There are now two COVID-19 vaccines that, at least according to preliminary reports, appear to be 94.5% and 95% effective. Both were developed in a record-breaking 11 months or so.
I am an infectious diseases specialist and professor at the University of Virginia. I care for patients with COVID-19 and am conducting the local site for a phase 3 clinical trial of Regeneron's antibody cocktail as a tool to prevent household transmission of COVID-19. I'm also conducting research on how dysregulation of the immune system during SARS-CoV-2 infection causes lung damage.
Despite the vaccines' relatively rapid development, the 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 several strains of the influenza virus, took 28 years to develop. It took 15 years to develop a vaccine for human papilloma virus, which can cause six kinds of cancer.
It also took 15 years to develop a vaccine for rotavirus, which commonly causes severe, watery diarrhea. It took Jonas Salk six years to develop and test the first polio vaccine, starting with the isolation of the virus.
The Pfizer-BioNTech and the 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 protein or weakened pathogen for the vaccine.
Traditional vaccines typically use a weakened version of the pathogen or a protein piece of it, but because these are grown in eggs or cells, developing and manufacturing vaccines takes a long time.
By contrast, by using just the genetic material that makes 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 genetic material mRNA is easy to make in a laboratory. Manufacturing an mRNA vaccine rather than a protein vaccine can save months, if not years.
Another factor that accelerated vaccine development was the swift and efficient recruitment of patients for clinical trials.
How is safety assured when vaccine development is so fast?
Safety is the first and foremost goal for a vaccine.
In my opinion, safety is not compromised by the speed of vaccine development and emergency use authorization. The reason that vaccines may be approved so quickly is that the large clinical trials to assess vaccine efficacy and safety are happening at the same time as the large-scale manufacturing preparation, funded by the federal government's Operation Warp Speed program.
Typically, large-scale manufacturing begins only once the vaccine has been tested in clinical trials.
In the case of COVID-19, the U.S. government wanted to be ready to begin distributing the vaccine the moment the results of the phase 3 trials were known and the safety data had been analyzed.
To this end, the pharmaceutical companies launched at-risk manufacturing – which means that the manufactured vaccine doses would be thrown away if the vaccine was ineffective or unsafe – during the FDA-mandated two-month safety waiting period.
The upside is that if the vaccine is safe and effective, it can be distributed immediately, and vaccination can begin.
Are these vaccines riskier than others?
No mRNA vaccines have been approved before because it is relatively new technology.
But these mRNA vaccines appear safe and no riskier than other tried and tested ones, like 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.
Side effects that have been reported are minor things that one would expect with any vaccine, including soreness at the site of injection and transient fatigue, muscle or joint aches.
How will EUA work?
EUA stands for emergency use authorization.
Under EUA, the FDA is requiring that a COVID-19 vaccine be at least 50% effective at preventing symptomatic illness.
It is also requiring a median of two months of follow-up after completion of the vaccination for half of the vaccine recipients (for most of the vaccines this is two doses). This two-month period is to allow detection of an adverse event from the vaccine.
This article was originally published by The Conversation. You can read it here.
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Will your current friends still be with you after seven years?
Professor shares how many years a friendship must last before it'll become lifelong
Think of your best friend. How long have you known them? Growing up, children make friends and say they’ll be best friends forever. That’s where “BFF” came from, for crying out loud. But is the concept of the lifelong friend real? If so, how many years of friendship will have to bloom before a friendship goes the distance? Well, a Dutch study may have the answer to that last question.
Sociologist Gerald Mollenhorst and his team in the Netherlands did extensive research on friendships and made some interesting findings in his surveys and studies. Mollenhorst found that over half of your friendships will “shed” within seven years. However, the relationships that go past the seven-year mark tend to last. This led to the prevailing theory that most friendships lasting more than seven years would endure throughout a person’s lifetime.
In Mollenhorst’s findings, lifelong friendships seem to come down to one thing: reciprocal effort. The primary reason so many friendships form and fade within seven-year cycles has much to do with a person’s ages and life stages. A lot of people lose touch with elementary and high school friends because so many leave home to attend college. Work friends change when someone gets promoted or finds a better job in a different state. Some friends get married and have children, reducing one-on-one time together, and thus a friendship fades. It’s easy to lose friends, but naturally harder to keep them when you’re no longer in proximity.
Some people on Reddit even wonder if lifelong friendships are actually real or just a romanticized thought nowadays. However, older commenters showed that lifelong friendship is still possible:
“I met my friend on the first day of kindergarten. Maybe not the very first day, but within the first week. We were texting each other stupid memes just yesterday. This year we’ll both celebrate our 58th birthdays.”
“My oldest friend and I met when she was just 5 and I was 9. Next-door neighbors. We're now both over 60 and still talk weekly and visit at least twice a year.”
“I’m 55. I’ve just spent a weekend with friends I met 24 and 32 years ago respectively. I’m also still in touch with my penpal in the States. I was 15 when we started writing to each other.”
“My friends (3 of them) go back to my college days in my 20’s that I still talk to a minimum of once a week. I'm in my early 60s now.”
“We ebb and flow. Sometimes many years will pass as we go through different things and phases. Nobody gets buttsore if we aren’t in touch all the time. In our 50s we don’t try and argue or be petty like we did before. But I love them. I don’t need a weekly lunch to know that. I could make a call right now if I needed something. Same with them.”
Maintaining a friendship for life is never guaranteed, but there are ways, psychotherapists say, that can make a friendship last. It’s not easy, but for a friendship to last, both participants need to make room for patience and place greater weight on their similarities than on the differences that may develop over time. Along with that, it’s helpful to be tolerant of large distances and gaps of time between visits, too. It’s not easy, and it requires both people involved to be equally invested to keep the friendship alive and from becoming stagnant.
As tough as it sounds, it is still possible. You may be a fortunate person who can name several friends you’ve kept for over seven years or over seventy years. But if you’re not, every new friendship you make has the same chance and potential of being lifelong.