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Johnson & Johnson’s single-dose COVID-19 vaccine candidate shows promise based on early results from the ongoing trial published in the New England Journal of Medicine.
The phase 1-2a trial, which began in July 2020 in the United States and Belgium, includes a total of 805 study participants – healthy adults between 18 and 55 years old and those aged 65 and over. plus – who have randomly received high or low doses of the COVID-19 Vaccine Candidate or a placebo.
Early data shows that after a single dose of the vaccine candidate, neutralizing antibodies to COVID-19 were found in 90% or more of study participants on day 29 of the trial, regardless of the dose of vaccine administered, and 100% of participants aged 18. at age 55 on day 57, according to the study. A Johnson & Johnson press release on the study said the antibodies “remained stable through day 71” – the length of time measured so far in the current trial.
Data on the duration of the immune response in trial participants over 65 will be available in late January, according to the press release, which also noted that the researchers plan to do “longer-term follow-up as well.” up to one year ”. According to CNBC, “The company is expected to release the results of its Phase III trial of 45,000 people later this month.”
The study found that the vaccine candidate was “generally well tolerated” in all study participants. The most common side effects included fatigue, headache, muscle aches and pain at the injection site, and fever.
Dr Purvi Parikh, allergist and immunologist for the Allergy and Asthma Network, told Yahoo Life that the vaccine candidate is “very promising if it proves effective” in the next phases of the trials. “So far from the first data on 800 participants, it seems 90 percent of the participants got immunity one month after the stroke and all had it two months after. Now we need to see how reproducible this is in the larger phase III studies with 30,000 to 60,000 people. We also need to see how this prevents infection and spread. “
Dr. Philip Grant, an infectious disease physician and principal investigator of the Johnson & Johnson COVID-19 vaccine trial at Stanford University, tells Yahoo Life the study results are “encouraging,” adding: “I am optimistic.”
Grant says early trials show “a good immune response” to the vaccine without many side effects. “I think it’s encouraging that it’s being well tolerated,” Grant says.
It is not yet clear how protective the Johnson & Johnson vaccine is against COVID-19 (Pfizer and Moderna are around 95% effective). Grant explains that the phase III trial will show what the percentage of effectiveness will be.
How does the Johnson & Johnson COVID vaccine candidate work?
Johnson & Johnson’s vaccine candidate uses an adenovirus (a common virus that causes cold-like symptoms) that has been modified so that it cannot replicate and make people sick. “The adenovirus carries a coronavirus gene in human cells, which then produce the coronavirus spike protein, but not the coronavirus itself,” according to a statement from Johnson & Johnson. “This spike protein is what prepares the immune system to fight off further infection with the virus.”
Adenoviruses have been used for years in other drugs – for example, Johnson & Johnson used it in their Ebola vaccine, saying in the statement that there is “a lot of long-term safety data for it” .
Pfizer and Moderna’s COVID vaccines, meanwhile, use mRNA technology, which “instructs our cells to make a harmless piece of what’s called ‘spike protein’,” according to the Centers for Disease Control. and Prevention found on the surface of the virus that causes COVID-19. “Our immune system recognizes that protein has no place and begins to build an immune response and make antibodies. … At the end of the process, our body has learned how to protect itself against future infections.
How is the Johnson & Johnson COVID vaccine candidate different from Pfizer and Moderna vaccines?
Johnson & Johnson’s COVID-19 vaccine candidate requires only one injection – what Grant calls a “huge” advantage over the vaccines from Pfizer and Moderna, which both require a second dose spaced 21 days and 28 days apart, respectively. days.
Another plus: Johnson & Johnson’s COVID vaccine “can be stable for several months in routine refrigerators only,” Grant says. “The distribution will therefore be similar to most of the others [non-COVID] vaccines. ”However, Pfizer’s vaccine must be shipped in extremely cold temperatures (-70 ° C) and can only be stored for five days at a refrigerated temperature of 2 ° C to 8 ° C. Moderna’s vaccine must also be stored in a freezer between -25 ° C and -15 ° C.
What would a third vaccine mean for vaccine deployments in the United States?
Grant and Parikh agree that a third vaccine option could potentially help speed up vaccinations in the United States. “It would definitely help to achieve collective immunity faster, because there would be more vaccines,” Parikh says, “and with just one dose we can get people vaccinated faster. “
More than 9 million Americans were vaccinated just a month after the first COVID-19 vaccine was administered in the United States. Grant says that while the goal is to have at least 150 million people vaccinated by the summer, “you can see we’re way behind on that pace to get to that number. … Unless there is another vaccine, it does not appear to be happening.
Grant adds, “Given the current pace, it looks like we wouldn’t be out of the woods until October, if we’re optimistic. I think this [third vaccine] Would potentially bring us to the point where in summer we are in a much better place than now.
What happens next?
If Johnson & Johnson’s single-dose COVID vaccine candidate is found to be safe and effective in its Phase III trials, the company will submit an emergency use authorization (EUA) application to the Food and Drug Administration. United States, according to the press release. . Grant estimates that the earliest the vaccine could get EUA is in February, the first person who can potentially receive the vaccine in late February or early March at the earliest.
For the latest news and updates on the coronavirus, follow to https://news.yahoo.com/coronavirus. According to experts, people over 60 and those with compromised immune systems continue to be at greatest risk. If you have any questions, please consult the CDC‘the sand WHO resource guides.
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