See DPH Statement on the FDA/CDC lifting the pause of the Johnson & Johnson’s Janssen vaccine.
DPH Statement on FDA and CDC’s decision to lift the pause of Johnson & Johnson vaccine
Friday, April 23, 2021, the CDC and FDA recommended lifting the pause on the use of the Johnson&Johnson Janssen vaccine, after the CDC’s Advisory Committee on Immunization Practices (ACIP) met and voted to recommend use of the vaccine continue.
Providers may begin administering the J&J vaccine again.
The Delaware Division of Public Health (DPH) has shared updated FDA materials with providers and updated the FDA materials for providers and the public further down on this page, the General public page and Medical Provider page of this website. The CDC has indicated additional communication and materials will be available next week.
DPH will also resume the use of J&J and will share plans for the next vaccine opportunity as soon as details are finalized.
The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19, according to a CDC press release issued Friday evening. 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 blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS) occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk, and ask providers to make women under 50 aware of this risk.
We remain unaware of any issues of blood clots in Delaware that may be related to this vaccine. The effects that would indicate a blood clot are different than the usual flu-like symptoms experienced between 1 and 3 days after vaccination (minor headache, soreness or redness at the injection site, fatigue, nausea).
Seek immediate medical attention if you experience the following symptoms within three weeks of getting the vaccine:
- Severe headache
- Blurred vision
- Severe pain in your abdomen or stomach
- Severe pain in your chest
- Leg swelling
- Shortness of breath
- Tiny red spots on the skin
- New or easy bruising or bleeding.
Contact your health care provider if you have questions.
As a reminder, CDC and FDA recommended this pause after the monitoring systems that make sure vaccines are safe received a small number of reports nationwide of people who received the J&J vaccine experiencing a rare and severe type of blood clot with low platelets. The pause was intended to gather more information about situation and give the agencies time to communicate with, and prepare the health care system to recognize and treat patients appropriately. There had been more than 7.5 million doses of the J&J/Janssen COVID-19 vaccine administered as of the time of the pause in the United States. This situation tells us that the safety systems in place work. This potential safety issue was caught early, and this pause reflects the federal government’s commitment to transparency as CDC and FDA reviewed the data.
See the CDC’s press release here: https://www.cdc.gov/media/releases/2021/fda-cdc-lift-vaccine-use.html
Compare the Three Vaccines:
Pfizer EUA Information
Moderna EUA Information
- EUA Letter
- Patient and Caregiver Fact Sheet
- Moderna Website
- CDC information (side effects, efficacy, eligibility, breakdown of trial participants)
Johnson & Johnson EUA Information
- EUA Letter (updated 4/23/21)
- Patient and Caregiver Fact Sheet (updated 4/23/21)
- Healthcare Providers Fact Sheet (updated 4/23/21)
- DPH Position Paper On Johnson & Johnson Vaccine
Is it OK for Me to Get the Vaccine?
Vaccine Safety Monitoring
V-SAFE Vaccine Safety Monitoring
Vaccine safety has been and will continue to be one of CDC’s top priorities. Once COVID-19 vaccines are made available in the United States, CDC will rely on existing systems and a new system, V-Safe, to monitor vaccine safety.
V-Safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after someone receives a COVID-19 vaccination. Through V-Safe, vaccine recipients can quickly tell CDC if they have any side effects after getting the COVID-19 vaccine. Depending on their responses, CDC may follow up with them by phone to get more information. V-Safe will also remind them to get their second COVID-19 vaccine dose, if needed.
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program run by CDC and the Food and Drug Administration (FDA). VAERS serves as an early warning system to detect possible safety issues with U.S. vaccines by collecting information about adverse events (possible side effects or health problems) that occur after vaccination.
How to Report Adverse Events to VAERS:
There are 2 ways to submit a report to VAERS:
Option 1: Submit a VAERS Report online (Preferred)
The online VAERS Report must be completed and submitted in the same session; it cannot be saved and edited at a later time.
Note: sessions time out after 20 minutes of inactivity; no information is saved.
Option 2: Download a Writable PDF Form and upload when ready
The Writable PDF Form can be downloaded and completed electronically on your own time. When ready, return to the VAERS Writable PDF web page (use link above) and follow Step 2 instructions to upload the form.
More Information about VAERS
Report Vaccination Violations
Additionally, any health care provider who intentionally or willfully provides or distributes, or who supervises someone who intentionally or willfully provides or distributes the COVID-19 vaccine to any individual who is not authorized to receive such vaccine pursuant to the Vaccination Guidance is guilty of unprofessional conduct as defined in Title 24 and may be subject to licensure discipline. Send your complaints to Division of Professional Regulation about this conduct.
Get More COVID Data
For more data on Delaware COVID cases, testing and outcomes, including demographic breakdowns, go to My Healthy Community