The U.S. Food and Drug Administration authorized use of the single-dose shot on Saturday based on its 66% effectiveness at preventing moderate to severe Covid-19 disease in a large study that also showed it was safe. It was the third Covid-19 vaccine cleared by the FDA, after the agency’s clearance in December of shots from Pfizer Inc. with its partner BioNTech SE and from Moderna Inc.
With the FDA authorization, the U.S. Centers for Disease Control & Prevention’s Advisory Committee on Immunization Practices will soon issue recommendations on who should receive the vaccine and how it should be distributed.
The Johnson & Johnson vaccine is effective in preventing severe illness, hospitalization and death from COVID-19. Unlike previous vaccines approved by the FDA, this vaccine requires only one dose, and its less stringent storage requirements make it easier to transport and use. Once the CDC makes recommendations on who should receive the vaccine, Hawaiʻi state leaders will be able to move forward in coordinating distribution.
J&J said after the FDA clearance that it had started to ship doses of its vaccine for allocation and distribution by the federal government. The doses are expected to start reaching vaccine providers in the U.S. in the coming days, with vaccinations starting soon afterward. J&J expects to ship about four million doses right away, and to deliver another 16 million by the end of March. By the end of June, J&J expects to provide a total of 100 million doses for use in the U.S. The federal government has purchased the doses and is making them available free to people. The new supplies should help more people get vaccinated, especially after J&J increases its output. Yet health authorities don’t expect the availability of three shots will mean that many people will start having a choice among them soon. Each of the three authorized shots works well, according to the authorities, who encourage people to get whichever vaccine they can get.
The CDC’s vaccine advisory committee members—physicians, public-health officials and infectious-disease specialists—discussed the clinical evidence for J&J’s vaccine during an online meeting. Members of the committee generally had favorable comments about the vaccine, but some expressed concerns. One concern was that in the large clinical trial, J&J’s vaccine appeared to be less effective among people age 60 and older who had certain medical conditions such as diabetes and hypertension. The efficacy among American Indian and Alaska Natives also was lower than the overall efficacy in the study. Committee members also began to wrestle with the potentially difficult task of comparing the three authorized vaccines and giving guidance about whether people should choose one over the others. The question has arisen partly because the overall efficacy of J&J’s vaccine in a large trial was lower than that for Pfizer’s and Moderna’s from separate trials.
J&J’s Macaya Douoguih, head of clinical development and medical affairs with J&J’s Janssen pharmaceuticals unit, said those results should be interpreted with caution because they are based on a relatively small number of Covid-19 cases in that subgroup. She said it wasn’t in line with the rest of the trial data, which support that the vaccine provides protection.
For now, the committee isn’t expressing a preference, with members saying it is tough to compare and contrast the vaccines across different trials, and that all three were generally safe and effective. “We want to make sure the public understands the best vaccine is the one they can get access to,” said Dr. Jason Goldman, a liaison to the committee from the American College of Physicians
The addition of the J&J vaccine is expected to boost the mass vaccination campaign aiming to bring the pandemic under control. Demand for the previously authorized vaccines has outpaced supply so far. More than 75 million of the 96.4 million doses distributed nationwide have been administered, according to the CDC.
A release from The Hawaiʻi State Department of Health stated once the CDC makes a recommendations on who should receive the vaccine, Hawaii state leaders will be able to move forward in coordinating distribution.
“Today’s announcement validates the FDA’s findings that this vaccine is safe and effective at preventing severe illness, hospitalization, and death,” Hawai‘i State Health Director Dr. Elizabeth Char said. “Johnson & Johnson’s one-dose regimen and less stringent handling requirements will bolster Hawaii’s vaccination efforts. We look forward to reviewing the CDC’s recommendations so we can make informed distribution decisions.”
The Hawaiʻi State Department of Health is anticipating delivery of 67,280 doses of COVID-19 vaccines this week.
This includes 28,080 doses of Pfizer vaccines, 27,300 doses of Moderna vaccines, and 11,900 doses of Johnson & Johnson vaccines. The first shipment Johnson & Johnson vaccines will not arrive today but is expected to arrive within the next few days. All counties will all be receiving Johnson & Johnson vaccines.
The 67,280 doses the state expects to receive this week does not include an additional 10,380 doses the federal government is expected to ship directly to CVS / Longs this week as part of the Federal Retail Pharmacy Program.
