Johnson & Johnson Covid-19 Vaccine 

FDA Places Strict Limits On Johnson & Johnson Covid-19 Vaccine 

The US Food and Drug Administration (FDA) announced last week that it is limiting the emergency use authorization of the Johnson & Johnson Covid-19 vaccine for individuals 18 and older. The vaccine is now available for adults who don’t have access to other vaccinations and for adults who aren’t able to receive the other Covid-19 vaccine for personal medical reasons. 

The FDA released a statement in which they detailed the changes and why they’re being made. They explained that the change is being implemented due to the rare risk of a dangerous clotting condition known as thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine. 

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“We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. 

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

The agency also confirmed that the updated authorizations apply to booster doses as well. The FDA also emphasized that the benefits of the J&J vaccine outweigh the risks for certain individuals as well. 

In their statement, they wrote that individuals who had a severe allergic reaction to an mRNA vaccine (Pfizer or Moderna), have personal concerns over mRNA vaccines, or don’t have access to mRNA vaccines should definitely receive the J&J jab. 

According to the US Centers for Disease Control and Prevention, more than 18.7 million doses of the J&J vaccine have been administered in the US, and of all the Americans who are currently fully vaccinated, about 7.7% got the J&J vaccine. 

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The CDC’s vaccine advisory committee issued their own statement on Johnson & Johnson’s vaccine, saying it “makes a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged  ≥ 18 years in the United States.”

Both the CDC and FDA have made these statements mainly due to TTS concerns. When rare clotting events began appearing in the initial periods of vaccination in the US, Johnson & Johnson made a statement emphasizing their commitment to giving Americans a safe and effective vaccine. 

“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. … 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 FDA released data that showed around 60 cases of TTS since the J&J vaccine began its distribution, nine of those unfortunately were fatal. 

The FDA emphasized, however, that the risk for TTS is extremely rare. Current data shows that there’s about three cases of TTS for every million doses administered. 

Symptoms of TTS can appear within one to two weeks after vaccination, and they include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like headaches or blurred vision, and red spots appearing under the skin at the site of vaccination.