You want extreme measures to get the corona vaccine on the market faster



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More than 13,000 have been registered as voluntary test rabbits.

At least 108 possible corona vaccines are being developed, based on very different vaccine principles.

With so many, there is a good chance that several actually work, although more than 90 percent of the vaccines tested are never approved.

The most optimistic estimates of when the first vaccines may be ready for use are September, while most assume that 2021 is a more realistic time.

The Institute of Public Health, for its part, has assumed that extended Vaccination in Norway as soon as possible can occur in the fall of 2021.

The difficult phase 3

The question remains: why does it take so long to establish a vaccine that can work, when the world has so many opportunities?

The reason is that the development of the vaccine must undergo three phases of human testing before it can be approved.

  • Phase 1 It is performed on a very limited number of people to check if the vaccine is safe and to see what type of immune response is developing. There are currently eight vaccines at or after this stage.
  • Phase 2 it is somewhat larger and analyzes its effectiveness, including artificial infection. According to the WHO, seven vaccines have arrived here. If you are satisfied with the results of this, the vaccine can go to:
  • Phase 3: So far, no vaccine has gone that far. and this is where things start to take time:

In this phase, the vaccine will be tested on hundreds or thousands of people in different locations, to assess its effectiveness under normal circumstances, including side effects. This can generally take several years.

With an ongoing global pandemic, this is not the time.

in case of emergency

Since the start of the pandemic, it has become clear that authorities have been willing to go a long way in changing the premise to develop a vaccine.

Vaccines that could potentially be ready as early as the fall or early next year will not be approved, but can be used under the regulatory exception provision for the emergency use of people in particularly vulnerable groups. That the emergency use exception is used against vaccines is very unusual.

Also read: works with 70 vaccines, and one stands out in particular

Such an exception can be granted if one is reasonably sure that what he is doing is more useful than harmful, but the vaccines will not initially be aimed at the entire population. If one or more doses of the vaccine are given to 7 billion people, even rare side effects can affect many.

Gather thousands of volunteers to get infected

Therefore Nature reports that it has now created its own group called 1Day Sooner, which wants to do something about how long it will take to conduct clinical trials.

They are working to recruit volunteers for what WHO calls the “Human Challenge Trial” (HCT).

Click the pic to enlarge. A volunteer is injected with a syringe containing the vaccine or a placebo, at the start of a clinical trial established by TASK, a Cape Town-based clinical research organization, to see if Bacillus Calmette-Guerin

The group wants large numbers of volunteers to first receive the vaccine being tested and then try to become infected with the virus. That way, phase 3 of vaccine development can go faster.
Photo: Rodger Bosch (AFP)

This simply means that people who receive the vaccine subsequently are actively trying to become infected with the virus. Therefore, it will be much quicker to determine what actually happens to large numbers of people when they are exposed to the infection, rather than having to wait for a large group to become infected over a long period of time.

On Tuesday afternoon, they reported that more than 13,700 people in 102 countries have volunteered.

1Day Sooner is not affiliated with a particular research community or linked to a particular vaccine, but believes that accelerating vaccine development with one day can save 7,120 lives, or 220,000 lives in one month.

Ethically questionable

– This type of study has been carried out for hundreds of years and has contributed to the essential scientific knowledge that has led to the development of drugs and vaccines. But such research may appear to be in conflict with the basic medical principle of doing no harm. Historical examples of such studies would be considered unethical by current standards. Therefore, it is important that such studies can be conducted within an ethical framework with real informed consent, writes the WHO in an assessment of the principle from 2016.

The group wants to minimize the risk to volunteers by the fact that only people outside the classic risk groups participate and are between the ages of 20 and 45.

According to nature, it is already in the United States Congress to approve such attempts.

It is unclear if that will really help.

According to experts Nature has spoken with, the principle is considered exciting, but it is unclear to what extent it will actually accelerate development.

– I think there is potential, but we have so many questions that we have to work to understand if it can really help within the timeline we have, says Charlie Weller of Wellcome.

Read also: Norway will contribute NOK 13 billion in vaccines



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