The new recommendation: “mRNA vaccines are preferred over the Janssen Covid-19 vaccine for the prevention of Covid-19 for those 18 years and over.”
Earlier Thursday, the CDC’s Advisory Committee on Immunization Practices approved the updated recommendation after hearing new data indicating that a rare thrombosis syndrome is more common among people who have recently received a J&J vaccine than previously thought. CDC Director Dr. Rochelle Walensky accepted the updated recommendation within hours.
The CDC has registered 54 cases in the United States of thrombosis with thrombocytopenic syndrome or TTS in the United States since the vaccine became available. Nine people have died ̵[ads1]1; seven women and two men.
Prices are higher than previously estimated among both men and women, CDC’s Dr. Isaac See said at the meeting. While only a few cases have been seen for every million people vaccinated by age group, they are higher than previously thought when vaccine counselors were briefed.
“We have been hit after reviewing these cases of how quickly a patient worsens … to death,” See said. Symptoms always begin within two weeks of the vaccine and on average within nine days.
“The US TTS case reporting rate after Janssen Covid-19 vaccination is higher than what was previously presented for ACIP and the case reporting rate for men 40-49 years and for women 50-64 is similar to that for women 18-29 years,” See told the meeting.
39 of the 54 reported cases occurred before the CDC and US Food and Drug Administration stopped administering the vaccine in April to investigate the link. The agencies resumed the permit to use the vaccine later in April. Since then, the CDC has been informed of several cases, See said.
“The rates are now a little higher for all age groups,” he said. The highest incidence of TTS is among women – 10 per million vaccinations given in women aged 30 to 39 and 9 per million in women aged 40 to 49.
The committee weighed risks and benefits
The total risk of developing TTS is 3.8 cases per million given doses. The death rate is less than one per million given doses: 0.57 per million. The risk is higher for women than for men, but they are higher among men than previously known, said CDC’s Dr. Sara Oliver.
ACIP members reviewed the new data and weighed them against a series of studies showing that J & J’s vaccine is less effective than the Moderna and Pfizer / BioNTech vaccines in preventing infection.
“The U.S. supply of mRNA vaccines is plentiful – with nearly 100 million doses in the field for immediate use,” the CDC said later Thursday when it approved the vote.
“This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom. Given the current state of the pandemic both here and around the world, ACIP reaffirmed that it is better to receive any vaccine than to be unvaccinated. “add it.
“Individuals who are unable or unwilling to receive an mRNA vaccine will still have access to Johnson & Johnson’s COVID-19 vaccine.”
ACIP also discussed the risk of completely removing J & J’s vaccine as an alternative, as well as potential confusion and mistrust that may be caused by changed recommendations about the vaccine. “We want to emphasize the importance of training in the risk of these incidents,” Oliver said at the meeting.
“VE (vaccine efficacy) is lower for the Janssen vaccine compared to mRNA vaccines,” said Oliver.
The risk of myocarditis – a rare condition of the heart – is lower for the Moderna and Pfizer / BioNTech vaccines than the risk of blood clots from the J&J vaccine. But younger men may be advised to avoid mRNA vaccines, so Oliver said that complete removal of the recommendations for the J&J vaccine would cause problems. “It would remove the possibility of the vaccine for younger men, who are at higher risk for myocarditis,” she said.
In addition, the Janssen vaccine is often the only shot available to prison populations, the homeless and other high-risk groups.
Concerns about weakening confidence in vaccines
There may be other consequences of a decision to remove support from the J&J vaccine, Oliver warned. “Reduced access could undermine confidence in the COVID-19 vaccine program,” she said. “Lack of vaccine choice can contribute to mistrust and misinformation about available covid-19 vaccines,” she added.
Earlier this week, the FDA strengthened the language in the fact sheet that accompanies the Janssen vaccine, saying that it should not be given to anyone with a history of TTS. However, there is no clear risk factor for predicting who will develop the condition after receiving the vaccine, the CDC said.
The changes in the recommendation should assure Americans that public health experts monitor the safety of the vaccines, ACIP members said.
“I want to remind everyone that this is in part a reflection of the strength of our vaccine safety monitoring system,” said Dr. Matthew Daley of the Institute for Health Research at Kaiser Permanente Colorado at the meeting.
“This whole process should increase confidence in our vaccine safety monitoring system,” Dr. Sandra Fryhofer of Emory University and a non-voting contact person for the American Medical Association Committee said.
“I think this vaccine needs to be made available,” she added. “We need a number of vaccine platforms.”
The Pfizer / BioNTech and Moderna vaccines use a technology known as messenger RNA or mRNA to elicit an immune response, while the Johnson & Johnson vaccine uses a so-called vector – a non-replicating cold virus called an adenovirus – to carry the active vaccine material. into the body.
Different types of vaccines stimulate different immune responses. That can be important, Fryhofer said. “We do not know which variant is next,” she said.
About 16 million Americans have received the Janssen vaccine.
Dr. Penny Heaton, global therapeutic leader for vaccines at Janssen, told the meeting that the J&J vaccine is unique.
“We are confident in the positive benefit / risk profile of our vaccine. It saves lives in the United States here today and on all continents around the world. Our vaccine is diverse. It is long-lasting. It provides high levels of protection, and it provides breadth of protection, Heaton said at the meeting. “It’s easy to store and transport.”
Heaton said the J&J vaccine provides another type of immunity that grows more slowly but lasts longer. It is a single-dose vaccine, but the CDC now recommends that anyone receiving it receive a booster dose of available vaccine.
“Even in the United States, given its lasting protection, it may be the preferred choice for people who cannot or will not return for multiple vaccinations,” Heaton claimed. She said that the company has several studies underway to understand risk factors for TTS.
“Although TTS continues to be a rare occurrence, unfortunately there are no cases of Covid-19,” she said, noting that Covid-19 has a much higher risk of blood clots than vaccination.