COLUMBUS – The full approval of Pfizer’s COVID-19 vaccine granted by a federal government agency Monday may render a law prohibiting some vaccine mandates irrelevant.
The law signed by Gov. Mike DeWine in July prohibits public schools, colleges, and universities in Ohio from requiring people to get a vaccine if the vaccine did not have the full approval of the FDA.
The U.S. Food and Drug Administration approved the vaccine for those ages 16 and up Monday while those ages 12 to 15 can continue to be vaccinated under the emergency use authorization granted to the drug earlier.
The decision to grant full approval could push some vaccine holdouts toward getting the shots and could spur more vaccine mandates by companies, universities and local governments.
Since the law DeWine signed does not apply to vaccines granted FDA approval, those entities will be able to require vaccinations with the Pfizer drug without fear of running afoul of the prohibition.
The approval means the vaccine has undergone the same rigorous regulatory review as dozens of other established vaccines.
Health officials in Ohio and across the country say the approval should encourage more unvaccinated Americans to get the shots.
”The Pfizer COVID-19 vaccine was built upon decades of research on mRNA vaccines, and was thoroughly evaluated and tested in one of the largest vaccine clinical trials in history,” Ohio Department of Health director Dr. Bruce Vanderhoff said in a statement. “The world’s most comprehensive vaccine safety monitoring system has closely observed the more than 200 million doses that have been administered in the United States, including more than 6 million doses administered in Ohio.”
COVID-19 vaccines in the U.S. were initially rolled out under emergency use authorization, which lets the FDA speed the availability of medical products in public health emergencies.
The FDA initially required only about two months of safety monitoring data, the period when side effects are most likely to occur while it requires six months of data for full approval.
Ohio House Republicans debate anti-vaccination bill again
House Republicans are resuming debate on a bill that would prohibit public and private employers from requiring vaccinations or punishing workers who don’t receive them, though the legislation’s moment in the sun may be short-lived.
The GOP-controlled House Health Committee scheduled a new hearing for Tuesday but House Speaker Robert Cupp (R-Lima) issued a statement saying there would be no further hearings scheduled until the bill has been examined more closely.
The legislation has found support among some who do not want to take a coronavirus vaccine, but it also covers all other vaccines.
Backers say vaccinations should be a personal choice.
Opponents include major Ohio business groups and hospitals, state associations of doctors and nurses, and other health care groups.
It would strengthen notices that schools must provide parents about exemptions they can seek against having their children vaccinated.
Rise in respiratory illness in children worries officials, doctors
A surge of COVID-19 cases among children, combined with an increase in the number of cases of other respiratory infections, which usually don’t appear during the summer, is worrying state health officials and doctors at Ohio’s children’s hospitals.
Vanderhoff says the rise in cases of illnesses like respiratory syncytial virus, known as RSV, which usually show up in fall, winter and spring has health officials worried about the strain on children’s hospitals.
“This unseasonably early increase in RSV, coupled with rising pediatric cases of COVID-19, is a recipe for disaster,” Vanderhoff said in a briefing Monday.
Officials at Nationwide Children’s Hospital say the number of children hospitalized with COVID-19 has more than tripled in the past few weeks.
The 12 COVID patients is up from just three or four a few weeks ago, though hospital officials say they can handle the increase for now.