During the unique and difficult times, we have all risen to the call to find ways to make our lives work differently. We have become more flexible and learned to innovate on a scale that makes me proud of humanity as a whole. Although it feels as if we have never faced the adversity that we do today, our species is designed to adapt and conquer every situation with drive and innovation that makes us certain to survive and thrive by sheer will and grit.
As Georgia gears up to expand COVID-19 testing and we, as health care providers, try and educate patients about the myths and truths surrounding this ever-changing drama that sits on our doorstep every day. What we knew a month ago, may not hold water any longer as new data comes to light. As we race to develop a vaccine for the coronavirus, the smartest minds are hard at work. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, has been monitoring the collaboration of the bio-pharma industry and the government on the development of both therapeutics and vaccines to combat the coronavirus pandemic. One company is entering phase 3 clinical trial as we speak and we may see a vaccine fully operational in only 12-18 short months. This is warp speed for a vaccine as most vaccines take 10 years to develop.
What is a Vaccine?
Vaccines are our best defense against infection and help prepare our body’s immune system to fight disease. In general, vaccines are prepared by using ingredients that resemble the organism we are trying to mimic and are often made from weakened, killed forms of the organism or one of its outer cellular coatings. These items cause the body’s immune system to generate antibodies which in turn float around the body ready to jump in to fight any microbe that tries to invade the system. Although vaccination itself can cause side effects, the vaccines do not make you sick with the illness that they are trying to prevent. The boost to your immune system can make you feel a bit run down for a day or so, however; after you receive a vaccine, it does take some time for the process to be 100% effective – usually about 2 weeks. If you are exposed to the bacteria or virus once you have full immunity, your body remembers, and the antibodies that you have jumped in to fight the organism and protect you. Some vaccines impart lifetime immunity while others require booster shots. Think your Measles shots (once in your lifetime) vs. your Tetanus shots (every 10 years) vs. your annual Influenza shots.
Vaccine development is a tricky Business
If you thought your tax returns were complicated, you should try making a vaccine. Here are the steps:
EXPLORATORY PHASE
This is where the scientists do all the basic lab science. They identify the pathogen that needs to be prevented. They then identify the natural or synthetic antigens that prevent or treat the disease. This can last 2-4 years
PRE-CLINICAL PHASE
This involved Cell culture, tissue culture, and animal testing of the antigen to assess the safety and ability to produce antibodies. Researchers will vaccinate animals and then expose them to the virus to see if the vaccine is protective during this phase. This also allows researchers to determine the starting dose of the vaccine, method of administration, and what to expect when they administer it to humans. They can tweak the vaccine to make it more effective. This phase can last 2 years as well. MANY vaccines do not make it past this stage.
IND application (Investigational New Drug)
This is where the US Food and Drug Administration gets involved in the application before the vaccine can move to clinical trials on humans. It includes information about the testing and manufacture, and how the manufacturer intends to go forward with the vaccine. If approved, then the vaccine moved to human trials.
CLINICAL TRIALS:
1. PHASE I: small group trial. Usually 20-80 healthy, young individuals. This takes several months. About 70% move on from here
2. PHASE II: expands the group to more people similar to the people for who the vaccine is being developed (so it may include large age groups, people with medical illnesses, and even children) It can be several hundred individuals and are a more diverse set of patients. The dose, safety, immune response, are all evaluated. This phase can be several months to 2 years. About a third of vaccines/ medication make it past this phase.
3. PHASE III: large group (300 to thousands of patients) this looks for effectiveness and larger-scale side effects and other issues that would not be seen in small groups. This can take 1-4 years. About 20-30% of vaccines/ medication make it past this stage
APPROVAL AND LICENSURE
If the phase III Clinical trials are successful, the company submits a Biologics License Application to the FDA. The FDA evaluates the data, inspects the factory, and can even perform its own testing.
MANUFACTURE AND DISTRIBUTION
While this is all going on, the biopharmaceutical company researchers also have to develop a way to get all of this produced so that it can be distributed to the whole world. Making vaccines for a few hundred that they use in the lab setting for testing to making millions of doses that are stable for transportation to every corner of the world is a whole other undertaking. This strategy can be a multi- year process as well. They have to have these processes in place before the vaccine is even approved, so that manufacture can commence the second that the life-saving vaccine is approved. Among these challenges are how to move vaccines that require special handlings, such as temperature control, stabilization of the molecules without preservatives that harm the patients, and clean technique even in parts of the world where there is no running water and electricity.
So as you can see, this is a Herculean effort on the part of many people to make us safe. And when you wonder why does it cost so much for “FILL IN THE BLANK” medicine/ vaccine – now you know why.
WHAT CAN YOU DO TO BE PREPARED FOR THE FALL AND A POSSIBLE CONTINUED COVID STORM?
– Remain vigilant in your hygiene rituals
– Continue to wear a mask, wash your hands, cover your cough, stay home if you are sick, and take care of your overall health
– Educate your family, friends, and co-workers about infection control – ie. WASH YOUR HANDS, STAY HOME IF YOU ARE SICK
– GET YOUR FLU SHOT in September or October 2020 when it is available
– Get your PNEUMONIA vaccine if you are over 65 or have a chronic disease – discuss it with your physician if you are not certain that you need this
– Talk about vaccines in general with your friends and family – this is our best defense against ALL Infectious diseases
– Do your PREVENTATIVE medical services – mammograms, colonoscopy, eye exams, PAP smears, cholesterol testing, diabetes testing, medication refills
– There are OTHER things going on in this world besides COVID-19
– If you are depressed or anxious, call your health care provider, we can help you. We have Telemedicine visits available. We can get you in touch with a therapist or counselor.
– Check your smoke detectors and fire alarms – do the usual things that you do every year
– If you think you have COVID, call your physician and have a Telemedicine visit. Discuss where you may be able to get tested.
IF YOU HAVE HAD COVID-19 AND YOU ARE INTERESTED IN VOLUNTEERING FOR CLINICAL TRIALS — HERE IS SOME INFORMATION FOR YOU:
1. They are enrolling people in studies here in ATLANTA currently for vaccine trials. I heard that they are looking for 30,000 volunteers currently. Here is the website for that – https://www.coronaviruspreventionnetwork.org/clinical-study-volunteer/
Other trials can be found at the following sites: [this is not a complete list]
1. www.Clinicaltrials.gov
2. www.NIH.gov/clinicaltrial/healthy-volunteers
3. www.centerwatch.com
4. www.mayo.edu
5. www.medschoolumaryland.edu
6. www.dukehealth.edu
7. www.gsk.com
If you want to donate plasma or even just blood – there is a desperate need for just plain old blood – especially since it is SUMMER
1. www.RedCrossBlood.org/plasma4covid
2. www.RedCrossBlood.org