Johnson and Johnson’s one-dose coronavirus vaccine shows promise of being safe and effective with fewer side effects than other vaccines. The results of early trials were published in the New England Journal of Medicine.
The two vaccines approved by the FDA — Moderna and Pfizer/BioNTech — both require two doses about three weeks apart to become fully effective. The Pfizer vaccine has shown some worrying side effects in a small percentage of patients, including allergic reactions that could become life-threatening. There is less data on the Moderna vaccine but side effects have also been a problem.
J&J scientists randomly assigned healthy adults between the ages of 18 and 55 and those 65 and older to receive a high or low dose of its vaccine — called Ad26.COV2.S — or a placebo. Some participants in the 18-to-55 age group were also selected to receive a second dose of the vaccine.
Most of the volunteers produced detectable neutralizing antibodies, which researchers believe play an important role in defending cells against the virus, after 28 days, according to the trial data. By day 57, all volunteers had detectable antibodies, regardless of vaccine dose or age group, and remained stable for at least 71 days in the 18-to-55 age group.
The most common side effects were fever, fatigue, headache, muscle aches, and pain at the injection site, according to the trial data, with fewer side effects for those in the older age group.
Another potential advantage with the Johnson & Johnson vaccine is that the logistics of delivering and storing it are far less complicated.
Stoffels said the company plans to ship the vaccine at 2 to 8 degrees Celsius, which is about 36 to 46 degrees Fahrenheit.
“We have three months stability as of this moment at 2 to 8,” he said. “That will be expanded over the year as we generate more stability data. We know from our other vaccines it can go up to a year, but at the start we can’t do that because we don’t have it for this vaccine.”
In contrast, the COVID vaccine developed by Pfizer has to be stored at -94 degrees and needs specialized refrigeration to be stored and shipped. Being able to ship the Johnson & Johnson vaccine in regular refrigeration units will cut costs dramatically and make the vaccine more widely available.
If the new vaccine proves safe and effective, you have to wonder what’s going on in the minds of Chinese and Russian leaders. The Johnson & Johnson alternative will be the third vaccine approved by the FDA that’s safe and effective up to 95 percent of the time. Russia’s rollout of its Sputnik V coronavirus vaccine has been a disaster. No one believes the official statistics about its efficacy or how many Russians have been vaccinated with it.
But the Kremlin’s desire to be one of the world’s top performers is raising fresh concerns that its coronavirus-related numbers, once again, don’t add up. Independent analysis suggests Russia could be overstating the number of people it has vaccinated by five-fold.
The debate surrounding the vaccine echoes Moscow’s early statements that it was handling the pandemic better than other countries by keeping testing rates higher and cases and deaths lower — even as evidence mounted of a potentially dramatic undercount of the virus’ true toll.
Some analysts believe that Russia is slow-walking mass vaccinations because they know far more effective vaccines are on the way.
Meanwhile, the results of studies for China’s vaccine show that only 50 percent of those receiving it are immune. China calls that “acceptable” which I suppose you can say when you’ve got a population of 1.4 billion.