Authorization of J&J's COVID-19 Vaccine Increases States' Supplies by 25%

 As expected, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Janssen Pharmaceutical of Johnson & Johnson’s single-shot COVID-19 vaccine. The EUA covers individuals 18 years of age and older.

Unlike the Pfizer-BioNTech and Moderna vaccines, which were authorized late in 2020 and require two doses three or four weeks apart, respectively, the J&J vaccine is a single dose. And while the Pfizer-BioNTech and Moderna vaccines require extreme cold storage, particularly the Pfizer-BioNTech product that requires temperatures as low as -94 degrees F, the J&J vaccine remains stable for two years at -4 degrees F and a maximum of three months at routine refrigerator temperatures.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world—all of whom shared a goal of bringing a single-shot vaccine to the public,” stated Alex Gorsky, chairman and chief executive officer of J&J. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

The company has agreed to deliver 100 million doses of the vaccines by the end of June. It expects to begin delivering the vaccine on March 1 and can distribute more than 20 million doses in the U.S. by the end of March. The initial capacity immediately is about 3.9 million doses, according to Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials, which should increase vaccine capacity for states by about 25%.

Utah Gov. Spencer Cox, for example, told CNN he expects Utah will receive “several thousand doses” over the next several days. “We expect shots in arms this coming week. We know they have about 4 million doses on hand right now ready to go out. They’ll start shipping those out, we believe, on Monday. We should have those shots, we think, on Wednesday. And shots in arms on Thursday and Friday. That’s a big deal for our state and for Americans everywhere.”

Despite how fast the vaccines have been developed, the unprecedented manufacturing and distribution has been criticized for bottlenecks and slow rollout. Currently, Pfizer is ramping up the supply of the vaccine. At the beginning of this month, the company and BioNTech were delivering 4 to 5 million doses weekly. By mid-March, they project it will be 13 million doses per week, with expectations of delivering all 300 million doses it has a contract for with the U.S. government delivered by the end of July. This would allow for full vaccination of 150 million people in the U.S. Moderna said that by the end of March between it and Pfizer, they should have 220 million doses, a dramatic increase from the approximately 75 million delivered so far.

According to the U.S. Centers for Disease Control and Prevention (CDC)’s COVID Data Tracker, as of Sunday, February 28, 96,402,290 doses have been delivered with 72,806,180 having been administered. Of those, 23,698,627 have received two doses.

There has been some concern expressed by the public over the J&J vaccine’s lower efficacy rates than the Pfizer-BioNTech and Moderna vaccines. In J&J’s global clinical trial, it demonstrated 66% efficacy at preventing symptomatic COVID-19 infections. In the U.S. it was slightly higher, 72%. Both the Moderna and Pfizer-BioNTech vaccines demonstrated about 95% efficacy in trials. It’s very difficult to actually compare the results of different clinical trials, for several reasons. One, they don’t necessarily define “severe illness” or even “symptomatic illness” in exactly the same way. And two, they had different trial populations.

One of the key considerations, however, it their ability to prevent severe disease and death. All three appeared to be almost 100% effective in preventing COVID-19-related deaths. J&J’s vaccine was also tested in clinical trials in South Africa and has demonstrated protection against severe disease and death from the South African variant. Neither the Pfizer-BioNTech nor Moderna vaccines have been evaluated against the more virulent South African variant in clinical trials, although they were tested in laboratory assays and the companies have stated the vaccines continue to offer protection against the variants.

All three vaccines have similar side effects, all of which have been quickly resolved. They include fatigue, body aches, soreness at the injection site, nausea and fever. Many people have few, if any, side effects.

Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, told Reuters, “These vaccines are the path to getting your life back. These are vaccines you should not hesitate to get when offered.”

At this time, most vaccination centers are only receiving one brand of vaccine, so few people will have a choice of vaccines, and most experts say you should take what’s offered. The more people that receive the vaccine quickly, the faster the pandemic will end and the less likelihood of more dangerous variants emerging.

Paul Offit, a member of the FDA’s vaccines advisory panel and director of the Vaccine Education Center and attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, told NPR’s Scott Simon on Weekend Edition Saturday, the J&J vaccine “is very effective … at preventing severe disease after a single dose and it induces the kind of response, so-called cellular immune response, that looks like it’s going to have fairly long-lived memory, which is all good. This certainly provides protection against what you care about, which is hospitalization, ICU admission and death. It’s virtually 100% effective at doing that.”

https://www.biospace.com/article/single-shot-j-and-j-covid-19-vaccine-receives-emergency-use-authorization/