[Pic: duluthnewstribune.com]

Alex Bowser

Science/Tech Editor

akb6244@psu.edu

On February 27, the company, Johnson & Johnson, announced the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for their single-dose vaccine against COVID-19. Their decision solely involved scientific evidence in the researcher’s findings when testing the vaccine.

Johnson & Johnson released the first four million doses of their vaccine with the incoming approval. One of their ensemble studies demonstrated to the FDA that the vaccine was 85 percent effective after 28 days of vaccination when preventing severe developments from the COVID virus, such as hospitalization and death.

As a result, the FDA believes that more data needs to be gathered, but the current terms of the unanimously voted EUA by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) are still allowing the vaccine to be distributed and used. With more data required for updates, Johnson and Johnson additionally wants to work with the FDA a step further in late 2021 and attempt to file for a Biologics License Application (BLA).

The vaccine requires refrigeration at temperatures between 36 to 46 degrees Fahrenheit (or two to eight degrees Celsius), which can keep the vaccine stable for a maximum of three months. However, if stored at negative four degrees Fahrenheit (-20 degrees Celsius), the vaccine is predicted to last for two years.

Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson, commented with the news of the vaccine’s authorization, commending the “incredible work by [their] dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public.”

The Vice-Chairman of the Executive Committee and Chief Scientific Officer for Johnson & Johnson, Dr. Paul Stoffels, spoke for the company’s success found with their vaccine: “We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic,” Dr. Stoffels notes, “particularly as it shows protection across countries with different variants.”

In addition, Johnson & Johnson has also submitted a European Conditional Marketing Authorization Application to the European Medicines Agency as of late in an attempt to begin distributing the vaccine to countries overseas from North America (currently, the vaccine has been approved in both Canada and the United States). The company has also filed for an Emergency Use Listing (EUL) with the WHO.

In order to make the vaccine, Johnson & Johnson used the AdVac vaccine platform, which is a proprietary technology used in the development of other vaccines and commercial-wide manufacturing, such as Janssen’s European Commission-approved Ebola vaccine. The platform is also known to be used for Zika, RSV, and HIV vaccines.

Johnson & Johnson’s Phase 3 Ensemble study, the most successful study thus far and used for their demonstrated effectiveness rates, was conducted through a total of 43,783 participants age 18 years and older. According to their site, the study was “a randomized, double-blind, placebo-controlled clinical trial” which was “designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease.”

They took people from eight different countries across three different continents in order to evaluate a diverse population of people. This particular study also took into account people over the age of 60, which was 34 percent of the total participants; 44 percent of participants were in the United States. Out of this particular group, 74 percent were Caucasian, 15 percent were Hispanic, 13 percent were African American, and six percent were Asian.

Some important information before you receive this vaccine, which you can find in the public recommendations offered by Johnson & Johnson, including informing the vaccination provider about medical conditions, allergies, fever, having a bleeding disorder or are on a blood thinner, being immunocompromised or are on a medication that affects your immune system, being pregnant or are breastfeeding, or have received another COVID vaccine.

In addition, Johnson & Johnson advises not to get the vaccine if the patient has a severe allergy to any of the ingredients used in the vaccine. Some of the noted side effects include pain, redness, and swelling of the injection site, accompanied by headaches, tiredness, soreness, nausea, and fever.

They have also said that the vaccine has a “remote chance” of causing a severe allergic reaction, which would most likely occur within minutes to an hour of the injection. They advise that if you have difficulty breathing, swelling, fast heartbeat, rashes, or dizziness to call 9-1-1 or immediately go to the nearest hospital.

In light of the release of the vaccine, Detroit’s mayor, Mike Duggan, has released misleading statements based on these supporting materials regarding information about the vaccine from Johnson & Johnson. 

In a recent news conference last Thursday, Mayor Duggan made a claim regarding the quality of the Johnson & Johnson vaccine, stating that Pfizer’s vaccine and Moderna’s vaccine were the “best” and that Johnson & Johnson’s vaccine is not as good.

“Johnson & Johnson is a very good vaccine,” Mayor Duggan stated, and he believes that he needs “to make sure the residents of the City of Detroit get the best.” As a result, he rejected a shipment of 6,200 doses of the Johnson & Johnson vaccine, claiming that their demand has already been met.

However, only just over 15 percent of Michigan’s population has been vaccinated.