On 26 February 2020, the Johnson and Johnson (JNJ) COVID-19 vaccine underwent an FDA expert review, similar to the ones for the Pfizer and Moderna COVID-19 vaccines. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of the third vaccine in the USA to prevent COVID-19. On 27 February 2020, the USFDA gave clearance for an Emergency Use Authorization (EUA).
VRBPAC agreed that the vaccine was very effective, especially in preventing death and serious COVID-19 disease. They also found no serious safety signals, with the incidence serious adverse events were no higher compared to the placebo group or what would be expected in the general population.
The EUA approved the vaccine for use in adults 18 and older. Before JNJ can ship the vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet tomorrow to make recommendations on who can receive this vaccine.
What is this FDA expert review?
Almost all of the information in this article will come from the Johnson and Johnson COVID-19 vaccine documents that were submitted for review by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA) once the FDA reviews and approves the findings. I read through most of the material to save you all time during this holiday season (so please like this article and share it across the planet).
There is a myth pushed by the anti-vaccine crowd that the FDA summarily approves vaccines without even a cursory review. They think that the FDA trusts anything Big Pharma submits to them without thinking. That couldn’t be further from the truth.
Every drug, including the JNJ COVID-19 vaccine, is almost always reviewed by an expert committee of scientists alongside career FDA scientists. These are thorough, scientific, and open.
For vaccines, the Vaccines and Related Biological Products Advisory Committee, also known as VRBPAC, are made up of experts in vaccines, public health, and statistics. There are around 30 individuals on the committee (although several may not attend ) including one vaccine industry scientist (not from JNJ) and one consume representative. All of voting members of VRBPAC are scientists, statisticians, physicians, and FDA experts.
Because it will be a thing, Dr. Paul Offit, MD, who has been designated a demon Big Pharma shill by anti-vaxxers, is a member of the committee. Dr. Offit is one of the world’s experts on vaccines, who developed one of the rotavirus vaccines that have saved hundreds of thousands of lives across the world every year.
According to the FDA, the committee is charged with:
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.
These experts are not industry shills. They are some of the leading experts in all fields of vaccinology, not amateurs with a 15-minute education on vaccines. VRBPAC is a dignified committee that puts scientific evidence above all else.
What is the JNJ COVID-19 vaccine technology?
The JNJ COVID-19 vaccine is very different than the Pfizer and Moderna mRNA vaccines. But it still induces an adaptive immune memory response to the S-protein of the SARS-CoV-2 virus that causes COVID-19.
The JNJ COVID-19 vaccine, known as the JNJ-78436735, utilizes a recombined adenovirus vector, human Ad26.COV2.S., which expresses the S-subunit of the SARS-CoV-2 virus to induce an immune response. Basically, the adenovirus vector “carries” the genes for the S-subunit to the cell which will reproduce the protein, then inducing the immune response.
Adenovirus-based vaccines have been investigated for several decades. In fact, JNJ received approval for an Ebola adenovirus vaccine in July 2020, so the technology did not come out of nowhere just for COVID-19. However, like the mRNA vaccines, these adenovirus vaccines, also used by AstraZeneca, can be quickly developed deliver the most important antigen on the SARS-CoV-2 virus, which is the S-protein.
There is an advantage to adenovirus-based vaccines – they are much less fragile than mRNA vaccines because they are based on DNA which is more rugged than RNA.
Once the Johnson and Johnson COVID-19 vaccine is injected into the arm, the adenoviruses enter cells and moves to the nucleus, where the cell’s genes (DNA) are located.
The adenovirus then injects 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.
At this point, it is similar to the mRNA vaccines.
Normally, during the process called transcription, RNA polymerase makes a copy of a gene from its DNA to a corresponding mRNA fragment whenever required by the cell. In other words, the mRNA sequences in the cell usually correspond directly to the DNA sequences in our genes. These mRNA sequences “carry” that genetic message to a ribosome for translation, where tRNA triplets, which code for one amino acid, attach to the appropriate mRNA triplet, adding one amino acid to the protein chain.
As in DNA, genetic information in mRNA is contained in the sequence of nucleotides, which are arranged into codons consisting of three ribonucleotides each. Each codon codes for a specific amino acid, except the stop codons, which terminate protein synthesis.
Like with mRNA vaccines, the adenovirus does not change the genetic code of any of the 50 trillion cells that are in a human. All that happens is that the adenovirus injects DNA that is coded for the S-protein and the cell produces mRNA from that DNA that then causes the ribosomes to produce the S-protein.
Those S-proteins migrate to the surface of the cell which are then recognized by the immune system as foreign invaders. The immune system then remembers those antigens – when the actual SARS-CoV-2 virus attacks, the immune system is ready to attack.
The Johnson and Johnson COVID-19 vaccine also has one additional advantage over the mRNA vaccines – the adenovirus itself provokes the immune system to activate immune cells that are nearby. This leads to the immune system reacting more strongly to the spike proteins.
JNJ COVID-19 vaccine effectiveness
Probably the most important issue with any new vaccine is its effectiveness. According to the data, the vaccine efficacy (VE) of the Johnson and Johnson COVID-19 vaccine against severe/critical COVID-19 was 73.1% at least 14 days after vaccination and increased to 81.7% at least 28 days after vaccination. An effect was also seen on mortality, since all COVID-19-associated deaths in the study, all in the placebo group, occurred in participants from South Africa. Vaccine efficacy against moderate to severe/critical COVID-19 was 52.0% at least 14 days and 64.0% at least 28 days after vaccination.
For the immunogenicity results
Although the effectiveness of this vaccine may appear lower than the 95% reported for the mRNA vaccines, they are still within the statistical range of them. For example, individuals without comorbidities exhibited vaccine effectiveness of nearly 90%. In fact, the only group that showed very low effectiveness were those ≥60 years old with comorbidities.
This group is problematic with many vaccines, including the flu vaccine. In fact, there is a senior flu vaccine that has nearly a double dose to boost the immune system.
However, overall the vaccine showed 100% effectiveness against death and 86% effectiveness against the most severe forms of the disease. Although it may appear at the surface that the vaccine is less effective than the mRNA vaccines from Moderna and Pfizer, the JNJ COVID-19 vaccine is within the statistical range of them. It should not be dismissed as a viable vaccine.
Furthermore, it is difficult to compare one clinical trial to another to determine whether one vaccine is more effective than another. The Moderna and Pfizer COVID-19 vaccines were in clinical trials during the earliest part of the pandemic, whereas the JNJ vaccine underwent clinical trials during the later part of the pandemic where there were more virulent variants of the disease out in the world.
Any of the three vaccines will be very effective in preventing the disease. One shouldn’t pick and choose which vaccine they want, take the one that is available to you.
Now the USA has the third vaccine for COVID-19. Even though JNJ has had some production issues with the vaccine, they should be able to provide several million doses by the end of March.
Although this is all about the JNJ COVID-19 vaccine in the USA, the same analysis and data will be available to the EU, Canada, Japan, Australia, and New Zealand, which could also be including this vaccine in their armamentarium against this disease.
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