ACIP discusses safety of Janssen COVID-19 Vaccine (Johnson & Johnson); recommendations for clinicians issued by CDC

On April 14, the Advisory Committee on Immunization Practices (ACIP) held an emergency meeting to review new information on adverse events following receipt of the Janssen COVID-19 Vaccine (Johnson & Johnson). The meeting was called in response to the April 13 joint statement issued by FDA and CDC calling for a pause in administration of the Janssen vaccine. The agencies recommended the pause due to reports of six women who developed a rare and severe type of blood clot (cerebral venous sinus thrombosis [CVST]) occurring in combination with low levels of platelets (thrombocytopenia) after receiving the Janssen vaccine. The pause was called to allow time to collect and review additional data and to prepare healthcare providers (HCPs) to recognize, diagnose, properly treat, and report patients exhibiting these symptoms after recent vaccination with Janssen COVID-19 Vaccine. On April 13, CDC also issued a Health Alert Network (HAN) statement outlining recommendations for clinicians, public health agencies, and the general public.

During the meeting, ACIP reviewed available data, including:

• Use of the Janssen COVID-19 Vaccine began in the U.S. on March 2, and 6.85 million doses had been administered by April 12
• Between March 19–April 8, 6 cases of CVST in combination with thrombocytopenia were reported to the Vaccine Adverse Events Reporting System (VAERS). All 6 cases occurred in white females age 18–48 years within 6–13 days of the Janssen vaccination. No obvious patterns of risk factors were noted among these women. The combination of CVST and thrombocytopenia is so rare that the background rate in the general population is not known.
• Treatment with heparin is common for ordinary blood clots but worsens this condition: heparin should not be given to patients with CVST with thrombocytopenia
• Similar reports of serious blood clots with low platelet counts have been reported after receipt of the AstraZeneca COVID-19 Vaccine in Europe; both the AstraZeneca and Janssen vaccines are based on an adenovirus vector platform
• No reports of CVST with thrombocytopenia have been reported following receipt of the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech or Moderna; as of April 12, more than 182 million doses of these vaccines had been administered in the U.S. 

ACIP members favored extending the pause for up to 10 days to obtain additional information before voting on any changes to its recommendations for the use of Janssen COVID-19 Vaccine. As of April 13, 52% of Janssen vaccine recipients remained in the 2-week risk window after vaccination; additional cases are possible among these recipients. 

In the interim, HCPs should follow guidance outlined in the HAN:

• Be alert for symptoms that may represent serious blood clots and/or low platelet counts in patients who recently received the Janssen vaccine; if suspected, consultation with a hematologist is strongly recommended
• Evaluate patients with a blood clot and thrombocytopenia after Janssen vaccine with a screening PF4 antibody ELISA assay as would be performed for autoimmune heparin-induced thrombocytopenia (HIT)
• Do not treat these patients with heparin unless the HIT testing is negative. See CDC guidance for treatment considerations, including non-heparin anticoagulants and high dose intravenous immune globulin.
• Report serious adverse events such as these to VAERS 

ACIP will reconvene for further evaluation of the Janssen vaccine on Friday, April 23, from 11:00–5:00 p.m. (ET). Information on attending this meeting is posted on the ACIP website. ACIP also will meet on May 5 to discuss rabies and dengue vaccines. No registration is required to watch live ACIP meetings or listen via telephone. Opportunities for public comment are described on the website.

Related Links 

• CDC Health Alert Network message, April 13, 2021 
• ACIP Presentation Slides: April 14, 2021 meeting gateway page 
• Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine 
• CDC webpage for the general public: Recommendation to Pause Use of Johnson & Johnson’s COVID-19 Vaccine
• ACOG Statement on Johnson & Johnson COVID-19 Vaccine
• ACIP gateway page for recordings and content from previous meetings, as well as information about future meetings

Back to top  

---

IAC experts called on by news media

With vaccines in the news so much lately, journalists have sought out IAC experts to communicate the intricacies of running a quality vaccination program. Our insights have helped explain vaccines to the public and policy makers. We want to help them understand the complex work vaccinators do. We've reached mass markets and local stations, across the U.S. and overseas, via print, radio, television, blogs, and more. Here is a selection of our recent citations:

• USA Today: America Reaches Milestone with COVID-19 Vaccine Widely Available to Those Who Want It, but Hesitancy Still Casts a Shadow (4/19/21)
• Washington Post: All about Your Coronavirus Vaccine Card (and What to Do If You Lose It) (4/17/21)
• LA Times: COVID-19 Vaccines—minus the Needle? Researchers Working on Capsules, Nasal Sprays (4/16/21)
• The Atlantic: The mRNA Vaccines Are Looking Better and Better (4/14/21)
• USA Today: ‘Don’t Panic’ over Johnson & Johnson Vaccine Pause, Experts Say. Chances of Blood Clot Is Less than 1 in a Million. (4/13/21)

Related Link

• IAC in the News gateway page  

---

Not-to-miss immunization articles in the news
 
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.

• New York Times: Covid-19: On Capitol Hill, Top Health Officials Urge Americans to Get Shots (4/18/21)
• Times Square Chronicles: Two-Time Paralympic Medalist, Nick Springer Has Gone to Play with the Angels (4/17/21)
• Washington Post: American, Georgetown Universities Join Growing List of Campuses to Require Coronavirus Vaccines (4/16/21)
• DailyMail: Duke Researchers Are Developing a Flu Shot Using Coronavirus Vaccines' New mRNA Technology That Could Offer Protection for up to Five Years (4/16/21) 
• Verywell Health: Vaccine Confidence Rises alongside a Fourth Wave (4/16/21) 
• CNBC: Pfizer CEO Says Third COVID Vaccine Dose Likely Needed within 12 Months (4/15/21)
• New York Times: What Women Need to Know about the COVID Vaccine (4/14/21)
• New York Times: Moderna Reports Its Vaccine Remains More than 90 Percent Effective after Six Months (4/13/21)
• New Yorker: The Last Time a Vaccine Saved America (4/12/21) 
• NPR: More Colleges Say They'll Require Students to Have COVID-19 Vaccines for Fall (4/11/21)