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Ask Dr. Halverson: Johnson and Johnson COVID-19 pause; absolutely correct and reassuring

 web 4 17 Halverson photo
By Dr. Jim Halverson
On April 13, the Centers for Disease Control and Food and Drug Administration recommended a pause in the use of Johnson & Johnson/Janssen COVID-19 vaccine.
Of the nearly 7 million doses administered in the United States since the FDA’s Emergency Use Authorization Feb. 27, six cases of a rare and severe type of blood-clotting disorder have been reported in people after receiving the J&J/Janssen COVID-19 vaccine. 
All reports occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination. As of April 13, of the more than 180 million doses administered so far of the Pfizer-BioNTech or Moderna vaccines, no reports matching those of the J&J/Janssen vaccine had been received.
The CDC and FDA recommended this pause to communicate with and prepare the healthcare system to recognize this potential severe side effect and treat patients appropriately. This pause is also allowing the CDC’s independent advisory committee, the Advisory Committee on Immunization Practices (ACIP), to meet, review these cases, and assess their potential significance.

• Safety is a top priority
COVID-19 vaccine safety is a top priority of the federal government and all healthcare providers. All reports of health problems following COVID-19 vaccination are taken very seriously. This potential safety issue was caught early, and this pause reflects the federal government’s commitment to transparency as the CDC and FDA review these data. COVID-19 vaccines have undergone and will continue to undergo the most intense safety monitoring in U.S. history.

• What you should do if you received the J &J/Janssen vaccine?
If you received the vaccine more than three weeks ago, the risk of developing a blood clot is very low at this time.
If you received the vaccine within the last three weeks, your risk of developing a blood clot is also very low and that risk will decrease over time.

• When should I contact my healthcare provider?
Contact your healthcare provider and seek medical treatment urgently if you develop any of the following symptoms: severe headache, severe backache, new neurological symptoms, severe abdominal pain, shortness of breath, leg swelling or new and easy bruising.

 

• Should I still become vaccinated against COVID-19?
Absolutely! The United States is still averaging nearly 70,000 new cases and 700 deaths per day from COVID-19. Receiving your vaccine as soon as possible helps protect you and those around you from the potential severe short- and long-term consequences of this disease. If you were scheduled to get the J&J/Janssen vaccine, please work with your vaccine provider to reschedule your appointment to get another authorized and recommended COVID-19 vaccine. Both the Pfizer and Moderna vaccines have had no reported cases or deaths from this very unusual reaction.

• How long will the pause last?
The pause will continue to allow for more data to be analyzed by the ACIP and to determine if any additional events are identified in individuals who recently received the J&J/Janssen vaccine. At the time of the pause, the nearly 7 million doses had been given over a period of six weeks since the Feb. 27 FDA approval of this vaccine, and 3.8 million doses had been given in the two weeks prior to April 13. The ACIP is the independent agency that sets the vaccination schedules and reviews the safety and effectiveness data of all vaccines licensed for use in the United States. They are scheduled to meet again on April 23. 

 

• Are these cases likely to be vaccine-related?
Yes. All six women appear to have suffered a condition called autoimmune thrombocytopenia. Simply put, the immune reaction brought on by the vaccine caused a specific antibody to develop in these women that affected how their platelets function, thus making them more susceptible to blood clots and easier bleeding, a very unusual combination.
This condition has also been reported in a very small number of people in Europe who have received the AstraZeneca COVID-19 vaccine. This vaccine has not been authorized for use in the United States. Most (but not all) of those reported cases have also occurred in women younger than 50, some of whom were receiving estrogen-replacement therapy or oral contraceptives.
Let’s review how all of the licensed COVID-19 vaccines work and how the J&J/Janssen and AstraZeneca vaccines are different from the Pfizer and Moderna vaccines.  All four of the COVID-19 vaccines teach the immune system to recognize the coronavirus without exposing the body to the actual coronavirus. The vaccines pull this off by showing the immune system the spike proteins that stud the coronavirus surface.
A spike protein on its own isn’t dangerous. Bur since it’s foreign, the immune system will develop antibodies against it. Then, if a vaccinated person encounters the SARS-COV-2 virus, those antibodies will be ready to neutralize the spike proteins — along with the rest of the virus particle they’re attached to.
Instead of injecting a person with a real-life spike protein, the vaccines deliver a recipe for making spike proteins inside the body. Human cells follow that recipe after immunization — a process that requires one dose of the J&J/Janssen vaccine and two doses of the Pfizer, Moderna, or AstraZeneca vaccines.
What really differentiates the J&J/Janssen and AstraZeneca vaccines from the other two is the vehicle that delivers its genetic cargo. That vehicle is an adenovirus — a type of virus that can cause cold-like symptoms. The ones J&J/Janssen and AstraZeneca use have been genetically modified so that they can’t copy themselves and make people sick.
Safety monitors have not turned up cases of these rare blood clots in people receiving the Pfizer or Moderna vaccines, which use mRNA technology instead of adenoviruses. The instructions for making the  spike protein are encoded in messenger RNA and protected by a tiny ball of fat.

• Why do women have more reported cases than men up to this point?
Although the true cause(s) of this have yet to be clearly determined, there are two likely contributing factors. First, estrogen is known to increase the risk of blood clotting as demonstrated by the increased chance of women developing a blood clot if they are on estrogen-replacement therapy or oral contraceptives. 
Second, women are more predisposed to many autoimmune conditions. Rheumatoid arthritis, for example, is four to five times more common in women than in men under the age of 50 and continues to be twice as common in women than men in those people diagnosed over the age of 60.

• Will this pause significantly impact the vaccination efforts in the United States?
No. Remember that the federal government has already purchased enough Pfizer and Moderna vaccines to fully vaccinate all Americans by late summer. However, reduced access to the J&J/Janssen vaccine could impact the speed at which all Americans can become fully immune as that occurs two weeks after the single J&J/Janssen vaccine and does not occur until two weeks after the second Pfizer and Moderna vaccination. In addition, the single dose J&J/Janssen vaccine is a good option in getting people with limited access to vaccinations fully protected against COVID-19, including those who are homebound, those with transportation difficulties, and those made more vulnerable by addiction, poverty or homelessness.

• I believe this pause is absolutely correct and very reassuring.
These very rare cases of autoimmune thrombocytopenia were detected and reported within six weeks of the start of widespread J&J/Janssen in the United States. None were reported in the 15,000 recipients in the clinical trials for the J&J/Janssen vaccine as the incidence to date is about one per 1 million vaccinations. I am pleased at the CDC and FDA’s very rapid and correct response. That response reassures me that not only is our national vaccination program working, but that our safety-monitoring system is extremely well designed and working at a very high level.
If you have concerns about the safety of vaccines or have recently received any of the vaccinations and are having worrisome side effects, I urge you to contact your healthcare provider as soon as you can. “DO NO HARM,” a phrase from the Hippocratic Oath that we were all taught in medical school, is the guiding principle of medical care. We are available and extremely motivated to help keep all of you safe from COVID-19 and end this pandemic as soon as possible.
Stay hopeful, stay properly informed, follow the guidelines, stay safe and stay well.

— Dr. Jim Halverson is a longtime Ojai physician who writes a weekly column on COVID-19 for the Ojai Valley News.