Johnson and Johnson’s COVID-19 Vaccine Should Be Reviewed by FDA Soon

Through January 27, 2021, two mRNA vaccines have received FDA Emergency Use Authorization (EUA) to treat COVID-19. Another vaccine, manufactured by Johnson & Johnson, is expected to be reviewed for an FDE EUA in early 2021. Johnson & Johnson is working with Janssen, its pharmaceutical arm, to develop the vaccine which is, so far, known as Ensemble and Ensemble2. The vaccine is going through a clinical trial stage – where two different dose levels (single and double) are being tested.

How does the Johnson & Johnson vaccine work?

Johnson & Johnson’s vaccine is being studied as a single and two-dose adenovirus-based vaccine. The vaccine is “an experimental viral vector vaccine that uses a weakened live pathogen (adenovirus) as the delivery method (vector) for transporting a recombinant vaccine for COVID-19.”

“Recombinant vaccines use a small piece of genetic material from the virus to trigger an immune response.” “This genetic material for COVID-19 does not replicate in the body. A specific piece of the virus can be targeted, and recombinant vaccines are common and generally safe to use in a large population of people—even those with chronic health problems or who are immunocompromised.”

The Johnson and Johnson vaccine contrasts with the mRNA vaccines developed by Pfizer and Moderna. mRNA vaccines don’t use a genetic part of the virus. Instead, mRNA vaccines, according to the US Centers for Disease Control and Prevention “teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies.”

One of the problems with recombinant vaccines is that the vaccines may require booster shots. While the science behind recombinant adenoviral vector vaccines has existed for a good while, the “only commercially available adenovirus-based vaccine is a rabies vaccine for animals.” “Adenovirus-based vaccines may also pose some problems in that the adenovirus is so common that the vaccine may not be as effective once booster doses are given, or that some people may already have immunity to the virus used in the vaccine.”

According to the New York Times, the Johnson & Johnson vaccine is more formally called – JNJ-78436735 or Ad26.COV2. S. “Janssen Pharmaceutica, a Belgium-based division of Johnson & Johnson, is developing the vaccine in collaboration with Beth Israel Deaconess Medical Center.” Beth Israel Deaconess Medical Center is located in Boston, Massachusetts.

“The SARS-CoV-2 virus is studded with proteins that it uses to enter human cells. These so-called spike proteins make a tempting target for potential vaccines and treatments. “

“The Johnson & Johnson vaccine is based on the virus’s genetic instructions for building the spike protein. But unlike the Pfizer-BioNTech and Moderna vaccines, which store the instructions in single-stranded RNA, the Johnson & Johnson vaccine uses double-stranded DNA.”

J&J’s research adenovirus-based research is based on its development of an Ebola vaccine. The company is working on similar vaccines for H.I.V. and Zika. Oxford University and AstraZeneca are working on a chimpanzee adenovirus.

According to the New York Times article:

“Adenovirus-based vaccines for Covid-19 are more rugged than mRNA vaccines from Pfizer and Moderna. DNA is not as fragile as RNA, and the adenovirus’s tough protein coat helps protect the genetic material inside. As a result, the Johnson & Johnson vaccine can be refrigerated for up to three months at 36–46°F (2–8°C).”

“After the vaccine is injected into a person’s arm, the adenoviruses bump into cells and latch onto proteins on their surface. The cell engulfs the virus in a bubble and pulls it inside. Once inside, the adenovirus escapes from the bubble and travels to the nucleus, the chamber where the cell’s DNA is.”

“The adenovirus pushes its DNA into the nucleus. The adenovirus is engineered so it can’t make copies of itself, but the gene for the coronavirus spike protein can be read by the cell and copied into a molecule called messenger RNA, or mRNA.”

“The mRNA leaves the nucleus, and the cell’s molecules read its sequence and begin assembling spike proteins.”

“Some of the spike proteins produced by the cell form spikes that migrate to its surface and stick out their tips. The vaccinated cells also break up some of the proteins into fragments, which are presented on their surface. These protruding spikes and spike protein fragments can then be recognized by the immune system.”

“The adenovirus also provokes the immune system by switching on the cell’s alarm systems. The cell sends out warning signals to activate immune cells nearby. By raising this alarm, the Johnson & Johnson vaccine causes the immune system to react more strongly to the spike proteins.”

“When a vaccinated cell dies, the debris contains spike proteins and protein fragments that can then be taken up by a type of immune cell called an antigen-presenting cell.”

The NY Times article continues by discussing how  T cells, B Cells, and antibodies will help fight the COVID-19 virus.

What is the efficacy of the Johnson & Johnson COVID-19 vaccine?

So far, early laboratory results indicate just a single dose of the J&J vaccine could help 97% of the people who use the vaccine develop antibodies that neutralize the virus. The clinical results of the vaccine’s effectiveness should be disclosed by the time FDA reviews the vaccine.

What is the expected approval date?

The clinical results are expected to be published in early 2021. An approval can’t come soon enough as 100s of millions of people in the US still haven’t received a COVID-19 vaccine. The Johnson & Johnson clinical trial was delayed for a short time due to an unexplained illness. Due to patient privacy, no further details about the illness were provided. Regulators did determine that the illness wasn’t related to the vaccine which meant the trial could resume.

Johnson & Johnson seems confident the vaccine will receive FDA approval. It’s already entered into a contract with the US government for 100 million doses with the option to purchase an additional 200 million doses if the vaccine receives emergency use authorization.

The CDC is overseeing the distribution of the vaccine. The CDC’s Advisory Committee on Immunization Practices (ACIP) has “made recommendations on how to prioritize vaccine supplies.”

  • “Healthcare workers and people living in long-term care facilities are the first to receive the vaccines, the quantity of which will be limited at first.
  • The next priority groups are frontline essential workers, such as first responders, and people ages 75 and older
  • Followed by people ages 65 and older and people with high-risk medical conditions.”

The CDC anticipates that the supply of vaccines won’t reach demand for several months. 330 Americans need to be vaccinated. If two doses are used for each person, that means 660 million does will be required – if all the vaccines require two doses.

What is the cost of the Johnson & Johnson vaccine?

In order to seize control of the virus, the vaccine is free. The facilities or agencies that offer the vaccine may have to pay a price for the vaccine. “Public health programs and insurance plans are expected to reimburse patients for any costs associated with COVID-19 vaccination.”

Who Can Be Vaccinated with the Johnson & Johnson Vaccine?

The vaccines, so far, are targeting adults. Vaccine possibilities for teenagers and children are expected to develop throughout 2021. Currently, the Johnson & Johnson clinical trials are targeting people 18 and over – with a large representation of people 60 and older because older Americans are most prone to developing the disease.

Does the Johnson & Johnson vaccine have side effects and adverse events?

During the clinical trial, the participants are requested to record any reactions to the vaccine or medications that are administered.

“Adverse reactions are considered to be medication reactions directly caused by a vaccine, whereas a side effect is a physical reaction to a medication.” The initial information that has been released is that the most common reactions are the following:

  • Pain at the site of the injection
  • Tiredness
  • Headaches
  • Muscles that ache

When the final clinical trial report is published, there should be more detail about the adverse reactions and side effects.

How was the Johnson & Johnson vaccine project developed and funded?

The Johnson & Johnson vaccine project is part of “Operation Warp Speed, a public-private partnership initiated by the U.S. government to facilitate and accelerate the development of a COVID-19 vaccine, manufacturing, and distribution of COVID-19 vaccines, with funding from the Biomedical Advanced Research and Development Authority (BARDA)—a U.S. government program aimed at furthering the manufacture and distribution of vaccines to fight COVID-19.”

Johnson & Johnson has said the company and BARDA have invested $1 billion into the research and development of the vaccine.

The timeline of the Johnson and Johnson vaccine development

According to the New York Times, the development timeline for the company’s COVID-19 vaccine is:

  • January 2020. Work on the Johnson & Johnson vaccine starts.
  • “March. Johnson & Johnson receives $456 million from the United States government to help develop and produce the vaccine.”
  • “July. Phase 1/2 trial begins. Unlike the clinical trials for other leading vaccines, the trial involves one dose, not two. “
  • “August. The federal government agrees to pay Johnson & Johnson $1 billion for 100 million doses if the vaccine is approved.”
  • September. J&J starts its Phase 3 trial.
  • Oct. 8. The European Union agrees to buy 200 million doses.
  • Oct. 12. J&J “pauses its Phase 3 trial to investigate an adverse reaction in a volunteer.”
  • Oct. 23. The trial resumes.
  • “Nov. 16. Johnson & Johnson announces a second Phase 3 trial to observe the effects of two doses of their vaccine, instead of just one.”
  • “Dec. 17 Johnson & Johnson announces its Phase 3 trial is fully enrolled, with around 45,000 participants.”
  • January 2021 Preliminary results from the Phase 3 trial are anticipated. J&J aims to produce one billion doses in 2021.
  • “Jan. 13. Johnson & Johnson expects to release trial results in as little as two weeks. But the company is falling behind on its original production schedule.”
  • February. J&J hopes to obtain an FDA EAU – If trials show the vaccine is effective.

It will be very welcome news if Johnson & Johnson’s vaccine receives FDA EUA approval. There is a tremendous shortfall in Pfizer and Moderna vaccines. Johnson & Johnson’s vaccine is easier to store than the currently approved vaccines. the J&J COVID-19 vaccine may also only require that people receive one dose of the vaccine instead of two doses.

Doctors and medical practices should contact Cohen Healthcare Law Group, PC to review all their FDA compliance issues Our experienced healthcare attorneys explain FDA’s approval process.

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