By Daniel R. Lucey MD, MPH, FIDSA
On April 9 a request was filed with the U.S. Food and Drug Administration for Emergency Use Authorization of the Pfizer/BioNTech vaccine for 12-15 year olds.
Below are four reasons the FDA should convene its Vaccines and Related Biologic Products Advisory Committee (VRBPAC) for all COVID-19 vaccine EUA requests for use in adolescents and children.
- To continue the scientifically-rigorous pattern of independent expert review of all COVID-19 vaccines before granting an EUA, including for children.
- Doing so will help build trust and lower vaccine hesitancy on the part of parents, adolescents, and children.
- Doing so could offer support if and when needed in other nations for use of COVID-19 vaccines in children.
- To anticipate safety concerns that will occur if even one suspected case of multisystem inflammatory syndrome in children (MIS-C) temporally follows vaccination.
Last week, the first suspected case of multisystem inflammatory syndrome in adults (MIS-A) was reported by Umaydah, et al in a 22-year-old adult who was vaccinated soon after recovering from a mild case of SARS-CoV-2/COVID-19 in Abu Dhabi, UAE. The vaccine given was BBIBP-CorV (Sinopharm), an inactivated vaccine using aluminum hydroxide (alum) as an adjuvant.
No cases of MIS-C have been reported after any of the different international COVID-19 vaccines being tested in children around the world. Rare but serious adverse events such as MIS-C, however, would not likely be seen in studies involving only hundreds or a few thousand volunteers in a vaccine study.
In addition, MIS-C itself is unusual following SARS-CoV-2 infection. As of March 29, 2021, the CDC reported a total of 3,185 cases of MIS-C, of which 36 were fatal. CDC stated that:
- “Most cases were in children and adolescents between the ages of 1 and 14 years, with a median age of 9 years.
- 63% of reported cases have occurred in children who are Hispanic or Latino (1,023 cases) or Black, Non-Hispanic (868 cases).
- More than half (59%) of reported cases were male”.
Concern over the small theoretical possibility of vaccination causing MIS-C has been noted multiple times e.g., by Blumenthal and Burns at Boston Children’s Hospital.
A detailed analysis and protocol to monitor and evaluate vaccinees for MIS-C was published recently by 14 authors from six countries who were convened by the Coalition for Epidemic Preparedness and Innovation (CEPI): Vogel et al. “Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.”
The FDA and CDC experience this month with safety concerns regarding rare events of thrombosis and thrombocytopenia in adults who received an adenovirus-vectored COVID-19 vaccine in the USA, as well as similar concerns with another vaccine in Europe, should serve to emphasize the prudence of convening the existing FDA Vaccine Advisory Committee for all EUA requests for COVID-19 vaccines.
Parents, adolescents, children, and the essential trust-building process for COVID-19 vaccines deserve no less.
Daniel Lucey, M.D. MPH, FIDSA, FACP, is a Clinical Professor of Medicine at Dartmouth Geisel School of Medicine, Infectious Disease adjunct Professor at Georgetown Medical Center, senior scholar at Georgetown Law, Anthropology Research Associate at the Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee. He served as a volunteer to outbreaks overseas including hands-on Ebola patient care in Sierra Leone and Liberia (Doctors without Borders) 2014, MERS 2013, SARS 2003, as well as HIV, H5N1, Zika, yellow Fever, and pneumonic plague 2017 (with WHO/USAID/CDC). Since Jan. 6, 2020 he has contributed over 75 posts to Science Speaks on COVID-19 and traveled to China in February 2020. He initially proposed, then fundraised and helped design the content for 2018-2022 Smithsonian Exhibition on Epidemics due to zoonotic viruses. From 1982-1988 he trained at University of California San Francisco and Harvard and was an attending physician at the NIH (NIAID) in the 1990s while in the US Public Health Service.