COVID‐19 vaccines: the importance of transparency and fact‐based education

• Published in: British Journal of Clinical Pharmacology Vol. 86; no. 11; pp. 2107 - 2110
• Main Authors: Cohen, Adam F., Gerven, Joop, Burgos, Juan Garcia, Boer, Anthonius, Foucher, Ron A. M., Flore, H., Teitelbaum, Zvi, Eden, Willem, Webb, Andrew, Cremers, Serge
• Format: Journal Article Web Resource
• Language: English
• Published: England John Wiley & Sons, Inc 01.11.2020; John Wiley and Sons Inc
• Subjects: Animals; Clinical Trials as Topic; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - administration & dosage; COVID-19 Vaccines - adverse effects; COVID-19 Vaccines - standards; Drug Development; Humans; Immunization Programs - organization & administration; Immunogenicity, Vaccine; Information Dissemination; Mass Vaccination - psychology; Mass Vaccination - standards; Mass Vaccination - trends; Patient Safety - standards; SARS-CoV-2
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/bcp.14581

The difficulty in conveying messages around vaccines' benefits and risks is a fact, and general statements without qualification or proper explanation do not help. [...]it is particularly important to increase the public understanding that risks are inherent to all medicines, and that no vaccine is 100% effective in preventing a disease or 100% safe in all vaccinated people; despite that, we need to build public understanding and consensus that the benefits of vaccines are unquestionable when one considers, for example, that they made the eradication of smallpox possible, and have almost completely achieved this for polio. There are examples where Guillain Barre is listed in the EU prescribing information as adverse events detected post‐marketing, but frequency cannot be estimated from the available post‐marketing data.14 Post‐vaccination auto‐immune events are plausible as they also occur after infections and Guillain‐Barré syndrome has been described after the COVID‐19 outbreak in Italy.15 In addition, demonstration of causality can be a prolonged investigation for extended periods as has been shown for the possible association between the vaccine for H1N1 influenza and narcolepsy in Scandinavian countries in 2009.16 With this knowledge, the occurrence of a very rare adverse event at this stage, such as of transverse myelitis is not entirely unexpected and cannot be attributed with any confidence to the vaccine; the question is when an adverse event is enough reason to stop enrollment. Several COVID‐19 vaccines that are currently in development also make use of an adenoviral vector, and serious unexpected reactions that occur with one vaccine could also be relevant for other agents in the same class. [...]an analysis of the aggregate of side effects in the adenoviral vector population versus the RNA vaccines could be of scientific interest. In parallel the scientific community will need to be well informed to be able to maintain the trust that is an essential component of a vaccine that helps by strongly reducing the incidence of disease without serious safety issues rather than works by producing an immune response.