Advisors from the Centers for Disease Control and Prevention are under pressure to decide whether the US can resume the use of Johnson & Johnson’s Covid-19 vaccine, perhaps with some restrictions, ten days after its use.
Members of the CDC’s Advisory Committee on Immunization Practices will meet again on Friday to decide whether they have enough data to say who should – or not – have J & J’s chance. Options include a full resume, age or gender restrictions, or an extension of the break.
Wilbur Chen, a voting member of the committee and a professor at the University of Maryland School of Medicine, said he would like to see the vaccine used.
“I do not want to put it on the shelf anymore,” Chen said in an interview.
Last week, the panel took no action and chose to wait and see if there are more cases of rare blood clots observed in several people who received J & J’s vaccination. The decision has left millions of doses in refrigerators across the country, sparking debate over whether the side effect – seen in less than one in every million recipients – is the use of a vaccine against the infection that occurs more than once. killed must slow down 3 million people worldwide.
“Obviously they have to make a decision,” he said. Marci Drees, a liaison representative on the panel of the Association of Health care Epidemiology of America. “They can no longer extend the break for more data because there will always be more data as we get more time with the vaccine.”
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Some have questioned how much additional information will come to light. Europe’s drug regulator said on Tuesday that the benefits of J & J’s vaccination outweighs the risks of a possible link to the blood clots, which raises the spotlight on US advisers.
J&J, based in New Brunswick, New Jersey, did not respond to questions about expectations for the meeting. Its vaccine has been under scrutiny when US regulators keeps production at a plant that is managed Emergent Biosolutions Inc. after inspection. J&J said that supervision has intensified and that it is starting production network of ten sites to deliver vaccine worldwide.
Decision wanted
The CDC advisory committee shapes how vaccines are used in the U.S. state and local health departments, and individual physicians rely on ACIP’s recommendations. Its 15 voting members include immunologists and public health experts.
Although the six cases of CDC advisors linked by the vaccine last week were all in women aged 18 to 48 years, there was no clear association between the small sample patients. The problem is further clouded: a coagulation incident in which a young man was involved in a late-stage clinical trial. The chairman of the panel, Jose Romero, raised the possibility that the break will take place can be expanded if no more information comes to light.
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When the panel met earlier, half of the J & J vaccine administered in the US has been given over the past few weeks. Chen, the ACIP voting member, supported the break because he did not bird the panel had enough data to make a clear set of recommendations. He was also concerned that mistrust would arise if interim guidelines were provided to change it later.
However, a further extension of the break would send a clear message against the use of the vaccine, says Drees, who is also head of infection prevention and hospital epidemiologist at ChristianaCare, a health system in Wilmington, Delaware.
“The committee definitely wants to somehow make a decision to change something or not,” she said.
Age Restrictions
In March, advisers recommended J & J’s vaccine for anyone 18 years and older. Some see that its use is restricted by age, as European countries have done in response to similar coagulation incidents related to AstraZeneca Plc’s shot. Both vaccinations use an adenovirus – a cold virus – which researchers say has been linked to the clotting reaction.
The US has extensive supplies of shots not linked to blood clots Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE, and it’s perhaps a better option for people under 50 who seem more vulnerable to the side effect, Martin Kulldorff, a member of the technical subgroup for vaccine safety.
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“The biggest problem in interrupting it is for people over 50,” Kulldorff said. He is also a biostatistician and epidemiologist at Harvard Medical School. ‘They really need this vaccine; it is older people who are dying, and we need to vaccinate as much as possible. ”
The The European Medicines Agency, the EU’s drug regulator, said the blood clots should be listed as a very rare side effect so that doctors and people who get the chance can be aware of the symptoms. A representative of the Food and Drug Administration presented a similar idea at last week’s ACIP meeting, saying the agency thinks the J&J survey could be used with a new warning language.
Vaccine confidence
In a statement this week, the FDA said that the CDC is continuing to review safety data for the J&J vaccine and that ACIP will meet again as soon as possible to review additional scientific evidence.
“It is important that these deliberative processes that protect patients are followed so that the U.S. public has confidence in the safety and efficacy of vaccines,” an FDA spokesman said in an email.
Chen said he did not know what the panel’s proposal for using J & J’s vaccine was without seeing the data. There are ‘many scenarios that can play’, he said.
According to CDC data, J & J’s uptake is only 6% of the 272 million doses delivered in the US, but the single-shot format is preferred for hard-to-reach populations such as the homeless and people living in remote areas.
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States were disappointed with the outage because there was so much demand for J & J’s shot, which is also easy to store, which only needs refrigeration, he said. Marcus Plescia, medical officer of the Association of Civil Servants and Territorial Health Officers.
“The concern is that it’s going to be difficult to make a decision this Friday,” he said, “what is the end point that will enable them to come to a decision?”
– Assisted by John Lauerman
(Updates with comments from ACIP member starting in third paragraph)