The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination. GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis. Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports of GBS following vaccination with the Janssen vaccine after approximately 12.5 million doses administered. Of these reports, 95 of them were serious and required hospitalization. There was one reported death. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder. GBS has also been observed at an increased rate associated with certain vaccines, including certain seasonal influenza vaccines and a vaccine to prevent shingles. Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines. FDA continues to work with its partner in vaccine safety surveillance, the CDC, to monitor reports of GBS following vaccination with the Janssen COVID-19 Vaccine. Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks.
The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about GBS and the Fact Sheet for Recipients and Caregivers has been revised to include information about GBS. The warning in the Fact Sheet for Healthcare Providers Administering Vaccine notes that reports of adverse events suggest an increased risk of GBS. Additionally, the Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine: weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function.
- Today the agency authorized 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 five 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.
- The FDA Center for Drug Evaluation and Research has published a From Our Perspective on the FDA’s Clinical Methodologies Group’s recent U.S. Department of Health and Human Services (HHS) award, which will fund expansion of the CURE ID platformExternal Link Disclaimer. The platform will allow automated anonymized data collection from electronic health records and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases. This work may facilitate the clinical, research, and regulatory communities to identify signals of potentially safe and effective COVID-19 therapies that may also be candidates for additional study in randomized clinical trials. In the future, CURE ID’s expansion will also include a platform for patients with long COVID to upload information on their treatments, in addition to the treatment outcomes they consider most important.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to one network operating two websites, www.premierdream.com and www.eirmed360.com, for marketing unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 396 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 282 molecular tests and sample collection devices, 85 antibody and other immune response tests and 29 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 11 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 572 revisions to EUA authorizations.