COVID 19 VACCINES

Mar. 18, 2022

 

 

March 18, 2022

 

Please see the attached E-book for:

 

“Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022”

Link when live: https://www.cdc.gov/mmwr/volumes/71/wr/mm7112e1.htm?s_cid=mm7112e1_w

 

“COVID-19–Associated Hospitalizations Among Adults During SARS-CoV-2 Delta and Omicron Variant Predominance, by Race/Ethnicity and Vaccination Status — COVID-NET, 14 States, July 2021–January 2022”

 

Link when live: https://www.cdc.gov/mmwr/volumes/71/wr/mm7112e2.htm?s_cid=mm7112e2_w

 

Thank you,

Dec. 21, 2021

21 Dec 2021 Your two key COVID-19 weekly reports

 

 

 

Weekly COVID-19 Reports Update

 

Weekly Epidemiological Update

 21 December

During the week 13-19 December, the global number of new cases remained similar to those reported during the previous week; however, the weekly incidence of deaths decreased by 9%. Nonetheless, this corresponds to over 4.1 million new cases and just under 45 000 new deaths. As of 19 December, over 273 million cases and over 5.3 million deaths have been reported globally

In this edition an update is also provided on SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs)

Please note, the next two issues of the Weekly Epidemiological Report (to be published on 28 December and 6 January) will be condensed versions covering only the global and regional epidemiology.

Weekly Operational Update

21 December

  • Implementing national studies on the real-world effectiveness of COVID-19 vaccines in Armenia
  • Delivering critical equipment and supplies in the Western Pacific to Vanuatu and Fiji
  • Boosting Sierra Leone’s COVID-19 response and disease surveillance with laboratory commodities
  • Bringing COVID-19 vaccination to the most vulnerable via the Global Health Cluster
  • Supporting the global scale-up of infodemic management
  • Strengthening genomic surveillance: WHO in collaboration with GISAID organizes training workshops for laboratory experts
  • Conducting the first Universal Health and Preparedness Review (UHPR) Pilot: Bangui, Central African Republic
  • Updates on WHO’s financing to support countries on COVID-19 response implementation to suppress transmission, reduce exposure, and protect the vulnerable and save lives
  • Progress on a subset of global indicators that demonstrate country and global progress to end the acute phase of the pandemic
 

Donors making a difference - Highlights of the COVID-19 response

Stories from Sierra Leone, Viet Nam, Guyana, Uganda, Islamic Republic of Iran, Lao People's Democratic Republic, Sri Lanka, Yemen and more 

Photo ©WHO/Islamic Republic of Iran

WHO SPRP 2021 Mid-term Report - WHO Strategic Action Against COVID-19

WHO COVID-19 SPRP: Updated Appeal September 2021 - March 2022

New ACT-Accelerator Appeal: Supporting the spinal cord of the global COVID-19 response - December 2021

 

Read more stories of ongoing work in countries around the world in support of the COVID-19 Strategic Preparedness and Response Plan 2021

This week we have received additional funds from the Republic of Korea and United Nations Children's Fund (UNICEF). Thanks to all donors and partners contributing to the WHO COVID-19 Response

 

Dec. 21, 2021

WHO lists 10th COVID-19 vaccine for emergency use: Nuvaxovid

21 December 2021 - Geneva, Switzerland - The World Health Organization issued an emergency use listing (EUL) for Nuvaxovid, following its assessment and approval by the European Medicines Agency (EMA) earlier today.

The new vaccine was developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI), and is the originator product for the Covovax vaccine that received WHO emergency use listing on 17 December.

Both vaccines are made using the same technologies. They require two doses and are stable at 2 to 8 °C refrigerated temperatures.

WHO’s Strategic Advisory Group of Experts on Immunization has also issued policy recommendations for Nuvaxovid / Covovax.

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.

See all EUL listings 

 

Dec. 17, 2021

 

WHO lists 9th COVID-19 vaccine for emergency use with the aim to increase access to vaccination in lower-income countries

17 December 2021 

 

Geneva

 

Today, the World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named CovovaxTM, is produced by the Serum Institute of India under license from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.

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

“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. ‘This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”

CovovaxTM was assessed under the WHO EUL procedure based on the review of data on quality, safety, and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.

CovovaxTM is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at 2 to 8 °C refrigerated temperatures. The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.

The originator product produced by Novavax, named NuvaxovidTM, is currently under assessment by the European Medicines Agency (EMA). WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation.

A meeting of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) this week also reviewed the vaccine. SAGE formulates specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women) and will issue recommendations for NuvaxovidTM/CovovaxTM in the coming days.

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 continuing 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.

See all EUL listings

Nov. 29, 2021

Joint Statement on Dose Donations of COVID-19 Vaccines to African Countries

Addis Ababa/Geneva, 29 November 2021 – Building on lessons learned from our collective experience with dose donations over the past several months, the African Vaccine Acquisition Trust (AVAT), the Africa Centres for Disease Control and Prevention (Africa CDC) and COVAX wish to draw the attention of the international community to the situation of donations of COVID-19 vaccines to Africa, and other COVAX participating economies, particularly those supported by the Gavi COVAX Advance Market Commitment (AMC).

AVAT and COVAX complement each other’s efforts to support African countries to meet their immunization targets, recognizing the global goal of immunizing 70% of the African population. Dose donations have been an important source of supply while other sources are stepping up, but the quality of donations needs to improve.

AVAT and COVAX are focused on accelerating access to and rollout of COVID-19 vaccines in Africa. Together we are rapidly expanding supply to the continent, and providing countries with the support to be able to utilize the doses they receive. To date, over 90 million donated doses have been delivered to the continent via COVAX and AVAT and millions more via bilateral arrangements.

However, the majority of the donations to-date have been ad hoc, provided with little notice and short shelf lives. This has made it extremely challenging for countries to plan vaccination campaigns and increase absorptive capacity. To achieve higher coverage rates across the continent, and for donations to be a sustainable source of supply that can complement supply from AVAT and COVAX purchase agreements, this trend must change.

Countries need predictable and reliable supply. Having to plan at short notice and ensure uptake of doses with short shelf lives exponentially magnifies the logistical burden on health systems that are already stretched. Furthermore, ad hoc supply of this kind utilizes capacity – human resources, infrastructure, cold chain – that could be directed towards long-term successful and sustainable rollout. It also dramatically increases the risks of expiry once doses with already short shelf-lives arrive in country, which may have long-term repercussions for vaccine confidence.

Donations to COVAX, AVAT and African countries must be made in a way that allows countries to effectively mobilize domestic resources in support of rollout and enables long-term planning to increase coverage rates. We call on the international community, particularly donors and manufacturers, to commit to this effort by adhering to the following standards, beginning from 1 January 2022:

  • Quantity and predictability: Donor countries should endeavour to release donated doses in large volumes and in a predictable manner, to reduce transaction costs. We acknowledge and welcome the progress being made in this area, but note that the frequency of exceptions to this approach places increased burden on countries, AVAT and COVAX.
  • Earmarking: These doses should be unearmarked for greatest effectiveness and to support long-term planning. Earmarking makes it far more difficult to allocate supply based on equity, and to account for specific countries’ absorptive capacity. It also increases the risk that short shelf-life donations utilise countries’ cold chain capacity – capacity that is then unavailable when AVAT or COVAX are allocating doses with longer shelf lives under their own purchase agreements.
  • Shelf life: As a default, donated doses should have a minimum of 10 weeks shelf life when they arrive in-country, with limited exceptions only where recipient countries indicate willingness and ability to absorb doses with shorter shelf lives.
  • Early notice: Recipient countries need to be made aware of the availability of donated doses not less than 4 weeks before their tentative arrival in-country.
  • Response times: All stakeholders should seek to provide rapid response on essential information. This includes essential supply information from manufacturers (total volumes available for donation, shelf life, manufacturing site), confirmation of donation offer from donors, and acceptance/refusal of allocations from countries. Last minute information can further complicate processes, increasing transaction costs, reducing available shelf life and increasing risk of expiry.
  • Ancillaries: The majority of donations to-date do not include the necessary vaccination supplies such as syringes and diluent, nor do they cover freight costs -  meaning these have to be sourced separately – leading to additional costs, complexity and delay. Donated doses should be accompanied with all essential ancillaries to ensure rapid allocation and absorption.

AVAT, Africa CDC and COVAX remain committed to collaborate with donor countries, vaccine manufacturers and partners on ensuring these standards are upheld, as we continue to work together towards achieving Africa’s vaccination goals.

Notes to Editors

About African Union

The African Union (AU) is a continental body consisting of the 55 Member States that make up the countries of the African Continent. It was officially launched in 2002 as a successor to the Organisation of African Unity (OAU, 1963-1999). https://au.int/en/overview

About Africa CDC

Africa Centres for Disease Control and Prevention (Africa CDC), is a specialized technical institution of the African Union that strengthens the capacity and capability of Africa’s public health institutions as well as partnerships to detect and respond quickly and effectively to disease threats and outbreaks, based on data-driven interventions and programmes. Learn more at: www.africacdc.org

About the African Vaccine Acquisition Trust (AVAT)

The African Vaccine Acquisition Trust (AVAT) is a special purpose vehicle, incorporated in Mauritius. AVAT acts as a centralised purchasing agent on behalf of the African Union (AU) Member States, to secure the necessary vaccines and blended financing resources for achieving Africa’s COVID-19 vaccination strategy which targets vaccinating a minimum of 70% of Africa’s population based on a whole-of-Africa approach. AVAT was established by the COVID-19 African Vaccine Acquisition Task Team, which was set up in November 2020 by His Excellency President Cyril Ramaphosa, President of the Republic of South Africa, in his capacity as Chairperson of the African Union (AU), as a support component to the COVID-19 Immunisation Strategy that was endorsed by the AU Bureau of Heads of State and Government in August 2020. AVAT’s main partner institutions are the African Union’s Africa Centres for Disease Control and Prevention (Africa CDC), the African Export-Import Bank (Afreximbank), and the United Nations Economic Commission for Africa (ECA).

About COVAX

COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by CEPI, Gavi and WHO – working in partnership with UNICEF and PAHO as delivery partners, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both high-income and lower-income countries.