Prevention
Although Pfizer and Moderna have COVID-19 vaccines authorized for emergency use in the U.S., other vaccine candidates are still in progress, including a single dose option from Johnson & Johnson, which has about 45,000 people enrolled in phase clinical trials. 3 in progress. According to the first data released by the company, this vaccine also shows promise.
The provisional data for phase 1 / 2a was published on January 13 in the New England Journal of Medicineand the results show that the company’s vaccine candidate has created an immune response in patients for at least 71 days – the total period measured in the study so far.
The vaccine was also “generally well tolerated” in study participants, said Johnson & Johnson in a press release. Although the Pfizer and Moderna vaccines are similar, the Johnson & Johnson vaccine also has many differences. Here’s what we know so far, in addition to what’s to come.
How does the Johnson & Johnson COVID-19 vaccine work?
Johnson & Johnson has an andenovector vaccine, which 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, which use single-stranded RNA.
In the Johnson & Johnson vaccine, the researchers added a piece of genetic material from the new coronavirus spike protein (the piece that clings to human cells) into another virus, Adenovirus 26, which has been modified to have the ability to enter cells, but do not reproduce within them. Adenoviruses are common viruses that usually cause symptoms similar to those of the cold, but since the one used in the vaccine has been changed and cannot replicate, it cannot make you sick. (Other COVID-19 vaccines, including Oxford and the AstraZeneca candidate, use similar adenovirus technology.)
When you receive the Johnson & Johnson vaccine, the modified adenovirus that carries a piece of the spike protein clings to the surface of cells. It is pulled inside, where the modified virus travels to the nucleus of the cell, where its DNA is. The adenovirus then places its DNA in the nucleus, the gene for the spike protein is read by the cell and then copied into the messenger RNA (mRNA).
After that, the mRNA leaves the nucleus and serves as a set of instructions for other cells, which begin to produce peak proteins. They are then recognized by your immune system and your body reacts by producing antibodies against the perceived threat (even if there is no threat).
The cells in your immune system then remember how to fight the distinct part of SARS-CoV-2, the new coronavirus, so that if you come into contact with it in the future, your body will have the ability to fight it more efficiency.
This technology is unique, but Johnson & Johnson has a lot of experience with it, as it has already been used for its Ebola vaccine. “They gave hundreds of thousands of doses of this similar vaccine,” which had no major safety concerns, says William Schaffner, MD, an infectious disease specialist and professor at Vanderbilt University School of Medicine.
While still being tested, Johnson & Johnson’s COVID-19 vaccine may only require 1 shot instead of two. Their tests so far have found that administering one or two doses of the vaccine stimulated an effective immune response against SARS-CoV-2 in study participants, but nothing is definitive until phase 3 clinical trials are completed and the company has sufficient data to support your single dose.
How effective is the Johnson & Johnson COVID-19 vaccine?
It is not entirely clear at this point. Published data from early-stage studies revealed that more than 90% of vaccinated people developed neutralizing antibodies (which should prevent SARS-CoV-2 from infecting their cells) 29 days after receiving the first dose of the vaccine. Two months after the first dose, all participants developed neutralizing antibodies, which remained for at least 71 days.
What are the side effects of Johnson & Johnson COVID-19 vaccine?
According to the data so far, it can cause “mild to moderate side effects typically associated with vaccinations,” similar to those expected from the Pfizer and Moderna vaccines. This includes cold-like symptoms, such as headache, body aches, pain at the injection site, and fever – a normal sign that the body’s immune response is being prepared.
How is Johnson & Johnson’s COVID-19 vaccine stored?
One of the biggest advantages of the Johnson & Johnson vaccine is its durability. Because it does not harbor delicate mRNA like the Pfizer and Moderna vaccines (which need to remain frozen), it is much less fragile and can remain stable in a normal refrigerator (36–46 ° F) for up to three months.
“This is a huge advantage,” says Thomas Russo, MD, professor and chief of infectious diseases at the University of Buffalo in New York. Safely storing the other available vaccines, particularly the Pfizer vaccine (which needs to be kept at a cold temperature of -94 ° F), presents challenges for the doctor’s office or ordinary pharmacy, as most locations don’t have special freezers that reach those temperatures.
When will an emergency use authorization be granted by the FDA?
“It’s too early to say, because we don’t have phase 3 clinical data yet,” said infectious disease specialist Amesh A. Adalja, MD, a senior fellow at the Johns Hopkins Center for Health Safety.
However, he is hopeful, because “the results of the phase 2 clinical trial look strong”. Dr. Russo agrees that “as of now, there are no major concerns about the safety signs”.
The Johnson & Johnson phase 3 clinical trial is expected to be completed in mid-February. If all is well, the company can apply for emergency use authorization from the Food and Drug Administration (FDA), says Dr. Russo. As soon as the FDA grants its approval, it is possible that the vaccine will be authorized in March.
In August, the company signed a $ 1 billion contract with the federal government, committing itself to producing 12 million doses of its vaccine by February and 100 million doses by the end of June. Yet, The New York Times reporting can be delayed by about two months.
Will you be able to choose which COVID-19 vaccine you will get?
At this point, this does not seem likely. “At this early stage of vaccination, there will probably not be much of a choice for people,” says Dr. Adalja. Instead, the health department or agency that administers the vaccine will make the decision, primarily based on which vaccine is readily available in a specific area.
But a lot of it really comes down to what the data says. “Exactly how effective is this vaccine?” Dr. Schaffner says. “If there is a noticeable difference, it can change things.”
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