when used to treat, diagnose or prevent such disease or condition, outweigh the known and potential risks of the product; and that there are no adequate, approved and available alternatives. Emergency use authorization is NOT the same as FDA approval or clearance.
Q. What does this EUA allow? What are the authorized limitations of use?
A. EUA authorizes emergency use of unapproved product Paxlovid (nirmatrelvir co-packaged with ritonavir) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years and over) weighing at least 40 kg) with a positive direct viral test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), and who are at high risk of progression to severe COVID-19 , including hospitalization or death. Paxlovid is not approved for any use, including for the treatment of COVID-19.
Paxlovid is not allowed:
• for the initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19.
• for pre-exposure or post-exposure prophylaxis for the prevention of COVID-19.
• for use for more than five consecutive days.
Q. How is high risk defined in the EUA?
A. Information on conditions that put a patient with mild to moderate COVID-19 at an increased risk of disease progression or death can be found at the Centers for Disease Control and Prevention website: People with Certain Conditions medical. Healthcare providers should consider the risk-benefit ratio for an individual patient.
Q. Are there any potential side effects of Paxlovid?
A. Possible side effects of Paxlovid include dysgeusia (altered or altered sense of taste), diarrhea, increased blood pressure, and myalgia (muscle pain).
Nirmatrelvir and ritonavir, which make up Paxlovid, also interact with other drugs, which can cause serious or life-threatening side effects. Patients should tell their health care providers about all medicines they are taking, including over the counter medicines and herbal supplements, when they decide to take Paxlovid.
Liver problems have occurred in patients receiving ritonavir. Therefore, care should be taken when administering Paxlovid to patients with pre-existing liver disease, abnormal liver enzymes or hepatitis. Patients should speak with their health care provider if they have a history of liver problems.
Paxlovid is not recommended for patients with severe kidney problems, and a different dose is needed for patients with moderate kidney problems. Patients should talk to their healthcare provider if they have a history of kidney problems.
Since nirmatrelvir is co-administered with ritonavir, there may be a risk that HIV-1 will develop resistance to HIV protease inhibitors in people with uncontrolled or undiagnosed HIV-1 infection.
Patients with HIV who are not on treatment with an “undetectable” viral load should talk to their healthcare provider before taking Paxlovid. There are limited clinical data available for Paxlovid. Serious and unexpected side effects can occur that have not been previously reported with the use of Paxlovid.
Q: Is Paxlovid FDA approved to prevent or treat COVID-19?
A. No. Paxlovid is not approved by the FDA to prevent or treat any disease or condition, including COVID-19. Paxlovid is an investigational medicine.
Q. How can Paxlovid be obtained for use in the EUA?
A. If you have any questions on how to obtain Paxlovid, please contact [email protected]
Q. Who can prescribe Paxlovid under the EUA?
A. Paxlovid can only be prescribed to a patient by physicians, advanced practice registered nurses, and medical assistants who are licensed or licensed under state law to prescribe drugs in the therapeutic class to which it belongs. Paxlovid (i.e. anti-infectives).
Q. When should Paxlovid be given to a patient?
A. Patients should speak with their healthcare provider to determine if, based on their personal circumstances, they are eligible to receive Paxlovid. Treatment with Paxlovid should be started as soon as possible after the diagnosis of COVID-19 and within 5 days of the onset of symptoms. More information on administration is available in the Information Sheet for Health Care Providers.
Q. Does the EUA authorize the use of Paxlovid for certain hospital patients?
A. Yes, Paxlovid is licensed for the treatment of hospital patients with mild to moderate COVID-19, such as patients admitted for drug interaction monitoring. Paxlovid is also authorized for patients hospitalized for conditions other than COVID-19, provided that the conditions of the authorization are otherwise met. Paxlovid is also authorized for patients requiring hospitalization due to severe or critical COVID-19 after starting treatment with Paxlovid. These patients should take the full 5-day course of treatment at the discretion of the healthcare provider.
Q. Is there any data showing that Paxlovid may be of benefit for the treatment of mild to moderate COVID-19 in some patients?
A. Yes. The primary data supporting this EUA for Paxlovid comes from EPIC-HR, a randomized, double-blind, placebo-controlled clinical trial investigating Paxlovid for the treatment of symptomatic outpatients with a laboratory-confirmed diagnosis of SARS-CoV-2 infection. Patients were adults aged 18 and older with a predefined risk factor for progression to serious disease or were aged 60 and older, regardless of predefined chronic medical conditions. Not all of the patients had received a COVID-19 vaccine and had not previously been infected with COVID-19. The main outcome measured in the trial was the proportion of people hospitalized due to COVID-19 or died from any cause during 28 days of follow-up. Paxlovid significantly reduced by 88% the proportion of people hospitalized or died from any cause compared to placebo among patients treated within five days of symptom onset who did not receive therapeutic treatment by COVID-19 monoclonal antibody. In this analysis, 1,039 patients received Paxlovid and 1,046 patients received placebo and of these patients, 0.8% who received Paxlovid were hospitalized or died within 28 days of follow-up versus 6% of patients who received Paxlovid. received the placebo. Of those who received Paxlovid, no patient died during this period, compared to 12 people who received placebo.
Details of clinical trial results can be found in section 14 of the Authorized Health Care Provider Information Sheet.
Q. Are there any reporting requirements for healthcare facilities and providers under the EUA?
A. Yes. Under the EUA, the FDA requires healthcare providers who prescribe Paxlovid to report all medication errors and serious adverse events considered potentially related to Paxlovid through the FDA’s MedWatch Adverse Event Reporting program. . Suppliers can complete and submit the report online; or download and complete the form, then fax it to 1-800-FDA-0178. This requirement is described in the EUA Information Sheet for Healthcare Providers. FDA MedWatch forms must also be provided to Pfizer.
Health care facilities and providers should report treatment information and usage data according to instructions from the US Department of Health and Human Services. This information and data should be reported through HHS Protect, Teletracking, or the National Health Care Safety Network (NHSN).
Q. Do patient outcomes have to be reported under the EUA?
A. No, reporting of patient results is not required under the EUA. However, reporting of all medication errors and serious adverse events considered potentially related to Paxlovid occurring during treatment is required.
Q. The FDA has issued a number of EUAs, including for therapeutic purposes. If state laws place different or additional requirements on the medical product covered by an EUA, are those state laws preempted?
A. As stated in the FDA’s Emergency Use Authorization of Medical Products and Related Authorities Guidance, “The FDA believes that the terms and conditions of an EUA issued under Section 564 take precedence over national or local law, both legislative requirements and common law obligations, which impose different or additional requirements on the medical product for which the EUA has been issued in the context of the emergency declared under section 564. The guide explains the basis of the FDA’s opinions on this topic.
Q. Can healthcare providers share the Patient / Caregiver Information Sheet electronically?
A. Pursuant to the authorization, Pfizer must make the Authorized Fact Sheets available on its website at: www.COVID19oralRX.com. Health facilities and health care providers should ensure that information sheets are made available to patients, parents and caregivers through ‘appropriate means’ and that electronic delivery of the information sheet is made available to patients, parents and caregivers. information is an appropriate medium.