April 13, 2021
FDA & CDC Recommend 'Pause' for J&J Vaccine
State: 'Do Not Administer'
Following news that the Johnson & Johnson COVID-19 vaccine may be linked to a rare blood clot disorder, the Michigan Health Alert Network issued a warning to immunization providers not to administer the vaccine until further notice.

Clinics that are scheduled to administer the vaccine should be rescheduled to use a different vaccine. According to the state, providers that have inventory of this vaccine should separate in their storage unit, mark "do not use" and store appropriately until further notice.
The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) released a joint statement this morning on the Johnson & Johnson COVID-19 Vaccine. The statement, attributed to Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, is as follows:

"As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

"CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

"Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their healthcare provider. Healthcare providers are asked to report adverse events to the Vaccine Adverse Event Reporting System.

"CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel."
 Secure Disposal of COVID Vaccine Vials Urged
Due to Security Concerns
Concerns raised at the federal level over an increased threat of fake or counterfeit vaccines have led to a joint recommendation about secure disposal of vials and packaging from the Cybersecurity & Infrastructure Security Agency (CISA) and the Centers for Disease Control and Prevention (CDC). The Michigan Department of Health and Human Services (MDHHS) released the document to immunization providers this week after receiving numerous inquiries about proper disposal.
The document reviews the recommended actions suggested by the Department of Defense in relation to the increased threat of fake or counterfeit vaccines. It is recommended that vaccine administration sites dispose of wasted COVID-19 vaccines in accordance with their jurisdiction’s procedures and take appropriate steps to properly dispose of empty vaccine vials and product packaging. Recommended actions to further protect COVID-19 vaccine empty vials and packaging are:

  • Action 1 (Preferred method): Treat vials and packaging similarly to medical waste by placing in red sharps container; OR
  • Action 2: Deface all or safely crush materials so it cannot be reintroduced or reproduced. After the products are sufficiently defaced, then dispose with regular waste.

Additionally, vaccines are only available and administered through state-authorized vaccination locations. Non-medical companies or private persons are not authorized to provide, sell or administer vaccines. Any offers related to the sale or use of COVID vaccines, not from a medical provider, should be considered suspicious and reported to the appropriate state or jurisdiction. This may include: state or local departments of health; the U.S. Department of Health and Human Services, Office of the Inspector General at 1-800-HHS-TIPS or www.oig.hhs.gov; or submit a tip to the Federal Bureau of Investigation: tips.fbi.gov.
COVID 'Snowbird' Guidance on Second Shots
Many individuals returning to Michigan from winter residences have already received their first dose of vaccine in another state, and immunization providers have asked the Michigan Pharmacists Association (MPA) for additional guidance on best practices. In response to MPA's inquiry, the Michigan Department of Health and Human Services (MDHHS) acknowledged the department has been doing a great deal of education on "snowbirds" returning to Michigan.

MDHHS is requesting providers enter their first doses into their EMR as historical so the doses get transferred into the Michigan Care Improvement Registry (MCIR), and there is a record of the dose in the state system. Then, MDHHS asks that providers use the same vaccine at the appropriate schedule when vaccinating.

"We realize that many scheduling systems are not set up for just a second dose appointment, so we are educating the general public to call pharmacies and [local health departments] LHD's to call for an appointment for just a second dose," said Terri Adams with MDHHS in an email.

For the vaccinating site, MDHHS is asking that providers use first-dose vaccine to vaccinate the snowbirds, so that it doesn’t impact their allocations. This way, they will still have supply coming in and will also have a second dose provided by the Centers for Disease Control & Prevention (CDC) supplied to have on hand. This could be used as an “extra dose” if they happen to obtain an additional dose from a vial.

Please be sure all COVID cards are updated with the second dose administered and reported to MCIR. Also, be sure all pharmacies are using our recently updated Michigan Emergency Use Authorizations (EUA’s) as they now contain the fetal cell statements that are required per recent legislation.

More information can be found at www.michigan.gov/covidvaccine.
EUA Fact Sheet Information
COVID-19 vaccine providers are required to provide an Emergency Use Authorization (EUA) fact sheet to each vaccine recipient/parent/legal representative prior to vaccination. Providers need to use the EUA fact sheets from the Michigan Department of Health and Human Services (MDHHS) website as they include both the Michigan Care Improvement Registry (MCIR) and Fetal Cell statements below.

MCIR Language
“To allow medical care provider(s) accurate immunization status information, an immunization assessment, and a recommended schedule for future immunizations, information will be sent to the Michigan Care Improvement Registry. Individuals have the right to request that their medical care provider not forward immunization information to the Registry.”

Fetal Cell Language

Janssen EUA:
The Johnson & Johnson COVID-19 vaccine has been produced by growing the virus in fetal cells during vaccine development and manufacturing (using the PER.C6 line). Such cells were derived from a historic cell line. Even though fetal cells are used to grow the vaccine virus, vaccines do not contain these cells or pieces of DNA.

Moderna and Pfizer BioNTech EUA:
The mRNA vaccines (those by Pfizer and Moderna) did not use a fetal cell line to produce or manufacture the vaccine. However, a fetal cell line was used in a very early phase to confirm efficacy prior to production and manufacturing.

For direct access to each EUA Fact Sheet with these statements:
USP Vaccine Handling Toolkit Updated
As part of their ongoing COVID-19 response, the U.S Pharmacopeia (USP) has engaged stakeholders and convened experts to identify and help address operational efficiency gaps across U.S. states and territories to help increase COVID-19 vaccinations. The resulting COVID-19 Vaccine Handling Toolkit is developed by over 30 independent expert volunteers led by USP’s Healthcare Safety and Quality Expert Committee and others. It is informed by USP’s public quality standards for compounding, microbiology, containers, distribution, stability and storage.

The COVID-19 Vaccine Handling Toolkit provides strategies that can support healthcare practitioners to:

Version 3.0, released on March 12, features updates related to:
  • Preparation, storage and transportation considerations including beyond-use date information for the newly authorized Johnson & Johnson (J&J) Janssen COVID-19 Vaccine
  • Updated transportation and storage information for the Pfizer-BioNTech COVID-19 Vaccine
  • Ancillary supply re-distribution considerations, when applicable