Key Messages on Resuming Johnson & Johnson Vaccine
Top-line messages:
● On April 23, CDC’s Advisory Committee on Immunization Practices met to review vaccine safety data on the Johnson & Johnson vaccine. They voted to resume using the vaccine for all adults.
o The use of the vaccine was paused on April 13 after some cases of an extremely rare type of blood clot were reported in people who had received the vaccine.
o The data showed that the benefits of this vaccine outweigh the very small risk.
o People, especially women younger than 50 years old, should be aware of the rare but increased risk of this adverse event.
● This announcement is good news for Minnesotans and underscores the importance that is placed on vaccine safety.
o The pause allowed time for experts to review the data and help make providers and patients aware of the risk so it can be factored into decision making.
o The resumption adds to the number of available vaccines against COVID-19 for Minnesotans.
o Providers now have information they need about this rare event, how to recognize it, and how to effectively treat it.
● Providers have some doses of Johnson & Johnson vaccine on hand that had been distributed before the pause. Providers can begin using that vaccine now.
● We continue to encourage people to get whatever vaccine is available to them.
o Americans are fortunate to have three safe and effective vaccines that are helping get us closer to the end of this pandemic.
What happens next?
● On April 23, CDC and FDA recommended that Johnson & Johnson vaccine start to be used again for all adults.
● The pause allowed time to review data and information to prepare health care providers to recognize and diagnose patients, treat them appropriately, and report cases that may be related to the vaccine. This condition is treatable, but doctors must know how to recognize it, how to report it, and how to treat it. This pause ensured that can happen.
● We will update our information and guidance with the official recommendations from CDC.
● The FDA has updated their fact sheets for providers and patients about the Johnson & Johnson vaccine and to watch for symptoms of this rare clotting syndrome.
● Providers can start using the vaccine again once they have reviewed the updated EUA fact sheet for providers and are prepared to provide the updated fact sheet for patients.
● Orders for Johnson & Johnson vaccine will resume the week of April 26.
● Watch for more information about making appointments for Johnson & Johnson vaccine.
What does the public need to know?
● This announcement is good news for Minnesotans and underscores the importance that is placed on vaccine safety.
● We continue to encourage people to get whatever vaccine is available to them, and that will once again include the Johnson & Johnson vaccine.
● Americans are fortunate to have three safe and effective vaccines that are helping get us closer to the end of this pandemic. To bring that end even closer, it is very important that all eligible Minnesotans get vaccinated. All three vaccines protect you from COVID-19, but they do much more than that. They also protect your family, your friends and your community. They get us closer to the day when we are able to do all those things we’ve missed over the last year plus.
● Reports of adverse events following the use of Johnson & Johnson vaccine suggest an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS). Nearly all reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old.
● This adverse event is rare, occurring at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years and older and men of all ages, this adverse event is even more rare.
● People, especially women younger than 50 years old, should be aware of the rare but increased risk of this adverse event and that there are other COVID-19 vaccine options available for which this risk has not been seen. Talk to your health care provider if you have questions.
What should you know if you already received the Johnson & Johnson vaccine or want to in the future?
● If you received the Johnson & Johnson vaccine more than a month ago, you are unlikely to develop this related condition. Contact your health care provider if you have concerns.
● If you have received the Johnson & Johnson COVID-19 vaccine in the last few weeks, you should be aware of symptoms that occur if clotting develops. Symptoms are likely to occur between 6 days and up to 3 weeks after vaccination and include:
o Severe headache
o Blurred vision
o Abdominal pain that doesn’t go away
o Leg swelling
o Bruising easily
o Shortness of breath
● Contact your health care provider, or go to the emergency room or urgent care if you develop one or more of these symptoms. Let your health care provider know that you recently received Johnson & Johnson vaccine.
● If you experience any adverse events after vaccination, report them to v-safe and the Vaccine Adverse Event Reporting System.
● The FDA fact sheet for patients has been updated, and your health care provider will be able to help discuss the risks and benefits of the vaccine.
What is the health department doing?
● We are committed to safety, and are following CDC and FDA guidance. We will continue to monitor their recommendations and share information with Minnesotans and providers.
● More information will be shared with clinicians, state officials, pharmacies, and other partners about current CDC recommendations for vaccination and how to recognize and treat this rare blot clot disorder.
What is your message to people who may be concerned about receiving a vaccine?
● Health care providers and public health officials at all levels share a commitment to vaccine safety and effectiveness. The recommendation to temporarily pause the use of Johnson & Johnson vaccine from CDC and FDA is a powerful sign of just how strong that safety commitment is.
● The available vaccines for COVID-19 were shown to be highly effective and safe in clinical trials, and the evidence from real-world use backs that up. The clot issue reported with the Johnson & Johnson vaccine showed up in less than seven in a million women age 18-49 years vaccinated with that vaccine, but officials still wanted to pause and make sure doctors and others knew to look out for even such a rare occurrence.
● All that said, it is natural to have questions about any medical issue, including vaccines.
● One of the best things to do with those questions is to talk to a trusted expert like your primary care doctor or other health care provider. They can share information and help you put that information into the context of your own life and circumstances.
Why did health officials pause the use of J&J vaccine?
● Health officials at all levels share a commitment to vaccine safety and effectiveness. The pause was recommended in order for scientists to further evaluate reports of a rare and severe type of clotting syndrome called Thrombosis with Thrombocytopenia (TTS).
● The pause was recommended after six cases were identified. As of April 21, 15 cases of TTS have been identified, including the original six, from the vaccine safety surveillance system.
● While the risk posed from COVID-19 infection far exceeds the risk of the clot issue they found, they brought the information to health care providers and the public as soon as possible. They also called for a temporary pause in the use of the Johnson & Johnson vaccine while they share information with health care providers and determine what other steps should be taken to respond.
What should people do if they had an appointment to receive this vaccine?
● Anyone who had an appointment to receive the Johnson & Johnson vaccine before the pause should have received a notification from their provider about canceling, postponing or rescheduling the appointment. You can now seek an appointment to get the Johnson & Johnson vaccine. Watch for further communications from your provider, or you can look for other vaccine appointments through your local pharmacy, the Find Vaccine Locations Map (https://mn.gov/covid19/vaccine/find-vaccine/locations/index.jsp), and the Vaccine Connector (https://mn.gov/covid19/vaccine/connector/index.jsp).