51成人动漫

Pfizer and Moderna's COVID-19 vaccines are recommended over Johnson & Johnson's for all adults, the CDC's Advisory Committee on Immunization Practices (ACIP) said on Thursday.

The ACIP voted 15-0 that either of the two mRNA vaccines are preferred over the Johnson & Johnson vaccine for adults ages 18 and older. This interim recommendation applies to the vaccines both as a primary series and a booster dose. Previously, the committee had no preferential recommendation for any COVID vaccine.

Many committee members wanted more forceful language, such as "strongly preferred," but CDC staff noted that the strength of the recommendation would be communicated in the clinical considerations.

After the meeting, CDC endorsed these updated recommendations, noting that they follow similar recommendations from Canada and the U.K.

"The U.S. supply of mRNA vaccines is abundant -- with nearly 100 million doses in the field for immediate use," the agency said in a statement. "Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to Johnson & Johnson's COVID-19 vaccine."

The change was due to updated data on the rare complication, thrombosis and thrombocytopenia syndrome (TTS) associated with the vaccine. The FDA for emergency use authorization (EUA) of Johnson & Johnson COVID vaccine on December 14, adding a contraindication to the vaccine for adults with a history of TTS following either this vaccine or any other adenovirus-vectored vaccines, such as AstraZeneca's vaccine.

Moreover, they noted TTS was reported in men and women, in a wide range of age ranges, with the highest rate in women ages 30-49 (about 1 case per 100,000 doses). The agency added that about 15% of TTS cases were fatal.

ACIP did not recommend against the vaccine's use due to concerns that it would leave certain adults without protection, such as those with contraindications to mRNA vaccines, homeless individuals, prisoners, and those in rural areas.

"Legitimately, there are some people who might opt for the [Johnson & Johnson] vaccine even after being appropriately informed" about risks of TTS, "and I don't think that it's right for us to make that option unavailable to them," said Beth Bell, MD, of the University of Washington in Seattle.

Oliver Brooks, MD, of Watts HealthCare Corporation in Los Angeles, added that a recommendation against the Johnson & Johnson vaccine could have "worldwide implications that the United States ... [is] not recommending using this vaccine" which may be the only one available in some countries, he said.

Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, New York, likened the committee's choice to the "trolley problem" in ethics, noting that if the vaccine is taken away due to the risk of severe effects, it may put people at risk of severe effects from COVID-19 disease.

Other committee members were less equivocal.

"I cannot recommend a vaccine that's associated with a condition that may lead to death," said Pablo Sánchez, MD, of The Ohio State University – Nationwide Children's Hospital in Columbus. "I'm not recommending it to any of my patients' parents. I tell them to stay away from it."

However, liaison members said that having a preferential recommendation would help them when their patients ask about which vaccine they should get.

CDC staff presented more detailed data on the 54 cases of TTS in the U.S., and nine TTS deaths. Median age of cases was about 45, but ranged in age from 18 to 70. Thirty-seven cases were in women, and 83% were white. More than half (54%) of cases had cerebral venous sinus thrombosis (CVST). All these cases occurred after one dose of the vaccine.

Median time from vaccination to symptom onset was 9 days. All patients were hospitalized, including 36 who were administered to the ICU. They stayed for a median of 9 days, and 37 were discharged home.

Among the nine deaths, all had features of severe CVST, seven with confirmed CVST and four received craniectomy or craniotomy for a brain hemorrhage. None received heparin.

Isaac See, MD, of the CDC, noted that median time from admission to death was 1 day.

"We've been struck when we've been doing these cases by how quickly the patient deteriorates," he said.

ACIP Chair Grace Lee, MD, of Stanford University, who was one of the strongest proponents for continuing to recommend the Johnson & Johnson vaccine for all adults after the pause in its use in April, said that the ACIP thought that early recognition of TTS and appropriate management might alleviate these cases.

"I don't think we ... had enough information to see what the outcome following TTS would look like," she said. "We've been presented information that suggests it really is challenging for us as clinicians to mitigate the risk of severe complications."

"In most cases, it's too rapid for much more to be done," See said.

As usual, all recommendations by ACIP are not considered final until they are published in the Morbidity and Mortality Weekly Report.

Comment