There are a lot of things to understand with vaccines. Contec produced two previous articles discussing facts, production and regulations. The first article reviews how vaccines work with the immune system. Vaccines help the population become immune to infectious disease through herd immunity. Some people are concerned taking the vaccine because of how fast it came to market however the COVID-19 vaccine was a comprehensive global initiative with pharmaceutical manufacturers around the world focused on its production. The second article reviews regulations facilities must follow to maintain contamination control in their facilities. The COVID-19 vaccine is an mRNA vaccine which is a revolutionary technology that, one day, may allow one vaccine to provide protection from multiple diseases. It’s still a bit scary to think about taking a new vaccine, without any history of usage, for the first time. We get it, but knowledge is power! - so let’s be sure we get the facts straight.
At Contec®, we’re doing our part.
Cleaning between batches: Federal regulations require a specific description of each step of a cleaning procedure between manufacturing batches. These steps are built into a facility’s Standard Operating Procedures (SOP) and indicate things such as:
- Solutions/disinfectants used (including concentration, application, dwell time, temperature etc.)
- Cleaning tools used
- Sequence of each cleaning step
- Instructions on how to disassemble, clean, and reassemble equipment if needed
- Number of rinse steps required
- Monitoring of cleaning effectiveness
- Monitoring of facility cleanliness, before, during, and after production
Some of the products and services we provide to assist with the critical cleaning steps noted above include:
COVID-19 vaccines will not give you COVID-19: Vaccines teach our body to recognize and fight the virus. Like any vaccine, it can cause fever as your body builds immunity – this is normal.
People who have had COVID-19 may benefit from getting vaccinated: At this point, experts do not know everything about COVID-19 and how long someone is protected from getting sick with it again. Both natural immunity and vaccine-induced immunity are important aspects of COVID-19 protection and prevention.1
More than 1.6 million people have died worldwide from COVID-19: The impact of COVID-19 is real and worldwide. It has affected people of all ages and we have the ability to slow it down and stop the spread with a vaccine.2
Vaccine approval process: A new vaccine follows a multi-step approval process before it is manufactured including:
- Application process
- Vaccine trials
- Inspection of manufacturing facilities
- Presentation of findings to the FDA’s Vaccines and Related Biological Products Advisory Committee
As mentioned in article two of this series, these steps still need to be taken whether a vaccine is created in 8 months or 2 years. After approving a vaccine, the FDA continues to oversee production to ensure safety, including inspections, and testing results for potency, safety, and purity of each vaccine lot.3
This has been a year many of us would like to forget. But the hope is this vaccine will put an end to the quarantines, isolation, risk, and fear associated with COVID-19. Don’t miss your shot!
Note: This article is part one of a three-part series. Be sure to take your research further by checking out: