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China: Tests Find Bird Flu Vaccine Safe

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China: Tests Find Bird Flu Vaccine Safe

Our Review Summary

While this article did contain a cautionary note that the vaccine reported upon would ‘face more tests before it could be approved for human use’ the focus of the article is that the Chinese have developed a vaccine to protect individuals at high risk of contracting H5N1. It is not clear why the Chinese announcement has generated such enthusiasm. A trial of a H5N1 vaccine was completed in the US (45 subjects) demonstrating the safety of the product. The optimal dose for peak immune response was also preliminarily identified. Recruitment is ongoing for a Phase 3 trial of the product. This information is readily available at http://www3.niaid.nih.gov/news/newsreleases/2005/H5N1QandA.htm.

Although it is possible that additional testing will find that the vaccine reported might be both safe and effective protection against H5N1 infection, without the data indicating both of these to be true, the entire article is mere speculation. It does not provide any information about this flu strain or vaccine development that is helpful to the reader and only serves to fuel the fire of concern about the possibility of global pandemic without providing any context for evaluating the potential of occurence.

Bird flu needs to be put into context . There have been about 200 people known to be infected and about 100 deaths worldwide. Although this 50% mortality rate has been quoted, it is unclear if this is the case. It is very likely that a small minority of cases of bird flu have actually been identiifed. It is very likely that hundreds if not thousands of people have been infected, become ill and recovered. Bird flu has the potential for mutating just like any other influenza virus. If it does and can be spread from human to human we will have a problem. So it is something for health authorities to be concerned about and a vaccine is important. But,for perspective, last year standard influenza hospitalized about 200,000 people and killed over 36,000 people in the US according to the CDC.

This article does not provide information that serves the reader well.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no cost estimate mentioned in the article for the vaccine, the number of doses that would be needed to establish immunity, nor the length of time from vaccination that an individual would be expected to be protected.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The article mentioned that “any vaccine would face more tests before it could be approved for human use” but made it sound like the vaccine reported on was ready for use. While the title of the article “Test finds bird flu vaccine safe” suggests that the appropriate testing necessary for this conclusion have been conducted, the vaccine discussed in the article was tested in only 6 individuals as opposed to the 20-30 individuals typically involved in a phase I clinical trial. The next step would be to establish whether the vaccine actually was protective against infection with H5N1, a phase II clinical trial, which typically involves 100 – 300 people. With a vaccine given to 6 people, it is not possible to evaluate the potential for benefit from treatment.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

As only 6 individuals were given the vaccine, it is not possible to know much about the potential harms it may cause. Typically a phase III clinical trial, which will involve 1,000 – 3,000 individuals, will be conducted to determine the relative frequency with which side effects occur. Being inoculated with an ineffective vaccine would give those vaccinated a false sense of security.

It is likely that the vaccine will have side effects and will cause significant harm to people. How much harm and to how many people is unclear at the moment. No drug is completely safe. To suggest that safety is assured based on testing in six healthy controls is ridiculous.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

While mentioning that the new vaccine proved initially safe and effective, the vaccine has been tested in only 6 individuals which is hardly convincing. It is unclear whether the individuals inoculated were subsequently placed in contact with the H5N1 virus. From the evidence presented, it is not possible to evaluate whether the vaccine is actually safe or whether it is really protective against infection against the virus. It is therefore not possible to judge either its safety nor its effectiveness. The headline is totally misleading.

Does the story commit disease-mongering?

Not Satisfactory

Mention of the potential for H5N1 to mutate, possibly resulting in a global pandemic is disease mongering in this context. There was no discussion about the likelihood of the sort of mutation necessary to enhance its magnitude of infectivity to this extent.

Bird flu needs to be put into context . There have been about 200 people known to be infected and about 100 deaths worldwide. Although this 50% mortality rate has been quoted, it is unclear if this is the case. It is very likely that a small minority of cases of bird flu have actually been identiifed. It is very likely that hundreds if not thousands of people have been infected, become ill and recovered. Bird flu has the potential for mutating just like any other influenza virus. If it does and can be spread from human to human we will have a problem. So it is something for health authorities to be concerned about and a vaccine is important. But, for perspective, last year standard influenza hospitalized about 200,000 people and killed over 36,000 people in the US according to the CDC.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Although ‘researchers’ are quoted as saying the vaccine is safe and effective, as there were only 6 people inoculated and no mention of the protocol, it is unclear how this conclusion was drawn. The article provides the reader with absolutely no information about the trial, the exact strain of the virus used in vaccine development, how long the subjects were followed, the dose of vaccine etc. The relation between the un-named ‘researchers’ and the individuals conducting the study is not known. There were no comments from other scientists experienced in this area.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There was no mention of protective measures to be taken to avoid exposure to H5N1 or of antiviral drugs that may diminish the severity of infection.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The vaccine reported on was said to be intended for individuals in high risk groups. While the article mentioned that the Chinese government was ready to start mass production, there was no estimate for when the vaccine would be ready, even for the limited target population. Mention of the current clinical trials underway by the U.S. National Institute of Allergy and Infectious Disease was a bit confusing as none of the clinical trials in the U.S. make use of the vaccine developed in China.

Does the story establish the true novelty of the approach?

Not Satisfactory

This article is about a vaccine developed in China for use against the H5N1 strain of bird flu. The development of a vaccine against H5N1 is not unique to this group; that there are several firms and national laboratories around the world which have developed such vaccines and are currently testing them was not mentioned. It’s a major oversight that the story didn’t mention that NIH sponsored trials are now enrolling subjects for Phase 3 testing.

Does the story appear to rely solely or largely on a news release?

Not Applicable

No obvious use of information from sources other than a press release is present, though it is not possible to establish that this article relied on a press release for its content.

Total Score: 0 of 9 Satisfactory

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