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The participant in the vaccine study, who did not receive the 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 candidate vaccine, but a placebo.
Also read: Participant in vaccine test died
The incident shows a new ethical dilemma facing vaccine companies.
Strengthen requirements for vaccinations
Never before has vaccine development been faster than now. And it is precisely the speed that has helped increase skepticism about an upcoming vaccine.
Also read: Erna Solberg: – Fortunately, support for vaccination is generally high
This skepticism means that health authorities have become very careful about taking shortcuts, even during a pandemic.
There was long hope that two vaccines could be approved before next week’s US elections, but the FDA made such approval impossible by tightening the requirements to be able to grant an emergency approval of the vaccine.
A double dilemma
The way the 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. Nobody gets to know who is in which groups. For the vaccine to be considered effective, people who received the vaccine must achieve significantly better results than people in the control group.
Typically, such a study can take 1 to 2 years, but having many participants, in heavily infected areas, it is hoped that reliable data can be obtained much earlier.
Also read: the Oxford professor believes that the vaccine will be ready before Christmas
Companies can request a so-called emergency vaccine, or limited approval, if these results show that the vaccine is more than 50 percent effective.
But a study shouldn’t just find out about the vaccine jobs, but also about the side effects it can cause.
Many side effects appear very quickly, such as a rash around the needle stick and fever, while other side effects can appear after a long time. When the FDA recently tightened the requirements for emergency approval, it was by requiring that information on side effects be available at least two months after participants received the vaccine.
At a meeting held at the FDA advisory group Advisory Committee on Vaccines and Related Biological Products (VRBPAC) before the weekend, according to Science magazine, several members thought this should be extended to 6 months.
The dilemma one faces is, therefore, that the longer one waits for a possible effective vaccine to be approved, the more people will get sick and die. But if you approve a vaccine that is not effective enough or you have problems, then the trust problem of a coronary vaccine will explode:
– We only have one chance to get this right. If we fail, then the race is over, VRBPAC member Sheldon Toubman said 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 vaccine studies who are part of the control groups.
Like the person who recently died in Brazil.
According to FDA guidelines, vaccine studies’Continue collecting placebo-controlled data for as long as possible.».
Also read: People will be paid 48,000 crowns to become infected with the coronavirus
In practice, this means that volunteers participating in vaccine trials cannot access the vaccine once it is 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 study participants of an approved emergency vaccine, if it is approved. If Pfizer’s vaccine is to receive emergency approval, we want to change the study so that everyone in the placebo group can receive the vaccine if they wish, Pfizer writes in a letter to the FDA.
Pfizer is not the only one feeling this challenge: at the meeting, the vaccine company Moderna reported that they have already started receiving 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 belong to is that companies lose any opportunity to control the study with placebo, which will reduce the quality. If, on the other hand, they don’t report, they prevent participants from gaining access to an effective vaccine and potentially may also run the risk of participants choosing to get vaccinated twice.
You may end up with a temporary solution.
According to the FDA, one way out of this dilemma may be for the vaccine not to receive emergency approval, but instead issue a more limited permit (expanded access) specifically for selected groups in high-risk groups. Then one can continue with 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 may end up approving vaccines in a whole new way.
P.S! Europe is running its own race for vaccine approvals, but it will rely heavily on the same information as the US FDA.
Also read: The new vaccine has ended up on the fast track for approval
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