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LITTLE ROCK, Ark. (AP) – As U.S. regulators weigh in on final approval of some COVID-19 vaccines, governors in states hit hard by the pandemic are hoping the move will help persuade many of their states’ reluctants to finally get the shot.
The governors of Arkansas and Ohio – where cases and hospitalizations are on the rise – have issued a public appeal in recent days for full approval, saying it would help fight vaccine reluctance and could also pave the way for more companies to demand that their employees be vaccinated.
It’s a subject Republican Gov. Asa Hutchinson has faced as he holds town halls across Arkansas., which leads the country in the number of new cases per capita but has one of the lowest vaccination rates. Only about 35% of the state’s population is fully vaccinated.
“Anytime you have low immunization rates you want to eliminate any objections people have, and one of the objections that has been voiced is that this is only approved under emergency use authorization.” said Hutchinson, who also recently took over the chairmanship of the National Association of Governors.
The three vaccines authorized for use in the United States has gone through an expedited approval process – but that hasn’t ignored the normal massive testing required for any vaccine. Pfizer and Moderna have requested full approval and a decision from Pfizer is expected shortly.
The Pfizer, Moderna and Johnson & Johnson vaccines have been studied in tens of thousands of people to show that they prevent symptomatic coronavirus infections – especially serious illnesses – and that they are safe. Once widespread use began, the Food and Drug Administration and the US Centers for Disease Control and Prevention stepped up the usual surveillance to detect side effects too rare to occur, even in these large studies.
Acting FDA Commissioner Dr Janet Woodcock was asked by a Senate committee this week about people reluctant to get a vaccine that has not been fully approved.
“We haven’t cut corners,” she replied. “Compared to other vaccines they would review, these really grabbed the attention of the press when it came to review and study. “
In Ohio, with less than half of the population vaccinated, Republican Governor Mike DeWine has exhausted all means of getting vaccinated in his arms. The state recently completed a five-week, million-dollar draw for adults or a full scholarship to an Ohio university for those under 18 who receive their first COVID-19 vaccine. .
Last week, DeWine announced plans for an incentive that gives out smaller amounts of money to increase the chances of winning more people. But that is on hold as the governor and his administration are urging full FDA approval to appease an unvaccinated segment of the community that may budge.
“This is one of the most common reasons we hear from people who don’t get the vaccine,” DeWine said of his conversations with residents across the state. “And my concern is that the FDA is not going from emergency use to full approval, some people are not vaccinated who would be vaccinated and these people are going to die.”
In Kansas, Democratic Governor Laura Kelly has expressed hope to avoid renewal of mask terms and other restrictions to get more people vaccinated. After a call with governors and the White House this week, she said the Biden administration was “fully aware” that governors wanted full approval for COVID-19 vaccines.
“It would eliminate a variable that seems to be used as an excuse not to get the shot,” Kelly said.
The governors’ efforts are taking place against a backdrop of increasing cases in every state due to the rampant spread of the delta variant.
At the same time, lawmakers in GOP-controlled legislatures are moving forward with legislation that limits the ability of businesses and schools to mandate vaccines, specifically targeting COVID-19 vaccines that have not yet received the vaccine. FDA full seal of approval.
In Ohio, GOP Senator Andrew Brenner pushed through a last-minute clause that would ban public schools and state universities from mandating vaccines without full FDA approval.
“When I brought this amendment forward, I look at it from an individual liberty perspective,” Brenner said. But, he added, “despite having received emergency use clearance, typical vaccines take about 10 years of testing and testing to find out about side effects and everything.”
However, COVID-19 vaccines were the result of more than a decade of behind-the-scenes research and huge injections of funds. who laid the groundwork for them to be deployed so quickly.
Hutchinson noted that full vaccine approval could encourage more hospitals and businesses to require vaccinations.
The FDA has never had as much evidence to use in deciding whether or not to approve a vaccine as it has for the Pfizer and Moderna injections. Over 188 million doses of the Pfizer-BioNTech vaccine have been administered in the United States and over 137 million doses of the Moderna vaccine. The FDA can also consider evidence from several other countries that successfully use injections.
Pfizer recently announced that the FDA deemed its application eligible for “priority review” and would make a decision no later than January. But the agency is generally expected to complete its work much sooner.
Full approval carries the strongest FDA approval for a product and, among other steps, typically requires six months of monitoring for safety. For emergency use, the agency required two months of safety follow-up, the period during which side effects are most likely to occur. The agency will also carry out detailed inspections of vaccine manufacturing plants.
Health experts say they view refractories awaiting full approval as more accessible than others clinging to misinformation or those who are downright hostile to vaccines.
“There is clearly a degree of reflection in understanding the FDA approval process and waiting for it to happen,” said Dr. Cam Patterson, University of Arkansas chancellor for medical science, which has been strained by the latest increase in Arkansas cases.
“My hope and expectation is that they will follow this train of logic in the doctor’s office to get vaccinated once the FDA gives full approval for the vaccines.”
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Amiri reported from Columbus, Ohio. AP medical writer Lauran Neergaard in Washington, DC, and John Hanna in Topeka, Kansas, contributed.
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