CH Allegheny Enterprise

Vaccine front-runners The Moderna vaccine was found to be 94.5% effective against the coronavirus, according to early data released by the company, which made it the second vaccine in the Unit- ed States to have a high success rate. The first, from Pfizer, was found to be 90% effective and then 95% effective. Both vaccines were in the third phase of their respective studies. Dr. Andrea Amalfitano, dean of Michigan State Univer- sity’s College of Osteopathic Medicine, says he’s cautiously optimistic about the interim vaccine results. “We do not know yet whether (these vaccines) will elicit similar levels of protection when delivered to large popu- lations,” he says. “However, I am hopeful these early results are very promising.” Amalfitano stresses that it’s “very important” to have a vaccine for this particular virus for two major reasons. “The first being it is highly transmissible from individual to individual, increasing the likelihood it can spread across large populations and eventually to vulnerable populations rapidly,” he says. “This is coupled with the second reason, that being that once infected, the subsequent symptoms, morbidity and mortality are higher than for the common flu. “While one can dispute how high those numbers will be — we will eventually learn full infection rates and not just cases vs. mortality rates — it is clear that older individuals and the immunocompromised will be predictably more vulnerable, and those same individuals are at risk due to annual flu epidemics. This is why we justify annual flu vac- cines and vaccination campaigns, and therefore must even more vigorously pursue COVID-19 targeted vaccines and COVID-19 vaccination campaigns.” Challenges and concerns Medical experts and health department officials were hopeful that a successful coronavirus vaccine was going to be out by the end of 2020. If it gets emergency use autho- rization from the Food and Drug Administration, experts say it would likely be prioritized for essential workers such as doctors and nurses, and those most at risk, including people with underlying conditions and older adults. Wider distribution for all Americans still likely wouldn’t come until later in 2021. Data from early COVID-19 vaccine trials, including Mod- erna and Pfizer, has also suggested that consumers will have to be prepared for side effects that, while technically mild,

could disrupt their daily lives. “The side effects which have been reported in the first few clinical trials include fever, body aches, chills and symptoms consistent with the flu,” says Quincy Byrdsong, vice provost for health affairs and a profes- sor at Lipscomb University in Nashville. “Additionally, the longevity of the symptoms seems to vary from a few hours to a few days.” Byrdsong says he sees some challenges ahead when a COVID-19 vaccine is available. “The biggest challenge is the perception that the vac- cine will have an immediate impact on the pandemic,” Byrdsong says. “It is still being determined how long it takes these vaccines to take effect in an individual or in a population.The biggest challenge is ensuring the pre- vention measures are not relaxed because the vaccine is being distributed.” Like Amalfitano, Byrdsong is also optimistic about Moderna’s and Pfizer’s interim vaccine results, but he also has his own concerns. “I am optimistic with the technology because it does not involve the introduction of the virus into humans as a way to produce protective antibodies,” Byrdsong says. “My major concern surrounds the push to release the vaccine under an FDA Emergency Use Authoriza- tion. ... I worry if we use the vaccine before the FDA has approved it, it may hinder the ability of the clinical trials to carry out their regulatory responsibilities of ensuring safety and efficacy. I feel we have to get this right out the gate. It would be better to stress con- tinued preventive measures — social distancing and masks — and nail down the FDA approval of the vac- cine when it has gone through the appropriate checks and balances than to release it prematurely and cause more damage from a public health prospective.” Amalfitano adds that the timetable for delivery and distribution are important concerns because the Pfizer vaccine has to be kept extremely cold — at minus 94 degrees (colder than winter in Antarctica). The Mod- erna vaccine has to be frozen, too, but “only” at minus 4 degrees. “That may well limit the distribution ... to large or distant populations,” he says, and emphasizes he is still hopeful, given that early studies show this formulation can elicit protection from natural COVID-19 infection, as compared to subjects receiving a placebo.

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