While Pfizer and Moderna both have COVID-19 vaccines that may be for emergency use in the U.S., other vaccine candidates are still underway, including a single-dose option from Johnson & Johnson, which has about 45,000 people participating in the ongoing phase 3 clinical trials. . According to early data released by the company, this vaccine also shows great promise.
Interim Phase 1 / 2a data are on January 13 in the New England Journal of Medicine, and the results show that the company’s vaccine candidate created an immune response in patients for at least 71 days – the full time measured so far in the study.
The vaccine was also generally well tolerated by study participants, Johnson & Johnson said in a press release. While the Pfizer and Moderna vaccines are similar, Johnson & Johnson’s vaccine also has many differences. This is what we know so far, plus what lies ahead.
How does the Johnson & Johnson COVID-19 vaccine work?
Johnson & Johnson has a vaccine vaccine that uses double-stranded DNA to promote an immune response in the body. This technology works differently from the mRNA vaccines available from Pfizer-BioNTech and Moderna, both of which use single-stranded RNA.
In the Johnson & Johnson vaccine, researchers added a piece of genetic material from the new coronavirus’ vein protein (the piece that clings to human cells) in another virus, Adenovirus 26, adapted to penetrate the cells, but does not reproduce within them. Adenoviruses are common viruses that usually cause cold symptoms, but because the one used in the vaccine has changed and cannot recur, it can not make you sick. (Other COVID-19 vaccines, including the Oxford and AstraZeneca candidate, use similar adenovirus technology.)
When you get the Johnson & Johnson vaccine, the modified adenovirus that contains a piece of the protein sounds on the surface of your cells. It is drawn inwards, where the modified virus moves to the cell nucleus, home of its DNA. The adenovirus then places its DNA in the nucleus, the vein protein gene is read by the cell and then copied into messenger RNA (mRNA).
Thereafter, the mRNA leaves the nucleus and serves as a set of instructions for other cells, so that they begin to make peak proteins. It is then recognized by your immune system and your body responds by producing antibodies to the perceived threat (although there is no threat).
Your immune system cells then remember how to fight the different pieces of SARS-CoV-2, the new coronavirus. If you come into contact with it in the future, your body will have the ability to fight it more effectively.
This technology is unique, but Johnson & Johnson has a lot of experience with it, as it has already been used for the Ebola vaccine. “They gave hundreds of thousands of doses of this similar vaccine,” which had no major safety concerns, says William Schaffner, MD, a specialist in infectious diseases and a professor at Vanderbilt University School of Medicine.
While still being tested, Johnson & Johnson’s COVID-19 vaccine may just be needed one shot rather than two. The trials so far have found that the administration of either one or two doses of the vaccine elicited an effective immune response against SARS-CoV-2 in study participants, but nothing was left until phase 3 clinical trials were completed. is not and the company has enough data to support the single dose.
How effective is the Johnson & Johnson COVID-19 vaccine?
This is not yet entirely clear at this stage. Published data from the early stages of trials found that more than 90% of people vaccinated developed neutralizing antibodies (which are expected to prevent SARS-CoV-2 from infecting your cells) 29 days after taking the first dose of vaccine received. Two months after the first dose, all participants developed neutralizing antibodies, which remained for at least 71 days.
What are the side effects of the Johnson & Johnson COVID-19 vaccine?
According to the data so far, it can cause ‘mild to moderate side effects commonly associated with vaccinations’, similar to those expected from Pfizer and Modern vaccines. These include cold-like symptoms, such as headache, body aches, injection site pain and fever – a normal sign that the body’s immune response is starting to go up.
How is the Johnson & Johnson COVID-19 vaccine stored?
One of the biggest benefits of the Johnson & Johnson vaccine is its durability. Because it does not contain fine mRNA, like the Pfizer and Moderna vaccines (which must remain frozen), it is much less fragile and can remain stable for up to three months in a normal refrigerator (36–46 ° F).
“This is a huge benefit,” said Thomas Russo, MD, professor and head of infectious diseases at Buffalo University in New York. Safely storing the other available vaccines, especially the Pfizer vaccine (which should be kept in a -94 ° F refrigerator), presents challenges for the average doctor’s office or pharmacy, as most places do not have special freezers that have the temperature does not reach.
When will the FDA grant an authorization for emergency use?
“It’s too early to tell because we do not yet have Phase 3 clinical data,” said infectious disease expert Amesh A. Adalja, MD, senior scholar at the Johns Hopkins Center for Health Safety.
However, he is hopeful because “the phase 2 clinical trial results look strong.” Dr. Russo agrees that “from now on there is no major concern with the safety signals.”
The Phase 3 clinical trial of Johnson & Johnson is expected to be completed by mid-February. If all goes well, the company can apply for emergency use permission from the Food and Drug Administration (FDA), says Dr. Russo. Once FDA approval, it is possible that the vaccine may be approved somewhere in March.
In August, the company signed a $ 1 billion contract with the federal government and promised to produce 12 million doses of its vaccine by February and 100 million doses by the end of June. But, The New York Times production reports can be about two months behind schedule.
Can you choose which COVID-19 vaccine you are getting?
At this point, it does not seem likely. “In this first phase of vaccinations, there is probably not much choice for people,” says Dr. Adalja. The health department or agency administering the vaccine will rather make the decision, usually based on what vaccine is readily available in a particular area.
But a lot of this really comes down to what the data will say. “How effective is this vaccine exactly?” Dr. Schaffner says. “If there is a significant difference, it can change things.”
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