Characteristics of Special Regulatory Pathways Used to Authorize COVID-19 Vaccines in Latin America

Objectives: The project maps the use and characteristics of special regulatory pathways used to grant COVID-19 vaccines market authorization in Latin America and identifies properties that make for effective and efficient emergency use and reliance pathways.

Method: Data regarding legislations that facilitate vaccine authorizations was collected mainly from the public domain. A database containing all COVID-19 vaccine approvals in Latin America was constructed including review times, submission dates and regulatory mechanisms (e.g., reliance, recognition).

Results:In our initial data collection 15 Latin American countries were assessed for their use of specific pathways to review COVID-19 vaccines. Of these, 6 were found to have introduced legislation specifically targeting COVID-19 related products. So far, 25 authorizations of 5 different vaccines were identified in 15 countries. Most authorizations concern the AstraZeneca, Pfizer, or Sputnik vaccine. These were approved 8, 8, and 6 times, respectively. No authorizations of the Moderna vaccine were identified in Latin America. Of the 24 approvals, 12 were found to utilize either reliance or recognition mechanisms and 3 indicated a mainly independent assessment. In 10 cases, the assessment process is yet unknown. Based on incomplete public data, authorization times varied. Some authorization followed just hours after a vaccine was approved for emergency use in large markets with comprehensive regulatory review procedures (e.g., EU, US, UK), while others took several weeks.

Conclusion: In response to the COVID-19 pandemic Latin American countries have, like most countries, drastically shortened regulatory review times when granting emergency use authorization to COVID-19 vaccines. The way they achieve this varies significantly. Some countries have applied or adapted existing regulatory pathways, some introduced novel COVID-19-specific pathways and others do not seem to follow regulatory review procedures at all. In conclusion, COVID-19 vaccines authorizations in Latin America do not follow conventional regulatory procedures. More insight into the characteristics of these emergency regulatory pathways is required to identify properties that make for effective and efficient emergency use and reliance pathways.