On Friday, a government advisory committee voted unanimously to recommend authorizing Johnson & Johnson's (J&J's) single-dose COVID-19 vaccine for use in adults.
FDA works to start rolling out J&J's single-dose COVID-19 vaccine
Committee member Dr. Archana Chatterjee, dean of the Chicago Medical School, said after casting her vote that she thinks authorization of J&J's single-dose vaccine will help meet the present needs. J&J's COVID-19 vaccine would be the third vaccine distributed in America, joining Pfizer-BioNTech and Moderna that provided shots to 46 million people since December.
The approval of the Food and Drug Administration advisory board, known as the Advisory Committee on Vaccines and Associated Biological Products, was required after the company followed all the requirements to be approved by the FDA last year for a vaccine: a large-scale trial showing efficacy and evidence that the company can reliably and safely develop the vaccine. According to USA Today via MSN, both three vaccines are safe and effective, said several committee members after the vote.
Dr. Cody Meissner, chief of pediatric infectious disease at Tufts University School of Medicine in Boston, said that people must not think that one vaccine is better than the other. While Dr. Arnold Monto, the committee's acting chair and an epidemiologist at the University of Michigan School of Public Health, added, "In this environment, whatever you can get, get."
US advisers endorse J&J's single-shot COVID-19 vaccine
On Friday, U.S. health advisors supported a one-dose COVID-19 vaccine from J&J, placing the world on the brink of adding an alternative that is easier to use to fight the pandemic. In a tweet, the FDA acting director said the department would work immediately to implement the decision.
This would make J&J's shot the third vaccine approved for emergency use in the United States. Vaccinations are reaching momentum. However, to keep ahead of a mutating virus that has killed more than 500,000 Americans, new supplies are desperately needed, the AP News reported.
The FDA panelists voted unanimously after day-long talks that the vaccine's effects outweighed the risks for adults. Shipments of a few million doses may start as soon as Monday if the FDA takes a final decision.
More than 47 million people in the U.S., or 14 percent of the population, have received at least one injection of the two-dose Pfizer and Moderna vaccines approved by the FDA in December. However, insufficient supplies and disruptions caused by winter storms have delayed vaccines.
Although early J&J supplies will be limited by the end of March and a total of 100 million by the end of June, the company has said it can supply 20 million doses. The J&J vaccine protects against the worst COVID-19 effect after one shot. It can be kept at refrigerator temperatures for up to three months, making it simpler to treat than the previously frozen vaccines. With the first U.S. vaccinations' remarkable success, one obstacle in carrying out the new vaccine would be describing how protective the J&J shot is.
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J&J would roll out 3-4 million doses next week
The single-dose COVID-19 vaccine from J&J was 100 percent successful in avoiding deaths from coronavirus in trials, and 66 percent of mild to severe infections were avoided. The vaccine was 64 percent successful in South Africa experiments, where the worrisome B1351 form is prevalent.
The panel was particularly pleased to hear that vaccines can be kept at only 35.6 and 46.4F in the refrigerator, as per Daily Mail on MSN. One of the panelists, Dr. Ofer Levy, a professor at Harvard Medical School and director of Boston Children's Hospital's vaccine program, described this as "very practical for rural areas in the United States and around the world."
In a 44,000-person trial, J&J's single-dose COVID-19 vaccine has reduced the incidence of side effects. Sixty-one percent of respondents had a response.
But just 2.3 percent were considered severe. Nausea, fatigue, headaches, body aches, or fevers are present in most patients who have had side effects.
The J&J vaccine can be kept at normal temperatures in the refrigerator, making it cheaper to administer than the Pfizer Inc/BioNTech SE and Moderna Inc vaccines that use mRNA technology and must be delivered frozen. If the FDA's acting commissioner confirms, three to four million doses of the J&J's single-dose COVID-19 vaccine are likely to be carried out next week.
