Hope or Hype: Part 2: How Safe is the Covid Vaccine?

Peter Doshi is an Associate Professor of Pharmaceutical Health Services at the University of Maryland, an Associate Editor at the BMJ, and a leading advocate for clinical trial transparency.  In a November 26 editorial in the BMJ, Dr. Doshi noted that we still don't know whether the vaccine saves lives or prevents transmission of the disease to others. Moreover, he argued that without access to the patient-level data, we don't even really know whether the vaccine has any efficacy regarding the primary endpoint of the trial, which is Covid-19 infection of any severity.  Related Series: • Hope or Hype: Part 1: How Effective is the Covid Vaccine? • Hope or Hype: Part 2: How Safe is the Covid Vaccine?

Peer-reviewed articles systematically underreport the number of adverse events

The trial protocol calls for participants to contact the site immediately if they experience any of a long list of potential symptoms of Covid-19 infection, in order to be tested for the presence of the virus. But the same protocol also contains these words of caution for clinicians:

During the 7 days following each vaccination, potential COVID-9 symptoms that overlap with solicited systemic events (i.e., fever, chills, new or increased muscle pain, diarrhea, vomiting) should not trigger a potential COVID-19 illness visit  unless, in the investigator's opinion, the clinical picture is more indicative of a possible COVID-19 illness than vaccine reactogenicity. (Emphasis added.)

This is an astonishing statement. Why not test everyone who has symptoms? As Dr. Doshi points out, this is tantamount to asking investigators to guess whether participants are in the treatment arm or the placebo arm – a blatant violation of the very principal of a blinded trial. It's hard to imagine why Pfizer included this stipulation – unless it wanted clinicians to systematically undercount the number of cases in the treatment arm.  Did this affect the trial results significantly? Dr. Doshi argues that without access to the patient-level data, we can't know.  In a November 9 interview with Axios, Pfizer CEO Albert Boula promised that when the study is completed the data would be published in a peer-reviewed journal article. That would mean we would be able to see the data that Pfizer wants us to see, and nothing more than that. That's not good enough. Peer-reviewed articles systematically underreport the number of adverse events, including serious and even fatal ones. 

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Moreover, it's our data. We paid for it

Moreover, it's our data. We paid for it. Boula told Axios that Pfizer did not accept government money for the development of the covid vaccine. But money is fungible. Only fourteen percent of prescription drug costs in the U.S. are paid for out-of-pocket, which means the remaining burden is dispersed through taxes and insurance costs, which we all pay for whether we want the drugs or not.  We're also paying to indemnify the vaccine manufacturers against liability under the National Childhood Vaccine Injury Act of 1986. Other nations have similar programs in place to limit compensation for patients harmed by vaccines.  Patient safety advocate Kim Witczak offered these words of caution in her testimony the FDA advisory committee that granted emergency approval for the covid vaccine:

Ultimately, the public – the real-world clinical trial – is one big human experiment. The only ones that have 100% immunity in this will be the pharmaceutical companies. They get all the benefits of sales without any legal liability, should something go wrong.

How widespread might those harms be? We don't know, but a recent tender request by the MHRA (the Medicines and Healthcare products Regulatory Agency, or the British equivalent of the FDA) called for an "artificial intelligence software tool to process the expected high volume of  Covid-19 vaccine Adverse Drug Reaction (ADRs)." That's not exactly the sort of thing guaranteed to inspire confidence. 

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Data transparency

The very same day Pfizer announced that its vaccine showed more than ninety percent efficacy, CEO Boula cashed out sixty percent of his stock in the company, worth $5.6 million or 30% of his annual base salary. That's not the sort of thing guaranteed to inspire confidence, either.  We've been here before. A rushed and ill-advised 1976 emergency program to inoculate the entire United States population against the swine flu was followed by hundreds of cases of Guillain-Barre syndrome. There shouldn't be any question that all the trial data should be available to the public.  Another editorial in the BMJ written by Dr. Doshi along with David Healy, Professor of Family Medicine at McMaster University, noted: Data transparency is not "nice to have." Claims made without access to the data – whether appearing in peer-reviewed publications or in preprints without peer review – are not scientific claims.  Indeed. A recent study looked at "vaccine hesitancy" specifically pertaining to the Covid-19 vaccine in Hong Kong nurses and concluded "Future research is also needed in order to investigate why older nurses have a higher vaccine hesitancy, and explore potential strategies in consciousness raising and attitude changing towards vaccination." Not even a moment's consideration was given to the possibility that nurses -- particularly older nurses -- may have grounds for being wary of the covid vaccine. Instead, these highly trained and experienced professionals are to be treated as balky mules who just need to be driven in the right direction. There has been a lot of concern raised as of late about "vaccine refusal," and anyone who raises any concerns about the safety and effectiveness of any vaccine may find himself smeared as a no-nothing or worse. But if the people raising these concerns are sincere, they ought to join in the demand for vaccine trial transparency. Nothing less will restore public confidence in vaccines.