New Vaccines and the FDA Approval Process
How does a product receive approval from the most trusted organization in the world?
In my previous newsletter, I outlined a comprehensive guideline on the Michigan vaccination timeline and how you can receive a vaccine, check it out here.
Some housekeeping… many of you are informing me that you are not receiving my emails; sometimes when I include many outside links, the email server will automatically place it in the Promotions tab or classify it as Junk/Spam, so make sure to find them and move them to the Primary inbox. Also, just a reminder, all of my sources are linked (look for the underlined words)!
Johnson & Johnson’s Vaccine
The Janssen vaccine is now the third emergency approved vaccine that will be distributed in the United States, alongside Pfizer and Moderna. The U.S. now has 3 efficacious vaccines that will be critical in ending the coronavirus pandemic, as we are approaching the one-year mark (I think March 11th, 2020 is a day we will not easily forget). Compared to both Pfizer and Moderna, J&J’s vaccine is “less complicated” to say the least.
To summarize, the Johnson and Johnson vaccine:
is only a one dose shot (Pfizer and Moderna are two doses)
does not need to be kept in ultra cold or freezing temperatures but instead can be stored in refrigerator temperatures for months
does not use mRNA technology (Pfizer and Moderna do); uses viral vector technology
J&J Efficacy:
the overall global efficacy was 66% (72% in the U.S portion of the trial) against moderate to severe illness, HOWEVER
it was 85% effective against severe disease
100% effective at preventing death (no one was hospitalized or died during the trial)
Overall, this is great news. We now have three highly effective vaccines readily available. The important thing to note about J&J’s vaccine is that it started testing much later than Pfizer and Moderna, when the new variants were starting to circulate, and conducted trials in different countries. Therefore, one cannot compare this vaccine to the others since they were developed during different times of the pandemic and tested in different populations. Vaccine experts agree that all three provide sufficient protection and prevent the onset of severe illness.
Technicalities of the J&J Vaccine:
As mentioned previously, Moderna and Pfizer use mRNA technology where RNA is inserted into the body, instructing it to form the spike protein that are on the outside of the SARS-CoV-2 virus. Johnson & Johnson utilizes a similar approach but uses DNA instead. This gene is inserted into a modified cold virus called adenovirus. This will infect cells but cannot give you a cold; it provides genetic instructions to create that spike protein. In general, DNA is more stable than RNA, thus the logistics for the J&J vaccine are much easier to develop and distribute, especially in developing parts of the world.
FDA Approval Process
With these much needed medical products rolling out, I thought it would be interesting to lay out how a product or drug receives approval from one of the most trusted agencies in the world, the Food and Drug Administration. The FDA is responsible for regulating almost every product we use on a daily basis:
food, including infant formula, bottled water, dietary supplements
drugs, including prescription and over-the-counter
biologics, including vaccines, blood products, tissue products
medical devices, including pacemakers, surgical implants, dental devices
electronic products that give off radiation, including microwaves, x-rays, lasers
cosmetics, including nail polish, perfume, color additives found in makeup
veterinary products, including pet foods, drugs, and devices
tobacco products, including cigarettes and smokeless tobacco
Firstly, the FDA’s main responsibility is to protect the public's health by ensuring any and all products are safe and effective to use. The FDA does not approve companies; they have the right to evaluate the facilities used to ensure they are complying with manufacturing laws. Before companies can market new drugs and biologics, they must be proven safe and effective to the FDA’s satisfaction. The FDA does not test the products themselves rather they analyze the outcomes of the laboratory clinical testing done by the companies. If granted approval, the benefits of the product must outweigh the known risks that can occur after use. However, there are many things the FDA cannot approve: tobacco products (there is no such thing as a safe tobacco product), cosmetics, medical foods, infant formula, dietary supplements, and food labels. While they do not have to undergo the approval process, many ingredients used in these products must be approved, such as color additives in makeup. In general, these companies must comply with good manufacturing practices according to the FDA and many must undergo yearly inspections. Overall, these companies are all under direct oversight from the FDA and must follow their strict regulations.
I also want to clarify that the vaccines being distributed are not FDA approved rather they are approved for emergency use. During public health emergencies, the FDA can use the Emergency Use Authorization mechanism to allow for medical products, like vaccines, to be used for the public. These products must meet certain guidelines to receive emergency approval. For the COVID-19 vaccines, the prerequisite was at least 50% efficacy in their clinical trials, and we know that all three are way above this threshold which is simply astonishing.
Suggested Reading
The WHO has conducted new virus studies on the origins of the coronavirus pandemic, read about it here.
In honor of Women’s History Month (!!!!), read about the current CDC director Dr. Rochelle Walensky, here.
If you have any questions, please email me at reemlfawaz@gmail.com.