July 15, 2021
Guillain-Barre Syndrome (GBS) Reported after Johnson and Johnson COVID-19 Vaccination
The U.S. Food and Drug Administration (FDA) announced a new warning for the Johnson & Johnson coronavirus vaccine this week, saying the shot has been linked to a serious but rare side effect called Guillain-Barré Syndrome (GBS), in which the immune system attacks the nerves.

About 100 preliminary reports of GBS have been detected in vaccine recipients after the administration of 12.8 million doses of the Johnson & Johnson Janssen (J&J/Janssen) COVID-19 vaccine in the United States, according to a companion statement from the Centers for Disease Control and Prevention (CDC), which monitors vaccine safety systems with the FDA. Of these reports, 95 were serious and required hospitalization, the FDA statement said. There was one death. Neither agency provided details about the death, according to the Washington Post.

The CDC and FDA are monitoring reports in the Vaccine Adverse Event Reporting System (VAERS). GBS is a neurological disorder that can lead to muscle weakness or, in severe cases, paralysis, however most people fully recover from GBS. Though reports of GBS after the J&J/Janson COVID-19 Vaccine are rare, it does indicate a small possible risk of this side effect following vaccine administration.

The cases have been reported mainly two weeks after vaccination and mostly in males aged 50 years and older. There is currently no indication of a similar pattern with mRNA vaccines (Pfizer-BioNTech and Moderna). At present, nearly all COVID-19 hospitalizations and deaths are occurring in unvaccinated individuals. The risk of adverse events following COVID-19 vaccination remains rare, and it is recommended that everyone aged 12 and older receive a COVID-19 vaccine. 

The Michigan Department of Health and Human Services (MDHHS) is working to update the relevant provider fact sheets from the FDA and will post them HERE. The updated fact sheets for J&J vaccine reflect the FDA’s requirement to include information about an increased risk of GBS during the 42 days following vaccination.

For questions regarding COVID-19 vaccination, please contact CHECCimms@michigan.gov.
Pfizer 450 Shipper Shortage
The Michigan Department of Health and Human Services (MDHHS) has been notified that Pfizer is running short of COVID-19 vaccine shipper boxes and Controlant temperature monitors. This is due to two factors:

  1. The smaller packaging (450 doses versus 1,170 doses) requires more shipper boxes and Controlant temperature monitors to deliver the same number of doses.
  2. International donations have required additional shipper boxes and Controlant temperature monitors and this is reducing the number of domestic shippers in the supply chain.

Effective on all orders placed after 9:30 a.m. EST, Thursday July 15, 2021:
To assist with addressing these shortages, Pfizer 450 orders of two or more to the same location may automatically be combined within the same shipper box. For example, if an order includes two Pfizer 450 orders, 900 doses of Pfizer vaccine will be packed in the same shipper box with a single Controlant temperature monitor. This practice will reduce both the number of shippers used each day and the number of Controlant monitors shipped. 

Jurisdictions and providers may still order Pfizer 450 packages in single shippers by placing individual orders for each Pfizer 450 package. If an order for a total of 900 doses requires two separate 450-dose packages, two separate orders for Pfizer 450 will need to be placed in VTrckS or VPOP. This policy will not change the configuration of ancillary kits. Ancillary kits will still be shipped in separate boxes of 450 doses each. When placing orders, providers will still need to establish if adult or pediatric vaccine will be ordered.
Currently, in Michigan, vaccine orders that are being placed are being filled through redistribution of vaccine from existing inventory throughout the state.

As a reminder, you can assist with this shortage by returning your shippers and Controlant temperature monitors as soon as possible. Please check the shippers to verify they are completely empty before returning them. Please do not return vaccine or ancillary products in the shippers.
Pfizer, BioNTech Announce Development of Vaccine Targeting COVID-19 Delta Variant
In an effort to combat the COVID-19 Delta variant, Pfizer and BioNtech have announced the development of a booster vaccine and expect to launch clinical trials in August, according to a press release.

Despite encouraging findings about the efficacy of currently available vaccines, the companies are developing a booster shot specifically designed for the Delta variant, according to reporting by The New York Times. The Delta variant is believed to be approximately 60 percent more contagious than the UK variant, which emerged earlier in 2021. It could be twice as transmissible as the original COVID-19 virus.

The Delta variant is also the dominant strain in the United States, according to recent estimates from the Centers for Disease Control and Prevention (CDC). Although hospitalizations and deaths have declined over the past few months, new cases may be rising. Experts do not know, however, whether this increase is because of the variant, as it could also be attributable to slowing vaccination rates and increased reopenings.
COVID-19 Antibody Study Demonstrates Importance of Second Vaccine Dose
A new study demonstrates that patients who received the second dose of COVID-19 vaccine had significantly increased antibody production compared to those who had received only one dose. The study compared the saliva of individuals who only received one dose versus those who received two doses. Click below to learn more about the study.