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COVID-19 Status Update for 05/06/2021

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Johnson & Johnson Vaccines

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Message on Johnson & Johnson vaccines:

April 23, 2021: Today, both the CDC and FDA approved continued use of the Johnson & Johnson (J&J) vaccine after extensive review by the Advisory Committee on Immunization Practices’ (ACIP).  Marin County Public Health is making plans to resume use of the Johnson & Johnson vaccine once the Western States Scientific Safety Review committee completes its own evaluation.  We concur with ACIP’s findings that the benefits of the J&J vaccine far outweigh the risks and that we can continue to administer this life-saving vaccine safely.

To date, Marin County Public Health has administered just over 1,000 doses of the J&J vaccine to Marin residents with no reported cases of blood clots. This type of adverse reaction is extremely rare with 15 reported cases nationwide out of 6.8 million doses administered.  COVID-19 vaccine safety is a top priority for us. We will continue to monitor the situation and look to the CDC for any additional future guidance. 

The J&J vaccine is a valuable tool in our vaccination toolkit for reaching our highest risk populations where administering a two-shot regimen may be challenging.  In addition, many Marin residents have requested the J&J vaccine because of the “one-and-done” ease of the product.  While we do not have sufficient supply on hand to offer immediate, wide-spread access to the J&J vaccine, we look forward to offering it to our residents very soon.   In the meantime, please review our frequently asked questions for more information about the J&J vaccine.

The public is encouraged to get vaccinated as soon as possible. All vaccines are proven to be highly effective at preventing hospitalization or death from COVID-19. The longer you wait to get vaccinated, the greater the risk of contracting COVID-19.


Frequently Asked Questions

 

Q. What is happening with Johnson & Johnson vaccines? 

A.  The CDC has approved continued use of the Johnson & Johnson (J&J) COVID-19 vaccine, effective April 23.  Previously, distribution had been temporarily "paused" on April 13 after a handful of reported cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. 

Out of an abundance of caution, both CDC and FDA recommended the pause in order to gather more data about the people who had developed the clotting, to identify additional cases, and to speak with health care providers about the best course of treatment. At no time has the CDC or FDA indicated the J&J vaccine was banned from use.

Currently, Marin County Public Health is awaiting for final approval from the California Department of Public Health's Western States Scientific Safety Review committee to complete its own evaluation.  Once that is obtained, Marin Public Health will resume use of the J&J product in Marin County.

 

Q. Who decided it was okay to resume distribution of the Johnson and Johnson vaccine?

A. CDC's Advisory Committee on Immunization Practices (ACIP) -- which includes doctors, public health experts, state leaders and federal officials-- reviewed the potential significance of the cases and performed a rigorous evaluation of the J&J vaccine. CDC cited that of the 8 million people in the U.S. that have received the vaccine, only 15 have been diagnosed with the rare blood clots, making this an extremely rare occurrence.   As a precautionary measure, the FDA will update the label for the vaccine, indicating that women under the age of 50 with low platelet levels should be aware of the potential risk of a rare blood clotting syndrome.

In addition, the California Department of Public Health's Western State’s Scientific Advisory Committee is also reviewing the cases and is expected to soon endorse continued use of the vaccine.

 

Q. Where can I find a Johnson & Johnson COVID-19 vaccine

A. It may take a few days for the "paused" supplies of vaccine to be available at vaccine distribution points. Please check with your local pharmacy to see if they are providing J&J and when appointments for the J&J vaccine will be available.   You can review a list of all vaccine suppliers in Marin county on our vaccine appointment webpage.

 

Q. I am a woman under the age of 50. Should I be concerned about receiving a Johnson & Johnson vaccine?

A. Anyone of any gender or any age should make an informed decision about which vaccine is right for them. Women under the age of 50 with low platelet levels should be aware of the potential risk of a rare blood clotting syndrome and talk with their doctor to determine if a J&J vaccine is the best personal choice over an available Pfizer or Modera vaccine. 

The risk of developing the rare clotting disorder is extremely low. According to the CDC, to date there have been only 15 confirmed cases of the rare clotting event among nearly 8 million total doses administered in the USA, all in females, which translates to a risk of about 2 cases per million doses overall, and 7 cases per million doses among women between 18 and 49 years of age. 

For those who have a confirmed case of COVID-19, the risk of dying from it in the United States is 1 in 56.

 

Q. I received the Johnson & Johnson vaccine. Will I get blood clots or have other adverse reactions? 

A. Everyone reacts to vaccine differently, but adverse reactions are very rare. Both the CDC and FDA state that blood clots are an extremely rare reaction.  There have been more than 6 million doses nationally of the Johnson and Johnson vaccine administered in the U.S. and only 6 reported cases. To date, no severe adverse reactions have been reported among those that received the vaccine in Marin.   

  • For people who got the vaccine more than a month ago, the risk to them is very low at this time. 
  • For people who recently got the vaccine—within the last few weeks—they should be aware of any symptoms.  
  • If you have received the vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath, they should contact their healthcare provider and seek medical treatment. It is important to note these symptoms are different from the common mild flu like symptoms many experience shortly after receiving a vaccination. 

 

Q. Who is being affected by these blood clots? 

A. So far, blood clots have been reported by women between the ages of 18 and 48 and symptoms emerged between 6 and 13 days after vaccination. However, it is too soon to say if there is a particular subgroup is more likely to experience these severe side effects. 

 

Q. What kind of blood clot is this? 

A. The FDA says the clots are a rare and severe type called cerebral venous sinus thrombosis or CVST, and it is being seen in combination with low levels of blood platelets (a condition called thrombocytopenia).

 

Q. How is this treated? 

A. 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. 

 

Q. What are the warning signs that I may have developed a blood clot after receiving the Johnson & Johnson vaccine? 

A. Those who have developed severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider.  It is important to note these symptoms are different from the common mild flu like symptoms many experience shortly after receiving a vaccination. 

 

Q. If blood clots are such a rare reaction, why was use of the Johnson & Johnson vaccine paused? 

A. The temporary pause in the use of the J&J vaccine was because this type of blood clot was not listed on the list of potential adverse side effects that were part of the emergency use authorization for J&J. This pause was being made out of an abundance of caution, to give health care providers time to know all the potential adverse effects and how best to treat them.  
 

Q. How do I track or report side effects?  

A.  After receiving their first vaccination, all vaccine recipients –whether Pfizer, Moderna or Johnson & Johnson – should enroll in V-Safe and begin tracking their daily symptoms, even if they are mild. V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. Through v-safe, you can quickly tell CDC if you have any side effects after getting a COVID-19 vaccine. Depending on your answers to the web surveys, someone from CDC may call to check on you and get more information. However, v-safe does not provide medical advice. If you have symptoms or health problems that concern you at any time following COVID-19 vaccination, please contact your healthcare provider or local medical clinic.  Alternatively, you can report to VAERS

 

Q: Did the pause in J&J vaccinations impact the pace of vaccine administration?

A: No, this pause did not affect Marin County's vaccination efforts.  At the time the J&J vaccines were paused, they made up less than 3% of Marin's cumulative (since December) allocation.  Marin County pivoted and provided Moderna or Pfizer vaccines where J&J had previously been offered.  No appointments had to be cancelled, although patients were given the option to reschedule if they preferred to receive J&J over an alternative.

 

Q: These vaccines have been promoted to communities as “one and done.” What is your message to these communities who trusted the public health leaders and may be concerned about their health in light of this news? 

A:  We are excited to see this safe and effective vaccine available to the public once again. Many statewide public health leaders including Dr. Mark Ghaly, secretary of the California Health and Human Services Agency,  and Dr. Matt Willis, Marin's Public Health Officer, have received the Johnson & Johnson vaccine, and it has been shown to be overwhelmingly effective and safe.  Everyone should continue getting their vaccines so we can end the COVID-19 pandemic and get closer to a sense of normal.

 


 

Original statement: issued by Marin Public Health on April 13, 2021.

Marin County Public Health has paused local use of the Johnson & Johnson (J&J) vaccine at the request of U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) following a report of six cases of a rare type of blood clot in individuals who received the J&J COVID-19 vaccine. We will safely store all available J&J supply until FDA and CDC conclude their investigation of the product.

In Marin County, J&J COVID-19 vaccine doses account for less than 3% of our cumulative vaccine allocation. The temporary halt will mainly impact our mobile operations, where J&J’s one dose increased vaccination capacity. Starting today, mobile teams will resume using Pfizer and Moderna to continue our efforts to vaccinate harder to reach groups.

We have experienced a “pause” once before, when on January 17, the California Department of Public Health (CDPH) issued an advisory to pause administration of a specific lot of the Moderna COVID-19 vaccine after some adverse reactions were observed at a vaccine site in Southern California.  In that event, all Marin County vaccine providers held unused Moderna doses until they were given the “all clear” to safely resume use from CDPH about one week later.

We are encouraged to see that the vaccine monitoring and surveillance systems are functioning as intended to ensure the safety of all vaccine recipients across the U.S.  While CDC and FDA investigate these cases carefully, we encourage everyone who is eligible to continue pursuing either a Pfizer or Moderna vaccine. The COVID-19 vaccine remains a safe and powerful tool in our COVID-19 pandemic-ending toolkit, along with wearing a mask, watching your distance and washing your hands frequently.