How it works
VICKSBURG, Miss. (Vicksburg Daily News) – When a virus infects a person for the first time, the immune system must produce all the necessary tools to fight the infection. After the first infection, the immune system will remember what tools are needed to protect against that pathogen, so the next time it’s encountered, the immune system responds much more efficiently. This is called adaptive immunity, and it is the reason vaccines work.
For COVID-19 vaccines, all of the approved vaccines so far used the spike protein. The spike protein is located on the outside of a coronavirus and is how SARS-CoV-2 enters human cells.
The spike protein is unique to SARS-CoV-2 – it doesn’t look like other proteins your body makes. So antibodies created against the spike protein won’t harm your body, they will only target coronavirus.
Because the vaccine does not use live or even disabled virus, just the recipe for the spike protein, the vaccines cannot give you COVID-19 or cause you to shed any vaccine components.
How it was developed so quickly
One key factor in getting the vaccine created quickly was the wealth of research available to build on. mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV) and research on mRNA vaccines has been ongoing since the early ’90s. As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.
Funding was nearly immediate and abundant. Lisa Cornish estimates $39.5 billion in US spending alone.
COVID-19 has a high rate of transmission, which allowed trials to collect data more quickly. In a normal scenario, it might take years to accumulate enough case information for statistical analysis. In addition, the public was engaged in the process. Enrollment for trials as large as the ones conducted for COVID vaccines usually takes years to fill, but participants lined up quickly for COVID-19 trials. These two factors took YEARS off the process.
Cutting red tape, not corners, assisted in expediting vaccine development.
“[What] happened with the regulatory agencies across the world is that they were able to prioritize COVID studies, and as soon as they came in, they… reviewed them and brought on additional staff in order to process it,” said Lynlee Burton, head of center for vaccines and emerging infectious diseases at PRA Health Sciences.
Regulatory agencies also instituted rolling reviews, meaning they would accept data from pharmaceutical companies on an ongoing basis throughout the trials rather than waiting to receive it all at the end of the trial.
All these factors came together to allow a speedy, yet safe, vaccine. Along with a little bit of luck. It was pretty lucky that the pandemic came in form of a coronavirus, something familiar and previously studied.
Is it safe?
mRNA vaccines have been held to the same rigorous safety and effectiveness standards [332 KB, 24 pages] as all other types of vaccines in the United States. The only COVID-19 vaccines the Food and Drug Administration (FDA) will make available for use in the United States (by approval or emergency use authorization) are those that meet these standards.
It is also important to note that even though Operation Warp Speed fast-tracked development, the final clinical trials for COVID-19 vaccines were huge, enrolling between 30,000 and 45,000 participants.
“These studies are so much bigger than the studies we do for many licensed vaccines,” said Dr. Ruth Karron, director of the Center for Immunization Research at Johns Hopkins University. “Some trials for previously approved vaccines have included as few as 3,000 participants.”
Studies have shown that two-dose COVID-19 vaccines are around 95% effective at preventing illness, while the single-dose shot is around 72% effective.
“You have your proof in terms of efficacy and safety,” says Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. If you are still refusing, “then that’s because you’re not a skeptic anymore. You’re a cynic.”See a typo? Report it here.