U.S. lift paved the way to suspend J & J vaccination and resume shots

File-File on Wednesday, March 3, 2021 In the photo, the pharmacist has a vial of Johnson & amp ;. Johnson COVID-19 Vaccine at a Hospital in Bay Shore, NY Janssen Pharma is a division of Johnson & amp ;. Johnson.  On Wednesday, April 21, 2021, the Food and Drug Administration announced that a major contractor was Johnson & amp; Johnson's COVID-19 vaccine was dirty, did not follow proper manufacturing procedures, and was poorly trained by staff. The vaccine batch was contaminated.  (AP Photo / Mark Renihan)

The hospital pharmacist has a vial of Johnson & Johnson COVID-19 vaccine. (Mark Renihan / Associated Press)

The US Food and Drug Administration and the US Centers for Disease Control and Prevention withdrew the suspension of use of Johnson & Johnson’s COVID-19 vaccine on Friday, paving the way for the state to resume vaccination with a single dose.

This decision was made just hours after the Federal Advisory Committee recommended resuming vaccination with the J & J vaccine, despite the small risk of blood clots.

The CDC Vaccination Advisory Committee voted 10 to 4 to reaffirm the previous guidance on using the vaccine for people over the age of 18.

Safety concerns about injections arose from six rare, severe and complex coagulopathy cases seen in vaccinated individuals. All six cases involved women between the ages of 18 and 48.

The blood clot was abnormal because it was accompanied by dangerously low levels of platelets, a component of the blood clot. This makes it difficult to treat blood clots.

When safety experts returned to review the record of side effects for the J & J vaccine, the first 6 cases increased to 15. All of these cases involved women, all but one under the age of fifty.

Still, the advisory board said the risks were still small. In effect, there are 1.9 cases per million people in the general population, or 7 cases per million women under the age of 50.

The FDA and the CDC science and medical team have agreed that the “known potential benefits” of the vaccine outweigh its “known potential risks.”

“The FDA and CDC are confident that this vaccine is safe and effective in preventing COVID-19,” the agencies said in a joint statement, “we are still wary of continuing to investigate this risk.” Added.

The federal team contacted doctors across the country to confirm that they knew how to recognize and treat a rare coagulopathy called thrombosis-thrombocytopenia syndrome (TTS).

This is similar to what is known as autoimmune thrombocytopenia. This happens when the immune system misfires and produces antibodies to the patient’s own platelets.

A similar reaction to another COVID-19 vaccine produced by AstraZeneca caused the European Union to temporarily suspend its use. Regulators there published 44 reports of vaccine-induced immune thrombocytopenia (VITT) in the 20.2 million doses administered. (The vaccine is not licensed for use in the United States)

Both AstraZeneca and Johnson & Johnson vaccines are needed to recognize and attack the SARS-CoV-2 virus using adenovirus, a common cold bacterium that has removed the ability to get sick. Sends a prompt to the immune system. The J & J vaccine uses human adenovirus. One of the AstraZeneca vaccines comes from chimpanzees.

At a meeting on Friday, the CDC Advisory Committee will clarify that women between the ages of 18 and 50 are “aware” of the risk of coagulopathy and “may choose” another COVID-19. Rejected the plan explicitly requested by. vaccine.

Panel members may appear to require such words to require these women to give explicit consent to take Johnson & Johnson shots, or to carry alternative vaccines to vaccine clinics. Mandated, warning that it may impose logistical and other restrictions that could prevent vaccination.

FDA Grant an emergency use authorization February J & J Vaccine, and Over 8 million times Shown are federal figures that are nationally controlled.

This vaccine is considered a valuable part of the country’s vaccination weapons because it is easier to store and transport than other COVID-19 vaccines. In addition, its single-dose design is ideal for vaccination of difficult-to-reach populations.

Friday’s move, albeit informally, has widespread implications worldwide, as vaccine experts are looking to the world’s toughest regulators to set safety standards in other countries. He said he would give.

When the FDA and CDC first demanded a suspension, public health leaders worried that it would cost more lives than they saved. Especially in poor countries When skepticism about vaccines increases and other vaccination options are limited.

“This will help restore confidence in the vaccine. There is no doubt about it,” he said. Dr. William Schaffner, Vanderbilt University Infectious Diseases Expert.

“The Ministry of Health will pay attention to this action,” he said around the world.

Health officials in Los Angeles County said they plan to resume distribution of the J & J vaccine within a day or two.

Dr. Paul Simon, Chief Science Officer, LA County Public Health Department, said: In the safest way. “

Pfizer-BioNTech and Moderna vaccine supplies remain high and shot demand is slowing, so suspensions do not appear to limit access to the vaccine in LA County, he added.

Whether the members are civilians or not, whether they are chilled by the Johnson & Johnson vaccine, is still unclear, even though the CDC panel claims it is safe to resume shots.

“It’s not yet entirely clear how much this was a setback,” Simon said. “We don’t want to see vaccine shopping. We really want people to get their first vaccine.”

Corey MatthewsThe Chief Operating Officer of the Community Coalition, a South Los Angeles organization that helped set up and operate the vaccine site, said some of the people his group served were hesitant about Johnson & Johnson vaccines, even before the suspension. I said I had it. They considered it a second-rate shot because it wasn’t as effective in clinical trials as the Pfizer and Moderna vaccines. And the publicity about the rare blood coagulation disorder didn’t help.

“We certainly did a bit of a blow to the momentum of vaccination of people, especially those who weren’t originally used to it,” Matthews said.

However, the J & J vaccine was especially praised by those who appreciated the simplicity of its single dose.

“Some people just don’t like needles,” he said. “I am grateful for the immediate resurrection.”

Times staff writers Colleen Shalby, Emily Baumgaertner and Deborah Netburn contributed to this report.

This story was originally Los Angeles Times..