Two months, one week, and five days. That’s how much time has passed since Pfizer and BioNTech filed for approval from the U.S. Food and Drug Administration for their Covid-19 vaccine. The agency has not hinted when that decision might be coming.
Moderna formally asked the FDA for approval of its vaccine seven weeks ago. There’s been no word on when the agency will complete its review.
Experts say the FDA will likely grant the applications “priority review.” Translating from the bureaucrat-ese, that’s within six months of receiving an application.
That’s some way of defining “priority.” Covid-19 has killed more than 600,000 Americans. Less than half of the U.S. population has received a full course of the shots since they received emergency use authorization in December.
At least some of the holdouts might be persuaded to sit for their shots if they had full approval. Every jab puts us one step closer to ending this pandemic. The FDA needs to get in gear.
There’s a distinct difference between an emergency use authorization and full approval. EUAs make a treatment, medical device, or vaccine temporarily available until a particular emergency declaration ends. They can be revoked at any time and are only issued when there are no other alternative treatments.
Full approval requires a more comprehensive review to “determine whether the clinical data and other information show the drug is safe and effective for its intended use.” That process typically takes several months or even years.
Dr. Anthony Fauci, President Biden’s top Covid-19 adviser, recently said he’d be “astounded” if the vaccines didn’t get approval. He merely attributes the delay to the FDA needing to “cross all the t’s and dot all the i’s.”
It’s unclear what those t’s and i’s are. Both vaccines proved 100% effective at preventing severe disease in clinical trials last year. Since then, “real world” studies have revealed efficacy rates of 90% and higher.
Both are also effective against the delta variant of the coronavirus, which is now responsible for the majority of new cases in the United States.
The FDA’s cautious posture has contributed to vaccine hesitancy. Back in April, the agency paused administration of the Johnson & Johnson vaccine because of reports of blood clots. At that point, the risk was less than one in a million.
Immediately following the pause, nearly 75% of unvaccinated Americans said they were unwilling to get the Johnson & Johnson shot, according to a poll from the Washington Post and ABC News.
The seven-day average for doses of all vaccines administered dropped by nearly 1.3 million between April 13—the day of the announcement—and May 13. As of mid-July, we’re averaging just half a million shots per day.
According to recent data from the U.S. Census Bureau, half of vaccine-hesitant adults are either “concerned about side effects” or “don’t trust” the vaccines. Another poll found that one-quarter of unvaccinated folks believe that all vaccines cause blood clots.
Survey data indicate that people would be more willing to get the jab if it had full approval. It’s the make-or-break factor for one-third of Americans, according to a May poll from the Kaiser Family Foundation. Eric Topol, director and founder of the Scripps Research Translational Institute, told the Washington Post in July that “[t]ens of millions of Americans will get vaccinated” once Pfizer’s vaccine is approved.
Time is of the essence. In states across the Deep South, about one in five adults is still hesitant to get the vaccine. The share is even higher in Wyoming, North Dakota, and West Virginia.
New cases and deaths are increasing in many of these areas. Last week, the U.S. Centers for Disease Control and Prevention announced that the delta variant accounted for nearly three-quarters of cases in Missouri and more than four in ten in Nevada. Less than half of Missourians have received at least one dose of vaccine; just over half have gotten one shot in Nevada.
“Virtually all Covid-19 hospitalizations and deaths in United States are now occurring among unvaccinated individuals,” said Jeff Zients, the White House’s coronavirus response coordinator.
According to an analysis from Georgetown University, these unvaccinated “clusters” could be a breeding ground for new variants—and put the rest of the country at risk.
There’s plenty of evidence that the Covid-19 vaccines are safe and effective. It’s high time the FDA declared as much by formally approving them.
Sally C. Pipes is President, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All (Encounter 2020). Follow her on Twitter @sallypipes.
FDA Foot-Dragging On Vaccines Is Unfortunately No Surprise
Sally C. Pipes
Two months, one week, and five days. That’s how much time has passed since Pfizer and BioNTech filed for approval from the U.S. Food and Drug Administration for their Covid-19 vaccine. The agency has not hinted when that decision might be coming.
Moderna formally asked the FDA for approval of its vaccine seven weeks ago. There’s been no word on when the agency will complete its review.
Experts say the FDA will likely grant the applications “priority review.” Translating from the bureaucrat-ese, that’s within six months of receiving an application.
That’s some way of defining “priority.” Covid-19 has killed more than 600,000 Americans. Less than half of the U.S. population has received a full course of the shots since they received emergency use authorization in December.
At least some of the holdouts might be persuaded to sit for their shots if they had full approval. Every jab puts us one step closer to ending this pandemic. The FDA needs to get in gear.
There’s a distinct difference between an emergency use authorization and full approval. EUAs make a treatment, medical device, or vaccine temporarily available until a particular emergency declaration ends. They can be revoked at any time and are only issued when there are no other alternative treatments.
Full approval requires a more comprehensive review to “determine whether the clinical data and other information show the drug is safe and effective for its intended use.” That process typically takes several months or even years.
Dr. Anthony Fauci, President Biden’s top Covid-19 adviser, recently said he’d be “astounded” if the vaccines didn’t get approval. He merely attributes the delay to the FDA needing to “cross all the t’s and dot all the i’s.”
It’s unclear what those t’s and i’s are. Both vaccines proved 100% effective at preventing severe disease in clinical trials last year. Since then, “real world” studies have revealed efficacy rates of 90% and higher.
Both are also effective against the delta variant of the coronavirus, which is now responsible for the majority of new cases in the United States.
The FDA’s cautious posture has contributed to vaccine hesitancy. Back in April, the agency paused administration of the Johnson & Johnson vaccine because of reports of blood clots. At that point, the risk was less than one in a million.
Immediately following the pause, nearly 75% of unvaccinated Americans said they were unwilling to get the Johnson & Johnson shot, according to a poll from the Washington Post and ABC News.
The seven-day average for doses of all vaccines administered dropped by nearly 1.3 million between April 13—the day of the announcement—and May 13. As of mid-July, we’re averaging just half a million shots per day.
According to recent data from the U.S. Census Bureau, half of vaccine-hesitant adults are either “concerned about side effects” or “don’t trust” the vaccines. Another poll found that one-quarter of unvaccinated folks believe that all vaccines cause blood clots.
Survey data indicate that people would be more willing to get the jab if it had full approval. It’s the make-or-break factor for one-third of Americans, according to a May poll from the Kaiser Family Foundation. Eric Topol, director and founder of the Scripps Research Translational Institute, told the Washington Post in July that “[t]ens of millions of Americans will get vaccinated” once Pfizer’s vaccine is approved.
Time is of the essence. In states across the Deep South, about one in five adults is still hesitant to get the vaccine. The share is even higher in Wyoming, North Dakota, and West Virginia.
New cases and deaths are increasing in many of these areas. Last week, the U.S. Centers for Disease Control and Prevention announced that the delta variant accounted for nearly three-quarters of cases in Missouri and more than four in ten in Nevada. Less than half of Missourians have received at least one dose of vaccine; just over half have gotten one shot in Nevada.
“Virtually all Covid-19 hospitalizations and deaths in United States are now occurring among unvaccinated individuals,” said Jeff Zients, the White House’s coronavirus response coordinator.
According to an analysis from Georgetown University, these unvaccinated “clusters” could be a breeding ground for new variants—and put the rest of the country at risk.
There’s plenty of evidence that the Covid-19 vaccines are safe and effective. It’s high time the FDA declared as much by formally approving them.
Sally C. Pipes is President, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All (Encounter 2020). Follow her on Twitter @sallypipes.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.