TERRE HAUTE, Ind. (WTHI) - Sites supported by federal vaccine allotments immediately stopped giving the Johnson and Johnson vaccine for now after reports surfaced of complications with the vaccine on Tuesday. However, it’s up to individual states to make the decision because they are given a separate allocation of doses.
Indiana State Department of Health’s Chief Medical Officer Dr. Lindsay Weaver spoke to the media on Tuesday morning. She says the state is following the federal agencies in pausing the Johnson and Johnson vaccine. State health officials have notified all vaccine providers of this recommendation.
STATEMENT FROM THE VIGO COUNTY HEALTH COMMISSIONER
The FDA and the CDC today recommended a pause in the continued administration of the Johnson & Johnson CoVID 19 Vaccine in the US, amidst reports of six cases of a rare blood clotting issue seen in younger women who received the vaccine. More than 6.8 million doses of the vaccine have been administered thus far. The recommendation is no more than a usual precaution being taken as the individual cases are studied in further detail. The blood clotting issue being studied are called cerebral venous sinus thrombosis, a serious disorder of clots in the collecting veins of the brain.
While these cases are alarming, it is imperative to recognize the natural incidence of this disorder is around 0.5 cases per 100,000 people on average, or 1 case per every 200,000 population essentially. That is roughy 5 natural cases per 1 million population. The natural cases are 3 times more likely in females than male, and often follow with estrogen-containing birth control pills and or recent pregnancy, all of which increase the relative likelihood of blood clots. There have been six case reports within 3 weeks of receiving the vaccine thus far, following 6.8 million doses, an incidence of roughly 1 in 1.1 million vaccine recipients. The incidence, therefore, is much less than the usual natural incidence of the disorder. Much of the details about the six reported individual cases are not yet widely known, but are being fully investigated by the FDA’s Center for Biologics Evaluations and Research.
At this time there is no clear conclusion to be drawn the vaccine caused these events, but an abundance of caution is being followed to fully explore the potential role that receiving the vaccine may have played in the development of these clots. Similar concerns of blood clotting issues have been reported in the UK with the Astra Zeneca vaccine, which has not yet received emergency use authorization in the US (as no formal request has been submitted to date). The platforms for these two vaccines are similar, which likely adds to the concern of these cases within the J&J recipients. The call to action to pause the distribution comes a wise step to insure every possible safety precaution is being followed with the vaccine rollout. The action of the FDA and CDC should be taken as a comfort, and not as an outward warning alarm.
Symptoms of blood clots can range from pain and swelling of the legs or upper extremity (typically one extremity), severe abdominal pain, intractable headaches, unexplainable neurological complaints such as visual disturbances or disequilibrium, and or selling in the neck veins. Anyone who has already received the J&J vaccine should immediately seek emergency medical attention should they experience any of these symptoms, or speak with your medical provider regarding any concerns.
Please remember these cases are exceedingly rare, as in 0.00008% of the vaccines administered in the US to date. In fact, a person is 2.5 times more likely to be struck by lightning than to experience this potential, unproven, side effect. Moderna and Pfizer vaccines (mRNA platforms) remain readily available. Anyone previously scheduled to receive a J&J vaccine should be encouraged to register and receive either of these two other two vaccines. The CoVID 19 vaccines are SAFE and highly effective in protecting the population from the ill effects of the virus. Deaths and serious health outcomes have plummeted within the vaccinated population. In sharp contrast, the surges in recent hospitalizations are mostly younger and unvaccinated individuals. The vaccines WORK, and side effects of any kind, are unbelievably rare. Please stay encouraged, and encouraged those around you, to seek out a vaccine of your choosing very soon. Vaccination is the way through the pandemic, and to a path of normalcy for us all very soon.
Darren Brucken, MD
Vigo County Health Commissioner
Tuesday morning, the Indianapolis Motor Speedway vaccination clinic shifted immediately to offering the Moderna vaccine. People scheduled on Tuesday were notified, and 95% of them still went ahead and got vaccinated. That, of course, is with a two-shot vaccine.
Weaver says the state is still figuring out details on where individuals can get that second dose 28 days after the first. She says to keep in mind that this is a very, very rare occurrence. Six cases of blot clots surfaced of the 6.8 million doses of the Johnson and Johnson vaccine that have been administered.
The Federal Advisory Committee for Immunization Practices will meet on Wednesday. The state is waiting to get more information on a course of action in the coming days.
Weaver says this is exactly how the process is supposed to work. This is why the state reports adverse events. She says you should still definitely get a Pfizer or Moderna vaccine as soon as possible.
“We really need people to get vaccinated by whichever vaccine they have available to them,” Weaver said, “We are seeing an increase in our cases. We are watching closely for hospitalizations. We know the variants are here in Indiana and across the country.”
Illinois is also pausing the use of the Johnson and Johnson vaccine. The state notified all providers to discontinue using the vaccine for now. The state wants providers to switch to the Pfizer or Moderna vaccines in order to keep appointments. Those two vaccines make up the vast majority of does on-hand.
Local and state health departments will be communicating changes for patients. Here’s a look at the direction Wabash Valley Health Departments are going:
Vigo and Knox Counties say they are following Indiana’s recommendation. Both of those counties will be pausing Johnson and Johnson vaccines.
Parke, Clay, Daviess, and Martin Counties said that they had not been receiving Johnson and Johnson vaccines to begin with. They only offer the Moderna vaccine. As for Vermillion, Sullivan, and Greene Counties, News 10 did not hear back from them.
Dr. Weaver did offer guidance for those who have recently received the Johnson and Johnson vaccine.
“I think that they can be rest assured that this seems to be extremely rare,” Weaver said, “However if you do develop a headache, shortness of breath, or chest pain in the three weeks after you got your vaccine then yes, you need to seek healthcare and talk to your healthcare provider.”
“I just want to assure people that this is part of the process: Having these pauses, taking these recommendations, and making plans to move forward,” Weaver concluded, “Getting vaccinated is so, so important. We still have a long way to go in Indiana to get as many people vaccinated as we like.”
Weaver says all vaccine clinics in the state can shift easily to offering the Pfizer or Moderna vaccines.
Johnson & Johnson released the following statement:
"The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.
We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.
The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."