Tweet
By Jon Cohen
Aug. 28, 2020 , 6:55 PM
When President Donald Trump accepted his party’s nomination for another term last night at the Republican National Convention, he pledged that the push by his administration’s Operation Warp Speed to deliver a COVID-19 vaccine would succeed “before the end of the year, or maybe even sooner.”
That promise concerns many vaccine veterans. They worry that political forces—the U.S. presidential election on 3 November, nationalistic pride to “win” a race, the need to resuscitate economies—could lead to premature and dangerous approvals under mechanisms such as the emergency use authorization (EUA), a pathway used by the U.S. Food and Drug Administration (FDA) to allow rapid access to diagnostics, treatments, and vaccines. Long a bastion of regulatory rigor that many other countries look to for guidance, FDA has been criticized for issuing EUAs for two COVID-19 treatments, convalescent plasma and hydroxychloroquine, based on scant data and apparent political pressure. (The hydroxychloroquine EUA has since been revoked.) Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia who is a member of a group that advises FDA about its vaccine decisions, suspects the Trump administration might seek a COVID-19 vaccine EUA before the elections and say: “We Warp Speeded our way to a vaccine.”
... Peter Marks, who runs the FDA division that oversees vaccine approval, has vowed that he would resign if the Trump administration pushed through a vaccine that was not clearly safe and effective. And he insists that FDA will consult with the Vaccine and Related Biological Products Advisory Committee (VRBPAC), which Offit sits on, to publicly discuss data related to any approval request.
What safety and efficacy evidence would FDA require before issuing an EUA?
FDA issued a “guidance for industry” in June that says any emergency decision on a COVID-19 vaccine would be based on factors such as “the target population, the characteristics of the product, [and] the preclinical and human clinical study data.” The guidance specifies that FDA will only approve an EUA for a vaccine that has at least 50% efficacy. But estimates of efficacy have error bars of sorts; for a COVID-19 vaccine, FDA wants 95% confidence that efficacy is no lower than 30%. The decision to consider an EUA request would likely be based on data reviewed by the independent boards, set up by the vaccine’s sponsors or clinical trial investigators, that monitor safety and efficacy during the study.
What harm could an EUA do?
Public Citizen, a public advocacy group, has argued that regardless of whether a COVID-19 vaccine is effective, an EUA could fuel existing vaccine hesitancy. “The ‘logic’ of saving several months by a faster but riskier EUA pathway will surely be outweighed by the loss in public confidence in the vaccine, accompanied by decreased willingness to be vaccinated,” Public Citizen warned in a 6 August letter to Marks and his superiors. An EUA for a vaccine might also make it more difficult to recruit people for clinical trials of that vaccine and others, because participants might not want to take the risk of receiving a placebo when they can get a shot of a product that’s authorized for use.
What if the vaccine doesn’t work well or causes harm?
Vaccines go into healthy people, so putting them into use before fully assessing their risks and benefits is a bigger gamble than issuing an EUA for an experimental treatment for someone already ill. If a hastily approved COVID-19 vaccine candidate proves ineffective or has serious side effects, confidence in what many see as the best hope to ending the pandemic could plummet. The Solidarity Vaccines Trials Expert Group of the World Health Organization (WHO) argued in an editorial published in The Lancet yesterday that a weakly effective vaccine could actually worsen the pandemic if it induced authorities to relax control measures, such as mask wearing, or if vaccinated people believed they were immune and increased their risk-taking behavior.
Has an EUA ever been used for a vaccine?
Vaccines go into healthy people, so putting them into use before fully assessing their risks and benefits is a bigger gamble than issuing an EUA for an experimental treatment for someone already ill. If a hastily approved COVID-19 vaccine candidate proves ineffective or has serious side effects, confidence in what many see as the best hope to ending the pandemic could plummet. The Solidarity Vaccines Trials Expert Group of the World Health Organization (WHO) argued in an editorial published in The Lancet yesterday that a weakly effective vaccine could actually worsen the pandemic if it induced authorities to relax control measures, such as mask wearing, or if vaccinated people believed they were immune and increased their risk-taking behavior.
Aug. 28, 2020 , 6:55 PM
When President Donald Trump accepted his party’s nomination for another term last night at the Republican National Convention, he pledged that the push by his administration’s Operation Warp Speed to deliver a COVID-19 vaccine would succeed “before the end of the year, or maybe even sooner.”
That promise concerns many vaccine veterans. They worry that political forces—the U.S. presidential election on 3 November, nationalistic pride to “win” a race, the need to resuscitate economies—could lead to premature and dangerous approvals under mechanisms such as the emergency use authorization (EUA), a pathway used by the U.S. Food and Drug Administration (FDA) to allow rapid access to diagnostics, treatments, and vaccines. Long a bastion of regulatory rigor that many other countries look to for guidance, FDA has been criticized for issuing EUAs for two COVID-19 treatments, convalescent plasma and hydroxychloroquine, based on scant data and apparent political pressure. (The hydroxychloroquine EUA has since been revoked.) Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia who is a member of a group that advises FDA about its vaccine decisions, suspects the Trump administration might seek a COVID-19 vaccine EUA before the elections and say: “We Warp Speeded our way to a vaccine.”
... Peter Marks, who runs the FDA division that oversees vaccine approval, has vowed that he would resign if the Trump administration pushed through a vaccine that was not clearly safe and effective. And he insists that FDA will consult with the Vaccine and Related Biological Products Advisory Committee (VRBPAC), which Offit sits on, to publicly discuss data related to any approval request.
What safety and efficacy evidence would FDA require before issuing an EUA?
FDA issued a “guidance for industry” in June that says any emergency decision on a COVID-19 vaccine would be based on factors such as “the target population, the characteristics of the product, [and] the preclinical and human clinical study data.” The guidance specifies that FDA will only approve an EUA for a vaccine that has at least 50% efficacy. But estimates of efficacy have error bars of sorts; for a COVID-19 vaccine, FDA wants 95% confidence that efficacy is no lower than 30%. The decision to consider an EUA request would likely be based on data reviewed by the independent boards, set up by the vaccine’s sponsors or clinical trial investigators, that monitor safety and efficacy during the study.
What harm could an EUA do?
Public Citizen, a public advocacy group, has argued that regardless of whether a COVID-19 vaccine is effective, an EUA could fuel existing vaccine hesitancy. “The ‘logic’ of saving several months by a faster but riskier EUA pathway will surely be outweighed by the loss in public confidence in the vaccine, accompanied by decreased willingness to be vaccinated,” Public Citizen warned in a 6 August letter to Marks and his superiors. An EUA for a vaccine might also make it more difficult to recruit people for clinical trials of that vaccine and others, because participants might not want to take the risk of receiving a placebo when they can get a shot of a product that’s authorized for use.
What if the vaccine doesn’t work well or causes harm?
Vaccines go into healthy people, so putting them into use before fully assessing their risks and benefits is a bigger gamble than issuing an EUA for an experimental treatment for someone already ill. If a hastily approved COVID-19 vaccine candidate proves ineffective or has serious side effects, confidence in what many see as the best hope to ending the pandemic could plummet. The Solidarity Vaccines Trials Expert Group of the World Health Organization (WHO) argued in an editorial published in The Lancet yesterday that a weakly effective vaccine could actually worsen the pandemic if it induced authorities to relax control measures, such as mask wearing, or if vaccinated people believed they were immune and increased their risk-taking behavior.
Has an EUA ever been used for a vaccine?
Vaccines go into healthy people, so putting them into use before fully assessing their risks and benefits is a bigger gamble than issuing an EUA for an experimental treatment for someone already ill. If a hastily approved COVID-19 vaccine candidate proves ineffective or has serious side effects, confidence in what many see as the best hope to ending the pandemic could plummet. The Solidarity Vaccines Trials Expert Group of the World Health Organization (WHO) argued in an editorial published in The Lancet yesterday that a weakly effective vaccine could actually worsen the pandemic if it induced authorities to relax control measures, such as mask wearing, or if vaccinated people believed they were immune and increased their risk-taking behavior.
