The United States could be receiving a third COVID-19 vaccine as soon as next month.
Johnson & Johnson announced Friday that its single-shot COVID-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease, according to national media reports.
The preliminary statement says the vaccine was 72% efficacious in preventing COVID-19 in the U.S. population, but only 57% efficacious in preventing COVID-19 in South Africa, where a new mutation, B.1.351, is now the dominant virus strain.
The company plans to apply for U.S. Food and Drug Administration emergency-use authorization on Feb. 5, and at that time, the complete set of trial data will be made available for review by experts as well as the medical community and the public.
The authorization could be granted as soon as Feb. 12.
The vaccine requires only one shot, and can be stored in a refrigerator for three months and stay viable under those conditions.
Johnson & Johnson has produced 7 million doses as of Friday, and is slated to have 30 million by the end of April.
“Providing the FDA EUA is granted in mid-February, I am excited to see another vaccine to become available in the near future,” Dr. Henning Ansorg, Santa Barbara County’s public health officer, told the News-Press. “The simplicity of the one shot regimen and the less complicated storage requirements will make it a preferred vaccine option for certain situations (smaller practices, use in mobile units to reach out to homeless or other vulnerable populations where a follow up for the second dose can be difficult to guarantee).”
Dr. Lynn Fitzgibbons, a Cottage Health infectious disease specialist, said she’s “very excited” to hear the news, but added that it’s important to remember that this vaccine is very different from the Moderna and Pfizer vaccines the country is already using.
“We’re comparing apples to oranges,” she told the News-Press. “The mRNA vaccines have been very effective, but they’re designed differently.”
She said that because mRNA vaccines have to be stored in very cold temperatures, they’re not feasible in some parts of the world and the U.S. because they require such large logistical operations to ensure a huge population of people can receive not just one dose, but two.
“The fact that the J&J vaccine can be refrigerated and not frozen for up to three months and have this kind of success with just a single dose, which was its design, I think, is very, very encouraging,” she said.
Dr. Fitzgibbons said she also thinks it’s important for the public to remember that the 95% success rate of the mRNA vaccines such as Pfizer and Moderna “was absolutely unprecedented in the world of clinical vaccine trials.”
“We were pleased historically if we had a flu vaccine that hit between 40 and 60% at one time,” she said. “If the mRNA vaccines, because of their storage requirements and the need for two vaccines, cannot be given to a large group of people, it doesn’t matter if they’re 100% effective. It’s 0% effective for those people that can’t get it, so if we have the ability to vaccinate a larger percentage of the population because of the more practical feasibility of the J&J vaccine, I think 72% is still a very, very good result.”
She added that it’s possible that the Pfizer and Moderna vaccines’ efficacy rate were so high because they had second doses.
“If the J&J was to be replicated with a booster dose, from just a pure immunology perspective, we would absolutely expect it to improve that 72% upwards. Whether that would increase it to 95% or 80% or 99%, I don’t think anyone knows,” Dr. Fitzgibbons said.
She concluded saying that she thinks this news is good and could help Santa Barbara and the nation get the curve under control before any COVID variants get a strong foothold in any of the local communities.
“There are obviously large parts of our communities across the country which have not had good access to vaccines,” she said. “I think that as we diversify the vaccine products that we have access to, as we increase our supply, as we increasingly see vaccines that can be used in deeper corners of our communities without such strict repeat dosing requirements and deep freezer requirements, I really think is nothing but positive in the ongoing fight to try to protect as much of our community as possible.”