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US health authorities were close to simply warning about a blood clotting risk of the Johnson & Johnson Covid-19 vaccine, but decided to recommend the use of an interruption because doctors would treat the condition improperly.
In the past four weeks, U.S. health officials have become concerned about similar blood clotting conditions in Europe involving a Covid-19 vaccine from AstraZeneca PLC, the people said. Officials dug into a U.S. vaccine safety database and identified the cases of major concern, but debated what steps to take.
Last Monday night, officials decided that urgent action was needed, the people said. Four out of six women in the U.S. who developed the blood clots days after vaccination initially received heparin, according to the U.S. Centers for Disease Control and Prevention. Its use could aggravate the patients’ condition, the people said.
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That evening, the country’s leading health officials agreed at a one-hour Zoom meeting to take the strongest step: recommending that the use of the vaccine be suspended in public while investigating the adverse cases, the people said .
Since the announcement, the Food and Drug Administration has studied other reports of additional blood clotting cases among people who received J & J’s vaccine, but has not confirmed whether any of them reflect the same phenomenon. Yet officials are more convinced, the people added, that the six total cases reported so far are related to the shot.
Health officials are now looking at limiting the J&J vaccine to older people, under options, and can make a decision as early as this week.
FDA has been waiting to see what a vaccine advisory panel recommends for the CDC, the people said. The two most likely options are to limit the shot to an age group such as men and women over the age of 50, or to give a return to widespread use, but with a warning about the benefits and risks of the shot.
The CDC panel, called the Advisory Committee on Immunization Practices, is scheduled to meet on Friday to review the break, after postponing a vote on how to proceed during an emergency meeting last week.
Anthony Fauci, President Biden’s chief medical adviser, said he expected J & J’s vaccine to be used in the United States again by Friday. “I believe we will come back with an indication that is a little different than before the break,” said Dr. Fauci said on ABC.
Among the more than seven million people in the U.S. who received J & J’s Covid-19 vaccine before the break, it was reported that a total of six cerebral blood clots had developed and that they also had a low count of the colorless cells in the blood, known as platelets, registered. helps the blood to clot.
J&J said he was aware of the cases of blood clots and was working with health authorities. Researchers at the company recently sent a letter to a medical journal saying there was no evidence to determine a link between the vaccine and the adverse events so far.
The recommended break has interrupted a mass vaccination campaign that wants to vaccinate as many people as possible before coronavirus variants emerge that could make vaccination less effective. The campaign was picking up steam, in part due to the introduction of the J&J vaccine, which can be stored more easily and requires only one dose.
Following the announcement last Tuesday morning, states, cities and communities had to be forced to cancel vaccination appointments with J & J’s lap, or to find doses of the alternatives to give.
The FDA and CDC have criticized some health experts for fearing that the agencies’ joint recommendation would exacerbate fears among those already reluctant to be vaccinated and give a boost to the immunity needed to control the virus. distribute, develop.
Health and Human Services, Xavier Becerra, CDC Director Rochelle Walensky, FDA Acting Commissioner Janet Woodcock, and Director of the National Institute of Allergy and Infectious Diseases, Dr. Fauci, considering the implications of a public announcement, the people said.
The people, along with Peter Marks, the FDA’s vaccine chief, decided that caution and safety should take precedence.
“It is essential for health professionals to know that the treatment of these blood clots is different from our current standard of care,” said Dr. Walensky said during an information session in the White House last week.
The private consultation among top federal health officials that led to the recommendation to discontinue the use of J & J’s vaccine has not been reported before. The following outline of the rapid turn of events leading up to the recommendation is based on interviews with people familiar with the discussions.
The people said they are helping the decision-making are two sources for reports on the rare side effects.
According to the people, the health regulators in Europe were one source. They investigated reports of unusual coagulation cases with another vaccine from AstraZeneca and the University of Oxford.
The AstraZeneca-Oxford vaccine is based on a similar technology to J & Js. Both viral vector vaccines use a modified cold virus to carry genetic instructions that teach a human cell to make a version of the protein found on the surface of the Covid-19 virus. The body of a vaccine then responds to the nails and forms immunity to Covid-19 infection.
In March, health authorities in several countries on the continent restricted the use of the AstraZeneca-Oxford shot to investigate clotting cases. This month, European medicine regulators expanded their investigation into J & J’s Covid-19 vaccine.
Dr Marks, director of the FDA’s center that regulates vaccines, and colleagues became interested in the risk of blood clots over the past month. The people said cases in Europe related to the vaccine developed by AstraZeneca and the University of Oxford have gone up.
According to the people, the FDA collaborators became concerned that the phenomenon could also be related to the vaccination of J&J that is already used in America.
The J&J reports come from the other source of blood clotting cases: the vaccine reporting system. Doctors and the public report safety issues to the three-decade-old database. The people who submit reports do not know if the events are really vaccine related, but the FDA and CDC are investigating.
The people submitted the first report of a blood clot case to a person who received the J&J vaccine on March 19. By April 9, the two agencies had removed several other similar cases from the VAERS database. According to the people, FDA and CDC officials have begun to suspect that the recording of J & J plays a role.
The weekend of 10 and 11 April, dr. Marks and dr. Walensky of CDC searched the reports on a case-by-case basis.
Last Monday, VAERS had six reports, all involving women. One died while others were or were in intensive care.
Federal health officials are concerned that the risk of blood clots could be significantly higher than initially suspected, if one problem was focused only on younger women. According to the CDC, about 1.5 million women between the ages of 18 and 50 received J & J’s vaccine.
In light of the cases of blood clots involving people with the AstraZeneca-Oxford vaccine, U.S. health officials were also concerned about a ‘class effect’ in terms of virus-vector vaccinations, the people said.
Last Monday at 8 p.m., Health Secretary Becerra joined other senior health officials at a Zoom meeting to discuss what to do, the people said.
After a clinical review of the cases, the participants in the meeting discussed potential reactions. One of the people said that doctors should warn against heparin as heparin is often given to coagulation patients.
Four of the six women were initially treated with heparin, according to data that the CDC and J&J later submitted to the ACIP, the agency’s vaccine advisory panel.
In one case, doctors administered the medicine to a 48-year-old woman after they found extensive blood clots in veins in her brain and abdominal cavity, as well as an alarmingly low number of platelets in her blood.
Despite the heparin, blood clots continued, according to a report J&J submitted to the ACIP and a description of the case in the New England Journal of Medicine.
According to the J&J and NEJM reports, the woman was switched to another blood thinner called argatroban, along with intravenous immunoglobulin. Her platelet count improved significantly over the next five days, but she remained critically ill early last week. She was vaccinated for two weeks before developing symptoms.
One of the people said the discussion switched to recommending a break during use, after the participants discussed whether a warning could simply be added to cause calls for stronger action. One concern: the ACIP may convene such advice and provide advice while matters are further investigated.
The group quickly agreed that if there was to be a break in a few days, it would be safer to do so immediately to avoid possible new coagulation cases, one of the people said. Such drastic action will also attract the attention of the public which may give rise to the reporting of any other cases of blood clot.
Participants regret the announcement, which would take place at 07:00 the next morning, and would not give time to fully inform the state health authorities.
Yet it would mean that people who would be vaccinated that day, especially those in the Eastern time zone, would know it in advance, rather than learning the news while waiting in line for a shot.
Write to Thomas M. Burton at [email protected] and Betsy McKay at [email protected]
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