[ad_1]
There are currently two COVID-19 vaccines that, at least according to preliminary reports, appear to be 94.5% and 95% effective. Both took place in a record 11 months.
I am an infectious disease specialist and professor at the University of Virginia. I care for COVID-19 patients and am directing the local site for a phase 3 clinical trial of Regeneron’s Antibody Cocktail as a tool to prevent home transmission of COVID-19. I am also investigating how dysregulation of the immune system during SARS-CoV-2 infection causes lung damage.
Despite the relatively rapid development of vaccines, normal safety testing protocols are still in place.
How long does most vaccine development take?
Vaccines typically take at least a decade to develop, test, and manufacture. Both the chickenpox vaccine and FluMist, which protects against various strains of the influenza virus, took 28 years to develop. It took 15 years to develop a vaccine against the human papillomavirus, which can cause six types of cancer. It also took 15 years to develop a vaccine against rotavirus, which commonly causes severe watery diarrhea. It took Jonas Salk six years to develop and test the first polio vaccine, starting with isolating the virus.
The Pfizer-BioNTech and Moderna COVID-19 messenger RNA vaccines, by contrast, have been developed in less than a year. That’s a game changer.
How was this vaccine developed so quickly?
The mRNA vaccines produced by Pfizer and Moderna are faster to develop as they do not require companies to produce weakened proteins or pathogens for the vaccine.
Traditional vaccines often use a weakened version of the pathogen or a portion of protein, but because these are grown in eggs or cells, it takes a long time to develop and manufacture vaccines. In contrast, by using only the genetic material that produces the Spike glycoprotein, the protein on the surface of the coronavirus that is essential for infecting human cells, the design and manufacture of the vaccine is simplified.
The mRNA from genetic material is easy to produce in a laboratory. Making an mRNA vaccine instead of a protein vaccine can save months, if not years.
Another factor that accelerated vaccine development was the rapid and efficient recruitment of patients for clinical trials.
How is safety guaranteed when vaccine development is so fast?
Safety is the first and foremost goal of a vaccine.
In my opinion, safety is not compromised by the speed of vaccine development and authorization for emergency use. The reason vaccines can be approved so quickly is that large clinical trials to evaluate the efficacy and safety of vaccines are taking place at the same time as large-scale manufacturing preparation, funded by the Operation Warp Speed program. Of the federal government.
Large-scale manufacturing typically begins only after the vaccine has been tested in clinical trials. In the case of COVID-19, the US government wanted to be ready to begin distributing the vaccine by the time the results of the phase 3 trials were known and the safety data was analyzed.
To this end, drug companies launched manufacturing at risk, meaning that manufactured vaccine doses would be discarded if the vaccine was ineffective or unsafe, during the FDA-mandated two-month safety waiting period.
The advantage is that if the vaccine is safe and effective, it can be distributed immediately and vaccination can begin.
Are these vaccines more risky than others?
No mRNA vaccines have been approved before because it is a relatively new technology.
But these mRNA vaccines appear safe and pose no higher risk than other proven ones, such as the childhood measles vaccine. To date, no significant side effects have been reported in the interim phase 3 studies of the Moderna and Pfizer vaccines.
[Deep knowledge, daily. Sign up for The Conversation’s newsletter.]The side effects that have been reported are minor things one would expect with any vaccine, including injection site pain and transient fatigue, muscle or joint pain.
How will the USA work?
USA stands for Emergency Use Authorization.
According to the USA, the FDA requires that a COVID-19 vaccine be at least 50% effective in preventing symptomatic illness.
It also requires a median of two months of follow-up after completion of vaccination for half of the vaccine recipients (for most vaccines it is two doses). This two-month period is to allow for the detection of an adverse vaccine event.
William Petri, professor of medicine, University of Virginia
This article is republished from The Conversation under a Creative Commons license. Read the original article.
[ad_2]
