Advisors at the Centers for Disease Control and Prevention are under pressure to decide whether the U.S. can resume use of Johnson & Johnson’s Covid-19 vaccine, perhaps with some limitations, within a 10-day break to use it. .
Members of the CDC Advisory Committee on CDC Immunization Practices will meet again Friday to decide whether they have enough data to say who should (or should not) receive the J&J shot. Options include a full resume, age or gender restrictions, or extended break.
Wilbur Chen, a voting committee member and professor at the University of Maryland School of Medicine, said he would like the vaccine to be used.
“I don’t want him to sit on the shelf any longer,” Chen said in an interview.
Last week, the group took no action and decided to do so wait to see if there are more cases of rare blood clots seen in several people who received J&J vaccination. The decision left millions of doses sitting in refrigerators across the country, sparking debate over whether the adverse reaction (seen in less than one in a million recipients) should delay the use of a vaccine against the infection that died over 3 million people worldwide.
“Obviously they have to make a decision,” he said Marci Drees, representative of link to the panel of the Society of Health care Epidemiology of America. “They can’t keep extending the pause for more data, because there will always be more data as we gain more time with the vaccine.”
Read more: Blood clots, Anaphylaxis and other vaccine fears
Some have questioned how much additional information will emerge. The European drug regulator said Tuesday that the benefits of the J&J vaccine they overcome the risks of a possible link with clots, intensifying the focus on US advisors.
J&J, based in New Brunswick, New Jersey, did not answer questions about meeting expectations. His vaccine came under additional scrutiny when U.S. regulators put one keep production in a plant run by Emergent Biosolutions Inc. after an inspection. J&J said it has intensified oversight and is establishing a manufacture network of 10 sites to supply vaccines worldwide.
You want a decision
The CDC Advisory Committee defines how vaccines are used in U.S. state and local health departments, and individual physicians depend on ACIP recommendations. Its 15 voting members include immunologists and public health experts from outside the agency.
Although the six cases of vaccine-related coagulation CDC counselors reviewed last week corresponded to women aged 18 to 48, there were no obvious connections between the small sample of patients. Huge problem, this is a coagulation incident that involved a young man during a final phase clinical trial. The president of the panel, Jose Romero, has raised the possibility of a break it can be expanded if no more information comes out.
Read more: Viruses return a scourge once again when markets wake up Until Risks
When the group met earlier, half of the U.S.-administered J&J vaccine had been administered in recent weeks. Chen, the voting member of the ACIP, supported the break because he did not feel the panel had enough data to make a clear set of recommendations. He was also concerned that providing interim guidelines only to change them later would generate mistrust.
However, another extension of the break would send a clear message against the use of the vaccine, said Drees, who is also head of infection prevention 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 it changes anything,” he said.
Age restrictions
In March, advisors recommended the J&J vaccine for anyone 18 years of age or older. Some see a case for restricting its use for ages, as European nations have done in response to similar related coagulation incidents. Shot by AstraZeneca Plc. Both inoculations use an adenovirus (a cold virus) that some researchers have said could be related to the clotting reaction.
The US has a lot of traits that have not been related to clots Moderna Inc. and the collaboration of Pfizer Inc. i BioNTech SE, and these may be a better option for people under the age of 50, who seem more vulnerable to the side effect, he said. Martin Kulldorff, member of the technical vaccine safety subgroup.
Read more: The EU urged to limit Astra’s firing to too many people 60 inches Unified rules
“The big problem to stop it is for people over 50,” said Kulldorff, who is also a biostatistician and epidemiologist at Harvard Medical School. “They really need this vaccine; they are elderly people who die and we must vaccinate as much as possible ”.
He The European Medicines Agency, the EU’s drug regulator, said blood clots should be listed as very rare side effects so doctors and people receiving the vaccine can be aware of the symptoms. A representative from the Food and Drug Administration suggested a similar idea at last week’s ACIP meeting, saying the agency thought the J&J feature could be used with a new language of warning.
Confidence in the vaccine
In a statement this week, the FDA said so and the CDC continues to review safety data for the J&J vaccine and that ACIP will meet as soon as possible to review additional scientific evidence.
“It is important to follow these deliberative processes that protect patients so that the American public has confidence in the safety and effectiveness of vaccines,” an FDA spokesman said in an emailed statement.
Chen said he does not know what the group’s suggestion will be to use the J&J vaccine without seeing the data. There are “a lot of scenarios that could be played out,” he said.
According to CDC data, J&J shooting accounts for only 6% of the 272 million doses administered in the United States, but its single shot format is preferred for hard-to-reach populations such as the homeless and people living in the United States. remote areas.
Play this Bloomberg podcast: “Doubt”
States are disappointed by the pause because there was so much demand for J&J shots, which is also easy to store, they just need refrigeration, he said. Marcus Plescia, chief physician of the Association of State and Territorial Health Officials.
“The concern is if they have a hard time making a decision this Friday,” he said, “what’s the end point that will allow them to make a decision?”
– With the assistance of John Lauerman
(Updates with comments from ACIP members from the third paragraph)