The Caribbean Public Health Agency’s Caribbean Regulatory System (CARPHA – CRS) has issued a recommendation of a diagnostic test kit for the novel SARS-CoV-2 coronavirus 2019 for emergency use authorization and/or import by the Member States of the Caribbean Community (CARICOM). The agency has implemented a verification review process for medicines, vaccines and test kits, that were approved for emergency use by recognized regulatory authorities, according to a PAHO document  “Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19)” that provides guidance to national regulatory authorities and regulatory systems on practical ways to implement reliance for emergency use of medicines and other health technologies in and around a pandemic.

To date,  more than 100 medicines and other health technologies has been ercommended by CARPHA-CRS to CARICOM Member States. Such recommendations are based on verification that the same products have been approved in reference agencies. Over 20 different companies have submitted products, which are typically generic versions of essential medicines, including products for non-communicable diseases like hypertension and cancer. The CARPHA-CRS has recommended innovator products as well, including a product that is curative for Hepatitis C, which was recently registered in Jamaica.

Further information available at:

https://carpha.org/More/Media/Articles/ArticleID/343/CARPHA%E2%80%99s-Caribbean-Regulatory-System-CRS-Recommends-Its-First-COVID-19-PCR-Test-Kit-for-Pandemic-Use-to-CARICOM

CRS recommended medicines list

Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19)

The Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program created by the FDA. It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.

The FDA continues to support clinical trials that are testing new treatments for COVID-19 to gain valuable knowledge about their safety and effectiveness.

Further information at: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap

Attention: 

The FDA is advising consumers not to use hand sanitizer products manufactured by Eskbiochen due to the potential presence of methanol, a substance that can be toxic when absorbed through the skin or ingested.

Further information: https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-hand-sanitizer-products-manufactured-eskbiochem

The WHO/BS/2020.2381-  Amendment to WHO Guidelines for the safe production and quality control of poliomyelitis vaccine (Annex 4, WHO TRS No. 1016) is available at WHO biological website (http://www.who.int/biologicals/en/, right-hand) .

This document has been prepared based on the discussions at the 4^th CAG meeting in July 2019 and the WHO ECBS meeting in Oct 2019; it has taken into consideration comments received from the 1^st round Public Consultation on WHO website during February-April this year.  This version has gone through 1^st WHO editorial review and has been submitted as BS document for review by the upcoming ECBS meeting in late August.

This draft is being published to get feedback from public audience including regulatory authorities, manufacturers, and other stakeholders. Comments to be received during this round Public Consultation will be reviewed by the drafting group and presented to ECBS subsequently.

DEADLINE for submission of comments: 3 August 2020. Send your comments to Dr Tiequn Zhou at: zhout@who.int using the form available at https://www.who.int/biologicals/Comment_Form_POLIO_2_June_2020.doc?ua=1 

Further information: https://www.who.int/biologicals/POLIO_WHO_Amendments_Annex_4_TRS1016_1_JUNE_20.pdf?ua=1.

Recently, regulatory entities in the Caribbean have moved to implement the PAHO recommended procedure reliance for Emergency Use Authorization in the COVID-19 pandemic (https://iris.paho.org/handle/10665.2/52027)

The National Regulatory Authority of Guyana (Government Analyst, Food and Drug Department) and the Caribbean Public Health Agency/ Caribbean Regulatory System, have both taken decisions to adopt the procedure for drugs, vaccines, and test kits.

These are important developments for many reasons. Medicines and other health technologies are available (test kits) now, or will potentially become available in the coming months, and it will be important that countries have the tools in place to properly make decisions on authorization in an expeditious manner, while based on a trusted regulator’s best scientific and regulatory judgment.

Additional information: https://carpha.org/What-We-Do/CRS/Operational-Policy and https://www.paho.org/en/news/30-4-2020-new-guideline-use-reliance-emergency-use-authorization-medicines-and-other.

CECMED´s actions on COVID-19 are available at https://www.cecmed.cu/covid-19

CECMED has authorized the SOBERANA 01 clinical trial, entitled “Phase I / II, randomized, controlled, adaptive, double-blind and multicenter study to evaluate the safety, reactogenicity and immunogenicity of the prophylactic FINLAY-FR-1 anti SARS–CoV–2  Vaccine Candidate in a two-dose schedule. (COVID-19) “. Recruitment will be carried out between 24 August and 30 October, in two sites in the province of Havana, until the sample of 676 healthy volunteers between 19 and 80 years old is completed. The site of the Cuban public registry of clinical trials is available at: https://rpcec.sld.cu/ensayos-por-fecha

New publications 

Contact tracing is an important tool for pandemic response. The possibility of conducting it digitally increases its potential and poses new ethical challenges. This is the topic of the following new publications:

Ferreti et al. Quantifying SARS-CoV-2 transmission suggests epidemic control with digital contact tracing, available from https://science.sciencemag.org/content/368/6491/eabb6936

Kahn J (ed). Digital contact tracing for pandemic response: Ethics and governance guidance, available from https://muse.jhu.edu/book/75831 

For WHO guidelines on ethical issues in public health surveillance, which provide relevant guidance and include a guideline focused on public health emergencies, go to https://apps.who.int/iris/bitstream/handle/10665/255721/9789241512657-eng.pdf?sequence=1.

The use of restrictive and physical distancing measures during a pandemic raises a number of important ethical issues. This publication of WHO’s COVID-19 ethics working group is available at the site of the Public Health Emergency Preparedness and Response Ethics Network (PHEPREN): https://epidemicethics.tghn.org/articles/ethics-sars-cov-2-restrictive-measures-and-physical-distancing/.

The document has been developed on the basis of WHO’s Guidance For Managing Ethical Issues In Infectious Disease Outbreaks (available at: https://apps.who.int/iris/bitstream/handle/10665/250580/9789241549837-eng.pdf?sequence=1). The document can be accessed directly at: https://media.tghn.org/articles/Ethics__COVID-19__Restrictive_Measures_-_Apr_14.pdf).

PAHO has published the document on Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19). This document provides guidance to national regulatory authorities (NRAs) and regulatory systems on practical ways to implement reliance for emergency use of medicines and other health technologies in and around a pandemic. Note that countries use different terminologies for emergency use and the Pan American Health Organization (PAHO) will use the term “Emergency Use Authorization” (EUA).

The publication is available at https://iris.paho.org/handle/10665.2/52027.