Your COVID-19 vaccine questions-answered
From vaccine basics to cleaning protocols, learn more about this life-saving innovation and Contec's role in supporting pharmaceutical manufacturers.
What do I need to know about vaccines?
WATCH THE RECORDING: CLEANOVATORS SPECIAL EVENT: VACCINE EXPERT PANEL
What do I need to know about vaccines?
Why are production regulations important?
Vaccines: Facts over fear
Contec has worked with pharmaceutical manufacturers to ensure their contamination control practices are effective and robust as they produce vaccines.
What is a vaccine and how does it work?
What about my immune system?
What is Herd Immunity?
Vaccine Testing
Vaccines contain the same organisms that cause a particular disease, but they have been modified, killed or inactivated, so they can’t make a person sick. Vaccines spark an immune response that helps your body fight off and remember the organism so it can attack it if it ever invades again.
The immune system is a network of cells, tissues and organs that work together to defend the body from harmful organisms.
Herd immunity occurs when a sufficient proportion of the population is immune to an infectious disease, so that the spread from person-to-person is unlikely. It can be achieved by:
They must go through extensive testing before approval for use, and the safety of a vaccine must be monitored before and after administration prior to final approval. Before a vaccine is ever recommended for use, it is tested in labs, which can also take years.
Naturally developed immunity. Your body is exposed to a virus and makes antibodies on its own to fight off infection.
Immunity through vaccination.
It makes your body think you have already had a virus. You don’t get sick, and your immune system still makes protective antibodies.
Phases of testing a vaccine
Click on plus sign to see details
Preclinical testing
Phase I
Safety Trials
Phase II
Safety Trials
Phase III
Safety Trials
Approval
It usually takes about two years to bring new vaccines to market; however, priority vaccines can advance faster.
What’s next for the COVID-19 vaccines?
3
The novel coronavirus is “not very stealthy or tricky.
2
Scientists have tools available today to fight the pandemic that they lacked in previous outbreaks.
1
The global research collaboration is unprecedented.
1
Labs, companies and scientists worldwide are working closely together to tackle the problem.
The global research collaboration is unprecedented.
3
The novel coronavirus is “not very stealthy or tricky.
2
Scientists have tools available today to fight the pandemic that they lacked in previous outbreaks.
3
The novel coronavirus is “not very stealthy or tricky.
2
Scientists have tools available today to fight the pandemic that they lacked in previous outbreaks.
1
The global research collaboration is unprecedented.
Some of these technologies include genetic engineering, gene sequencing, electron microscopes, supercomputers, artificial intelligence, and expanded global communication.
1
The global research collaboration is unprecedented.
2
Scientists have tools available today to fight the pandemic that they lacked in previous outbreaks.
3
The virus does not have lots of defense mechanisms or evasive measures, unlike other challenging viruses like HIV and influenza.
The novel coronavirus is “not very stealthy or tricky.
Read the full article
Sources
NEXT: Why are production regulations important?
Why are production regulations important?
Distribution speed and efficiency is vital, but vaccine manufacturers must face this time-sensitive and monumental task while following stringent guidelines and protocols.
There are numerous governmental regulations and industry standards pharmaceutical manufacturers must follow when establishing cleaning and disinfection standard operating procedures (SOPs). This ensures the highest quality and safety of the product with every “batch” of pharmaceuticals produced, including the COVID-19 vaccines.
Regulations and SOPs
Items covered by SOPs include, but are not limited to:
Contec’s partnership with pharmaceutical manufacturers is stronger than ever as the need is greater for cleaning and disinfection products
How is Contec helping?
The COVID-19 challenge
The Contec response
In the first quarter of 2020, COVID-19 pressed the need for cleaning consumables to the brink.
•
Remaining in constant communication to fill orders as quickly as possible.
•
Increasing our manufacturing and training capabilities
•
Working alongside customers at both the supply-chain and end-user levels to find product alternatives.
•
Continue to push through with products necessary to meet the stringent regulations they must follow to create billions of contamination-free doses of vaccines for the global population.
•
Ensure we can meet the needs of our customers to the absolute best of our ability.
Contec has been working with our manufacturing facilities around the world to:
The increased need for vaccine production capacity has resulted in an increased volume of consumables (wipes, mops), disinfectants and hardware (buckets, mop frames and handles).
The COVID-19 challenge
The Contec response
Cleaning and disinfecting activity has significantly ramped-up and will continue to do so with the increased vaccine production in the coming months.
The COVID-19 pandemic has proven that people can come together to produce a vaccine for the masses in a relatively short time, but this means facilities are having to follow these regulations more closely than ever. They understand the urgency and they are rising to the challenge — and Contec is proud to play a part in keeping these facilities in compliance with stringent and specific regulatory requirements.
NEXT: Vaccines: Facts over fear
Sources
Read the full article
Proper gowning techniques
Sterility testing
Movements and behavior of personnel to prevent contamination
Endotoxin control
Environmental monitoring and methods used
Training protocols
Disinfectant efficacy
Training protocols
Previous: What do I need to know about vaccines?
Vaccines: Facts over fear
It’s still a bit scary to think about taking a new vaccine for the first time. We get it, but knowledge is power — so let’s be sure we get the facts straight.
Previous: Why are production regulations important?
Read the full article
Click on circles to see detail
COVID-19 vaccines will not give you COVID-19
People who have had COVID-19 may benefit from getting vaccinated
The impact of COVID-19 is real and worldwide
There’s a multi-step vaccine approval process
There’s still important protocol after a vaccine is approved
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.
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.
It has affected people of all ages and we have the ability to slow it down and stop the spread with a vaccine.
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
•
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.
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:
Cleaning between batches
Number of rinse steps required
Monitoring of cleaning effectiveness
Solutions/disinfectants used
Cleaning tools used
Sequence of each cleaning step
Instructions on how to disassemble, clean, and reassemble equipment if needed
Monitoring of facility cleanliness, before, during, and after production
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!
Regulators in each country review the trial results and decide to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval.
Scientists give the vaccine to thousands of people and wait to see how many become infected compared to volunteers who received a placebo.
Scientists administer the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them.
Scientists give the vaccine to a small number of people to test its safety and dosage, as well as to confirm that it causes an immune response.
Scientists give the vaccine to animals, such as mice or monkeys, to see if it produces an immune response.
https://www.cdc.gov/vaccines/parents/diseases/forgot-14-diseases.html
https://www.webmd.com/lung/what-is-herd-immunity#1
https://news.usc.edu/172028/coronavirus-vaccine-covid-19-development-approval-usc-experts/
Source
1
2
3
Sources
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice
4
Source
Sources
Sources
Sources
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html
https://en.wikipedia.org/wiki/Template:COVID-19_pandemic_data
https://www.cdc.gov/vaccines/basics/test-approve.html
7
6
5
Source
