May 18, 2021

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J&J COVID-19 vaccine and rare blood clots: what to know

J&J COVID-19 vaccine and rare blood clots: what to know

Doctors with long experience diagnosing very ill patients describe it as one of the rarest and most baffling scenarios they have seen: A patient arrives in a hospital emergency room with one or more life-threatening blood clots in the brain, lungs, legs or abdomen while having low levels of platelets, the cells that are the raw material for blood clots.

It’s the medical equivalent of a traffic light flashing red and green at the same time.

“Whoa!” said Mayo Clinic internist Dr. Gregory Poland. “This grabs everyone’s attention.”

The condition is called autoimmune thrombocytopenia. It occurs when the immune system breaks down and generates antibodies against the patient’s blood platelets, sometimes spontaneously but more often in patients treated with blood-thinning heparin.

Poland said it has seen it once, maybe twice, in a decade-long career studying immune responses to diseases and vaccines.

But within a few weeks it was reported in six patients in the United States.

They were all women. All were between the ages of 18 and 48. And they all had received Johnson & Johnson’s single-injection COVID-19 vaccine between six and 13 days before developing one of several telltale signs of a blood clot: sudden shortness of breath, aching, swollen pain. leg, an attack of extreme and unusual stomach pain, or severe and rapid onset headache or neurological symptoms such as blurred vision, disorientation or muscle weakness.

The six reports emerged after 6.8 million doses of the J&J vaccine ended up in the arms of Americans. Although extremely rare – apparently less than one in a million – these cases have left one US patient dead and a second in critical condition.

And on Tuesday, they prompted the US Centers for Disease Control and Prevention and the Food and Drug Administration to recommend a “pause” in administering Johnson & Johnson’s COVID-19 vaccine.

During that hiatus, independent and federal experts will investigate whether the nation’s most recent addition to its vaccine arsenal is the cause of those bleeding disorders and whether the vaccine should continue to be recommended for use in all older adults. at 18 years old. The CDC will meet on Wednesday on its Advisory Committee on Immunization Practices to review such applications.

The pause comes in the wake of the European Union’s decision to temporarily suspend the administration of a similar COVID-19 vaccine manufactured by AstraZeneca.

Following the administration of 20.2 million doses of the two-dose vaccine, European regulators have collected approximately 44 reports of vaccine-induced immune thrombotic thrombocytopenia, or VITT. These are thought to have been caused not by heparin or a random autoimmune reaction, but by the AstraZeneca vaccine.

Most of these cases have been seen in patients younger than 40 years of age and 4 of 5 have been reported in women.

In a study of 11 patients in Germany and Austria who suffered from VITT, six died. All showed high levels of anti-factor 4 platelet antibodies, which are implicated in autoimmune thrombocytopenia.

The authors of that report speculated that the free DNA in the AstraZeneca vaccine could potentially trigger these abnormal antibodies.

Although distinct in many ways, the vaccines made by AstraZeneca and Johnson & Johnson are linked in one important respect. Both use an adenovirus – a common cold germ deprived of its ability to get sick – to give the immune system the prompt it needs to recognize and attack the SARS-CoV-2 virus.

The AstraZeneca vaccine uses a chimpanzee-derived adenovirus, while the Johnson & Johnson vaccine uses a human adenovirus.

“It is clearly obvious to us already what we are seeing with [the Johnson & Johnson] vaccines is very similar to what we are seeing with the AstraZeneca vaccine, ”said Dr. Peter Marks, chief of drug evaluation at the FDA.

Regulators, he added, would examine “the totality of evidence” to determine whether the rare immune response is linked to the common vectors of the two vaccines.

AstraZeneca has not yet asked the FDA for emergency use authorization for its COVID-19 vaccine, although the company said it intends to do so soon.

There have been no reported cases of blood clots in the presence of low platelet counts among patients who received the COVID-19 vaccines manufactured by Pfizer-BioNTech or Moderna, both of which use mRNA technology instead of adenoviruses.

Warnings from the FDA and CDC also alerted doctors to symptoms and proper treatment of blood clotting complications in patients who have received a recent dose of the Johnson & Johnson vaccine.

“You get these clots and doctors normally reach for heparin, and that’s a no-no in this disorder,” said Dr. Jeffrey Weitz, president of the International Society of Thrombosis and Hemostasis and professor of medicine at McMaster University in Canada. . Instead, he said, doctors are advised to treat such clotting disorders with intravenous immunoglobulins.

The cause of these rare blood clots is unknown. But Dr. Hanny Al-Samkari, a hematologist and researcher at Massachusetts General Hospital and Harvard Medical School, said the immune system can form antibodies against some components of those adenovirus vaccines, which then cross-react with blood platelets. and cause them to activate, creating “clots where they shouldn’t be”.

Women’s stronger immune systems can make these reactions more common in them than in men, Al-Samkari said.

And while it’s too early to draw a link to oral contraceptives, Poland says researchers will likely also explore the possibility that women who take the birth control pill, which can increase their risk of developing blood clots, are advised to avoid vaccines. adenovirus.

In a statement released Tuesday, Johnson & Johnson said it was “aware of an extremely rare disease” involving people with blood clots in combination with low platelets in a small number of individuals who have received its COVID-19 vaccine.

The company said it was reviewing cases with both US and European regulators and “made the decision to proactively delay the launch of our vaccine in Europe.”

Reports of blood clots are likely to deepen the concerns of about 30% of Americans who are reluctant to get the vaccine or have said they will not receive a COVID injection. But federal officials said Tuesday that the “pause” was necessary and that government transparency should reassure Americans.

Poland, who has served as a consultant for Johnson & Johnson, AstraZeneca and other vaccine manufacturers, added that the speed at which government watchdogs detected and responded to a weak signal of potential problems should inspire confidence.

“Even in the midst of all this fog, our safety signals picked it up,” he said. “In a haze of pea soup, you see a light: is it a ship? Is it a lighthouse, is it the coast? We can’t say yet. These things are so difficult to discover and they are so rare. It is a logical reason for a break. “


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