Lift Recommended Pause on Janssen Vaccine

On April 23, the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.

“The pause is a good sign that the health community is taking side effects seriously. Existing safety systems detected a small number of reports of low platelets combined with a rare and severe type of blood clot among people who had received the J&J vaccine. Out of more than seven million vaccines, the CDC/FDA were able to detect and quickly respond to a handful of reported blood clot events.

That means our reporting system is working. CDC and FDA recommended a pause in vaccine administration. The pause allowed the medical community to review the best ways to detect and treat a rare blood clot known as cerebral venous sinus thrombosis (CVST),” – said Dr. Chinni Pulluru, who supports Clinical Innovation, Transformation and Operations for Walmart.

COVID-19 Vaccines

Technology has allowed us to speed up the process and create three safe and effective vaccines to fight COVID-19. There are two types of vaccines from three suppliers currently available.

The first, mRNA vaccines, such as Pfizer and Moderna, contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. These vaccines do not contain any live virus, and they cannot give someone COVID-19. Our cells make copies of the protein and destroy the genetic material from the vaccine. Our immune systems react to the protein and create a defense system that will fight the virus that causes COVID-19 if we are infected in the future.

The health and wellness community has increased its interest in these types of vaccines because they can be developed in a laboratory using readily available materials and technology, which means although some hesitation comes from the idea that this vaccine was developed too quickly, mRNA vaccines have been studied and worked with for decades, and technology helped us develop the COVID-19 vaccine faster. It’s a bit like comparing typewriters to word processors or laptops. Once you have a template that works, you can reuse it over and over —even copying and pasting specific parts you like, rather than having to start over again every time you want to create a document. Everything is moving faster due to technology, and lucky for us, so are health and wellness solutions.

Secondly, we have viral vector vaccines like J&J. Viral vector vaccines use a modified, harmless virus (not related to the virus that causes COVID-19) to enable cells in our body to produce a protein from the COVID-19 virus. The protein is harmless and cannot cause COVID-19, but stimulates our immune systems to fight future infections. In that sense, they are similar to the mRNA virus. Also, like the mRNA vaccines, viral vector vaccines can be created and modified rapidly, so if boosters are required in the future, say, to protect us against variants that the original vaccine doesn’t protect against, we will be able to manufacture and administer such boosters quickly.

Recommended Pause on Janssen Is Lifted

Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.

The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.

The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

“The risk of the specific health condition characterized by low platelets and unusual blood clots is considered very low. Also, health care providers administering the vaccine have additional information about the condition—how to identify and treat, for example—so our safety monitoring system has been further enhanced. This is good news: We should have even more confidence in the safety of the vaccines, and an effective vaccine can resume administration, which will boost our efforts to end the epidemic,” – said Lisa Smith, Senior Director, Clinical Excellence, Health & Wellness, Walmart U.S.