Would you get the vaccine? Not the flu vaccine, but THE vaccine? As in the coronavirus vaccine?
Right now, all eyes are on a coronavirus vaccine more than any other medical development.
It seems to be the elusive golden ticket with the potential save millions of lives. It could help lift the world out of quarantine and get society moving again. And, in the grand scheme of things, it's progressing at ludicrous speed.
Biotech companies have compressed vaccine trials to meet historically tight deadlines. But will a coronavirus vaccine be safe? Here's where we're potentially at with the COVID vaccine.
The COVID Vaccine in Perspective
The COVID-19 vaccine will be the fastest ever produced, and by a significant margin. Not since the mumps vaccine in the 1960s has a vaccine ever proceeded this quickly.
The mumps vaccine took four years to develop, from research to approval. If scientists meet the deadline shared by both the C.D.C. and the WHO (January 2021), the COVID-19 vaccine will have taken a total of one year to produce.
1) Preclinical Testing
After studying the virus, scientists test a preliminary vaccine on animals to see if it can invoke an immune response.
2) Phase 1 Safety Trials
Researchers test the vaccine on a small number of people. The test is for safety, as well as to determine the appropriate dosage and observe for an immune response.
3) Phase 2 Expanded Trials
The vaccine is then given to hundreds of people by different classifications - like age, for example. The test is for safety as well as an immune response.
4) Phase 3 Efficacy Trials
Researchers vaccinate thousands of people to observe who becomes infected. At this stage, depending on the disease, researchers may then expose the participants to the virus.
According to F.D.A. approval standards, at least 50% of trial participants exposed must display immunity for the vaccine to be considered adequate. Another advantage of Phase 3 trials is that they can show any potential side effects that previous tests could not.
5) Early/Limited Approval
The vaccine is made available to a limited number of people before widespread use.
The vaccine is now awaiting approval, and each country can decide whether or not to accept and begin to distribute the vaccine. Once widely distributed, researchers continue to monitor the vaccine for its efficacy and any side effects unseen in previous trials.
For decades, this process has been the standard for vaccine approval, and the coronavirus vaccine has taken a similar path.
Accelerating the Process
But what has made the coronavirus vaccine such an accelerated process? One way researchers can speed up development is by combining the trial phases.
For example, many drug companies will combine the first and second phase trials. Instead of testing on just a few trial participants first, an initial test may involve hundreds.
But that's not the only process that gets compressed, especially under the current global pressure. Researchers, government agencies, and drug companies have hastened every step in a process that usually takes a decade or more.
But we are far from normal times. From its January inception, the vaccine trials have excelled at such a pace that the first safety trials took place in March of this year.
The fact that a vaccine may be available within a year is truly remarkable. For some eye-opening perspective, check out this New York Times Coronavirus Timeline to see just how long it would take under typical circumstances.
How Will a COVID Vaccine Work?
You may understand the basics of how a vaccine works. The body is introduced to a version of the virus so that it can develop antibodies. The antibodies help the body develop an acquired immunity so it can recognize and fight off the actual virus.
Since their initial mapping and studying of the coronavirus genome, researchers have developed different approaches for an effective vaccine.
One approach is to use an adenovirus, a virus common to many types of infections, including the common cold. Scientists genetically alter the adenovirus, inserting a snippet of the Sars CoV-2 protein.
Since a piece of the genome is not the full coronavirus, the body has just enough information to recognize it, but not enough to get sick.
Another method is to develop a vaccine that delivers the messenger R.N.A. of the COVID virus into the body. The messenger R.N.A., or mRNA, acts as the "instructions" for replicating the virus.
Since this coronavirus is an R.N.A. virus, the mRNA method may be an effective way for the body to learn about the virus and develop the right antibodies to fight it.
Additionally, there are a few different ways to administer the vaccine as well. Some COVID vaccines will require multiple shots; some require just one.
Who Are the Major Players?
As one might imagine, the race to get a vaccine approved has been nothing short of monumental. With the government forking over millions, along with the historical notoriety that would come from being the first to market, there has been no shortage of incentive.
The U.S. government is pushing for 300 million vaccine doses, and the World Health Organization 2 billion, by 2021. Drug companies have, in total, around 200 vaccines in the works, and there are a few who are close to the January 2021 goal.
Here are the key players and where they're at so far:
Partnering with scientists from the University of Oxford, the drug company AstraZeneca is one of the frontrunners in the vaccine race.
Inserting snippets of the Sars CoV-2 protein spikes, the vaccine delivers the COVID information via an adenovirus, which the body is familiar with. Scientists genetically alter the adenovirus vector so that it won't reproduce. The body will then have enough information to recognize the coronavirus but not get infected.
This team is further along than most. Phase 3 trials are underway in South Africa and Brazil, and results from the combined Phase 1 and 2 trials have proven promising.
In over 95% of participants, there is evidence of a four-fold increase in antibodies, with two doses producing the most robust results. The participants continued to display an immune response as far as a month after the vaccination.
Moderna's mRNA approach reached Phase 3 human trials earlier in the summer. The final test will include 30,000 people across 80+ locations around the United States.
Working in partnership with the National Institutes of Health, the drug company has received billions from the federal government for its vaccine development. They are currently awaiting infection numbers from their first full-scale trial.
BioNTech in Collaboration with Pfizer and Fosun Pharma
This collaboration currently has vaccines in Phase 1, Phase 2, and the combined phases of development. In May, they launched two versions of an mRNA vaccine that required two doses.
While both versions produced antibodies, one version produced fewer side effects. This version, known as BNT162b2, has been used in a worldwide, 30,000-person trial that includes Argentina, Brazil, and Germany, as well as the U.S.
This collaborative boasts sizable initial orders from nations. The United States awarded a contract worth $2 billion for 100 million doses, with the option to purchase 500 million more.
Japan and the European Union have made arrangements to acquire vaccine doses as well. Japan is set to reach 120 million, and the E.U. will purchase 200 million doses.
Johnson & Johnson
Johnson & Johnson, though it's pharmaceutical arm Janssen, has recently launched a phase 3 trial of its version of a vaccine, which is a modified adenovirus. The test will consist of 60,000 adults from age 18 to over 60 years and include populations across seven countries.
Sinovac's CoronoVac vaccine uses an inactivated form of the virus. It has reportedly produced no side effects during its successful phase 2 trial in the Spring.
A reported 90% of participants showed antibodies after 14 days. The phase 3 trial will be in collaboration with Brazil's Instituto Butantan.
SinoPharm began its phase 3 trial in the United Arab Emirates in July. Researchers will study 15,000 volunteers, aged 18-60 for 3-6 months.
The phase 1/phase 2 study of over 1,000 adults showed strong antibody results in almost 100% of the population.
There are 11 vaccines in Phase 3 of testing, and five are already approved for early use. An additional 14 vaccines are already in Phase 2, and 27 in Phase 1. 2021-2023 should yield a mountain of vaccination options.
Some of the other drug companies that are in early to mid-phase testing include:
- Zydus (phase 2)
- CureVac (phase 2)
- AnGes, a Japanese biotech company (combined phases 1 and 2)
- Imperial College London (combined phases 1 and 2)
- Arcturus Therapeutics, in collaboration with Duke-NUS Medical School (combined phases 1 and 2)
- Chineses researchers Walvax Biotechnology, in collaboration with the Academy of Military Medical Sciences and Suzhou Abogen Bioscience (phase 1)
- Genexine, a Korean biotech company (phase 1)
- Inovio, an American biotech company (phase 1)
- Sanofi, a French pharmaceutical company (preclinical)
On top of this sizable list, there are at least a dozen other genetic vaccines in the preclinical stages of development.
By all accounts, a vaccine will be here at some point in 2021. Once a vaccine is available, you will want to know where you can get it.
Once the vaccine becomes available, there will be no shortage of information on where to access it. Most likely your local hospital or doctor's offices will have the vaccine ready for you.
When it comes to medication, PricePro Pharmacy will be there to provide you with the best prescription drug prices around. We pride ourselves in pricing drugs affordably so that you can access the meds you need.
A race toward a vaccine might leave some thinking, "is it safe?" Drugs are approved all the time, which later turn out to be harmful. Will the vaccine rush mean that safety measures get curtailed, leaving people like you to serve as guinea pigs?
Will It Be Safe?
The safety question is a valid one. Most of the concern with safety has to do with the speed of development and how little researchers still know about the disease.
In the trials underway so far, patients have shown side effects, sometimes moderate and, at times, more severe. The side effects have included:
- Muscle/joint pain
Safety does seem to be of concern. With the colossal liability looming over trials, the drug companies seem to be taking some reservations.
As recently as September, AstraZeneca put its testing on hold after a participant experienced a severe, unexplained illness.
Once approved, a coronavirus vaccine may turn out to be as safe as any other common vaccine, such as the flu vaccine people get every year. Unforeseen circumstances may prove that the vaccine needed more time.
The jury is still out. Most likely, many people are going to wait to see how safe the vaccine is.
Many options will likely become available. Certain types of vaccines may turn out to be more appropriate for specific populations.
The most vulnerable populations, like the chronically ill and elderly, might be first in line to receive a COVID vaccine. But they may also be the most susceptible to its side-effects.
If you have questions regarding the COVID vaccine, your doctor should be your COVID-19 update source. Your healthcare provider can get help you decide which type of COVID vaccine will be the best for you.
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