While the media lauds two vaccines now approved by for emergency use as light at the end of a long tunnel, some healthcare experts remain circumspect. Earlier this week, the WHO (World Health Organization) warned of a possible six more months of severe disease spread in the Americas. Meanwhile, roll out of the Pfizer and Moderna products is facing both logistical hurdles and new questions about safety.
Shaky Scientific Basis
As mentioned in previous blogs, multiple concerns remain regarding the design and methodology of the Pfizer clinical trial. A variety of questionable research practices have been identified in the study including confirmation bias, volunteer bias, optional stopping, and lack of blinding. Far from the wild speculation of fringe conspiracy theorists, these research flaws have been pointed out by respected medical experts such as Peter Doshi, Assistant Editor of the British Medical Journal. Whether or not the study findings were skewed by volunteer bias was even a subject during the FDA vaccine advisory panel meeting, but Pfizer representatives responded with the claim that researchers cannot control who is recruited for clinical trials.
If the Pfizer research—which was stopped halfway to the estimated date of completion—was hurried, the findings announced by their competitor Moderna almost 2 years early were far more premature. During a second FDA vaccine advisory panel meeting convened to decide whether to recommend Emergency Use Authorization for the Moderna jab, a vigorous discussion revealed significant gaps in the company’s science. The panel of advisors, however, apparently took vaccine guru Dr. Paul Offit’s plea to simply ignore numerous questions unanswered by Moderna scientists to heart, voting unanimously to recommend the experimental shot for immediate public use by all adults 18 and older.
Early Days and Adverse Events
Within 48 hours of the first public vaccination administered in the UK, two recipients had already experienced life-threatening anaphylaxis after being vaccinated. Another serious adverse event occurred in Alaska, soon followed by a report of four recipients of the Pfizer jab in Libertyville who seemed to suffer severe allergic reactions. In the last case, Advocate Condell Medical Center temporarily suspended giving the vaccines, but the program was quickly reinstated.
The suggestion that some individuals might have a sudden adverse response to vaccine products appears to have blindsided both Pfizer spokespeople and healthcare officials. The drug makers insists that its study did not identify any severe allergic reactions. Meanwhile healthcare officials on the ground have speculated that the issue may involve bad batches of vaccines rather than the safety of the drug itself.
Compared to many pharmaceutical drugs, vaccines generally boast a reasonably good safety profile. As with any drug, however, a risk of adverse events does exist. Despite familiar claims to the contrary, no vaccine is “perfectly safe”, and the emerging pattern with Pfizer’s investigational COVID jab warrants closer analysis and further study. In the meantime, all vaccine recipients should be fully informed and asked to stay vigilant and communicate clearly with their healthcare providers.
Sending the Wrong Message
Even if the remarkable claims of efficacy over 90% are accurate, Pfizer and Moderna have only demonstrated that their vaccines prevent symptomatic disease. Asymptomatic vaccine recipients could still be spreading infection, and, in the studies from both companies, a small percentage of those who were vaccinated did become infected and showed clinical symptoms (Pfizer confessed to failing to further investigate these 8 cases). If public health officials and media outlets continue to tout vaccine benefits without strongly urging the public to continue employing all recommended NPI measures including mask wearing and social distancing, those who receive the vaccine might let their guard down and the number of cases and deaths could climb even higher.