The future of Johnson & Johnson Covid Vaccine Shot depends on 15 prudent vaccine experts

A shipment of Johnson & Johnson vaccine arrives at a hospital in New York on March 3, 2021.

Counselors for the Centers for Disease Control and Prevention are under pressure to decide whether the United States can resume use of Johnson & Johnson’s Covid-19 vaccine, perhaps within certain limits, for 10 days during a break in use.

Members of the CDC Advisory Committee on Immunization Practices will meet again on Friday to decide whether they have enough data to say who should – or should not – receive J & J’s shot. Options include full resumption, age restrictions or sex or 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 the vaccine to be used.

“I don’t want to be on the shelf anymore,” Chen said in an interview.

Last week, the commission did not take any action, choosing to wait and see if there were more cases of rare blood clots seen in several people who received J & J immunization. The decision left millions of doses in refrigerators in across the country, sparking debate over whether the adverse reaction – seen in less than 1 in a million recipients – should delay the use of an infection vaccine that has killed more than 3 million people globally.

“Clearly, you have to make a decision,” said Marci Drees, a liaison to the board of the Society of Healthcare Epidemiology of America. “I can’t continue to extend the break for more data, because there will always be more data as we gain more time with the vaccine.”

Some have questioned how much more information will appear. The European Drug Enforcement Authority said on Tuesday that the benefits of the J&J vaccine outweigh the risks of a possible clot connection, with a focus on US advisers.

J&J of New Brunswick, New Jersey, did not answer questions about the meeting’s expectations. His vaccine came under additional control when U.S. regulators suspended production at a factory run by Emergent Biosolutions Inc. following an inspection. J&J said it has stepped up surveillance and is setting up a 10-site production network to supply vaccines worldwide.

Desired decision

The CDC Advisory Committee models how vaccines are used in the United States and local health departments, and individual physicians build on ACIP recommendations. Its 15 voting members include immunologists and public health experts from outside the agency.

While the six cases of CDC vaccine-related coagulation counselors analyzed last week were all in women between the ages of 18 and 48, there were no obvious links between the small sample of patients. Darkening of the problem is a coagulation incident involving a young person during a late stage clinical trial. The chairman of the commission, Jose Romero, supported the possibility that the break could be extended if more information is not revealed.

When the group met earlier, half of the US-administered J&J vaccine had been given in the past few weeks. Chen, a member of the ACIP vote, supported the break because he did not feel that the group had enough data to make a clear set of recommendations. He also worried that providing interim guidelines only to change them later would create mistrust.

However, another extension of the break would send a clear message against vaccine use, said Drees, who is also chief infection prevention officer and hospital epidemiologist at ChristianaCare, a Wilmington-based health system. Delaware.

“The committee definitely wants to make a decision one way or another whether or not to change something,” she said.

Age restrictions

In March, counselors recommended the J&J vaccine for anyone 18 and older. Some see a case for restricting its use according to age, as European nations have done in response to similar clotting incidents related to the AstraZeneca Plc shooting. Both vaccinations use an adenovirus – a cold virus – that some researchers have said could be linked to the clotting reaction.

The United States has a large number of unrelated photos from Moderna Inc. and the Pfizer Inc. partnership and BioNTech SE, and they could be a better option for people under the age of 50 who seem more vulnerable to the side effect, said Martin Kulldorff, a member of the vaccine safety technical subgroup.

“The big problem with stopping this is for people over the age of 50,” said Kulldorff, who is also a biostatistician and epidemiologist at Harvard Medical School. “They really need this vaccine; the elderly are dying and we need to vaccinate as many as possible. ”

The European Medicines Agency, the EU’s drug regulator, said blood clots should be listed as a very rare side effect so that doctors and people receiving the vaccine can be aware of the symptoms. A Food and Drug Administration representative suggested a similar idea at last week’s ACIP meeting, saying the agency thought J & J’s shot could be used with a new warning language.

Confidence in vaccines

In a statement this week, the FDA said the CDC is also 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 be followed so that the American public has confidence in the safety and effectiveness of vaccines,” an FDA spokesman said in an email.

Chen said he did not know what the commission’s suggestion for the use of the J&J vaccine would be without seeing the data. He said there were “a lot of scenarios that could be played”.

J & J’s images represent only 6% of the 272 million doses delivered in the United States, according to the CDC, but its unique format is preferred for hard-to-reach populations, such as the homeless and people living in remote areas.

States are disappointed by the break because there has been such high demand for J & J’s shot, which is also easy to store, requiring only refrigeration, said Marcus Plescia, chief physician of the Association of Health Officials. State and Territorial.

“The concern is if it’s hard for them to make a decision this Friday,” he said, “what’s the end point that will allow them to make a decision?”

(Except for the title, this story was not edited by NDTV staff and is published in a syndicated stream.)