The Food and Drug Administration on Friday approved the first vaccine to treat the novel coronavirus, putting the pandemic’s end nearer than ever.
“The known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals,” the FDA said of the vaccine. “In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.”
This news came the same day Monroe County Health Department Administrator John Wagner told the Republic-Times the county’s first shipment of the vaccine would be delayed.
That is because the Illinois Department of Public Health originally announced that the first vaccines in Illinois will be dedicated to hospital and health care workers in the 50 counties with the highest death rates per capita, a list Monroe County was on.
The IDPH later altered its plans after it realized Monroe County and a few other counties on that list did not have hospitals, so it redirected those counties’ allotments to places like Springfield that were just outside the top 50 but have hospitals.
“That’s fine. Since they want hospital and health care workers to get the first round, giving me that vaccine doesn’t really do anything,” Wagner said.
Red Bud Regional Hospital in Randolph County received its first shipment of the Pfizer COVID-19 vaccine on Wednesday.
The change means the first vaccine shipment here should arrive in Monroe County about a week later than originally planned, meaning the county would receive it Dec. 22.
After that, Wagner said weekly shipments should regularly arrive.
Even with the delay, Wagner said he was excited the first vaccine has been approved.
“It’s obviously a good thing. It’s still going to move fairly slowly and it’s not over, but now we see the end in sight. It’s just about getting people vaccinated,” he said. “It’s really the first step we’ve taken to ending this thing. All the other steps have been just to try to prevent the deaths and the cases from rising.”
According to November data from Pew Research Center, 60 percent of Americans planned to get the vaccine.
The approval, which comes 11 months after the virus first emerged, makes this vaccine the fastest ever developed, shattering the previous record of four years for the mumps vaccine.
Created by Pfizer and BioNTech, the coronavirus vaccine uses messenger RNA technology that has never been used in a commercial product and allows for much faster vaccine development.
The Moderna vaccine, which is expected to be approved by the FDA this week, uses the same technology.
Essentially, these vaccines contain a small piece of the virus’ genetic material that instructs the body to make the virus’ “distinctive ‘spike protein,’” the FDA explained. When a person is vaccinated, their body copies the spike protein, which triggers the immune system to react definitely and produce an immune response to the virus without causing any damage.
Although it has been OK’d for use, the Pfizer-BioNTech vaccine is not licensed.
The FDA granted emergency use authorization, a faster-than-normal regulatory process given the public health emergency presented by COVID-19.
The vaccine, which has already been approved by Britain, Bahrain, Canada, Saudi Arabia and Mexico, still went through rigorous examination.
The FDA took the unusual step in June of issuing guidelines that specified any vaccine must be at least 50 percent effective. It also later required manufacturers to produce two months of safety data for trial participants.
In addition, approximately 44,000 people from the United States, Germany, Turkey, South Africa, Brazil and Argentina participated in the late-stage clinical trial to determine the safety and efficacy of the vaccine.
The study began in late July, with roughly half the participants receiving two doses of the vaccine about 21 days apart and the other half getting a placebo. They were exposed to the coronavirus as they went about their lives.
To date, there have been 170 cases of COVID-19 illness among the participants, only eight of whom got the vaccine. Only one of those people had a serious case of the virus.
Those cases were confirmed using the accurate but slow molecular test.
That means the shot is 95 percent effective in preventing COVID-19 after at least a week after the second dose.
It was shown to be effective across racial and ethnic minorities, among people 65 and older and with those who have obesity, diabetes, hypertension and chronic cardiopulmonary diseases.
“Available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period,” the FDA found.
In reviewing results of the clinical trial data, the FDA Advisory Committee that recommended approving the vaccine found “no specific safety concerns” that would prevent authorization.
The most common side effects of the shots, which the FDA described as “mild to moderate,” were injection site reactions, fatigue, headache, muscle pain, chills, joint pain and fever.
Those usually lasted just a few days and occurred in 84.1, 62.9, 55.1, 38.3, 31.9, 23.6 and 14.2 percent of participants, respectively.
Severe adverse reactions were very uncommon, occurring in 0-4.6 percent of participants. They were more likely after the second dose and in those older than 55. The frequency of serious adverse reactions was less than .5 percent.
There were four cases of Bell’s palsy in the vaccine group, but the FDA reported that does “not represent a frequency above that expected in the general population.”
There were also no confirmed adverse effects of the vaccine related to pregnancy.
The FDA said the vaccine should not be used by those allergic to any ingredients in the shot. Ingredients in the vaccine include lipids, potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate and sucrose.