FDA & CDC Lift the “Pause” Almost Immediately after today’s advisory committee for immunization proactices meeting

The ACIP had a very good meeting all day today discussing the risks and benefits of the Johnson & Johnson vaccine. Today’s meeting was far more comprehensive than last week’s meeting. The materials that were presented were in-depth and included information about both the risks and unique benefits of the Johnson & Johnson vaccine. Most of the presentations are on the ACIP website at this location.

Because the J&J vaccine has simpler cold chain storage requirements and the fact that it is one-dose vaccine make it uniquely useful for certain difficult to reach populations. Also, many people prefer the J&J vaccine because they complete their full vaccination card with just one dose.

The FDA and CDC followed up almost immediately by lifting the “pause” in the administration of the J&J vaccine almost immediately. Remember, this vaccine was never in jeopardy of losing it’s Emergency Use Authorization status. The issue over the last couple of weeks has to do with the recommendation that follows EUA.

CDC and FDA determined the following:

  • Use of the Janssen COVID-19 Vaccine should be resumed in the United States.

  • The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.

  • The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

  • At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.

  • Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

The CDC will put putting our a Morbidity and Mortality Weekly Report out shortly that will cover all the public health bases.

Good meeting and good result today.