Coronavirus: Efficiency Alerts

The Corona vaccine is now being released to millions of people around the world, after the plight of the pandemic has led to the rapid temporary approval of so-called Pfizer-BioNTech and Moderna mRNA vaccines.

While vaccination with the Pfizer vaccine is already underway, the Moderna vaccine was approved this week for use by the European Medicines Agency (EMA).

Peter Doshi is one of the editors of the renowned British Medical Journal (BMJ).

In a commentary article in the magazine, Doshi, who also holds a professorship at the University of Maryland College of Pharmacy where he researches drug safety, questions the claim that corona vaccines should be 95 percent effective. hundred.

“Covid-19 suspect”

Doshi assumes that Pfizer in its vaccine study has reported 170 PCR-confirmed COVID-19 cases after vaccination.

8 in the vaccine group and 162 in the group that received a misleading drug, a so-called placebo, tested positive.

The study included a total of 43,448 people who were injected, 21,720 with the vaccine and 21,728 with placebo.

It is on this basis that calculations indicate that the vaccine protects against covid-19 with an efficiency of 95 percent.

However, Doshi expresses concern that many more, up to 3,410 study participants, experienced symptoms after vaccination.

His condition was categorized as “suspected covid-19”, without the coronavirus disease being confirmed by the PCR test.

1,594 of the people with “suspected covid-19” were in the vaccine group, 1,816 received deceptive drugs.

– not ignored

“With 20 times more suspects than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR result,” Doshi said in the comment.

Doshi combines the 3,410 suspected cases of coronary heart disease and the 170 confirmed cases of covid-19 and then makes “a rough estimate of the efficacy of the vaccine against developing symptoms of covid-19.”

Then it finds a relative risk reduction of just 19 percent, well below the 50 percent limit that approval authorities require for a vaccine.

When he also eliminates 696 cases of symptoms that occurred during the first seven days after vaccination and which can therefore be explained by reactions to the vaccine itself, Doshi still finds a low vaccine effect of only 29 percent.

Based on this, the editor of BMJ believes that the effect of the vaccine will be drastically reduced, if many of those who are “suspected of covid-19” in the study have false negative results.

However, Doshi emphasizes that flu-like illnesses can have myriad causes. Of course, many of the suspected cases of Covid-19 may be due to pathogens other than the coronavirus.

“The only way”

Doshi still believes it can be problematic if patients with “suspected covid-19” have a course of the disease that requires hospital treatment and puts pressure on the health care system.

The magazine’s editor is generally critical of the fact that vaccine studies provide too few clear answers to important questions.

“With 20 times more suspicion of covid-19 than confirmed covid-19 and studies not designed to evaluate whether vaccines can prevent the spread of infection, an analysis of serious diseases, the degree of hospitalization, intensive care and deaths among the Trial participants will seem justified, “Doshi writes, adding:

“It is the only way to assess the real capacity of vaccines to withstand the worst part of the pandemic.”

EMA in the field

There is little doubt that the BMJ editor’s commentary article is attracting a lot of attention, at a time when temporarily approved corona vaccines are being rolled out to millions of people around the world.

The BMJ is also ranked as one of the world’s leading medical journals, along with the New England Journal of Medicine and The Lancet.

On Wednesday this week, Dagbladet contacted Norwegian experts, including the Norwegian Medicines Agency and the National Institute of Public Health (NIPH), with questions related to the BMJ editor’s comment article on the efficacy of the vaccine. .

Steinar Madsen, medical director of the Norwegian Medicines Agency, contacted Dagbladet on Thursday afternoon with the message that a response could not be expected until Friday.

This is because the European Medicines Agency (EMA) is now working on a review of Peters Doshi’s article in BMJ, in order to provide clear answers to European authorities.

Internal discussions

Madsen initially wanted to see what the EMA thinks about it, before speaking to the media.

Additionally, Madsen admitted that there has been a meeting between the Norwegian Medicines Agency and FHI, where Dagbladet’s request for BMJ’s comment has been an issue.

On Friday, Madsen Dagbladet responds, on behalf of the Norwegian health authorities, without a response from the EMA that he will “spend a lot of time” doing a thorough assessment of the allegations by the editor of BMJ.

The director of the Norwegian Medicines Agency emphasizes that the health authorities have carried out a thorough evaluation and that both doctors and statisticians have participated in internal discussions.

– For most of what Doshi points out, which are already known figures to us, so-called sensitivity analyzes have been carried out, says Madsen.

As an example, he notes that for the dropouts in the study population, an analysis has been made of what he really has to say about the main outcome of the study.

– High degree of protection

– We do not see that there are ambiguities that indicate that the results are not valid. So we think Doshi’s claim is irrelevant to the main finding of the vaccine study: that the vaccine’s degree of protection is high, says Steinar Madsen.

He describes Peter Doshi as a “known and feared critic.”

– Doshi is a general critic of drugs and sometimes shoots a little over the target, says Madsen.

Reiseklinikken physician and vaccine expert Gunnar Hasle has read the BMJ editor commentary article.

He does not hide the fact that he is surprised by what Doshi says about the 3,410 study participants with “suspected covid-19.”

– funny

– Yes, this was weird, says the vaccine expert.

Hasle notes that “suspected covid-19” can include the flu, colds and bacterial pneumonia.

The vaccine expert does not share the BMJ editor’s fears that the vaccines will not be as effective as the manufacturers have assumed.

– No one has claimed that mRNA vaccines work against anything other than covid-19. It is the PCR that we use to distinguish the suspected covid-19 from the real one. Now no one died in the phase 3 studies, and therefore mortality was not compared, but the studies showed a convincing effect in the clinical cases confirmed by PCR, Hasle notes.

In completely different contexts, for example when it comes to studies of cholesterol-lowering drugs and blood pressure drugs, the objections Doshi raises are relevant, Hasle believes.

– If the drug reduces cholesterol or blood pressure, but not the number of cardiac deaths or overall mortality, one is concerned. But here you have a certain criteria for clinical covid-19 and you find a 95 percent reduction, and I think that’s good enough to say that vaccines have an effect, Hasle says.