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Coronavirus Disease 2019 (COVID-19) updates
Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
Additional batch of Janssen COVID-19 vaccine released
FDA authorized (PDF) the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date a total of four batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management. (July 2, 2021)
COVID-19 vaccines safety and diversity videos
Diverse researchers and scientists who mirror the diversity in our communities have been developing vaccines to help protect us from COVID-19. Learn why you and your loved ones should get vaccinated as soon as a vaccine is available to you in this FDA video (1:22) in English and American Sign Language. This video is also available in: Spanish, Korean, and Navajo. |
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Drug approval milestone
In late June 2021, FDA reached a milestone of approving 1,000 original and supplemental generic drug applications to help in the treatment of patients with COVID-19 since the start of the pandemic. The Center for Drug Evaluation and Research prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with COVID-19, such as antibiotics, sedatives used in ventilated patients, anticoagulants, and pulmonary medications.
Reaching this milestone during the COVID-19 pandemic further supports the FDA’s everyday mission of improving access to safe, high-quality treatment options, which can result in more competition in the market and more affordable medicines for Americans.
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Emergency Use Authorization (EUA) updates
FDA no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators
FDA issued an updated Letter to Health Care Personnel and Facilities: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators. The FDA is revoking the EUAs for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. These actions are in follow-up to the May 27, 2021, letter in which the FDA recommended a transition away from non-NIOSH-approved disposable respirators as well as from reusing decontaminated or bioburden-reduced disposable respirators. (June 30, 2021) Read more
Diagnostic test EUAs
As of July 7, 2021, 393 tests and sample collection devices are authorized by FDA under EUAs. These include 281 molecular tests and sample collection devices, 84 antibody and other immune response tests, and 28 antigen tests. There are 52 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 5 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 11 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 560 revisions to EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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July 8, 2021: FDA Grand Rounds webcast - SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern, 12:00 - 1:00 p.m. ET
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New! July 13, 2021: Webinar on Revocation of EUAs for Non-NIOSH-Approved Respirators and Decontamination Systems, 12:00 - 1:00 p.m. ET - FDA will host a webinar to share information and answer questions about revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.
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July 14, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host an additional webinar in this series on July 28. Note that log-in information for this series has changed, as of July 14, 2021.
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July 19-23, 2021: Regulatory Education for Industry (REdI) Annual Conference 2021 - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements. The keynote speaker, Acting Commissioner Janet Woodcock, MD, will reflect on FDA’s use of EUAs and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.
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Save the date! August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
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Information for industry
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
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FDA is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
If you use one of these affected devices, talk to your health care provider to decide on a suitable treatment for your condition and follow these recommendations.
Philips Respironics is recalling affected devices manufactured between 2009 and April 26, 2021. For details, see Philips’ Respironics recall notification (PDF).(June 30, 2021)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
Find a COVID-19 vaccine near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. Learn more at vaccines.gov.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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