FDA reports rare complications with Pfizer COVID vaccine, updates J&J safety info

Regulatory NewsRegulatory News
| 13 July 2021 | By Kari Oakes 

A summary of results of near real-time monitoring of the safety of COVID-19 vaccines in  older individuals was reported Tuesday by the US Food and Drug Administration (FDA). The agency identified four potential health concerns associated with receiving one of the authorized vaccines.
Examining the database of Medicare health care claims for people aged 65 years and older who received the mRNA vaccine marketed by Pfizer/BioNTech, FDA identified four adverse events of interest (AEI) associated with receipt of the vaccine. These include pulmonary embolism, acute myocardial infarction, immune thrombocytopenia and disseminated intravascular coagulation.
Noting that the findings are being publicized “in the spirit of transparency," FDA made clear that “These four events may not be true safety concerns, and the screening method cannot establish that the vaccine caused these AEI.” An alternative explanation for the elevated rate of these events in individual who received the Pfizer-BioNTech vaccine might be that “many high-risk individuals who were older and had significant co-morbidities” received the vaccine.
More people in the US have received the Pfizer/BioNTech COVID-19 vaccine than the Moderna or Johnson & Johnson vaccines, the other two currently authorized for emergency use in the US during the public health emergency of the COVID-19 pandemic. FDA
The potential safety signal for these four AEIs in older people who have received the Pfizer/BioNTech vaccine has only been seen with the near real-time monitoring of the Centers for Medicare and Medicaid (CMS) claims database.
No signal has yet been detected in other data sources FDA and the US Centers for Disease Control and Prevention (CDC) use for safety surveillance. These other data sources include the CDC’s Vaccine Safety Datalink, which is a collaboration between CDC and nine health care organizations that uses electronic health data from participating sites. This collaborative project has been underway since 1990.
Data from the government’s Vaccine Adverse Event Reporting System (VAERS) has not shown any signal for an association between any COVID-19 vaccine and the AEI identified in the CMS database, according to the FDA update.
The agency says that “more rigorous epidemiological studies” are underway. “FDA strongly believes that the known and potential benefits of COVID-19 vaccination greatly outweigh the known and potential risks of COVID-19. There is no need to delay vaccination while the FDA continues its investigation,” noted FDA.
FDA updates J&J vaccine info to reflect risk of Guillain-Barré syndrome
Separately, FDA issued a letter Monday requiring the addition of new warning information on the label and emergency use authorization (EUA) fact sheet for the Johnson & Johnson vaccine produced by Janssen, the firm’s vaccines arm. The agency still judges that the benefits of receiving the vaccine “clearly outweigh the known and potential risks.”
After reviewing real-world safety data from the VAERS database, FDA required Janssen to add a sentence to the warnings and precautions section of the EUA fact sheet that reads, “Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.”
Guillain-Barré syndrome is a rare neurological condition that causes an ascending paralysis and sometimes necessitates mechanical ventilation and intubation; it is also seen rarely after receipt of some other vaccines.
According to the agency’s 13 July COVID-19 update email, the revisions were based on an analysis of VAERS data that found 100 preliminary reports of Guillain-Barré syndrome after administration of the Johnson & Johnson vaccine, out of about 12.5 million doses administered. One death and 95 hospitalizations occurred among those with reported Guillain-Barré syndrome.
“Although the available evidence suggests an association between the Janssen vaccine and increased risk of [Guillain-Barré syndrome], it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines,” wrote the agency in the update.
Language in the EUA fact sheet regarding the risk of thrombocytopenia with thrombosis was also adjusted “for clarity and consistency.”
Janssen’s COVID-19 vaccine webpage for healthcare providers features a popup drawing attention to updates to the fact sheet and prescribing information. Johnson & Johnson issued a statement Monday noting that “rare cases” of Guillain-Barré syndrome have been reported, mostly within 42 days of administration of the one-dose vaccine.
“While the chance of having this occur is very low, Johnson & Johnson has updated its COVID-19 Vaccine Factsheet to include important information about these rare cases and on the signs and symptoms of Guillain-Barré syndrome. Updates with this new information will be implemented in other regions of the world according to local regulatory procedures,” stated the firm.


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