Participant in vaccine study, who did not receive vaccine, died.
Before the weekend, it became known that a patient who participated in a vaccine study in Brazil died of covid-19. The patient was part of the control group that did not receive the vaccine candidate, but instead a placebo.
Read also: Participant in vaccine test died
The incident shows a new ethical dilemma facing vaccine companies.
Tightens the requirements for vaccines
Never before has the development of a vaccine been faster than now. And it is precisely the speed that has helped to increase skepticism about an upcoming vaccine.
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This skepticism means that health authorities have become extra careful about taking shortcuts, even during a pandemic.
There was long hope that two vaccines could be approved even before the US election next week, but the FDA made such approval impossible by tightening the requirements for an emergency vaccine.
A double dilemma
The way a so-called phase 3 study works is that around 30,000 participants are divided into two groups: those who receive the vaccine, and those who are a control group. Who is in which groups, no one gets to know. In order for the vaccine to be considered effective, the people who received the vaccine must achieve significantly better results than the people in the control group.
Normally, such a study can take 1-2 years, but by having many participants, in areas with a lot of infection, one hopes to be able to get reliable data much earlier.
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Companies can apply for a so-called emergency vaccine, or limited approval, if these results show that the vaccine is more than 50 percent effective.
But a study should not just find out about the vaccine works, but also about the side effects it can cause.
Very many side effects come very quickly, such as rash around the needle stick and fever, while other side effects can come after a long time. When the FDA recently tightened the requirements to be able to give emergency approval, it was by requiring that information on side effects be available at least two months after the participants had received the vaccine.
In a meeting held in the FDA’s advisory group Vaccines and Related Biological Products Advisory Committee (VRBPAC) before the weekend, according to the magazine Science, several members thought that this should be extended to 6 months.
The dilemma one faces is therefore that the longer one waits to approve a possible effective vaccine, the more people will get sick and die. But if you approve a vaccine that is not effective enough, or have problems, then the confidence problem of a coronary vaccine will explode:
– We only have one chance to do this correctly. If we fail, then the race is over, said VRBPAC member Sheldon Toubman at the meeting, according to Science.
The impossible dilemma of the emergency vaccine
But an additional dilemma that will arise if a vaccine receives emergency approval is how to deal with the tens of thousands of participants in the vaccine studies who are part of control groups.
Like the person who recently died in Brazil.
According to FDA guidelines, vaccine studies’continue to collect placebo-controlled data for as long as possible».
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In practice, this means that volunteers who participate in the vaccine trials are prevented from accessing the vaccine after it becomes available.
This is a position that the pharmaceutical giant Pfizer finds ethically challenging:
– It is our position that we have an ethical obligation to inform all participants in the study about an emergency-approved vaccine, if it is approved. If Pfizer’s vaccine were to receive emergency approval, we would like to change the study so that everyone in the placebo group can get the vaccine if they wish, Pfizer writes in a letter to the FDA.
Pfizer is not the only one who feels this challenge: At the meeting, the vaccine company Moderna informed that they have already started getting questions from their participants about when to get information about whether they have been vaccinated or are in a control group.
The challenge of informing participants about which group they are in is that companies lose all opportunity to placebo-control the study, which will reduce the quality. If, on the other hand, they do not inform, they prevent participants from gaining access to an effective vaccine – and potentially they may also risk that participants choose to be vaccinated twice.
May end up with temporary solution
According to the FDA, one way out of this dilemma may be that the vaccine will not receive an emergency approval, but that they instead issue a more limited permit (expanded access) specifically for selected groups in high-risk groups. Then one will be able to continue the vaccine studies as before, but at the same time severely limit who can get the vaccine.
This solution has its own challenges, and according to Science, one can thus end up approving the vaccines in a completely new way.
PS! Europe is running its own race for vaccine approval, but will largely rely on the same information as the US FDA.
Read also: New vaccine has ended up in the fast track for approval
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