By John J. Cohrssen and Henry I. Miller
We are in the midst of a pandemic of historic proportions. COVID-19 has killed more than a quarter of a million Americans, caused pain and suffering to many more, damaged a thriving economy, and caused great public anxiety. And it promises to get worse before it gets better. The numbers of cases, the percentage of positive test results, and hospitalizations are all trending upwards. That bodes particularly ill as the Thanksgiving and Christmas holidays approach, tempting many of us into high-risk situations.
Relief seems to be on the horizon—however distant. Pfizer, a major producer of pharmaceuticals, including vaccines, in partnership with biotechnology company BioNTech, has just reported 95% efficacy of their COVID-19 vaccine, based on nearly complete data from their late-stage (Phase 3) 43,000-subject trial. Moderna has reported 94.5% efficacy with their vaccine, based on a 30,000-subject trial. There are 65 other vaccines in clinical trials, including 12 in Phase 3, made with many different technological approaches. For example, the Oxford University-AstraZeneca vaccine is made from a weakened version of a common cold virus (adenovirus), from chimpanzees that has been genetically modified so it cannot grow in humans, while both the Pfizer/BioNTech and Moderna vaccines use “messenger RNA,” a DNA-like molecule that, when injected into humans, causes cells in the body to synthesize a coronavirus coat protein, which then elicits an immune response. Although none of these vaccines is likely to be widely distributed until mid-2021, the news is very encouraging, indeed. We expect to eventually have several vaccines available that will slow, or even halt, the spread of the infection.
However, even excellent vaccines are worthless if people don’t take them. In a recent survey by the STAT-Harris Poll, only “58% of the U.S. public said they would get vaccinated as soon as a vaccine was available when asked earlier this month [October], down considerably from 69% who said the same thing in mid-August.” A global survey conducted by Ipsos World Economic Forum survey during the week of October 8th yielded similar results; it found that only about 64% of Americans would get a vaccine if one were available.
Thus, we face a dilemma: We need to get lifesaving vaccines out as quickly as possible, while reassuring a somewhat skeptical public that speed does not imply uncertainty about safety or efficacy.
THE WRONG (I.E., THE BUREAUCRATIC) RESPONSE TO VACCINE HESITANCY
Some of the increasing resistance to the COVID-19 vaccine appears to stem from concerns that the White House might have exerted undue political pressure on the FDA to cut corners in the evaluation of the COVID-19 vaccines in the run-up to the November presidential election. There has also been widespread disinformation from anti-vaccine activists, including alarming, even bizarre claims. (In addition to the coronavirus pandemic, the World Health Organization recently declared an “infodemic”: “an overabundance of information—some accurate and some not—that makes it hard for people to find trustworthy sources and reliable guidance when they need it.”)
Damaged public confidence in the FDA’s review process has spurred several state governors to establish their own scientific committees to reassure the public by conducting independent state-level “reviews of vaccines’ safety and effectiveness. As New York Gov. Andrew Cuomo said, “Frankly, I’m not going to trust the federal government’s opinion, and I wouldn’t recommend [COVID-19 vaccines] to New Yorkers, based on the federal government’s opinion.” California, some other western states, and West Virginia have also established a “review” process.
These initiatives are a double-edged sword.
On the one hand, they are redundant, and likely to be a waste of time. The traditionally conservative FDA, which has access to confidential manufacturing and testing data and boasts extensive experience and expertise with new vaccines, will conduct thorough, science-based reviews for safety and effectiveness before granting marketing approval. Applications submitted to the FDA for regulatory approval of vaccines are both voluminous and complex, involving chemistry, medicine, pharmacology, clinical trial design, and statistics. In order to understand where the red flags are in all of those aspects of the product, institutional memory about similar, previous products is important, and that knowledge resides within the FDA. Moreover, every application for approval of a COVID-19 vaccine will also be reviewed by the FDA’s vaccines advisory committee comprised of independent outside experts, making state-level independent reviews both superfluous and inferior.
If these state-conducted checks can be performed quickly, efficiently, and proficiently, and reassure the public, they would serve the public interest. But if they delay access to the vaccines unnecessarily, or they raise spurious issues concerning safety or efficacy that discourage people from taking the vaccines, they will actually harm public health.
Another important consideration for governors is that if these individual state reviews become protracted or onerous, they are likely to be challenged in federal courts as violating the federal preemption doctrine, which prevents a state law from interfering or conflicting with federal law. Even the filing of such a case could defeat the goal of encouraging public acceptance of COVID-19 vaccines, and actually have the opposite of the intended effect.
The governors who established these advisory committees will need to remain alert to their possible shortcomings and should be ready to take appropriate steps, including disbanding the committees altogether, if it becomes obvious that they are superfluous or do not function well. At the federal level, the incoming administration should seek to restore public confidence in the FDA and the integrity of its evaluations, and to convince governors that their states’ reviews are unnecessary and costly. Even before supplies begin to trickle out from manufacturers, which could be within a month or two, the feds and states should focus on coordinating the “unprecedented challenge” of distributing them.
We need those vaccines: Almost 2,000 Americans died yesterday from COVID-19.
John J. Cohrssen is an attorney and statistician who served in senior positions for White House agencies including the Office of the Vice President.
Henry I. Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute. He was the founding director of the FDA’s Office of Biotechnology.
Unnecessary State Reviews of COVID-19 Vaccines Could Delay Distribution
Pacific Research Institute
By John J. Cohrssen and Henry I. Miller
We are in the midst of a pandemic of historic proportions. COVID-19 has killed more than a quarter of a million Americans, caused pain and suffering to many more, damaged a thriving economy, and caused great public anxiety. And it promises to get worse before it gets better. The numbers of cases, the percentage of positive test results, and hospitalizations are all trending upwards. That bodes particularly ill as the Thanksgiving and Christmas holidays approach, tempting many of us into high-risk situations.
Relief seems to be on the horizon—however distant. Pfizer, a major producer of pharmaceuticals, including vaccines, in partnership with biotechnology company BioNTech, has just reported 95% efficacy of their COVID-19 vaccine, based on nearly complete data from their late-stage (Phase 3) 43,000-subject trial. Moderna has reported 94.5% efficacy with their vaccine, based on a 30,000-subject trial. There are 65 other vaccines in clinical trials, including 12 in Phase 3, made with many different technological approaches. For example, the Oxford University-AstraZeneca vaccine is made from a weakened version of a common cold virus (adenovirus), from chimpanzees that has been genetically modified so it cannot grow in humans, while both the Pfizer/BioNTech and Moderna vaccines use “messenger RNA,” a DNA-like molecule that, when injected into humans, causes cells in the body to synthesize a coronavirus coat protein, which then elicits an immune response. Although none of these vaccines is likely to be widely distributed until mid-2021, the news is very encouraging, indeed. We expect to eventually have several vaccines available that will slow, or even halt, the spread of the infection.
However, even excellent vaccines are worthless if people don’t take them. In a recent survey by the STAT-Harris Poll, only “58% of the U.S. public said they would get vaccinated as soon as a vaccine was available when asked earlier this month [October], down considerably from 69% who said the same thing in mid-August.” A global survey conducted by Ipsos World Economic Forum survey during the week of October 8th yielded similar results; it found that only about 64% of Americans would get a vaccine if one were available.
Thus, we face a dilemma: We need to get lifesaving vaccines out as quickly as possible, while reassuring a somewhat skeptical public that speed does not imply uncertainty about safety or efficacy.
THE WRONG (I.E., THE BUREAUCRATIC) RESPONSE TO VACCINE HESITANCY
Some of the increasing resistance to the COVID-19 vaccine appears to stem from concerns that the White House might have exerted undue political pressure on the FDA to cut corners in the evaluation of the COVID-19 vaccines in the run-up to the November presidential election. There has also been widespread disinformation from anti-vaccine activists, including alarming, even bizarre claims. (In addition to the coronavirus pandemic, the World Health Organization recently declared an “infodemic”: “an overabundance of information—some accurate and some not—that makes it hard for people to find trustworthy sources and reliable guidance when they need it.”)
Damaged public confidence in the FDA’s review process has spurred several state governors to establish their own scientific committees to reassure the public by conducting independent state-level “reviews of vaccines’ safety and effectiveness. As New York Gov. Andrew Cuomo said, “Frankly, I’m not going to trust the federal government’s opinion, and I wouldn’t recommend [COVID-19 vaccines] to New Yorkers, based on the federal government’s opinion.” California, some other western states, and West Virginia have also established a “review” process.
These initiatives are a double-edged sword.
On the one hand, they are redundant, and likely to be a waste of time. The traditionally conservative FDA, which has access to confidential manufacturing and testing data and boasts extensive experience and expertise with new vaccines, will conduct thorough, science-based reviews for safety and effectiveness before granting marketing approval. Applications submitted to the FDA for regulatory approval of vaccines are both voluminous and complex, involving chemistry, medicine, pharmacology, clinical trial design, and statistics. In order to understand where the red flags are in all of those aspects of the product, institutional memory about similar, previous products is important, and that knowledge resides within the FDA. Moreover, every application for approval of a COVID-19 vaccine will also be reviewed by the FDA’s vaccines advisory committee comprised of independent outside experts, making state-level independent reviews both superfluous and inferior.
If these state-conducted checks can be performed quickly, efficiently, and proficiently, and reassure the public, they would serve the public interest. But if they delay access to the vaccines unnecessarily, or they raise spurious issues concerning safety or efficacy that discourage people from taking the vaccines, they will actually harm public health.
Another important consideration for governors is that if these individual state reviews become protracted or onerous, they are likely to be challenged in federal courts as violating the federal preemption doctrine, which prevents a state law from interfering or conflicting with federal law. Even the filing of such a case could defeat the goal of encouraging public acceptance of COVID-19 vaccines, and actually have the opposite of the intended effect.
The governors who established these advisory committees will need to remain alert to their possible shortcomings and should be ready to take appropriate steps, including disbanding the committees altogether, if it becomes obvious that they are superfluous or do not function well. At the federal level, the incoming administration should seek to restore public confidence in the FDA and the integrity of its evaluations, and to convince governors that their states’ reviews are unnecessary and costly. Even before supplies begin to trickle out from manufacturers, which could be within a month or two, the feds and states should focus on coordinating the “unprecedented challenge” of distributing them.
We need those vaccines: Almost 2,000 Americans died yesterday from COVID-19.
John J. Cohrssen is an attorney and statistician who served in senior positions for White House agencies including the Office of the Vice President.
Henry I. Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute. He was the founding director of the FDA’s Office of Biotechnology.
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.