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5 things we know about Johnson & Johnson's covid-19 vaccine

2022-05-06T09:41:56.237Z


The FDA has warned that Johnson & Johnson/Janssen's COVID-19 vaccine carries the risk of causing a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS).


Related video: Johnson & Johnson vaccine paused: should I worry if I have it?

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(CNN) --

The US Food and Drug Administration (FDA) warned Thursday that Johnson & Johnson/Janssen's Covid-19 vaccine carries the risk of generating a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) that can occur after receiving the vaccine.

The FDA will then limit the emergency use authorization of the Janssen vaccine to those who are 18 years of age or older and for whom other vaccines are not appropriate or accessible and those who choose J&J because they would not otherwise be vaccinated.

This is what we know.

1. Why will Johnson & Johnson's vaccine be limited?

The FDA warned this Thursday that after strict surveillance of the J&J covid-19 vaccine, it observed the appearance of thrombosis with thrombocytopenia.

Dr. Peter Marks, director of the FDA's Center for Biological Evaluation and Research, said they are reviewing updated information from surveillance systems and that the emergency use authorization of this vaccine will be limited.

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Emergency Use Authorization is when a medical product gets special authorization from the FDA to be used during an emergency.

Sometimes it's a product that the FDA has already approved for another condition, and sometimes it's a new product that hasn't yet received the green light from the agency.

"We recognize that Janssen's COVID-19 vaccine continues to have a role in the ongoing response to the pandemic in the United States and throughout the global community...Today's action demonstrates the strength of our safety surveillance systems." and our commitment to ensuring that science and data guide our actions."

The agency confirmed to CNN that the updated authorization also applies to booster doses.

The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks for certain people.

Study: High Efficacy of Two Doses from Johnson & Johnson 0:34

2. Who can continue to get vaccinated with this J&J vaccine?

The FDA recommends that certain types of people preferentially access this vaccine.

  • Those who have had a severe allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna

  • Those with personal concerns about mRNA vaccines who would remain unvaccinated if J&J's vaccine were not available

  • Those with limited access to covid-19 mRNA vaccines

As of Thursday, more than 18.7 million doses of the J&J vaccine have been administered in the United States, according to the CDC.

The agency's updated analysis of the vaccine includes cases reported to its Vaccine Adverse Event Reporting System (VAERS) database through March 18.

3. What is the risk of developing thrombosis with thrombocytopenia?

In an updated fact sheet on the vaccine, the FDA states that 15% of TTS cases have been fatal.

60 cases of TTS have been confirmed, including nine deaths.

In general, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered.

The highest rate of TTS has been in women 30 to 49 years of age.

About eight cases per million doses of vaccines administered have occurred in women in this age group.

TTS cases usually begin one to two weeks after vaccination.

Symptoms include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms such as headaches or blurred vision, or red spots just under the skin called petechiae away from the site where the vaccine was received.

  • FDA warns people with a history of certain blood clots to avoid Johnson & Johnson's vaccine

Johnson & Johnson vaccine: these are the symptoms of a rare case of blood clots 1:24

4. Is this alert new?

Not at all.

From the beginning, J&J's vaccine supply was more limited.

After the vaccine was licensed, the federal government briefly suspended its use due to safety concerns around rare blood-clotting events.

Even once vaccinations resumed, the pace of J&J vaccinations never picked up.

This time the FDA said it will put limits on the vaccine.

But as early as December 2021, the FDA had warned that people with a history of a rare type of blood clotting should avoid getting Johnson & Johnson's Covid-19 vaccine.

The fact sheet from December last year says that people who have had a severe allergic reaction after a previous dose of this vaccine or a blood clot along with a low platelet level should not receive the Janssen covid-19 vaccine ( blood cells that help your body stop bleeding) after receiving this vaccine or the one from AstraZeneca (not licensed or approved in the United States).

The CDC's vaccine advisory committee cited the same concerns about thrombosis with thrombocytopenia syndrome.

Both the CDC and the FDA previously recommended a pause in the use of this vaccine due to reports of TTS.

But then the agencies agreed to lift the pause in April 2021 after a comprehensive search turned up just 15 cases of the rare blood-clotting syndrome among nearly 8 million people who had received the vaccine.

5. What about the efficacy of the covid-19 vaccine?

While the new warning in the vaccine information sheet says "The Janssen Covid-19 vaccine may cause life-threatening thrombosis with thrombocytopenia (TTS)," a recent study revealed that the J&J remains durable and effective, even despite the spike in cases caused by the delta variant.

The vaccine was 76% effective overall in preventing COVID-19 infections and 81% effective in preventing COVID-19-related hospitalizations.

The study also showed that it provided lasting immunity for at least six months after the injections.

And a CNN analysis of data compiled by the US Centers for Disease Control and Prevention (CDC) showed that the J&J vaccine had the lowest rate of post-vaccination infections of all vaccines since the week ended. on December 25, the last five weeks of data available.

In January, during the omicron wave, post-vaccination infections were highest among those who received the Pfizer/BioNTech vaccine, followed by those who received the Moderna vaccine.

People vaccinated with the Johnson & Johnson vaccine had the lowest incidence of post-vaccination infections.

In the week ending January 22, there were 650 infections per 100,000 people with the J&J vaccine.

With Moderna, there were 757 per 100,000, and with Pfizer, the rate was 862 per 100,000.

-- With reporting from CNN's Katherine Dillinger, Deidre McPhillips, Jen Christensen, Maggie Fox and Sandee LaMotte-

covid-19vaccine against covid-19

Source: cnnespanol

All news articles on 2022-05-06

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