People who have avoided getting a COVID-19 vaccine have one less excuse as of Monday morning.
The U.S. Food and Drug Administration (FDA) granted full approval for Pfizer's coronavirus vaccine on Aug. 23 — the first approval among the three COVID-19 vaccines available in the United States. The approval replaces the emergency use authorization that the agency had given to Pfizer in December.
The approval for the vaccine — which will be marketed as Comirnaty — is for use in people ages 16 and older. The FDA says that the vaccine will continue to be available under emergency use authorization for those ages 12-15 and as boosters for immunocompromised individuals.
"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," acting FDA commissioner Dr. Janet Woodcock says in a news release.
With the full approval for Pfizer and more on the way, health experts throughout the country hope more people will get a COVID-19 vaccine.
Overall, COVID-19 vaccination rates within Ohio and throughout the United States have plateaued, starting for the most part in May and June when states lifted public health orders like masking and venue capacity limits. As of Aug. 23, only 51% of all Ohio residents have had at least one dose of an authorized vaccine since vaccines first became available in phases at the start of the year, while just 47% are fully vaccinated. According to the Centers for Disease Control and Prevention (CDC), a “fully vaccinated” person is one who is two weeks past their second dose of a two-dose vaccine (Pfizer and Moderna) or two weeks after a single-dose vaccine (Johnson & Johnson).
Most counties within Ohio show COVID-19 first-dose vaccination rates of less than 50%, and some counties such as Holmes and Adams have rates below 30%, according to Ohio's coronavirus dashboard.
Many vaccine holdouts frequently have said that they were waiting for FDA and CDC approval, not just emergency use authorization. The FDA originally had given emergency use authorization to administer Pfizer — and later, Moderna and Johnson & Johnson — vaccines while trials continued, using years of similar research and data to say that vaccine benefits outweighed most risks during the coronavirus public health crisis.
Monday's official approval from the FDA means that the Pfizer vaccine has gone through significantly more trials and researchers have examined more data. With this approval, businesses, schools, employers and other groups can mandate vaccination more easily, with many states already requiring a variety of vaccines for residents.
Pfizer is the first company to have applied for full FDA approval in the United States. Moderna also has applied and is being reviewed. Johnson & Johnson says it will submit its application later this year. All vaccine manufacturers will also continue to conduct trials and seek approval for use in teens and children.
Pfizer's approval comes as Ohio and Kentucky both are seeing sharp, sustained upticks in COVID-19 cases, hospitalizations and deaths, largely due to the highly transmissible Delta variant of the coronavirus. Scientists warn that this strain is much more dangerous than the original virus.
"The spread of the Delta variant has dramatically accelerated since I last spoke 10 days ago. We are at the high level of cases since last February,” Mike DeWine, governor for Ohio, said on Aug. 17.
People infected with Delta carry 1,000 times more of the virus, experts say, which makes it easier to transmit among others when speaking, singing, sneezing or breathing hard, particularly within indoor areas and regions with low vaccination rates. Health experts say that Delta is more than twice as easy to spread as the first strain. New studies are showing that the virus is becoming even more airborne.
Unvaccinated individuals are at the highest risk for severe infection and substantial health issues from coronavirus, experts say, though some vaccinated individuals also are becoming infected due to Delta's highly contagious nature. COVID-19 symptoms and rates are less severe in individuals who are fully vaccinated with a Pfizer, Moderna or Johnson & Johnson COVID-19 vaccine.
Public health experts have said that though COVID-19 transmission is less likely outdoors, precautions such as distancing and masking still should be taken in large crowds, particularly in high-transmission regions. According to charts on Aug. 23, the CDC considers each of the counties surrounding Cincinnati — both in Ohio and in Kentucky — to be high risk due to the prevalence of the virus. Nearly every state within the nation also now are considered high risk.
Some people who refuse to get COVID-19 vaccines because of government distrust are exploring other methods to prevent and treat coronavirus cases, though these are widely discredited and are potentially fatal. This weekend, the FDA urged United States residents to stay away from Ivermectin, a veterinary drug that some people have touted as a miracle cure. Ivermectin typically is used to prevent and treat parasites in animals, particularly horses. Ivermectin is not approved for human use.
FDA used its social media clout to try to dissuade people from attempting to use Ivermectin for COVID-19.
"You are not a horse. Stop it with the Ivermectin," the FDA posted to its accounts on Aug. 21.
In 2020, former President Donald Trump had suggested that ultraviolet light or "disinfectant" could be used to "cleanse" a body of the coronavirus. Scientists and medical experts loudly said — and continue to say — that these methods were not tested or approved.
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