Here’s what you need to know about Johnson & Johnson’s single dose COVID vaccine, which experts call ‘very promising’

Johnson & Johnson’s single-dose COVID-19 candidate vaccine looks promising based on the initial results of the ongoing trial published in New England Journal of Medicine.

The phase 1-2a trial, which began in July 2020 in the US and Belgium, includes a total of 805 study participants – healthy adults between 18 and 55 years of age and those 65 and older – who were randomly assigned high or low doses of Candidate Vaccine COVID-19 or a placebo.

The first data show that, after a single dose of the candidate vaccine, neutralizing antibodies against COVID-19 were found in 90 percent or more of study participants on day 29 of the trial, regardless of the dose of the vaccine administered, and 100 percent of participants aged 18 to 55 on day 57, according to the study. A Johnson & Johnson press release about the study said the antibodies “remained stable until day 71” – the time period measured so far in the ongoing test.

Data on how long the immune response lasts in trial participants over 65 will be available at the end of January, according to the press release, which also noted that the researchers plan to do a “one-year long-term follow-up” too. According to CNBC, “the company is expected to disclose the results of its phase III test with 45,000 people later this month.”

An illustrative image of medical syringes in front of the Johnson and Johnson logo displayed on a screen.  On Friday, January 8, 2020, in Dublin, Ireland.  (Photo by Artur Widak / NurPhoto via Getty Images)
Previous data show that, after a single dose of the candidate vaccine, neutralizing antibodies against COVID-19 were found in 90 percent or more of study participants on day 29 of the study, regardless of the dose of the vaccine administered. (Photo by Artur Widak / NurPhoto via Getty Images)

The study found that the candidate vaccine was “generally well tolerated” in all study participants. The most common side effects include fatigue, headache, muscle pain and pain at the injection site, in addition to fever.

Dr. Purvi Parikh, an allergist and immunologist at 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 tests. “So far, based on the initial data from 800 participants, it appears that 90% of the participants increased their immunity one month after the injection and all received it two months later. 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 it prevents infection and spread. “

Dr. Philip Grant, an infectious physician and principal investigator for the Johnson & Johnson COVID-19 vaccine trial at Stanford University, told Yahoo Life that the results of the study are “encouraging”, adding, “I am optimistic.”

Grant says the first tests show the vaccine’s “good immune response” without many side effects. “I think it is encouraging that it is well tolerated,” says Grant.

It is not yet known to what extent the Johnson & Johnson vaccine is protective against COVID-19 (both Pfizer and Moderna are about 95% effective). Grant explains that the phase III study will show what the percentage of effectiveness will be.

How does the Johnson & Johnson COVID candidate vaccine work?

The Johnson & Johnson vaccine candidate uses an adenovirus (a common virus that causes cold-like symptoms) that has been modified so that it does not replicate and make people sick. “Adenovirus carries a coronavirus gene into human cells, which then produce the coronavirus spike protein, but not the coronavirus itself,” according to a statement from Johnson & Johnson. “This peak protein is what prepares the immune system to fight a subsequent infection with the virus.”

Adenoviruses have been used in other drugs for years – for example, Johnson & Johnson used them in their Ebola vaccine, stating in the statement that “there is a lot of long-term safety data for this”.

Pfizer and Moderna’s COVID vaccines, on the other hand, use mRNA technology, which gives “instructions for our cells to make a harmless piece of what is called ‘peak protein'”, according to the Control and Control Centers. Disease Prevention, which is found on the surface of the virus that causes COVID-19. “Our immune system recognizes that the protein doesn’t belong there and starts building an immune response and producing antibodies. … At the end of the process, our bodies learned how to protect themselves from future infections. “

How else is the Johnson & Johnson COVID candidate vaccine different from Pfizer and Moderna vaccines?

Johnson & Johnson’s COVID-19 vaccine candidate requires only a single injection – what Grant calls a “huge” advantage over Pfizer and Moderna vaccines, which require a second dose at 21 and 28 days, respectively.

Another advantage: Johnson & Johnson’s COVID vaccine “can be stable for several months only in routine refrigerators,” says Grant. “Therefore, the distribution will be similar to most other [non-COVID] vaccines. “The Pfizer vaccine, however, needs to be shipped at extremely low temperatures (-70 ° C) and can be stored for only five days in a refrigerated temperature of 2 ° C to 8 ° C. The Moderna vaccine also must be stored in a freezer between -25 ° C and -15 ° C.

What would a third vaccine mean for the launch of vaccines in the USA?

Both Grant and Parikh agree that a third vaccine option could potentially help accelerate vaccinations in the United States. “This would definitely help achieve collective immunity more quickly, as there would be more vaccine supply,” says Parikh, “and with just one dose we can get people vaccinated faster. “

More than 9 million Americans were vaccinated just one month after the first COVID-19 vaccine was administered in the United States. Grant says that if the goal is to vaccinate at least 150 million people by the summer, “you can see that we are far behind schedule to reach that number. … Unless there is another vaccine, it doesn’t look like it will happen. “

Grant adds: “Based on the current pace, it looks like we wouldn’t be out of danger until October, if we’re optimistic. i think this [third vaccine] it would potentially take us to the point where, in the summer, we would be in a much better place than we are now. “

What happens next?

If Johnson & Johnson’s single-dose COVID candidate vaccine proves to be safe and effective in its phase III trials, the company will file an application for Emergency Use Authorization (USA) with the US Food and Drug Administration, according to the press release. Grant estimates that the earliest the vaccine can get in the USA is in February, with the first person potentially receiving the vaccine in late February or early March, at the earliest.

To latest coronavirus news and updates, go together on https://news.yahoo.com/coronavirus. According to experts, people over 60 and immunocompromised remain the most at risk. If you have questions, consult the CDC‘sand Who is it resource guides.

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