The US recommends pausing J&J recordings that affect vaccination drive – WISH-TV | Indianapolis News | Indiana weather

  The US recommends pausing J&J recordings that affect vaccination drive - WISH-TV |  Indianapolis News |  Indiana weather

WASHINGTON (AP) – The US on Tuesday recommended a “break” in the use of the Johnson & Johnson COVID-19 single-dose vaccine to investigate reports of rare but potentially dangerous blood clots, start a chain reaction around the world and cause a backlash the global vaccination campaign.

The Centers for Disease Control and Prevention and the Food and Drug Administration announced that they are investigating unusual blood clots in six women between the ages of 18 and 48 years. One person died.

The acting FDA commissioner expected the hiatus to only last a few days. However, the decision sparked swift action in Europe and elsewhere as the drug manufacturer, regulators and vendors stopped using the J&J vaccine, at least for the time being.

J&J said in a statement that it was aware of reports of blood clots but that it had not been linked to its vaccine. However, the company announced late Tuesday that it would be delaying the rollout of its vaccine in Europe and suspending new vaccinations in its ongoing studies until it can update its guidance on how to proceed.

Hundreds of thousands of doses should arrive in European countries where vaccinations have been plagued by supply shortages, logistical issues and blood clot concerns in a small number of people who received the AstraZeneca vaccine, which is not yet approved for use in the US

Slowing down the spread of the gunshots could have far-reaching implications for global vaccination efforts. The J&J vaccine showed immense promise as its single dose and relatively simple storage requirements would make it easier to use, especially in less affluent countries.

The clots that appeared in veins that drain blood from the brain six to 13 days after vaccination occurred along with low platelets, the fragments in the blood that normally form clots.

In the United States, more than 6.8 million doses of the J&J vaccine have been administered, the vast majority with no or minor side effects.

“We know there are a lot of critics who say, ‘Why? It’s just a couple of cases. Why don’t we just move on? “Said Dr. Peter Marks, director of the FDA’s Vaccine Center. He noted past episodes where health problems appeared in people who received new vaccines, such as the debut of the polio vaccine in 1955 and a vaccination campaign against a new form of flu in 1976.

When medical countermeasures hurt people in the US, “we don’t have a lot of tolerance for it, and that tends to undermine confidence in the vaccines,” Marks said. “So we just have to do everything we can to minimize or eliminate problems that could be viewed as friendly fire.”

The decision immediately turned some US vaccination programs on their head: In Atlanta, a mass vaccination event for public school teachers who should have used the J&J vaccine was scrapped. St. Louis health officials said they would reach 1,800 people who received the shots warning them of potential health problems. And in Montana, two colleges that were hoping to vaccinate students with doses of J&J canceled before going home to the summer clinics.

Authorities stressed they had found no signs of clot problems with the most widely used COVID-19 vaccines in the United States – from Moderna and Pfizer.

Seth Shockley of Indianapolis received the J&J vaccine on Sunday and was initially concerned when he heard of the possible side effects on Tuesday. His concern subsided when he learned that there were only six confirmed cases of blood clots.

“I would much rather take the risk with the vaccine – a much lower risk – than risk it with COVID,” he said. Now he’s more concerned that the reports could lead to more people refusing to get vaccinated.

The FDA said the cases studied resembled the clots that may be related to the AstraZeneca vaccine. European regulators have emphasized that the risk of AstraZeneca appears to be far lower than the chance of developing blood clots from birth control pills, which usually cause blood clots in around 4 out of 10,000 women who use them for a year.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said at the White House the hiatus would allow the FDA and CDC to investigate the coagulation cases and “bring them to the attention of doctors.”

A CDC committee will meet on Wednesday to consider the cases and the FDA has launched an investigation into the cause of the clots and low platelet counts.

FDA officials stressed that Tuesday’s action was not a mandate. Doctors and patients could continue to use J & J’s vaccine if they decide that its benefits outweigh the individual risks, Marks said.

The agencies recommend people who have received the J&J vaccine contact their doctor if they have severe headache, abdominal or leg pain, or shortness of breath within three weeks.

The US health authorities warned doctors against a typical clot treatment, the blood-thinning heparin. European authorities investigating the AstraZeneca cases have concluded that the clots resemble a very rare abnormal immune response that sometimes affects people treated with heparin, resulting in a temporary clotting disorder.

While it’s not yet clear whether the reports are related among J&J recipients, doctors would treat these types of unusual blood clots the way they treat people with a heparin reaction – using different types of blood thinners and sometimes an infusion of antibodies, said Dr. Geoffrey Barnes. a clot expert at the University of Michigan.

Even without the J&J vaccine, White House officials said they were on track to have enough supplies by the summer to vaccinate most American adults.

“We believe the system – Moderna and Pfizer – has enough vaccines for all Americans who want to get vaccinated by May 31st can do so,” said Jeff Zients, White House COVID-19 Response Coordinator.

The J&J vaccine received FDA emergency approval with great enthusiasm in late February. However, the shot makes up only a small fraction of the doses administered in the United States. J&J was plagued by production delays and manufacturing defects at a contractor’s Baltimore facility.

Last week, the drug maker took over the facility to ramp up production in hopes of fulfilling its commitment to the US government to provide approximately 100 million doses by the end of May.

At the Green Wave pharmacy in rural Clintwood, Virginia, many customers have specifically requested the J&J vaccine. Pharmacist Sheryl Pientka said the Appalachian pharmacy serves low-income and elderly people who would rather get one shot than two.

Although the pharmacy has Moderna vaccines in stock, some elderly and homebound customers might be waiting for the J&J shot to be cleared for use again, Pientka said.

“It’s a very small city where everyone knows everyone. People say, ‘I know the vaccine got this way and that. If she has no problem, I’ll get it, ”she said.

Associate press writers Mike Stobbe, Emily Wagster Pettus, Karen Matthews, Jill Bleed, Linda A. Johnson, Sophia Eppolito and Denise Lavoie also contributed to this report.

Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson # COVID19 vaccine. We recommend taking a break from using this vaccine as a precaution.

– US FDA (@US_FDA) April 13, 2021

As of April 4, the US CDC & FDA administered 6.8 million doses of the J&J vaccine. The FDA is reviewing the data of 6 reported US cases of a rare and severe type of blood clot in people after receiving the vaccine. At present, these adverse events appear to be extremely rare

– US FDA (@US_FDA) April 13, 2021

The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential relevance. The FDA will review this analysis as it is investigating these cases as well.

– US FDA (@US_FDA) April 13, 2021

Until this process is complete, we recommend taking this break. This is important to ensure that the healthcare provider community is aware of the potential of these adverse events and can plan based on the unique treatment required for this type of blood clot.

– US FDA (@US_FDA) April 13, 2021

The organization said safety is a top priority.