PAHO Director briefs PROSUR leaders on vaccine supply

25 Feb 2021

“We are still way behind where we should be as a Region”

Washington D.C. February 25 (PAHO) —  The Director Carissa F. Etienne today briefed leaders of PROSUR, the Forum for the Progress and Development of South America, on COVID-19 vaccine supply and procurement advances, saying, “PAHO shares your great concerns for equity of access to vaccines particularly for middle and low-income countries and we continue to advocate strongly for the LAC countries.” (…)

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WHO lists 2 additional COVID-19 vaccines for emergency use and COVAX roll-out: AstraZeneca/Oxford-developed vaccines to reach countries in the coming weeks


WHO lists 2 additional COVID-19 vaccines for emergency use and COVAX roll-out

 AstraZeneca/Oxford-developed vaccines to reach countries in the coming weeks

Geneva, 15 February 2021 – The World Health Organization (WHO) today listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.

WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

‘But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things – a scale-up of manufacturing capacity, and developers’ early submission of their vaccines for WHO review.”

The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.

In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took under four weeks.

The vaccine was reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and above.

The AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S [recombinant]. It is being produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09% efficacy and is suitable for low- and middle-income countries due to easy storage requirements.

WHO emergency use listing

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020.

See more on EUL

See SAGE recommendations

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PAHO Director says COVID-19 vaccines for the Americas still recommended despite new variants

10 Feb 2021

“PAHO’s surveillance network is keeping a close watch on today’s variants of concern.”

Washington, D.C., February 10, 2021 (PAHO) Pan American Health Organization (PAHO) Director Carissa F. Etienne said the COVID-19 vaccines soon to be available from COVAX in the Americas are still recommended for the region, despite new variants of the SARS-CoV-2 virus that causes the disease.

Based on the evidence we have now on the variants of concern, we are confident that our growing portfolio of COVID-19 vaccines remains useful and will guide us through the end of this pandemic.”

PAHO Director Carissa F. Etienne

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Episode #25 – Vaccines explained

Vismita Gupta-Smith Hello and welcome to Science in 5. I'm Vismita Gupta-Smith and this is WHO's conversations in science. We're going to continue our conversation on COVID-19 vaccines and explaining the science and evidence behind it is WHO's Chief Scientist Dr. Soumya Swaminathan. Welcome, Soumya.


The United States Pharmacopeia (USP): Global Seminar Series, Ensuring Quality Hand Sanitizer Production During COVID-19

USP is hosting a Global Seminar Series, Ensuring Quality Hand Sanitizer Production During COVID-19, to help ensure quality alcohol-based hand sanitizer production and support the safe use of alcohol-based hand sanitizer, February 25th, 2021.

For more information go to: USP Global Seminar Series: Ensuring Quality Hand Sanitizer Production During COVID-19 for Manufacturers and Healthcare Providers in Latin America – Event Summary | Online Registration by Cvent


Anvisa is approved for Pharmaceutical Inspection Co-operation Scheme – PIC/S

On Monday (30/11), Anvisa was formally informed of the successful completion of the Agency’s process of adhering to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Anvisa will become the 54th member of the international initiative in pharmaceutical inspection, and will have the international recognition of the excellence of inspections in Good Manufacturing Practices (GMP) of medicines and pharmaceutical inputs for human use.


WHO: Mask use in the context of COVID-19: interim guidance, 1 December 2020

This document, which is an update of the guidance published on 5 June 2020, includes new scientific evidence relevant to the use of masks for reducing the spread of SARS-CoV-2, the virus  that causes COVID-19, and practical considerations. It contains updated evidence and guidance on the following:
• mask management;
• SARS-CoV-2 transmission;
• masking in health facilities in areas with community, cluster and sporadic transmission;
• mask use by the public in areas with community and cluster transmission;
• alternatives to non-medical masks for the public;
• exhalation valves on respirators and non-medical masks;
• mask use during vigorous intensity physical activity;
• essential parameters to be considered when manufacturing non-medical masks (Annex).

Mask use in the context of COVID-19: interim guidance, 1 December 2020 (