With few new cases of coagulation, Johnson & Johnson’s hiatus may be over soon

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WASHINGTON – Federal health officials appear to be keen to lift their recommended break on use of the Johnson & Johnson coronavirus vaccine after finding only a limited number of additional cases of a rare blood clotting disorder in recipients.

Instead, the Food and Drug Administration is likely to attach a warning to the vaccine label to inform healthcare practitioners – and the public – of the extremely rare, but dangerous, possible side effect.

Federal health officials are waiting to act until they hear a panel of external experts advising the CDC The committee is due to meet Friday to discuss whether to recommend the lift, extension or change of the break initiated on April 13.

“We know it’s not a good thing to leave the break longer than necessary,” Dr Peter Marks, the Food and Drug Administration’s principal vaccine regulator, said Thursday, adding that an extended break could contribute to greater reluctance to vaccinate. “Once, essentially, the right discussion has taken place, we’re ready to act as quickly as possible.”

When senior federal health officials suddenly decided early last week to recommend a temporary cessation of vaccine use, six women reportedly suffered from the disorder, a combination of clots in the brain that led to bleeding and low platelets. blood that normally helps heal wounds.

It was less than one in a million recipients of Johnson & Johnson’s shooting in the United States. But officials feared more cases would be hidden or develop soon with the rollout of the new vaccine.

This fear did not materialize.

Dr Marks and acting FDA commissioner Dr Janet Woodcock said the bleeding disorder appeared to be almost as rare as they hoped when they recommended the break.

“We have now received more cases, but it is not an avalanche,” said Dr Woodcock. “We’re not seeing a big increase, which is a big relief.

Dr Marks declined to say how many new cases had been confirmed, but said the disease rate should not be higher “in terms of orders of magnitude.”

Even if the CDC advisory board decides on Friday that the benefits of Johnson & Johnson’s single-dose vaccine outweigh its risks, the company will still face manufacturing hurdles at a Baltimore plant that regulators have until now refused to certify. This plant was supposed to deliver most of the nearly 100 million doses the company had promised to prepare by the end of May.

But that would mean a temporary increase of around 10 million shots that were effectively put on hold when the break was announced. Some state officials had planned to use the single-dose, easily-storable vaccine to vaccinate students before the summer or other transient or hard-to-reach populations, but had to abruptly abandon those plans.

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Dr Rochelle P. Walensky, the director of the CDC, said in an interview Wednesday that federal officials had found “needles in haystacks”, an indication of extensive government surveillance. “We would like to make a decision soon after ACIP,” she said, using the acronym of the expert group called the Advisory Committee on Immunization Practices. “America and the world are interested in moving forward.”

European regulators, facing similar concerns, recommended earlier this week that the vaccine rollout should continue as long as a warning is added to the product about the risks of a blood clotting disorder. If US officials follow suit, they will revert to a precaution they envisioned early on.

In the days leading up to the start of the hiatus, FDA officials had drafted a brief warning about possible rare blood clots to attach to the section of the vaccine’s emergency use authorization outlining possible side effects.

Doctors had prescribed the abuse to several women who had received the vaccine and suffered from the bleeding disorder, possibly worsening their condition. With input from the CDC, officials expected the unusual warning to doctors about the need for specialized treatment and consultation could be released as early as Tuesday, April 13, according to people who heard. talk about planning.

But at an 8 p.m. meeting on Monday April 12, plans changed. Dr Walensky, Dr Woodcock and other senior health officials said they decided that a temporary halt in vaccine use would give federal doctors and scientists more time to recognize and understand any connection. possible between the vaccine and the clots.

Some federal health officials felt the move – one of the most important interventions the administration has made so far in its response to the pandemic – was a hasty overreaction that at least temporarily pulled a weapon invaluable in the midst of the country’s vaccination campaign with little evidence of a large risk to Americans.

Just a day after his own agency recommended the hiatus, Dr Doran Fink, a leading FDA vaccine regulator, suggested to the CDC advisory committee that if doctors and recipients were given enough information, the vaccine could. be put back into play while researchers continue to do so. study the potential risk.

“Our current thinking is that this risk could be managed through the inclusion of caveats,” Dr Fink told other experts at the first consultative meeting last Wednesday.

His remarks were unusually explicit, according to Dr William Schaffner, an infectious disease expert and consultant to the expert panel. They suggested the choice was not as obvious as the Biden administration presented it last week.

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In fact, the deliberations underscored how complicated and uncertain the work of policymaking in the midst of a public health emergency can be. Scientists eventually have to make life and death decisions while continuing to collect data under tight deadlines.

Dr Woodcock on Thursday acknowledged differences of opinion within the FDA over the benefits of a temporary shutdown versus the risks of additional coronavirus infections if the vaccine were temporarily put aside.

While European regulators, CDC and FDA officials grappled with reports of rare cases of coagulation in the weeks leading up to the hiatus, regulators have seen an undeniable similarity in the cases in the United States. All had occurred one to three weeks after vaccination and were grouped together in women under 50 years of age.

A woman in Virginia had died and three others had been hospitalized, including two in intensive care.

Dr Woodcock said a warning would have been insufficient if there was in fact a high rate of cases, such as one in 25,000 or 50,000 young women. “We would be putting people at risk if we did not have these. information, ”she said, and moving forward with uncertainty“ might actually cause a worse reaction among the population. ”

Some expressed concern, given the daily number of new infections and the number of Americans who could have been protected in the past 10 days had the vaccine remained in use.

“It’s just very difficult for me to see, even if you multiply the number of cases by five or by ten, that you come to the conclusion that it is not a good thing to do, to give you the vaccine.” said Dr. Ezekiel J Emanuel, professor of medical ethics and health policy at the University of Pennsylvania.

The decision to recommend the break was “not straightforward,” admitted Dr Walensky, but received “overwhelming support inside and outside the agency.” She said the vaccine “was going to take a hit anyway since we had to put the warning on it.”

Dr Anthony S. Fauci, the government’s top infectious disease specialist, said in an interview this week that his colleagues made the right choice. Public health emergencies often require policy choices laden with incomplete data, he said.

“It’s so painful or difficult when there isn’t an absolutely right or absolutely wrong way to say something. It’s just a gray area, ”Dr Fauci said, but“ a decision has to be made. “

Dr Matthew Wynia, an ethicist and infectious disease specialist at the University of Colorado, said health officials faced a frightening trade-off in choosing between a pause and a warning: they would only hypothetically know the lives that ‘a break might have cost. But they would know exactly who suffered or died from blood clots.

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Due to the unusual nature of this disorder, Dr Wynia said, a typical warning to doctors would not have attracted as much attention and “would not have had the impact it had.”

But Dr. Steven Joffe, a bioethicist at the University of Pennsylvania, said a warning would have sufficed, at least initially, when a break could be a problematic signal for the rest of the world “to perhaps be skeptical. with respect to the J. & J. vaccine, when it is such an important piece of the puzzle. He added that doctors would likely have recorded an appropriate alarm from a warning about a product in extraordinary demand.

At CDC headquarters in Atlanta over the past week, officials have reviewed and found an expected increase in reports of coagulation incidents, Dr Walensky said.

The CDC had also designed models to measure the effect of the break on people who might not get vaccinated without the Johnson & Johnson vaccine available – a “population-level benefit-risk” that was intended to help scientists. to understand the “real value of this vaccine,” said Dr. Walensky.

Some early polls on the break suggested Americans saw the move as a sign that the government was responsibly monitoring vaccines, while a poll released by the Boston Children’s Hospital showed Americans who want to be vaccinated are now much less willing to get the Johnson & Johnson. shoot.

“It only took six cases to do it,” said Dr Joseph Kanter, the top health official in Louisiana, where other vaccines had to be replaced by Johnson & Johnson during vaccination events. homeless people in New Orleans, church-based vaccination campaigns and at the university. campus. “Anyone with questions or concerns about the seriousness of security should take this as an example of putting security first.”

He said the postponement of appointments had been a “surmountable challenge”, and that the hiatus meant state officials “would just have to work a little harder to get people back.”

Dr Kanter and other state officials were surprised at the popularity of the vaccine with people eager for a single-dose vaccine and keen to use it, as demand for the vaccines could stagnate.

“We are clearly at the stage where we have more than enough vaccines. The demand is clearly not as much as the supply at this point, ”said Dr. José R. Romero, senior Arkansas health official and head of the CDC’s vaccine advisory committee. “This vaccine would help these people reach the limit.”