On the heels of Johnson & Johnson receiving emergency use authorization (EUA) for it's COVID-19 single-shot vaccine, researching the various vaccines' efficacy to emerging variants continues. Research labs across the world like Janssen Pharmaceuticals where the J&J vaccine was developed, continue to collect and analyze data while the EUA vaccines are in use.

After Emergency Use Authorization (EUA), Research Must Continue

Through the process to receive vaccine EUA, vaccine manufacturers conduct research, development, clinical trials, and data analysis for review by the FDA to determine if the known and potential benefits outweigh the known and potential risks. Once the FDA authorizes the vaccine for emergency use, the research must continue. Upon approval, the vaccine manufacturer provides strategies they will implement to ensure ongoing clinical trials assessing long-term safety and efficacy.

The research required for COVID-19 vaccine use will continue for some time to come. As the highly contagious virus continues to naturally mutate, new variants are discovered which will require ongoing research and development to understand each vaccine's effectiveness over time, along with human reaction and safety measures after administration of the vaccine.

Managing Ongoing Vaccine Clinical Trials and Research

Biotechnology labs and research companies are tasked with the demanding requirements set forth by federal guidelines to continue the coronavirus vaccine and variant research and development process. The use of chemistry, drug substance, and drug product are all categorically regulated components and require special handling. Regulated materials such as cell banks, cell cultures, and drug product excipients (agents, preservatives, or fillers) used in the vaccine research and development process must be properly reported and disposed of to ensure everyone's safety while the task of improving the critical need of effective COVID-19 vaccines continues.

Check out our "Know where to throw" guide with the do's and don'ts for discarding biotechnology and laboratory regulated, biohazardous or infectious waste, and our color-coded Waste Classification online resources for more information.

How We At Biomedical Waste Services, Inc. Can Help

Here at Biomedical Waste Services, Inc. we have over 45 years of experience collecting, transporting, and disposing of biohazardous and infectious waste for a variety of industries in the mid-Atlantic area, including Maryland, Virginia, Washington D.C., Delaware, Pennsylvania, and West Virginia. We've partnered with many biotech and research labs across the mid-Atlantic to help manage biohazardous and infectious waste produced in the vaccine and variant R&D processes so that they can stay compliant and continue focusing on the critical task at hand to help stop the spread of COVID-19. We are in this together. If your facility is managing coronavirus vaccines or you are in a biotechnology lab manufacturing or testing vaccines, we have resources and services to cover your needs. Call or contact us today to see how we can help your facility manage your biotechnology and laboratory biohazardous and infectious waste disposal needs.

References:

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA for Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic

https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic

FDA - The for a COVID-19 Vaccine from Research to Emergency Use Authorization

https://www.fda.gov/media/143890/download

FDA - Emergency Use Authorization for Vaccines to Prevent COVID-19, Guidance for Industry

https://www.fda.gov/media/142749/download

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