Johnson & Johnson coronavirus vaccine could be authorized for use in America shortly. It will be the third vaccine in the country after approval. Statistics about the single-shot coronavirus vaccine released on Friday, and the company now organizing its data to apply to the United States Food and Drug Administration for emergency use authorization.
The drug company made the vaccine in collaboration with Johnson & Johnson’s Belgium-based vaccine division, Beth Israel Deaconess Medical Center, and Janssen Pharmaceutical, and it works a bit differently. Previously, January Marks as the deadliest month in the U.S. for Coronavirus.
Here we will discuss how the vaccine works and how it will fit into the mix of vaccines.
How is the Coronavirus vaccine effective?
COVID-19 single-shot vaccine of Johnson & Johnson observed as sixty-six percent effective in preventing severe and moderate disease in a worldwide Phase 3 trial, according to the statement of the company. Overall, the vaccine is eighty-five percent effective at preventing hospitalization and the number of deaths in all regions where it tested.
Its efficacy against coronavirus ranged from one country to another:
- Seventy-two percent in the United States
- Sixty-six percent in Latin America
- Fifty-seven percent in South Africa
It measured starting one month after the shot. Whereas, in South Africa, ninety-five percent of the trial cases were because of variant B.1.351, which is more contagious and carries transmutations that may make the virus less vulnerable to the antibody immune response – including antibodies produced due to vaccination.
According to Janssen’s international head of research and development, even those who received moderate cases of coronavirus in the trial tended to develop fewer symptoms and a milder course, Dr. Mathai Mammen.
How does the Johnson & Johnson vaccine work?
The vaccine of J&J is known as a non-replicating viral vector vaccine, using adenovirus 26, a common cold virus. Scientists made the vaccine by taking a little bit of genetic material that codes for a piece of the COVID-19 and integrating it with a faded version of adenovirus 26. The scientists of Johnson & Johnson transformed this adenovirus so it can enter cells, whereas it can’t imitate and make people sick.
In the same way, AstraZeneca uses a similar platform, but its adenovirus comes from a chimpanzee. In addition, the adenovirus transports the genetic material from the COVID-19 into human cells, tricking them into COVID-19 spike protein pieces – the part it uses to attach to human cells. Afterward, the body’s immune system then reacts against these pieces of the COVID-19.
Dr. William Schaffner, an internist, and infectious disease specialist, explained that if you are not infected with the coronavirus, that can give you coronavirus when you get this vaccine. It only has some of the harmless coronavirus proteins on its surface. Therefore, basically, it is a sheep in wolf’s clothing, and when the human immune system sees it, it responds to it and develops protection against at present and in the future, the real virus that causes coronavirus. Furthermore, the technology used in the coronavirus vaccine worked with the Ebola vaccine by Janssen.
How is it different from the other Coronavirus vaccines?
The head of the Vaccine Education Center at Children’s Hospital of Philadelphia, Dr. Paul Offit, said that all coronavirus vaccines, Pfizer, Moderna, and Johnson & Johnson, take a similar approach. But there is a little bit of difference with the J&J approach. Offit says that you are just giving the genetic factor in a fat droplet or a lipid nanoparticle in the case of the Pfizer and Moderna vaccine.
Whereas, in the J&J vaccine, they are giving the gene in a virus that cannot reproduce itself. So far, the Johnson & Johnson vaccine is the only coronavirus vaccine that has only a single shot. Pfizer and Moderna’s use two. Just like Moderna, J&J also kept at normal refrigerated temperatures. Besides, it doesn’t need a deep freeze like Pfizer’s vaccine.
How does a single-dose shot vaccine affect the rollout?
A single dose of vaccine and will be much easier to administer and will mean more individuals will receive the vaccination because none of them need the second shot. Schaffner believes that adding a vaccine like this will really speed up the United States’ vaccination efforts and across the world. And this advantage goes up in neon. Dr. Dan Barouch of Harvard Medical School (he helped develop J&J’s vaccine candidate on Coronavirus Fact vs. Fiction podcast of CNN) says that it is a single-dose vaccine. So, its billion vaccine doses will translate into a billion people.
The cold-chain advantage
The other advantage of Johnson & Johnson is that you can store it at regular refrigerator temperatures, unlike the Pfizer vaccine, as it needs special deep freezers. Moreover, the vaccine is stable for almost three months at thirty-six degrees F to forty-six degrees F, according to the representative of the company. It means health care facilities wouldn’t need to buy extra equipment to store the vaccine safely.
The director of the Vaccine Center at Emory University, Dr. Rafi Ahmed, said that in case successful, these vaccines would especially be famous in the developing countries because they would be easy to store and manage. Likewise, the vaccines will also be popular in rural areas in America and regular doctor offices that may not have the approach or the budget to afford special equipment. In simple words, the administration will bring the vaccine to the people instead of bringing the people to the vaccine.
What Happens next?
Johnson & Johnson will request an emergency use authorization (EUA) from the Food and Drug Administration (FDA) in early February. The statistics will show a close look at the United States Centers for Disease Control and Prevention advisers and the FDA. Whereas the FDA is reviewing the facts, and it schedules a public meeting of its Vaccines and VRBPAC. The committee based on independent public health and science experts. So, they will discuss the Johnson & Johnson data and make approval to the agency.
After the submission of the application, the FDA looks sensibly at the data in each demographic and each age group, according to the statement of Dr. Anthony Fauci. After the meeting, staff members of the FDA consider the committee input along with an evaluation of the agency to the company’s data and will make a final decision about whether or not about the authorization of the vaccine. After the recommendation from the CDC committee and approval from the CDC director, J&J plans to ship the vaccines instantly, and it can go into the arms of the people right away.
How much the authorization process take time?
According to a member of the FDA’s VRBPAC, Offit, the process for the J&J vaccine should take the same time and process as it was for Pfizer and Moderna vaccines. The Pfizer vaccine took more than three weeks from the time the company submitted its data to an EUA. Whereas, in the case of the Moderna vaccine, it took few days over two weeks.
How many doses of J&J vaccines are there?
The United States ordered a hundred million doses. On the other hand, the drug company has been making it while it has been in the testing phase of the vaccine. Usually, companies wait to manufacture the vaccine after its approval, but this exercise changed during the global pandemic. According to J&J, it can meet a hundred million dose commitment by June 2021.