Pause of J&J Vaccine

VA has temporarily paused administration of the Johnson & Johnson COVID-19 vaccine based on CDC and FDA recommendations. VA Puget Sound is still offering Moderna and Pfizer vaccines, in which similar events have not been noted. Those scheduled for Johnson & Johnson will be rescheduled to either receive Moderna or Pfizer. You can learn more about guidance on the Johnson & Johnson pause by visiting the FDA website.

All health care eligible Veterans can call 206-716-5716 to schedule your vaccine. 

Newly eligible individuals under the SAVE LIVES Act can sign up for the vaccine by visiting the vaccine information page on va.gov

For information about vaccinations at VA Puget Sound, please visit our website at www.pugetsound.va.gov and visit www.va.gov to sign up for regular updates.

Here are some answers to frequently asked questions:

Why has the VA paused the used of the Janssen (Johnson and Johnson) COVID-19 vaccine?

On April 13, 2021, CDC and FDA recommended pausing use of the Janssen COVID-19 vaccine while they investigate reports of rare and serious blood clots called cerebral venous sinus thrombosis (CVST) in vaccine recipients: https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html.  

Out of an abundance of caution, VA has paused the used of this vaccine.

Why did the CDC and FDA make this recommendation?

The CDC and FDA closely watch all new vaccines for side effects. When serious side effects are reported by patients and health care providers, the CDC and FDA look closer to see if the side effected is related to taking the vaccine. Currently, CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

How many people have been given the Janssen (Johnson and Johnson) COVID-19 vaccine in the US and at the VA?

According to Centers for Disease Control and Prevention (CDC), in the United States, as of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S.

As of April 13, 2021, just over 100,000 persons had been given the Janssen vaccine from VA. https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary. There have not been events of CVST reported in patients vaccinated with Janssen vaccine by VA at this time, and further review is ongoing. 

Has the VA seen any cases of CVST?

CVST has not been reported in patients vaccinated with the Janssen (Johnson and Johnson) COVID-19 vaccine by VA at this time.What is CVST?

CVST, or Cerebral venous sinus thrombosis, happens when blood clot forms in the brain’s venous sinuses (type of blood vessel). This can cause symptoms including headache, vision changes, or symptoms of a stroke.

What are symptoms of CVST?

CVST may be suspected in patients who present with:

• New onset headache
• Headache that is different from the usual symptoms (for example, change in character or severity, and may occur 7 or more days after vaccine)
• Encephalopathy (acting confused or not like one usually acts)
• Signs or symptoms of intracranial hypertension (severe headache, visual changes)
• Focal neurologic symptoms and signs, or neurologic symptoms involving multiple vascular territories (like weakness, trouble speaking, or seizures)Diagnosis of CVST is via urgent neuroimaging with brain MRI and magnetic resonance (MR) venography, or with cranial CT with CT venography if MRI is not an option.

 

What should I do if I have symptoms of CVST?

Contact your health care provider if you have symptoms.

If your symptoms are severe, call 911.

 

How many people have been given the Janssen vaccine from VA?

As of April 13, 2021, just over 100,000 persons had been given the Janssen vaccine from VA.

This information is publicly reported here: https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary.

There have not been events of CVST reported in patients vaccinated with Janssen vaccine by VA at this time, and further review is ongoing.

 

Can non-Veterans and Veterans covered under the Save Lives Act receive health care from VA for a side effect experienced after a COVID-19 vaccine?

Yes. 

I received the Janssen (Johnson and Johnson) COVID-19 vaccine and am now worried. What do I need to know?

CVST events have been very rare. The CDC and FDA have been actively monitoring for possible reactions related to COVID-19 vaccines, and reported 6 cases in 6,800,000 doses. The events that did occur were in the first two weeks after receiving the Janssen (Johnson and Johnson) COVID-19 vaccine so persons who received the vaccine more than two weeks ago would be considered even less likely to have this happen. If you received the vaccine in the last 2 weeks and think you may have symptoms of CVST [listed above] please contact your health care team or call 9-1-1 if symptoms are severe.

Will I still be able to get a COVID-19 vaccine from VA?

There two other COVID-19 vaccines that are still available at VA. VA will offer these vaccines as a temporary replacement for the Janssen (Johnson and Johnson) COVID-19 vaccine until more is known about the safety of the Janssen vaccine.

I really wanted to get the Janssen (Johnson and Johnson) COVID-19 vaccine from VA

We understand that changing from a single dose to a two-dose vaccine may affect your plans significantly. However, we are highly committed to the stringent safety measures in place for COVID-19 vaccines under emergency use authorization.

VA will continue to carefully follow the FDA and CDC for guidance on the safety of all COVID-19 vaccines. The FDA and CDC review may find that the cases of CVST are linked to the vaccine or that they are not. VA will restart using the Janssen (Johnson and Johnson) COVID-19 vaccine if the FDA and CDC recommends the vaccine for use after their review.

Are there other symptoms that I should contact my health care team about?

Any potential significant side effect to any COVID-19 vaccine should be reported to your health care team. This is important for your health and is also critical for ongoing safety monitoring of the COVID-19 vaccines under emergency use authorization.

• Cases of unusual blood clots with low platelets have occurred in people who received the Janssen COVID-19 vaccine. Similar cases were seen in another type of COVID-19 vaccine not in use in the United States.
• The chance of having this occur is very low, but being aware of symptoms can help you get prompt medical treatment and avoid complications.
• You should seek urgent medical attention immediately if you have any of the following symptoms in the weeks following your Janssen COVID-19 vaccine:
• shortness of breath
• chest pain
• leg swelling
• persistent abdominal (belly) pain
• neurological symptoms, such as severe and/or persistent headaches or blurred vision
• tiny blood spots under the skin beyond the site of the injection.
• Speak to your healthcare professional if you have any questions about new symptoms or about the Janssen COVID-19 vaccine.
  

Have similar events been seen with the other COVID-19 vaccines VA is using?

CVST has not been observed in the other vaccines in use in the United States, namely the Pfizer-BioNTech and Moderna COVID-19 vaccines. Both of those vaccines are mRNA vaccines, which is a different type of vaccine than the Janssen COVID-19 vaccine.

Have similar events been seen with any other COVID-19 vaccine?

Yes, the combination of CVST and low platelets has been observed with the AstraZeneca COVID-19 vaccine, which is not currently authorized for use in the United States. The following link is a press release regarding events that occurred in recipients of the AstraZeneca vaccine. While this is a different vaccine from the Janssen COVID-19 vaccine, both are vaccines of the same type (adenovirus viral vector vaccines) https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

For the AstraZeneca vaccine, out of 25 million people who received vaccine, there were 62 cases of cerebral venous sinus thrombosis (CVST) and 24 cases of splanchnic vein thrombosis (clot in a vein that helps drain the digestive system). These cases were reported to the safety reporting systems in the EEA and UK.

Should I avoid taking any COVID-19 vaccine for now?

No. Currently, reported events from the Janssen COVID-19 vaccine are rare. Similar events have not been reported with the other FDA-authorized COVID-19 vaccines, which have been safely administered to millions of people in the United States. The pause in use of the Janssen vaccine is a good example of the intensive safety monitoring and proactive intervention from CDC and FDA.

Getting a COVID-19 vaccine adds one more layer of protection against infection for you, your families and friends, and our staff who care for you.We continue to prioritize Veterans at high risk, who are older, have existing health problems, those living in nursing homes or other group living facilities. And we continue to work with our equity and special populations teams to identify Veteran populations who may not be able to come in for their vaccines and to those who may be hesitant to get the vaccine. It is important to understand that we need to vaccinate the most vulnerable Veterans first, so if you are healthy and younger, you may be scheduled further out.

• While there is significant debate around the possibility of delaying second dose vaccines across the nation, we continue to follow Centers for Disease Control and Prevention recommendations. Additionally, Veterans are encouraged to get their second vaccine dose at the same place they received their first dose.
• If you are receiving a second dose vaccine, please bring in your COVID-19 Vaccination Record Card. And for your own safety, please don’t take selfies showing the card as it features your full name and birth date.
• Veterans must be health care eligible to be scheduled for vaccination, but do not need to be enrolled in primary care/Patient Aligned Care Team.
• If you are eligible to get a vaccine earlier than what we can offer, here’s the link to the Washington state Department of Health website—https://www.doh.wa.gov/YouandYourFamily/Immunization/VaccineLocations. Use the “phase finder” tool to determine eligibility and to be notified when residents become eligible.

 Patient and staff safety remain paramount, and our rigorous safety measures remain in place:

• 100% screening of patients and visitors for signs of COVID-19 infection.
• 100% use of approved face masks for everyone entering and inside any of our care sites (if you don’t have one, we will provide you with one; no medical waivers).
• 100% physical distancing.
• No walk-in patients outside of emergent care needs.
• No routine visitors.
  • Inpatient Visits:
    • Exceptions must be coordinated with your care team in advance.
    • Visits 30 minutes or less unless care team believes longer visit is in  best interest of the patient.
  • Outpatient Visits:
    • Patients can bring one person as an escort for navigation assistance or to provide care support.
    • Visitor must stay with the patient throughout visit unless specified otherwise by the health care team.
  • Approved Visitors:
    • Must be approved by care team in advance of visit.
    • Must be at least 18-years-old.
    • Must adhere to all safety measures.
    • Must use hand gel when entering and exiting a care area.
    • Are not allowed in the room during aerosol-generating procedures.
• No visitors under 18 allowed, with one exception: American Lake’s Child Care Center.
• Do not leave unaccompanied minors outside during your visit.
• 100% environmental cleaning recommendations as outlined by the CDC.
• Chapel services at Seattle campus (maximum seating capacity is 25%): Catholic Mass (Tuesdays, Thursdays & Sundays) at 12:15 p.m. and Protestant Services (Sundays) at 10 a.m.
  
• Onsite dining in our Canteens (maximum seating capacity is 25%).

Questions?

• Veterans with questions about COVID-19 or vaccination should call 1-800-myVA411 or (1-800-698-2411). press 8 for COVID information or visit www.va.gov/health-care/covid-19-vaccine/
• Veterans seeking additional information should visit the VA Coronavirus Vaccine FAQs webpage. 
• VHA Keep Me Informed which allows Veterans to sign up to receive email updates: https://www.va.gov/health-care/covid-19-vaccine/stay-informed

You can also get updates on social media: https://www.facebook.com/vapugetsound and https://twitter.com/VAPugetSound. If you would like to receive automated updates via email, please sign up with your email address on our website - https://www.pugetsound.va.gov/index.asp - look under the social media icons on right for "Subscribe to Receive Email Updates."

We also continue to maximize personalized virtual care options. We know these services have been a valuable link to our Veterans during this challenging time, providing increased access to care regardless of where you live. Here are some examples of ways you can access care from home:

• Telephone or Video Appointments: Receive care at home—either over the phone or via video using VA Video Connect on your computers, smartphones or tablets. To set up virtual appointments, send your health care team a secure message on My HealtheVet by visiting myhealth.va.gov. While Veterans may also call us at 1-800-329-8387, VA is requesting that Veterans only call with urgent needs at this time.
• Prescription Refills: Veterans can request prescription refills, order and ship medications home using My HealtheVet or Rx Refill mobile app. Download the app at mobile.va.gov/app/rx-refill.
• Secure Messaging: With a free My HealtheVet Premium account, Veterans can send secure messages to their health care team online to ask non-urgent health questions, request referrals and send updates about medical conditions. Other tools and services available to Veterans with the Premium account include, ability to access health records, view military service information and ability to join video visits using the VA Appointments tools. There are two ways to register, online or in-person at a VA facility. With the threat of COVID-19, the in-person option has been suspended.

To upgrade online using a VA HealtheVet sign-in partner (DS Logon and ID.me), follow these steps: From the My HealtheVet sign in page, sign in to your Advanced My HealtheVet account using a sign-in partner. Select the Upgrade Now button. Check the certification box to verify account owner. Select Continue. Check the Accept My HealtheVet Terms & Conditions box. Select Continue to complete the upgrade.