One-shot vaccine might be OK’d by this weekend
FDA committee will look at data today; doses shipped on Saturday
A third U.S. vaccine for COVID-19 — created by Johnson & Johnson, the company best known for producing Band-Aids — is on the way, promising to improve the speed and ease of our path to a post-pandemic world.
If approved after a review today by the FDA’s Vaccines and Related Biological Products Advisory Committee, the vaccine could be authorized as soon as Saturday. The company plans to begin shipping immediately.
While not quite as effective as existing Pfizer-BioNTech and Moderna vaccines, this drug has two huge advantages: It’s easy to store and ship and it works after only one shot.
“It’s not the world’s best at preventing you from becoming infected or developing minor respiratory symptoms,” according to Dr. Warner Greene, professor of medicine at UC San Francisco and the founding and emeritus director of Gladstone Institute of Virology and Immunology. “But this vaccine protects you from severe disease — having to go to the hospital and dying. And frankly, that’s what we want from a vac
cine. That is fantastic.”
Here’s what to know about this new vaccine:
Q
How effective is it?
A In U.S. trials, the Johnson & Johnson vaccine provided complete protection against death from COVID-19 28 days after vaccination. The rate at which it prevented less severe infections was 72% in U.S. trials 28 days after the shot. In all trials in the U.S., Latin America and South Africa, the vaccine was 85 percent effective in preventing severe disease.
The overall efficacy rates of Moderna and Pfizer-BioNTech vaccines are higher — both about 95%. But comparing the three vaccines is challenging because of differences in the designs and dosing regimens of the clinical trials, experts said.
Q How does the new vaccine work?
A The J&J vaccine uses a harmless virus, called an adenovirus, to carry a genetic code. The Pfizer-BioNTech and Moderna vaccines are made using messenger RNA, or mRNA, a technology that delivers a bit of genetic code to cells.
In all three vaccines, this code acts like a recipe to make a protein, called a spike. Our body sees this spike protein as an invader and triggers the immune system, producing
antibodies and T cells.
If the body later encounters the actual COVID-19 pathogen, it is able to respond faster and more effectively, as immune cells and antibodies specific to the virus are produced rapidly in the body to prevent disease.
Q What is the advantage to J&J’s approach?
A It makes it a simple one-dose shot. That’s a huge advantage when it comes to vaccinating as many people as possible, especially in rural areas.
It’s also more convenient to ship and store. It doesn’t need ultra-cold storage, like the Pfizer-BioNTech and Moderna vaccines. Instead, it can be kept at standard refrigerator temperatures for three months.
“We can set up more mobile units — ‘pop ups’ — that can really help get vaccine into the venues where some of our hardto-reach populations are,” Dr. Virginia A. Caine, director of Indiana’s Marion County Public Health Department, said at a Centers for Disease Control and Prevention forum on Wednesday.
Q Can the new vaccine defend against dangerous variant viruses?
A There is good news on that front. The Johnson & Johnson vaccine was tested at the height of the global pandemic. Its effectiveness was not influenced by the high prevalence of a variant in Brazil. In South Africa, with a different variant virus, the vaccine reduced severe or critical COVID-19 by 81.7% starting 28 days after vaccination. It was 64% effective against more moderate disease. In response, last week the South African government switched to J & J’s vaccines, instead of using Novavax or AstraZeneca vaccines.
Because Pfizer-BioNTech and Moderna’s vaccines were tested before the emergence of these troubling new variants, it’s not entirely clear how well they will work. In the lab, however, they showed a decreased ability to neutralize the strain now dominant in South Africa, worrying some researchers.
Q Is there a plan if it fails to work against a variant?
A Yes, it can be adjusted, or boosted. It’s relatively easy to modify all three vaccines. With the Pfizer-BioNTech and Moderna vaccines, scientists just synthesize a different strand of messenger RNA, Georgetown University virologist Angela Rasmussen said on the “Track the Vax” podcast. It’s the same with the viral vector vaccines like J&J’s, she said, “although it’s a little bit more complicated. They still are recombinant vaccine viruses and they can be edited quite easily in a lab to cover these variants.” Q Are there side effects?
A Side effects seem milder, and there were no reports of severe allergic reactions.
All three vaccines have modest side effects, such as pain at the injection site, fatigue, headache, muscle pain and joint pain. This doesn’t mean they’re unsafe. Rather, it shows that the immune system is kicking into gear.
Unexpected side effects for the J & J vaccine occurred at the same rate overall among volunteers who received vaccine and placebo: about 0.5%. A few rare conditions appeared more common with the vaccine, such as blood clotrelated conditions or tinnitus, a ringing in the ears.
Significantly, because no one suffered a severe allergic reaction, also known as anaphylaxis, which is seen in Pfizer-BioNTech and Moderna vaccines, people who get the J&J vaccine might not have to be monitored for 15 minutes after injection; easing and speeding up clinics.
Q Wait. Isn’t Johnson & Johnson a Band-Aid company?
A True. It was founded in the 1890s to sell disinfectants, bug-killing fumigants and a soap to wash dogs. In the 1920s, it invented the indispensable Band-Aid.
But now it’s focused on harder problems. The company was one of the first to vaccinate its employees during our devastating smallpox outbreak. It created an Ebola vaccine. In January 2020, it launched a major research effort for a COVID-19 vaccine.
Q When will people get the new vaccine?
A Due to manufacturing issues, there will only be about 4 million doses of its COVID-19 vaccine available to ship immediately as soon as the vaccine is authorized.
That’s far less than the 12 million doses the company originally promised by the end of February. And it’s a drop in the bucket to protect the estimated 260 million vaccine-eligible Americans.
But it’s ramping up. The company said it will deliver enough doses by the end of March to vaccinate more than 20 million Americans. It promises 100 million doses by the end of June. Globally, Johnson & Johnson has far larger dreams, aiming to produce 1 billion doses by the end of 2021.