Johnson and Johnson COVID-19 vaccine restricts by FDA due to blood clots.

Johnson and Johnson COVID-19 vaccine restricts by FDA on Thursday and strictly restricted who could receive Johnson and Johnson’s COVID-19 vaccination because of the threat of rare, but potentially serious blood clots.

The Food and Drug Administration said that the shot should be administered to adults who can’t receive a different vaccine or have specifically requested J&J’s vaccine. U.S. authorities for months have suggested that Americans begin the COVID-19 vaccinations with shots from Pfizer and Moderna vaccines instead.

In December, the Centers for Disease Control and Prevention suggested that people should be given priority to Moderna along with Pfizer vaccines over those of J&J due to security concerns. 

In the past, U.S. officials had given all three vaccines the same treatment as they’d all been proven to provide effective protection.

However, follow-up studies have shown a lower efficacy of J&J’s vaccination. Although blood clots associated with J&J’s vaccine are not common officials claim they’re being seen.

Federal scientists discovered 60 cases, of which nine were fatal in mid-March. It’s one blood clot for every 3.23 million J&J shots that were administered in the US, the FDA announced on Thursday. 

The vaccine comes with an explicit warning of the possibility of “long-term and debilitating health consequences” of the adverse result.

The FDA made its decision based upon “our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.”

Johnson and Johnson
image credit: timesofup.in

The issue of clotting first occurred in the spring of last year, in conjunction with the J&J shot being administered in the U.S. and with a similar vaccine manufactured by AstraZeneca that is being used in many other countries. 

In the meantime, U.S. regulators decided that the advantages of J&J’s single-use vaccine outweighed what was thought to be a rare risk for as long as those who received the vaccine were informed.

Johnson and Johnson COVID-19 vaccine restricts by FDA, Pfizer and Moderna are available

COVID-19 causes deadly blood clots, too. Johnson and Johnson COVID-19 vaccine restricts by FDA for this reason. However, the vaccine-linked type is distinct and is believed to develop as a result of a rogue immunological reaction to J&J or AstraZeneca vaccines due to the way they’re produced. 

It can form in unusual locations such as the veins which take blood out of the brain and in patients who suffer from abnormally low levels of the platelets that create blood clots. 

The symptoms of unusual clots can include headaches that are intense one or two weeks after the J&J vaccination, but not immediately along with nausea and abdominal pain.

A New Brunswick, New Jersey-based company revealed in the last month that it did not expect to make a profit from its vaccine this year, and it was suspending its sales projections.

The launch of J&J’s vaccine was hampered by a string of problems that included manufacturing issues at the Baltimore manufacturing facility which forced J&J to purchase millions of doses of the vaccine from overseas.

In addition, the regulators have added warnings regarding blood clots as well as the rare neurological reaction called Guillain-Barre syndrome.

Pfizer along with Moderna has given the majority of COVID-19 vaccines available in the U.S. More than 200 million Americans have been fully protected by the two-dose shots, while only 17 million Americans received J&J. J&J shots.

The U.S. Food and Drug Administration has imposed a ban on Johnson and Johnson’s Janssen COVID-19 vaccination as an alternative for those who are unable to accept an alternative vaccine from a different manufacturer.

Although the potential advantages of the vaccine are greater than its risks The FDA has announced that it would limit the usage of the Janssen vaccine. 

It will only be available to those who are 18 or older and who are medically ineligible for a different approved vaccine as well as people who possess access to the J&J vaccine and would like to have it according to an FDA announcement.

Researchers at The FDA along with the Centers for Disease Control and Prevention discovered that the vaccine caused sixty confirmed cases of thrombosis that were attributed to thrombocytopenia syndrome. 

This causes extremely rare, but potentially life-threatening blood clots, FDA declared, within a couple of weeks of having received the shot. There are a myriad of vaccines to choose from and a variety of vaccines available, the FDA chose to put off this J&J vaccine, with the intention that it could be considered if other options are not available.

The FDA declares that the advantages of this J&J vaccine outweigh the risk for certain individuals. Some of the people who could be able to receive the vaccine include:

  • Patients who experienced an extreme allergy to an mRNA vaccination like those from BioNTech or Pfizer or Moderna
  • People who have personal concerns regarding the mRNA vaccines would remain unvaccinated if they did not receive the J&J vaccine
  • People who have limited access to Covid-19 mRNA vaccines

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. 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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

“The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”

In excess of 18.7 million doses of the J&J vaccine have been given throughout the U.S. since it was first approved for use in emergencies in the year 2000, according to the Centers for Disease Control and Prevention announced. In all, a number of instances of TTS have been identified and nine deaths have been reported.

In the announcement in the release, the FDA stated “The factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown.” source

The Janssen vaccine rollout was suspended in spring of this year following six cases of rare blood clots that are reported. The pause was lifted several days after and a notice was given to healthcare professionals to keep an eye out for patients who have blood clots that are associated with low blood platelets.

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