Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

European Medicines Agency
News: EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
Last updated: 03/02/2021
EMA’s human medicines committee (CHMP) has started a rolling review of NVX-CoV2373, a COVID19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID19.
The company is currently conducting trials in people to assess its safety, immunogenicity (how well it triggers a response against the virus) and its effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.
The rolling review will continue until enough evidence is available for a formal marketing authorisation application…

News: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU (updated)
Last updated: 29/01/2021
Update: COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 29 January 2021.

Russia: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
Sputnik V authorized in Myanmar
Press release, 06.02.2021
…The vaccine was approved under the emergency use authorization procedure without additional clinical trials in the country…

Sputnik V authorized in Lebanon
Press release, 05.02.2021
…The vaccine was approved under the emergency use authorization procedure without additional clinical trials in the country…

Ministry of Health of Nicaragua has authorized the use of Sputnik V
Press release, 03.02.2021
…The vaccine was approved under the emergency use authorization procedure without additional clinical trials in the country…

Mexico becomes the first country of North America to register Sputnik V vaccine
Press release, 03.02.2021
…The vaccine was approved under the emergency use authorization procedure without additional clinical trials in the country…

A vaccine for all mankind: Sputnik V’s efficacy in fighting COVID-19 is validated by internationally peer reviewed data published in The Lancet
Press release, 02.02.2021
…:: Sputnik V is already registered in 16 countries: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia and Armenia.
:: In the first week of February, vaccination with Sputnik V will start in the following 12 countries: Bolivia, Kazakhstan, Turkmenistan, Palestine, UAE, Paraguay, Hungary, Armenia, Algeria, Bosnian Serb Republic, Venezuela and Iran.
:: In 10 countries out of 12, Sputnik V will be the first coronavirus vaccine approved for civil circulation.
[See referenced article and Comment from The Lancet below]

Sputnik V vaccine authorized in Armenia
Press release, 01.02.2021 16:00:00
…The vaccine was approved by a Decree of the Ministry of Health based on data of Phase III clinical trials in Russia without conducting additional trials in Armenia…

The Lancet
Articles Online First
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia
Denis Y Logunov, Inna V Dolzhikova, Dmitry V Shcheblyakov, Amir I Tukhvatulin, Olga V Zubkova,
Alina S Dzharullaeva, et al. and the Gam-COVID-Vac Vaccine Trial Group
Published: February 02, 2021 DOI: https://doi.org/10.1016/S0140-6736(21)00234-8
Summary
Background
A heterologous recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V), showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. Here, we report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial.
Methods
We did a randomised, double-blind, placebo-controlled, phase 3 trial at 25 hospitals and polyclinics in Moscow, Russia. We included participants aged at least 18 years, with negative SARS-CoV-2 PCR and IgG and IgM tests, no infectious diseases in the 14 days before enrolment, and no other vaccinations in the 30 days before enrolment. Participants were randomly assigned (3:1) to receive vaccine or placebo, with stratification by age group. Investigators, participants, and all study staff were masked to group assignment. The vaccine was administered (0·5 mL/dose) intramuscularly in a prime-boost regimen: a 21-day interval between the first dose (rAd26) and the second dose (rAd5), both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S. The primary outcome was the proportion of participants with PCR-confirmed COVID-19 from day 21 after receiving the first dose. All analyses excluded participants with protocol violations: the primary outcome was assessed in participants who had received two doses of vaccine or placebo, serious adverse events were assessed in all participants who had received at least one dose at the time of database lock, and rare adverse events were assessed in all participants who had received two doses and for whom all available data were verified in the case report form at the time of database lock. The trial is registered at ClinicalTrials.gov (NCT04530396).
Findings
Between Sept 7 and Nov 24, 2020, 21 977 adults were randomly assigned to the vaccine group (n=16 501) or the placebo group (n=5476). 19 866 received two doses of vaccine or placebo and were included in the primary outcome analysis. From 21 days after the first dose of vaccine (the day of dose 2), 16 (0·1%) of 14 964 participants in the vaccine group and 62 (1·3%) of 4902 in the placebo group were confirmed to have COVID-19; vaccine efficacy was 91·6% (95% CI 85·6–95·2). Most reported adverse events were grade 1 (7485 [94·0%] of 7966 total events). 45 (0·3%) of 16 427 participants in the vaccine group and 23 (0·4%) of 5435 participants in the placebo group had serious adverse events; none were considered associated with vaccination, with confirmation from the independent data monitoring committee. Four deaths were reported during the study (three [<0·1%] of 16 427 participants in the vaccine group and one [<0·1%] of 5435 participants in the placebo group), none of which were considered related to the vaccine. Interpretation
This interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort.
Moscow City Health Department, Russian Direct Investment Fund, Sberbank, and RUSAL.

Comment | Online First
Sputnik V COVID-19 vaccine candidate appears safe and effective
Ian Jones, Polly Roy ¹
Published: February 02, 2021 DOI: https://doi.org/10.1016/S0140-6736(21)00191-4
Denis Logunov and colleagues report their interim results from a phase 3 trial of the Sputnik V COVID-19 vaccine in The Lancet. The trial results show a consistent strong protective effect across all participant age groups. Also known as Gam-COVID-Vac, the vaccine uses a heterologous recombinant adenovirus approach using adenovirus 26 (Ad26) and adenovirus 5 (Ad5) as vectors for the expression of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. The use of two varying serotypes, which are given 21 days apart, is intended to overcome any pre-existing adenovirus immunity in the population.² Among the major COVID vaccines in development to date, only Gam-COVID-Vac uses this approach; others, such as the Oxford–AstraZeneca vaccine, use the same material for both doses. The earlier vaccine for Ebola virus disease, also developed at Gamaleya National Research Centre for Epidemiology and Microbiology (Moscow, Russia), was similar, with Ad5 and vesicular stomatitis virus as the carrier viruses,³ and the general principle of prime boost with two different vectors has been widely used experimentally.⁴

The recombinant adenovirus route to protection is shared with the Oxford–AstraZeneca vaccine, which uses a chimpanzee adenovirus (ChAdOx),⁵ the Johnson & Johnson vaccine that uses only Ad26⁶ whose detailed results are expected soon, and the CanSinoBIO-Beijing Institute of Biotechnology Ad5-based vaccine whose phase 3 trial began in September, 2020.⁷ The carrier viruses are modified and cannot initiate a productive infection; they enter cells, express the spike protein, and then stop (because they cannot continue the normal virus lifecycle), although a high-sensitivity analysis also showed that a few Ad genes were expressed, albeit at a low level.⁸ The vaccine-infected cells are eventually destroyed by the very immunity they are designed to elicit. Recombinant adenoviruses have been used widely as vaccine vectors because they can accommodate large genetic payloads and, although unable to replicate, they trigger the innate immunity sensors sufficiently to ensure robust immune system engagement.⁹ Consequently, they do not need an adjuvant and can provide immunity after just a single dose.⁴ Their physical robustness is thought to allow storage at temperatures around –18°C, which is feasible for many supply chains. The downside of recombinant adenovirus-based vaccines is that large doses are required, typically 1010 or 1011 particles, which makes large demands on the manufacturing and quantitation required for rollout on a global scale.

What then of the Sputnik V COVID-19 vaccine data published here? The earlier phase 1/2 data published in September, 2020, showed promising safety results and gave an indication that the immune response was at a level consistent with protection.¹⁰ Recipients generated robust antibody responses to the spike protein, which included neutralising antibodies, the proportion of the total immunoglobulin that inhibits the virus binding to its receptor. They also showed evidence of T-cell responses, consistent with an immune response that should not quickly wane. The interim report of the phase 3 data now presented¹ includes results for more than 20 000 participants, 75% of whom were assigned to receive the vaccine, and the follow-up for adverse events and infection. With a planned study power of 85%, those recruited were aged 18 years and older, were about 60% male, and were almost all white. Comorbidities, a known risk for COVID-19 severity, were present in about a quarter of those who entered the trial. 62 (1·3%) of 4902 individuals in the placebo group and 16 (0·1%) of 14 964 participants in the vaccine group had confirmed SARS-CoV-2 infection from day 21 after first vaccine dose (the primary outcome). A time-resolved plot of the incidence rate in the two groups showed that the immunity required to prevent disease arose within 18 days of the first dose. That protection applied to all age groups, including those older than 60 years, and the anecdotal case histories of those vaccinated but infected suggest that the severity of disease decreases as immunity develops. Three fatalities occurred in the vaccine group in individuals with extensive comorbidities, and were deemed unrelated to the vaccine. No serious adverse events considered related to the vaccine were recorded, but serious adverse events unrelated to the vaccine were reported in 45 participants from the vaccine group and 23 participants from the placebo group. Vaccine efficacy, based on the numbers of confirmed COVID-19 cases from 21 days after the first dose of vaccine, is reported as 91·6% (95% CI 85·6–95·2), and the suggested lessening of disease severity after one dose is particularly encouraging for current dose-sparing strategies.

The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency.¹¹ But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19. We declare no competing interests.

China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

China to offer vaccine doses to COVAX
2021-02-04
Nation to meet developing countries’ needs via initiative at request of WHO
China said on Feb 3 it will provide 10 million doses of COVID-19 vaccines to the global vaccine sharing initiative COVAX to meet the urgent needs of developing countries.
Foreign Ministry spokesman Wang Wenbin said at a daily news briefing that China is responding to a request from the World Health Organization as developing countries seek to make up for shortages of the vaccines.
The WHO has started to review the authorization for emergency use of the Chinese vaccines, Wang said, adding that Chinese enterprises will continue to cooperate actively and that he hopes the review process will be completed as soon as possible…
“We hope capable countries will swing into action, support COVAX through concrete actions, back the WHO’s work, assist developing countries in obtaining vaccines in a timely manner and contribute to the international community overcoming the pandemic at an early date,” Wang said.
He noted that Beijing is in close communication and cooperation with the WHO to ensure vaccine accessibility and affordability in developing countries…
China has exported large amounts of domestically developed vaccines to countries including the United Arab Emirates, Morocco, Indonesia, Turkey, Brazil and Chile, where clinical studies of Chinese vaccines have been conducted.
It also supports relevant companies in exporting vaccines to countries in urgent need that have approved Chinese vaccines and authorized their emergency use.
On Monday, the first shipment of China-donated COVID-19 vaccines reached Pakistan. The country formally started the drive to administer the vaccines to its front-line healthcare workers on Wednesday, Xinhua News Agency reported.
According to the Foreign Ministry, China is also providing vaccine assistance to another 13 developing countries and will continue to provide such assistance to another 38 developing countries in the next phase.

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 03 February 2021
:: The first Polio News edition of 2021 is now out containing the latest programme updates, news and donor information.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Afghanistan: one WPV1 and 14 cVDPV2 cases and two cVDPV2 positive environmental samples
:: Pakistan: three WPV1 and 18 cVDPV2 positive environmental samples and eight cVDPV2 cases
:: Benin: one cVDPV2 case and two positive environmental samples
:: Nigeria: one cVDPV2 case

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Editor’s Note:
Continuing with this edition, we include information about the last apparent update evident on the WHO emergency country webpages, recognizing almost universal and significant interims since last update regardless of the level of the emergency listed.

WHO Grade 3 Emergencies [to 6 Feb 2021]

Democratic Republic of the Congo – No new digest announcements [Last apparent update: 12 Jan 2021]
Mozambique floods – No new digest announcements identified [Last apparent update: 3 November 2020]
Nigeria – No new digest announcements identified [Last apparent update: 29 Jun 2020]
Somalia – No new digest announcements identified [Last apparent update: 17 July 2020]
South Sudan – No new digest announcements identified [Last apparent update: 4 February 2020]
Syrian Arab Republic – No new digest announcements identified [Last apparent update: 24 October 2020]
Yemen – No new digest announcements identified [Last apparent update: 30 June 2020]

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WHO Grade 2 Emergencies [to 6 Feb 2021]
Burkina Faso –
:: Au Burkina Faso, une lutte soutenue contre le cancer du sein 04 février 2021

Afghanistan – No new digest announcements identified [Last apparent update: 5 July 2020]
Angola – No new digest announcements identified [Last apparent update: 03 December 2020]
Burundi – No new digest announcements identified [Last apparent update: 04 July 2019]
Cameroon – No new digest announcements identified [Last apparent update: 22 August 2019]
Central African Republic – No new digest announcements identified [Last apparent update: 12 June 2018]
Ethiopia – No new digest announcements identified [Last apparent update: 22 August 2019]
Iran floods 2019 – No new digest announcements identified [Last apparent update: 12 March 2020]
Iraq – No new digest announcements identified [Last apparent update: 16 December 2020]
Libya – No new digest announcements identified [Last apparent update: 7 October 2019]
Malawi Floods – No new digest announcements identified [Last apparent update: 09 October 2019]
Measles in Europe – No new digest announcements identified [Last apparent update: 16-12-2020]
MERS-CoV – No new digest announcements identified [Last apparent update: 8 July 2019]
Mozambique – No new digest announcements identified [Last apparent update: 03 November 2020]
Myanmar – No new digest announcements identified [Last apparent update: :: 3 January 2021
Niger – No new digest announcements identified [Last apparent update: 29 December 2020]
occupied Palestinian territory – No new digest announcements identified [Last apparent update: 4 September 2019]
HIV in Pakistan – No new digest announcements identified [Last apparent update: 27 August 2019]
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements
Sudan – No new digest announcements identified [Last apparent update: 24 June 2020]
Ukraine – No new digest announcements identified [Last apparent update: 1 May 2019]
Zimbabwe – No new digest announcements identified [Last apparent update: 10 May 2019]

::::::

WHO Grade 1 Emergencies [to 6 Feb 2021]

Chad – No new digest announcements identified [Last apparent update: 30 June 2018]
Djibouti – No new digest announcements identified [Last apparent update: 25 novembre 2020]
Kenya – No new digest announcements identified [Last apparent update: 11 December 2020]
Mali – No new digest announcements identified [Last apparent update: 3 May 2017]
Namibia – viral hepatitis – No new digest announcements identified [Last apparent update: 20 July 2018]
Tanzania – No new digest announcements identified [Last apparent update: 21 October 2020]

::::::
::::::

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 23 As of 1 February 2021

Yemen – No new digest announcements identified

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (2 February 2021)

East Africa Locust Infestation
:: Desert Locust situation update 4 February 2021

::::::
::::::

WHO & Regional Offices [to 6 Feb 2021]
5 February 2021
WHO launches free OpenWHO.org training on rehabilitation for COVID-19

4 February 2021 News release
WHO receives nearly 1 200 entries for the second edition of Health for All Film Festival

3 February 2021
COVAX publishes first interim distribution forecast

3 February 2021 Departmental news
Breast cancer now most common form of cancer: WHO taking action

3 February 2021 News release
Michael R. Bloomberg and Dr Tedros Adhanom Ghebreyesus call for global focus on noncommunicable diseases

2 February 2021
WHO publishes public health research agenda for managing infodemics

1 February 2021
Updating WHO’s global strategy for malaria

::::::

Weekly Epidemiological Record, Vol. 96, No. 05/06, pp. 33–44 5 February 2021
:: Case report of laboratory-acquired vaccinia virus infection in India
:: WHO Advisory Committee on Variola Virus Research

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Rooting out female genital mutilation in Tanzania 06 February 2021
:: Reviving hope in cancer patients 04 February 2021

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
No new digest content identified

WHO European Region EURO
:: At the forefront of curtailing the pandemic 05-02-2021
:: Redoubling public health measures needed due to COVID-19 virus variants 05-02-2021
:: Catastrophic impact of COVID-19 on cancer care 04-02-2021
:: WHO/Europe launches ambitious initiative seeking to reduce lives lost to cancer 04-02-2021
:: World Cancer Day: know the facts – tobacco and alcohol both cause cancer 04-02-2021

WHO Eastern Mediterranean Region EMRO
:: King Salman Humanitarian Aid and Relief Centre supports infection, prevention and control programme in Sindh Province, Pakistan 3 February 2021

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 6 Feb 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
No new digest content identified.

MMWR News Synopsis Friday, February 6, 2021
:: Sexual Orientation Disparities in Risk Factors for Adverse COVID-19–Related Outcomes, by Race/Ethnicity — Behavioral Risk Factor Surveillance System, United States, 2017–2019
:: Decreases in Young Children Who Received Blood Lead Level Testing During COVID-19 — 34 Jurisdictions, January–May 2020
:: Racial and Ethnic Disparities in the Prevalence of Stress and Worry, Mental Health Conditions, and Increased Substance Use Among Adults During the COVID-19 Pandemic — United States, April and May 2020
:: Demographic Characteristics of Persons Vaccinated During the First Month of the COVID-19 Vaccination Program — United States, December 14, 2020–January 14, 2021 (Early Release February 1, 2021)
:: Early COVID-19 First-Dose Vaccination Coverage Among Residents and Staff Members of Skilled Nursing Facilities Participating in the Pharmacy Partnership for Long-Term Care Program — United States, December 2020–January 2021 (Early Release February 1, 2021)

Coronavirus Disease 2019 (COVID-19)– CDC
Selected Resources
:: Overall US COVID-19 Vaccine Distribution and Administration Update as of Fri, 05 Feb 2021 06:00:00 EST Friday, February 05, 2021
:: COVID-19 Vaccine Information for Specific Groups Thursday, February 04, 2021
:: When Vaccine is Limited, Who Gets Vaccinated First? Wednesday, February 03, 2021

Africa CDC [to 6 Feb 2021]
http://www.africacdc.org/
News
No new digest content identified.

China CDC
http://www.chinacdc.cn/en/
No new digest content identified.

National Health Commission of the People’s Republic of China [to 6 Feb 2021]
http://en.nhc.gov.cn/
News
Feb 6: Daily briefing on novel coronavirus cases in China
On Feb 5, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 12 new cases of confirmed infections.

China to offer vaccine doses to COVAX
2021-02-04
Nation to meet developing countries’ needs via initiative at request of WHO
[See China – COVID above for detail]

National Medical Products Administration [to 6 Feb 2021]
http://english.nmpa.gov.cn/news.html
News
Chinese mainland reports 6 new locally transmitted COVID-19 cases
2021-02-05
The Chinese mainland on Thursday reported 20 newly confirmed COVID-19 cases, including six locally transmitted, the National Health Commission said on Feb 5.

China has administered over 31 million doses of COVID-19 vaccines
2021-02-05
China has administered over 31 million doses of COVID-19 vaccines for key groups as of Feb 3.

Sinovac applies for conditional marketing authorization of COVID-19 vaccine
2021-02-05
Beijing-based Sinovac Life Sciences Co., Ltd. on Wednesday filed an application with Chinese authorities for conditional marketing authorization of its anti-COVID-19 vaccine CoronaVac.

Seven Chinese-made COVID-19 vaccines enter phase-3 clinical trials
2021-02-01
A total of seven Chinese-made COVID-19 vaccines have entered phase-3 clinical trials, according to an official with the Ministry of Science and Technology (MOST).

Mass inoculation shows safety, efficacy of Chinese COVID-19 vaccines: top expert
2021-02-01
China’s renowned respiratory-disease expert Zhong Nanshan said on Jan 31 that the mass inoculation of homegrown COVID-19 vaccines underway in China shows the vaccines are safe and effective.

Organization Announcements

Paul G. Allen Frontiers Group [to 6 Feb 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Press Release
New Allen Distinguished Investigators will tackle unanswered questions about metabolism and the immune system
February 3, 2021
Awards announced today by The Paul G. Allen Frontiers Group will fund research in health, disease, and technology development all centered on the emerging field of immunometabolism

BARDA – U.S. Department of HHS [to 6 Feb 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

BMGF – Gates Foundation [to 6 Feb 2021]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 6 Feb 2021]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X [to 6 Feb 2021]
https://carb-x.org/
News
02.03.2021  |
CARB-X is funding French biotech Mutabilis to develop a new class of antibacterials to treat infections caused by Carbapenem-resistant Enterobacterales (CRE) bacteria
CARB-X is awarding Mutabilis, a biopharmaceutical firm based in Romainville, France, up to US$6.4 million to develop a new drug to treat infections caused by Carbapenem-resistant Enterobacterales (CRE) bacteria.

02.01.2021  |
CARB-X is funding the development of Avails Medical’s rapid antibiotic susceptibility testing technology to identify the most effective antibiotic therapy for serious blood infections
CARB-X is funding Avails Medical, a Menlo Park, CA, USA, diagnostics company, to develop an electronic antibiotic susceptibility testing (AST) device to speed up health care providers’ ability to determine the most effective antibiotic treatment for serious and life-threatening blood infections.

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 6 Feb 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 6 Feb 2021]
http://cepi.net/
Latest News
03 Feb 2021
COVAX publishes first interim distribution forecast
The forecast provides interim information on early projected availability of doses in first half of 2021 to COVAX Facility participants.
[See COVID above for detail]

01 Feb 2021
A leap forward in vaccine technology
By building on the lessons learned in 2020, it should be possible in the long term to compress vaccine development timelines still further

01 Feb 2021
Preparing for the next “Disease X”
Why the world needs to prepare for the next pandemic

01 Feb 2021
CEPI and Dynavax collaborate to secure adjuvant for COVID-19 vaccines in 2021
Agreement supports the supply of Dynavax’s CpG 1018 vaccine adjuvant in 2021 for CEPI-funded COVID-19 vaccine development programmes

Duke Global Health Innovation Center [to 6 Feb 2021]
https://dukeghic.org/
Launch and Scale Speedometer
No new analysis identified.

EDCTP [to 6 Feb 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
30 January 2021
World NTD Day 2021 – a global call to End the Neglect

Emory Vaccine Center [to 6 Feb 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Commission [to 6 Feb 2021]
http://europa.eu/rapid/search-result.htm?query=18&locale=en&page=1
No new digest content identified.

European Medicines Agency [to 6 Feb 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA reviewing data on monoclonal antibody use for COVID-19
Last updated: 04/02/2021

News: EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
Last updated: 04/02/2021

News: EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
Last updated: 03/02/2021
EMA’s human medicines committee (CHMP) has started a rolling review of NVX-CoV2373, a COVID19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID19.
The company is currently conducting trials in people to assess its safety, immunogenicity (how well it triggers a response against the virus) and its effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.
The rolling review will continue until enough evidence is available for a formal marketing authorisation application…

News: EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab)
Last updated: 01/02/2021

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021 (updated)
CHMP, Last updated: 01/02/2021

News: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU (updated)
Last updated: 29/01/2021
Update: COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 29 January 2021.

European Vaccine Initiative [to 6 Feb 2021]
http://www.euvaccine.eu/
Latest News
EVI
Feb 4, 2021
VAC2VAC at the scientific conference “Towards replacement of animals for scientific purposes”

FDA [to 6 Feb 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
February 5, 2021 – Coronavirus (COVID-19) Update: February 5, 2021
:: On Feb. 4, the FDA revised the Letter of Authorization for COVID-19 convalescent plasma to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. Data indicates that plasma with low levels of antibodies may not be effective in treating COVID-19. The revision was based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020.

FDA – COVID-19 Vaccines [to 6 Feb 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
02/05/2021
Coronavirus (COVID-19) Update
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee; alerted health care professionals and compounders of potential risks associated with compounding remdesivir drug products; revised the Letter of Authorization for COVID-19 convalescent plasma; and issued a statement that FDA continues important work to support medical product development to address new virus variants.

02/04/2021
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.

02/04/2021
Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.

Fondation Merieux [to 6 Feb 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

Gavi [to 6 Feb 2021]
https://www.gavi.org/
News Releases
COVAX publishes first interim distribution forecast
3 February 2021
[See COVID above for detail]

GHIT Fund [to 6 Feb 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

Global Fund [to 6 Feb 2021]
https://www.theglobalfund.org/en/news/
News
Mozambique and Global Fund Launch New Grants to Fight HIV, TB and Malaria and Strengthen Systems for Health
05 February 2021
The Global Fund, the Government of Mozambique and health partners in Mozambique today launched the implementation of six new grants to fight HIV, TB and malaria and build resilient and sustainable systems for health

News
Global Fund Engages Partners to Develop New Strategy
02 February 2021
More than 300 representatives from across the world convened virtually today to kick off the Partnership Forums, a series of consultations to help shape the next multi-year Global Fund strategy.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 6 Feb 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

Hilleman Laboratories [to 6 Feb 2021]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 6 Feb 2021]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
Global COVI D Lab Meeting
February 25th speaker: Bali Pulendran, M.D., Ph.D., Stanford University
Feb 25, 2021

Global COVID Lab Meeting
Feb 11, 2021 speaker: Christos Kyratsous, Ph.D., Regeneron Pharmaceuticals

Special Issue 5: Two More Vaccines Found Effective, but Less So Against New Variants
Feb 01, 2021
By Kristen Jill Abboud, Science Writer/Editor

IAVI [to 6 Feb 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
February 3, 2021
First-in-human clinical trial confirms novel HIV vaccine approach developed by IAVI and Scripps Research
The experimental vaccine primed the immune system as the first stage in the production of broadly neutralizing antibodies.
NEW YORK and LA JOLLA, CA — FEBRUARY 3, 2021 — A Phase I clinical trial testing a novel vaccine approach to prevent HIV has produced promising results, IAVI and Scripps Research announced today. The vaccine showed success in stimulating production of rare immune cells needed to start the process of generating antibodies against the fast-mutating virus; the targeted response was detected in 97% of participants who received the vaccine…

February 3, 2021
Evolving access pathways for long-acting HIV prevention products

February 2, 2021
IAVI Remembers Philip Russell, Vaccine Scientist, Global Health Leader

January 25, 2021
Merck and IAVI Discontinue Development of COVID-19 Vaccine Candidate V590

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
Press Releases/Announcements
No new digest content identified.

IFFIm
http://www.iffim.org/
Press Releases/Announcements
Italy reaffirms support of Gavi and CEPI with €5 million grant to IFFIm
26 Jan 2021
Italy’s new grant will provide immediate funding for CEPI’s COVID-19 vaccine research and development programme.

IFRC [to 6 Feb 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
COVID-19: Warning of “deadly consequences” of vaccine inequality, IFRC launches plan to help vaccinate 500 million people
Geneva, 4 February 2021 – The overwhelming majority of COVID-19 vaccine doses administered so far have been delivered in high-income countries, according to analysis by the International Federation of Red Cross and Red Crescent Societies (IFRC). Nearly …
[See COVID above for detail]

Lebanon, Middle East and North Africa
Six months after Beirut Blast: Deteriorating humanitarian situation needs global solidarity
The Lebanese Red Cross (LRC) and the International Federation of Red Cross and Red Crescent Societies (IFRC) appeal for continued global solidarity with the Lebanese people who are suffering from a multi-layered humanitarian crisis. Six months after th …
4 February 2021

Institut Pasteur [to 6 Feb 2021]
https://www.pasteur.fr/en/press-area
No new digest content identified.

IRC International Rescue Committee [to 6 Feb 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
IRC applauds Biden’s Refugee Admissions Executive Order, helping restore America’s global humanitarian leadership
February 4, 2021

IVAC [to 6 Feb 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 6 Feb 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

JEE Alliance [to 6 Feb 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

Johns Hopkins Center for Health Security [to 6 Feb 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

MSF/Médecins Sans Frontières [to 6 Feb 2021]
http://www.msf.org/
Latest [Selected Announcements]
Access to medicines
MSF urges wealthy countries not to block COVID-19 patent waiver
Press Release 3 Feb 2021
Ahead of the next round of talks at the World Trade Organization (WTO) to discuss a proposal by South Africa and India to waive monopolies on COVID-19 medical tools during the pandemic, Médecins Sans Frontières (MSF) called on the wealthy countries opposing the proposal not to block it and ruin its lifesaving potential for billions of people in the rest of the world…

Coronavirus COVID-19 pandemic
Ravaged by new strain, southern Africa must get COVID-19 vaccines
Press Release 3 Feb 2021
:: An infectious new strain of COVID-19 is spreading quickly through southern African countries, leaving health systems struggling to cope.
:: Cases in Mozambique, Eswatini and Malawi are currently at levels exponentially higher than during the first wave of the pandemic.
:: With no COVID-19 vaccines yet available in these countries – partly due to hoarding from wealthy ones – frontline healthcare workers are exposed and are getting sick.
:: MSF is urging wealthy country governments and pharma companies to prioritise vaccines for the healthcare staff in these and other lower-income countries.

National Vaccine Program Office – U.S. HHS [to 6 Feb 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 6 Feb 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Fecal microbiota transplants help patients with advanced melanoma respond to immunotherapy
February 4, 2021 — Study is one of the first to demonstrate in patients that altering the composition of the gut microbiome can improve the response to immunotherapy.

Intranasal influenza vaccine spurs strong immune response in Phase 1 study
February 3, 2021 — The vaccine platform could be highly adaptable for use against other viruses.

PATH [to 6 Feb 2021]
https://www.path.org/media-center/
Press Release
No new digest content identified.

Sabin Vaccine Institute [to 6 Feb 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 6 Feb 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
1 February 2021
We are off track to meet the 2020 targets on the number of voluntary medical male circumcisions

UNHCR Office of the United Nations High Commissioner for Refugees [to 6 Feb 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected Announcements
UNHCR and IOM call for improved safeguards for the displaced on the frontlines of climate emergency
4 Feb 2021

The European Union, UNICEF and UNHCR join efforts to protect children on the move in Central America, Mexico and Southern Africa 2 Feb 2021

UNICEF [to 6 Feb 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement 02/03/2021
UNICEF Executive Director Henrietta Fore’s remarks at briefing on COVAX publishing interim distribution forecast
As delivered
[See COVID above for detail]

Unitaid [to 6 Feb 2021]
https://unitaid.org/
Featured News
05 February 2021
Unitaid’s response to COVID-19 praised in UK government review

03 February 2021
New patient-friendly tuberculosis preventive treatment to be rolled out in five high-burden TB countries at affordable price
:: Fixed-dose combination treatments reduce the pill burden from nine to three pills a week for adults and prevent TB in those at highest risk of developing the disease
:: Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe will be the first countries out of a total of 12 to provide the new regimen at a US$15 price thanks to funding from Unitaid, PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria

02 February 2021
Unitaid statement regarding Ivermectin as a potential COVID-19 treatment
Ivermectin, as well as other repurposed products, has been suggested as a potential treatment for COVID-19 based on preliminary promising evidence – further data is needed to support a definitive recommendation either for or against its use for COVID-19.
Unitaid has collaborated with the University of Liverpool to conduct the preliminary desk analysis of existing trials evaluating ivermectin in different countries of the world, in order to facilitate a review by WHO.
The preliminary analysis has incorporated data from randomised clinical studies that have been completed in Bangladesh, Egypt, Iran, India, Iraq, Lebanon, Pakistan, Turkey, Nigeria, Argentina, Mexico, and Spain.
In the coming weeks, results from additional trials in other countries are expected, and an in-depth analysis will be conducted by WHO to determine next steps, including the potential need for further targeted clinical studies.

Vaccination Acceptance Research Network (VARN) [to 6 Feb 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 6 Feb 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 6 Feb 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 6 Feb 2021]
https://wellcome.ac.uk/news
News
Opinion
Four reasons why we need multiple vaccines for Covid-19
Having a range of Covid-19 vaccines available for people to use around the world will be essential to bringing the pandemic under control. Here’s why. 
Charlie Weller, Head of Vaccines Programme
:: Going into 2021, a handful of vaccines to protect against Covid-19 were already approved for use in parts of the world.
:: So why, with highly effective vaccines already in use, is it important to keep working on and investing in the hundreds of Covid-19 vaccines still in development?

The Wistar Institute [to 6 Feb 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 6 Feb 2021]
https://www.wfpha.org/
Latest News
Which Vaccines and Why: The Evidence and the Deals
Feb 5, 2021

Operation Vaccination: An Analysis of Global COVID-19 Vaccine Rollout Strategies
Jan 29, 2021 | News
Operation Vaccination: An Analysis of Global COVID-19 Vaccine Rollout Strategies
The COVID-19 pandemic is the greatest public health crisis of our lifetimes. Mass immunization is the best chance we have of conquering the disease, but it presents a fiercely complex challenge for governments, healthcare systems and populations.
This weekly post will explore the policy, logistics, obstacles and controversies involved in procuring and distributing vaccines against COVID-19. Under investigation are 9 countries across 5 continents (Brazil, India, Indonesia, Ireland, Israel, Nigeria, Taiwan, the UK and the US), as well as COVAX, the global vaccine sharing initiative.
These articles are a means for the WFPHA to keep readers up to date with how the COVID-19 vaccine race is developing across the world. Each week will cover a different theme as it applies to each of the countries being covered:
COVAX
Brazil
India
IDN
IRL
Israel
NGA
TW
UK
US

World Organisation for Animal Health (OIE) [to 6 Feb 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 6 Feb 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
Alliance for Regenerative Medicine Responds to EU Beating Cancer Plan
February 3, 2021
WASHINGTON, DC and BRUSSELS, BELGIUM
The Alliance for Regenerative Medicine (ARM) – the ‘global voice’ of the regenerative medicine and advanced therapies sector – applauds the EU Beating Cancer Plan’s identification of Advanced Therapy Medicinal Products (ATMPs) as part of a comprehensive cancer solution. ATMPs include cell and gene therapies that have already revolutionized the treatment of some aggressive forms of blood cancers and hold great promise for addressing other types of cancer.

BIO [to 6 Feb 2021]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 6 Feb 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 6 Feb 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 6 Feb 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Patients, product development partnerships and private health sector representatives call for the rapid ratification of the African Medicines Agency Treaty to speed up timelines to vaccines and medicines approval
London / Geneva, 5 February 2021 – On the eve of the 34th African Union Summit, two years after the Treaty to establish an African Medicines Agency was agreed, over 40 leading organizations who represent hundreds of thousands of patients, product development partnerships, youth groups, researchers and industry leaders, are urging Heads of State and Government to ratify the Treaty as a matter of priority. Delaying the establishment of an African Medicines Agency (AMA) undermines the timely access to effective, quality therapies, and vaccines for all patients across Africa.

The COVID-19 pandemic has highlighted the importance of regulatory harmonisation in the context of public health emergencies and the urgent need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner.

Two years after African Union Heads of State and Government endorsed the treaty establishing the AMA, legal commitment from more countries remains to be secured for the continent-wide regulatory agency to become a reality. The Treaty has so far been signed by 19 countries¹, and 8 out of the necessary 15 have already ratified it ².

The agency would follow a similar mandate to other global medicines regulatory agencies, such as the European Medicines Agency and the U.S. Food and Drug Administration. The AMA would provide an enabling environment for research and development, country participation in clinical research and other scientific development activities, as well as open more opportunities to boost local manufacturing capacities. Furthermore, the AMA would help effectively manage the prevalence of substandard and falsified medical products, currently inflicting severe pain and harm on patient’s lives, due to porous borders and ineffective regulatory control…

Call to Heads of State of the African Union to Ratify the African Medicines Agency
05 February 2021

PhRMA [to 6 Feb 2021]
http://www.phrma.org/
Selected Press Releases, Statements
Takeda Pharmaceuticals U.S.A. President Ramona Sequeira Becomes PhRMA Board Chair-Elect
February 3, 2021

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

AMA Journal of Ethics
Volume 23, Number 2: E83-211 Feb 2021
https://journalofethics.ama-assn.org/issue/racial-and-ethnic-health-equity-us-part-1

Racial and Ethnic Health Equity in the US: Part 1
Health equity is defined by the World Health Organization as the “absence of unfair and avoidable or remediable differences in health among social groups.” Domestically and globally, health inequity is not a historical accident. Inequity today is not unfortunate—that is, not a product of a mere turn of the proverbial cosmic wheel—but unjust—that is, generated by colonial, White supremacist policies and practices structured and maintained over time, forged to persist in hierarchies that serve some of us, our ancestors, and our descendants well and some of us, our ancestors, and our descendants ill. This first of a 2-part theme issue focuses specifically on racial and ethnic inequity in morbidity, mortality, and access to services that are endemic to American life. We investigate health inequity as a product of transgenerational patterns of oppression that must be remediated by all of us compassionately and more deliberately and quickly than they were created.

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 6 Feb 2021)

Cost per DALY averted in low, middle- and high-income countries: evidence from the global burden of disease study to estimate the cost-effectiveness thresholds
Determining the cost-effectiveness thresholds for healthcare interventions has been a severe challenge for policymakers, especially in low- and middle-income countries. This study aimed to estimate the cost per disability-adjusted life-year (DALY) averted for countries with different levels of Human Development Index (HDI) and Gross Domestic Product (GDP).
Authors: Rajabali Daroudi, Ali Akbari Sari, Azin Nahvijou and Ahmad Faramarzi
Content type: Research
4 February 2021

BMJ Global Health
February 2021 – Volume 6 – 2
https://gh.bmj.com/content/6/2

Practice
Towards attainment of Indigenous health through empowerment: resetting health systems, services and provider approaches (5 February, 2021)
Cheryl Barnabe

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 6 Feb 2021)

The impact of non-pharmaceutical interventions on SARS-CoV-2 transmission across 130 countries and territories
Non-pharmaceutical interventions (NPIs) are used to reduce transmission of SARS coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19). However, empirical evidence of the effectiveness of s…
Authors: Yang Liu, Christian Morgenstern, James Kelly, Rachel Lowe and Mark Jit
Citation: BMC Medicine 2021 19:40
Content type: Research article
Published on: 5 February 2021

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 6 Feb 2021)

The importance of supplementary immunisation activities to prevent measles outbreaks during the COVID-19 pandemic in Kenya
The COVID-19 pandemic has disrupted routine measles immunisation and supplementary immunisation activities (SIAs) in most countries including Kenya. We assessed the risk of measles outbreaks during the pandemi…
Authors: C. N. Mburu, J. Ojal, R. Chebet, D. Akech, B. Karia, J. Tuju, A. Sigilai, K. Abbas, M. Jit, S. Funk, G. Smits, P. G. M. van Gageldonk, F. R. M. van der Klis, C. Tabu, D. J. Nokes, JAG Scott…
Citation: BMC Medicine 2021 19:35
Content type: Research article
Published on: 3 February 2021

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

Research
Associations between insurance-related affordable care act policy changes with HPV vaccine completion
Although all 11- or 12-year-olds in the US were recommended to receive a 3-dose series of the human papillomavirus (HPV) vaccine within a 12-month period prior to 2016, rates of completion of the HPV vaccine s…
Authors: Summer Sherburne Hawkins, Krisztina Horvath, Jessica Cohen, Lydia E. Pace and Christopher F. Baum
Citation: BMC Public Health 2021 21:304
Content type: Research article
Published on: 6 February 2021

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

Factors associated with participation in an ongoing national catch-up campaign against rubella: a cross-sectional internet survey among 1680 adult men in Japan
Since 2019, aiming to eliminate periodic rubella outbreaks, the Japanese government has provided a rubella immunization program targeting men born in fiscal years 1972 to 1978, who lacked the opportunity to be…
Authors: Ai Hori, Shiho Yoshii, Yukari Isaka and Koji Wada
Citation: BMC Public Health 2021 21:292
Content type: Research article
Published on: 4 February 2021

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

Empowering traditional birth attendants as agents of maternal and neonatal immunization uptake in Nigeria: a repeated measures design
Adequate immunization coverage in rural communities remain a challenge in Nigeria. Traditional birth attendants (TBAs) form an integral part of the social, cultural and religious fabric in most rural communiti…
Authors: Chinedu Anthony Iwu, Kenechi Uwakwe, Uche Oluoha, Chukwuma Duru and Ernest Nwaigbo
Citation: BMC Public Health 2021 21:287
Content type: Research article
Published on: 4 February 2021

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

A review of the quantitative effectiveness evidence synthesis methods used in public health intervention guidelines
The complexity of public health interventions create challenges in evaluating their effectiveness. There have been huge advancements in quantitative evidence synthesis methods development (including meta-analy…
Authors: Ellesha A. Smith, Nicola J. Cooper, Alex J. Sutton, Keith R. Abrams and Stephanie J. Hubbard
Citation: BMC Public Health 2021 21:278
Content type: Research article
Published on: 3 February 2021

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

Effect of intensive training in improving older women’s knowledge and support for infant vaccination in Nigerian urban slums: a before-and-after intervention study
One of the strategies for improving vaccination uptake is to make communities understand the importance of immunization and this is expected to drive the demand for vaccines. Building the capacity of older wom…
Authors: Folusho Mubowale Balogun, Olayinka Samson Bamidele and Eniola Adetola Bamgboye
Citation: BMC Public Health 2021 21:266
Content type: Research article
Published on: 2 February 2021

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

Feasibility of implementation of CARD™ for school-based immunizations in Calgary, Alberta: a cluster trial
Negative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immuni…
Authors: Anna Taddio, Joanne Coldham, Charlotte Logeman, C. Meghan McMurtry, Cheri Little, Tracy Samborn, Lucie M. Bucci, Noni E. MacDonald, Vibhuti Shah, Cindy Dribnenki, Joanne Snider and Derek Stephens
Citation: BMC Public Health 2021 21:260
Content type: Research article
Published on: 1 February 2021

The European Journal of Public Health
Volume 31, Issue 1, February 2021
https://academic.oup.com/eurpub/issue/31/1

Editorials
Learning from past mistakes? The COVID-19 vaccine and the inverse equity hypothesis
Adam Todd, Clare Bambra
European Journal of Public Health, Volume 31, Issue 1, February 2021, Page 2, https://doi.org/10.1093/eurpub/ckaa243

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 6 Feb 2021]

Open Letter Revised
How to engage communities on a large scale? Lessons from World Mosquito Program in Rio de Janeiro, Brazil [version 2; peer review: 1 approved, 2 approved with reservations]
Guilherme B. Costa, Ruth Smithyman, Scott L. O’Neill, Luciano A. Moreira
Peer Reviewers James V. Lavery; Delphine Thizy; Trudie Lang
Funders: Bill and Melinda Gates Foundation, Ministério da Saúde Brasil
LATEST VERSION PUBLISHED 04 Feb 2021

Global Public Health
Volume 16, Issue 2 (2021)
http://www.tandfonline.com/toc/rgph20/current

Special Issue: Understanding the health systems impacts of “Test and Treat” in sub-Saharan Africa: Findings from the SHAPE study; Guest Editors: Jenny Renju, Janet Seeley, Mosa Moshabela, and Alison Wrin

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 6 Feb 2021]

Commentary
Specific considerations for research on the effectiveness of multisectoral collaboration: methods and lessons from 12 country case studies
The success of the Sustainable Development Goals (SDGs) is predicated on multisectoral collaboration (MSC), and the COVID-19 pandemic makes it more urgent to learn how this can be done better. Complex challenges facing countries, such as COVID-19, cut across health, education, environment, financial and other sectors. Addressing these challenges requires the range of responsible sectors and intersecting services – across health, education, social and financial protection, economic development, law enforcement, among others – transform the way they work together towards shared goals. While the necessity of MSC is recognized, research is needed to understand how sectors collaborate, inform how to do so more efficiently, effectively and equitably, and ascertain similarities and differences across contexts. To answer these questions and inform practice, research to strengthen the evidence-base on MSC is critical.
Authors: Rachael Hinton, Corinne Armstrong, Eriana Asri, Klaus Baesel, Sarah Barnett, Carla Blauvelt, Saidatul Norbaya Bt Buang, Louise Bury, Jai K. Das, Jennifer Franz-Vasdeki, Helia Molina Milman, John Murray, Susana Palma, Ilona Renner, Marion Roche, Victoria Saint…
Content type: Commentary
1 February 2021

JAMA Network
COVID-19 Update February 6, 2021

These articles on COVID-19 were published across the JAMA Network in the last week.
Patient Information
Necessity of 2 Doses of the Pfizer and Moderna COVID-19 Vaccines
Edward H. Livingston, MD

JAMA Pediatrics
February 2021, Vol 175, No. 2, Pages 115-216
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
Clarifying the Sweeping Consequences of COVID-19 in Pregnant Women, Newborns, and Children With Existing Cohorts
Yanhong Jessika Hu, PhD; Melissa Wake, MD; Richard Saffery, PhD
free access has active quiz
JAMA Pediatr. 2021;175(2):117-118. doi:10.1001/jamapediatrics.2020.2395
This Viewpoint describes needs for defining the outcomes of the coronavirus disease 2019 pandemic on pregnant women, neonates, and children and proposes that fulfilling those needs will require engaging with existing research cohorts.

JAMA Pediatrics
February 2021, Vol 175, No. 2, Pages 115-216
http://archpedi.jamanetwork.com/issue.aspx

Should We Mandate a COVID-19 Vaccine for Children?
Douglas J. Opel, MD, MPH; Douglas S. Diekema, MD, MPH; Lainie Friedman Ross, MD, PhD
free access has audio
JAMA Pediatr. 2021;175(2):125-126. doi:10.1001/jamapediatrics.2020.3019
This Viewpoint examines the evidence for vaccination of children against coronavirus disease 2019 (COVID-19)….” Nevertheless, with these criteria as a framework, the only logical conclusion is that we currently know too little about the performance of any of the candidate COVID-19 vaccines or the epidemiology of SARS-CoV-2 in children to make any firm judgments about whether a COVID-19 vaccine should be mandatory in children. Yet, it is not too early to begin integrating these criteria into our planning to help ensure we get this decision right. Our nation’s children deserve as much.”

Journal of Infectious Diseases
Volume 223, Issue 2, 15 January 2021
https://academic.oup.com/jid/issue/223/2

COVID-19 PERSPECTIVE
Lessons From Bacille Calmette-Guérin for SARS-CoV-2 Vaccine Candidates
Marcel A Behr, Maziar Divangahi, Erwin Schurr
The Journal of Infectious Diseases, Volume 223, Issue 2, 15 January 2021, Pages 189–191, https://doi.org/10.1093/infdis/jiaa637

Journal of Medical Ethics
February 2021 – Volume 47 – 2
http://jme.bmj.com/content/current

Promoting the sustainability of healthcare resources with existing ethical principles: scarce COVID-19 medications, vaccines and principled parsimony (11 January, 2021) Free
Gerard Vong

Journal of Medical Ethics
February 2021 – Volume 47 – 2
http://jme.bmj.com/content/current

Feature article
Sustainability principle for the ethics of healthcare resource allocation (5 November, 2020)
Christian Munthe, Davide Fumagalli, Erik Malmqvist

Journal of the Royal Society – Interface
February 2021 Volume 18 Issue 175
https://royalsocietypublishing.org/toc/rsif/current

Life Sciences–Mathematics interface
Research articles
Trajectory of individual immunity and vaccination required for SARS-CoV-2 community immunity: a conceptual investigation
Chadi M. Saad-Roy, Simon A. Levin, C. Jessica E. Metcalfand Bryan T. Grenfell
Published:03 February 2021Article ID:20200683

The Lancet
Feb 06, 2021 Volume 397 Number 10273 p445-554
https://www.thelancet.com/journals/lancet/issue/current

Editorial
Genomic sequencing in pandemics
The Lancet

Lancet Digital Health
Feb 2021 Volume 3 Number 2 e67-e134
https://www.thelancet.com/journals/landig/issue/current

Viewpoint
Ethical issues in using ambient intelligence in health-care settings
Nicole Martinez-Martin, et al
Summary
Ambient intelligence is increasingly finding applications in health-care settings, such as helping to ensure clinician and patient safety by monitoring staff compliance with clinical best practices or relieving staff of burdensome documentation tasks. Ambient intelligence involves using contactless sensors and contact-based wearable devices embedded in health-care settings to collect data (eg, imaging data of physical spaces, audio data, or body temperature), coupled with machine learning algorithms to efficiently and effectively interpret these data. Despite the promise of ambient intelligence to improve quality of care, the continuous collection of large amounts of sensor data in health-care settings presents ethical challenges, particularly in terms of privacy, data management, bias and fairness, and informed consent. Navigating these ethical issues is crucial not only for the success of individual uses, but for acceptance of the field as a whole.

Lancet Global Health
Feb 2021 Volume 9 Number 2 e99-e217
https://www.thelancet.com/journals/langlo/issue/current

Comment
What could fair allocation of an efficacious COVID-19 vaccine look like in South Africa?
Keymanthri Moodley, Theresa Rossouw

Lancet Global Health
Feb 2021 Volume 9 Number 2 e99-e217
https://www.thelancet.com/journals/langlo/issue/current

Articles
Global Fund contributions to health security in ten countries, 2014–20: mapping synergies between vertical disease programmes and capacities for preventing, detecting, and responding to public health emergencies
Matthew R Boyce, Aurelia Attal-Juncqua, Jessica Lin, Stephanie McKay, Rebecca Katz

Lancet Infectious Diseases
Feb 2021 Volume 21 Number 2 p149-296, e16-e35
https://www.thelancet.com/journals/laninf/issue/current

Editorial
An exceptional vaccination policy in exceptional circumstances
The Lancet Infectious Diseases
Just as hope for relief from the COVID-19 pandemic brightened in December, with emergency use approval for vaccines following phase 3 trials and the start of immunisation programmes, unprecedented numbers of cases, hospital admissions, and deaths have been recorded, including in countries such as Germany and Japan that were previously celebrated for their public health response. Predictions that the northern hemisphere winter would be a difficult time for control of COVID-19, as is typically the case with respiratory viral diseases, have proved to be correct. Emergence in South Africa and the UK of new variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that are substantially more transmissible, has added to concerns that health services will be overwhelmed.

Alarm over the rapid rise in cases led to an unexpected policy twist in the UK on Dec 30: on top of a third national lockdown, the chief medical officers of the four nations of the UK announced that the second dose of vaccines against SARS-CoV-2 should be given at up to 12 weeks after the first dose rather than the recommended interval of 3–4 weeks, on the basis of advice from the Joint Committee on Vaccination and Immunisation (JCVI). While supplies of vaccine remain limited, the JCVI recommends “initially prioritising delivery of the first vaccine dose as this is highly likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19”. The rationale is that if 95% of people are protected from disease after two doses (as determined in the phase 3 trial of the Pfizer-BioNTech vaccine) and 90% after one dose (JCVI estimate), then 19 of 20 people will be protected by two doses but when given as single doses to 40 people 36 will be protected. The WHO Strategic Advisory Group of Experts (SAGE) on immunisation has advised that the interval between doses of the Pfizer-BioNTech vaccine can be up to 6 weeks in “exceptional epidemiological circumstances”. The Canadian province of British Columbia will extend the vaccine interval to 5 weeks, and other countries are reported to be considering extending the dosing interval while awaiting delivery of more vaccine.

Given that vaccine approval is based on a dosing interval of 3 or 4 week, that efficacy of single doses was not formally tested in randomised trials, and that estimated efficacy of single doses is based on unplanned analyses of few data from these trials, the decision to prioritise the first dose has naturally drawn criticism. The British Medical Association described the decision as “unreasonable and totally unfair”, pointing out the logistical difficulties in rebooking vaccination appointment for the elderly and vulnerable people who have already received their first immunisation. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said that the US vaccination programme would proceed with the approved two-dose schedule, noting the lack of data on extending the period to the second immunisation.

An important concern is the durability of immunity in the extended dosing interval. Some COVID-19 cases after the first vaccine dose are inevitable among people infected around the time of immunisation—as was observed in clinical trials—because protective immunity takes about 2 weeks to become established. However, if immunity wanes during the interval between doses, post-vaccination infections will be more common, thus reducing the impact of—and public confidence in—the vaccination programme. As John Roberts and colleagues point out, duration of immunity to viral spike protein induced by mRNA vaccines such as the Pfizer-BioNTech and Moderna ones is unknown, and in animal models neutralising antibody production falls at about 28 days from first vaccination. By contrast, these authors note that for viral-vector vaccines (eg, Oxford-AstraZeneca ChAdOx1), there is evidence to support an extended interval between doses. Another unknown is whether potentially suboptimal immunity will foster evolution of vaccine-escape mutants of SARS-CoV-2. In this regard, some reassurance comes from a report that the Pfizer-BioNTech vaccine produces antibodies that neutralise SARS-CoV-2 carrying the N501Y mutation found in the South African and UK variants.

Independent SAGE, a group of UK scientists not known for their support of government COVID-19 policy, has endorsed the decision “to pursue coverage of as high a proportion of the population as possible, as quickly as possible”, noting that it must be part of a comprehensive strategy that includes prospective evaluation of different dosing intervals. Given the urgent need to suppress a rise in cases caused by a new viral variant, we believe that extending the dosing interval is an expedient, short-term decision while there are constraints on vaccine supply.

Lancet Infectious Diseases
Feb 2021 Volume 21 Number 2 p149-296, e16-e35
https://www.thelancet.com/journals/laninf/issue/current

Articles
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
Yanjun Zhang, et al

Lancet Infectious Diseases
Feb 2021 Volume 21 Number 2 p149-296, e16-e35
https://www.thelancet.com/journals/laninf/issue/current

Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial
Guy de Bruyn, et al

Lancet Infectious Diseases
Feb 2021 Volume 21 Number 2 p149-296, e16-e35
https://www.thelancet.com/journals/laninf/issue/current

Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial
Judith Absalon, et al

Lancet Infectious Diseases
Feb 2021 Volume 21 Number 2 p149-296, e16-e35
https://www.thelancet.com/journals/laninf/issue/current

Safety and immunogenicity of co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in Gabonese adults: a randomised, controlled, double-blind, phase 1 dose-escalation trial
Ayola A Adegnika, et al for the HookVac Consortium

Lancet Infectious Diseases
Feb 2021 Volume 21 Number 2 p149-296, e16-e35
https://www.thelancet.com/journals/laninf/issue/current

Immunogenicity and persistence of trivalent measles, mumps, and rubella vaccines: a systematic review and meta-analysis
Julie Schenk, et al

Lancet Infectious Diseases
Feb 2021 Volume 21 Number 2 p149-296, e16-e35
https://www.thelancet.com/journals/laninf/issue/current

Review
What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2
Susanne H Hodgson, et al

Lancet Public Health
Feb 2021 Volume 6 Number 2 e82-e135
https://www.thelancet.com/journals/lanpub/issue/current

Editorial
COVID-19—break the cycle of inequality
The Lancet Public Health

Lancet Respiratory Medicine
Feb 2021 Volume 9 Number 2 p117-216, e11-e21
https://www.thelancet.com/journals/lanres/issue/current

Editorial
Realising the potential of SARS-CoV-2 vaccines—a long shot?
The Lancet Respiratory Medicine
… The ability of SARS-CoV-2 vaccines to prevent infection or ongoing transmission remains unclear. The impact of immunisation on hospital admissions will be an important focus as countries aim to keep health-care systems running and protect those most at risk of severe disease in the face of high levels of transmission. Emerging SARS-CoV-2 variants are a cause for concern. New variants include B.1.1.7, which recently emerged in the UK, B.1.351, and P.1. These lineages appear to be more transmissible than previous strains, although there is currently no evidence that they cause more severe disease or compromise the efficacy of available vaccines. Surveillance is needed to detect escape variants at an early stage. New variants also emphasise the ongoing need for public health mitigation strategies and add to the urgency of vaccine rollout across the globe…

Nature
Volume 590 Issue 7844, 4 February 2021
http://www.nature.com/nature/current_issue.html

Article | 02 November 2020
Age-specific mortality and immunity patterns of SARS-CoV-2
The relative risk of COVID-19-associated death for younger individuals (under 65) is consistent across countries and can be used to robustly compare the underlying number of infections in each country.
Megan O’Driscoll, Gabriel Ribeiro Dos Santos[…] & Henrik Salje

Nature Reviews Immunology
Volume 21 Issue 2, February 2021
https://www.nature.com/nri/volumes/21/issues/2

Progress | 18 December 2020
Viral targets for vaccines against COVID-19
As the world races to develop vaccines against SARS-CoV-2, Dai and Gao highlight which viral targets are best to include in a vaccine and how this impacts the induced immune response and, ultimately, the safety and efficacy of a vaccine.
Lianpan Dai  & George F. Gao

Nature Reviews Immunology
Volume 21 Issue 2, February 2021
https://www.nature.com/nri/volumes/21/issues/2

Review Article | 22 December 2020
A guide to vaccinology: from basic principles to new developments
This Review, aimed at a broad scientific audience, provides an introductory guide to the history, development and immunological basis of vaccines, immunization and related issues to provide insight into the challenges facing immunologists who are designing the next generation of vaccines.
Andrew J. Pollard  & Else M. Bijker