A sophisticated global audience, including IFAPP Academy students, alumni, Global Fellows in Medicines Development, and members of the IFAPP National Member Associations, recently challenged the faculty during a fascinating discourse (Conversations with the Academy, March 30, 2021) on several ethical, policy, and access facets that have emerged as various COVID-19 vaccines are being made available in different nations.
Sandor Kerpel-Fronius, Professor, Semmelweis Medical University, Budapest, one of our eminent panel members, opines….
- US, UK, EU, AUS, Japan blocked an IP waiver for “generic” COVID vaccines to be mass-produced… this is an enormous ethical dilemma; how did Medical Affairs in Pharma play into this landmark decision?The technique producing mRNA vaccines might be very difficult and probably not easily manageable. Personally, I think the best approach would be to build production sites by the companies in less-developed regions.
- What about covid mRNA vaccines in pregnant women?Yes, they can be used; antibodies were even detected in newborn babies.
- What do you think about the recent prolongation of interval between first and second doses? Do you expect, with time, this time period can become even longer? Or, do you think this can lead to the situation that only one dose of vaccine will be sufficient for application?The prolongation is feasible since already after the first dose, marked antibody titers can be measured. Although this will provide some decrease in the protection against infection but will decrease the severity of the infection. However, the booster injection will be needed after the extended interval. Ethically, the advantage of more extensive vaccination of the population over slightly diminished individual protection can be justified.
- Given the lethal nature of COVID-19 and the importance of vaccines, what do you think about a degree of flexibility on the part of the regulators for approval of the vaccines, in the first instance, and then follow-up with real-world data?The follow-up of accelerated approval of orphan drugs is increasingly based on RWD. This approach might be possibly used also for vaccines to decrease the time until EUA is approved. However, the successful collection of RWD must be very carefully planned together with the communities receiving these vaccines.
- What type of social contract would the panel propose for worldwide distribution of the COVID-19 vaccines?An approach similar to COVAX but it should deal together with WHO to introduce an internationally acceptable unified approach for EUA procedure before donating or marketing vaccines internationally.
- Is it ethical that some parts of the world have not as yet received any vaccine due to their geographical location and economic situation and yet 60% of the adults have already been vaccinated in the UK? However, the enormous political pressure of the local citizens for first satisfying local needs will overrule internationally more correct ethical decisions. It might be argued in favor of such approach that rich nations can support international vaccination programs if their economic basis remain functional to support altruistic programs.
- Access, I believe, is the most hot-potato ethical issue. Do you offer any solution for equitable access?It would be necessary to improve local vaccine production also in underdeveloped regions making these regions capable for rapidly producing locally vaccines. The technical assistance of advanced producers will be needed.
- What is your view regarding informed consent for Human Challenge Trials of vaccines?The fact that the natural history of the disease is not well understood, together with frequent fatal outcomes and lack of treatment, makes challenge studies ethically highly questionable. One should consider that Ethics Committees have to defend physically the subject and psychologically both the subject as well as the performer of such studies. In addition, also the society must be protected from the disastrous consequences of possible tragedies.
- I can see the practicality of asking for vaccine passports, but is it ethical? And is it in line with social liberty?Very difficult question. The introduction of such passports would be entirely ethical only after all people requesting vaccination would receive the treatment all over the world.
- What happens to those who are generally against vaccines because of religion and personal reasons?Personally, I think that it is not ethical if religion(s) interferes with medical treatments. Those people who refuse vaccination should ethically and administratively accept the possible negative consequences of their decision from the side of the community.
Sandor Kerpel-Fronius, MD, DSc, GFMD