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Recently, the head of the US Food and Drug Administration (FDA), Stephen Hahn, told the Financial Times that he is prepared to urgently approve a covid-19 vaccine before the candidate has undergone the phase three, where it undergoes extensive and time-consuming testing.
There are particular fears for three results of such a decision: false safety, serious side effects and lack of confidence in the population about the vaccine. All of this poses a significant risk of increased numbers of infections and deaths.
Anne Spurkland, an immunologist and professor in the Department of Basic Medical Sciences at the University of Oslo, cautions strongly.
– If you urgently approve a vaccine, you really don’t know the effect or side effects. At worst, the vaccine can make you even sicker, and that way it hurts worse, Spurkland tells Dagbladet.
Experts disagree
Hahn was quoted as saying that “the benefits outweigh the risks in a public health crisis.” A researcher at the Department of Immunology and Transfusion Medicine at the University of Oslo, Gunnveig Grødeland, believes that urgent approval is not the solution.
– I agree with the principle, but I do not agree with the urgency of approving a vaccine against covid-19. We have other tools that we know work, like distance and good hand hygiene, Grødeland tells Dagbladet.
It warns that an ineffective vaccine can give the population a false sense of security and cause people to resume behaviors that increase the risk of infection and infection.
– A vaccine must have been subjected to the necessary tests so that we know how and to what extent it works before vaccinating the population. This is also important for the public’s confidence in the vaccine.
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Fine trust
The uncertainty is already linked to the confidence of Americans in a possible vaccine against Covid-19. In May, the AP news agency published a survey in which only half of the American population responded that they would take a possible vaccine against covid-19. Up to 20 percent said no, while 31 percent said they were not sure.
A similar trend was also observed in the UK in August when Kings College London released the results of a survey. Only 53 percent said they would get vaccinated against covid-19, while 16 percent said no, according to Sky News.
Spurkland warns of the consequences of a failed vaccine policy.
– If an emergency approval has an unfortunate result, it affects the confidence of the population in vaccines in general, and not only in the covid-19 vaccine. Covid-19 is not so dangerous for most people that a bad vaccine is better than nothing.
Controversy
FDA chief Stephen Hahn criticized himself for exaggerating the effect of blood plasma treatment against COVID-19. This after hastily approving the treatment in the USA. Hahn’s vaccine proposal is now suspected of being the result of political pressure, which Hahn himself denies.
– It is quite obvious that it is about the re-election of Donald Trump. I have noticed that the FDA chief has received strong criticism from researchers for his urgent approval proposals for the vaccine and the possible beneficial effect of blood plasma, says immunologist Spurkland.
Politics
The United States presidential elections will be held on November 3. So far, President Donald Trump has come under massive criticism for his handling of the COVID-19 situation. With more than six million cases of infection and more than 183,000 deaths, the United States is among the countries in the world that have been most affected.
– I think it is problematic that vaccines and health interventions become policy no matter what country it is from. We have had vaccines with side effects before, and we know that it is very troublesome to speed up the process more than good tradition dictates. It is suitable for weakening public confidence in vaccines, says researcher Grødeland.
The phases
In developing a vaccine, candidates go through three phases in which they are tested in humans under controlled conditions. The process takes a long time, but approved candidates are probably safe.
On Wednesday, pharmaceutical giant AstraZeneca told Dagbladet that trials of its candidate vaccine, which has reached phase three, have been suspended indefinitely on suspicion of a “potentially unexplained disease.” Health Minister Bent Høie told Dagbladet that this could delay vaccination in Norway.
According to The Guardian overview, there are currently 29 vaccine candidates against COVID-19 in phase one, 18 in phase two, and nine in phase three. Health Minister Bent Høie recently stated that the best forecasts show that a vaccine can be approved even before Christmas.
– When a vaccine has gone through the necessary phases, there is an overwhelming chance that it is safe. At that point, it would be better to get vaccinated than not, Grødeland says.
Even with a current approved vaccine, several obstacles remain. For example, Norway must have access to a vaccine, the vaccine must be produced and distributed to a sufficient degree, and we must prepare an order for who should be vaccinated first. Norway must also guarantee sufficient syringes and needles.
