Comment COVID-19 vaccines for children in LMICs: another equity issue
Beate Kampmann, Uduak Okomo … During deliberations on the potential benefits of COVID-19 vaccines for CYP, it is important to recognise that this pandemic has already deprived more than 8 million children, primarily in LMICs, from life-saving, routine childhood vaccines.19 Immunisation services are preoccupied with the implementation of COVID-19 vaccine programmes for adults. At present, greater benefit for children’s health globally will be derived by delivering the health interventions we already know will save their lives, such as vaccines against measles and other vaccine-preventable diseases, than by focusing on delivering COVID-19 vaccines to part of a population that does not currently represent a strategic priority in the response to this pandemic. Although maybe not equitable, we believe this approach is more important for the health of CYP at this point in time.
Perspective | 08 July 2021 After the pandemic: perspectives on the future trajectory of COVID-19
This Perspective discusses possible future patterns of SARS-CoV-2 infection, the development of variants, potential changes in the patterns of spread and the implications for vaccine deployment and the potential consequences of these issues for the development of policy.
Amalio Telenti, Ann Arvin, Herbert W. Virgin
Original Articles A Monoclonal Antibody for Malaria Prevention M.R. Gaudinski and Others Conclusions
Among adults who had never had malaria infection or vaccination, administration of the long-acting monoclonal antibody CIS43LS prevented malaria after controlled infection. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 612 ClinicalTrials.gov number, NCT04206332. opens in new tab.)
PNAS – Proceedings of the National Academy of Sciences of the United States of America
August 17, 2021; vol. 118 no. 33 https://www.pnas.org/content/118/33
Editorial Colleges must require vaccination
By Michael A. McRobbie
Science27 Aug 2021 : Summary
This week, the US Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech coronavirus vaccine for individuals 16 years and older. This milestone decision, the first full approval of a vaccine for COVID-19, will almost certainly clear a path for businesses, hospitals, and government agencies that have not already done so to adopt vaccine mandates for their employees. For colleges and universities that have been on the fence about requiring the vaccine, the FDA’s decision may be especially welcome news.
In Depth Unethical? Unnecessary? The booster debate intensifies
By Gretchen Vogel
Science27 Aug 2021 : 949-950 Restricted Access As United States reveals its plan to offer an extra dose of COVID-19 vaccine, equity and scientific questions abound. Summary
As the extraordinarily infectious Delta variant of SARS-CoV-2 continues to spread around the world, vaccines’ powers are showing their limits. Although they are still extremely effective at preventing severe COVID-19, the tantalizing hope that the shots could block almost all infections—and squelch transmission—has evaporated. That has upended return to office and school plans, threatened economic recoveries, and spurred fresh political rows over mask and vaccination mandates. Now, amid new studies hinting that vaccine-induced immunity may be waning, policymakers and scientists are debating whether widespread booster shots could help or getting shots into the arms of the unvaccinated should remain the top priority. And many people wonder whether one booster will suffice or periodic COVID-19 vaccination will become the new normal, as it is for influenza.
Research Articles The animal origin of SARS-CoV-2
By Spyros Lytras, Wei Xia, Joseph Hughes, Xiaowei Jiang, David L. Robertson
Science27 Aug 2021 : 968-970 Full Access
Trading of animals susceptible to bat coronaviruses is the likely cause of the COVID-19 pandemic
medRxiv medRxiv is a free online archive and distribution server for complete but unpublished manuscripts (preprints) in the medical, clinical, and related health sciences. Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information. medRxiv is for the distribution of preprints – complete but unpublished manuscripts – that describe human health research conducted, analyzed, and interpreted according to scientific principles… https://www.medrxiv.org/content/about-medrxiv
[Accessed 28 Aug 2021]
Shedding of Infectious SARS-CoV-2 Despite Vaccination
Kasen K. Riemersma, Brittany E. Grogan, Amanda Kita-Yarbro, Peter J. Halfmann, Hannah E. Segaloff, Anna Kocharian, Kelsey R. Florek, Ryan Westergaard, Allen Bateman, Gunnar E. Jeppson, Yoshihiro Kawaoka, David H. O’Connor, Thomas C. Friedrich, Katarina M. Grande
medRxiv 2021.07.31.21261387; doi: https://doi.org/10.1101/2021.07.31.21261387
Vaccines and Global Health: The Week in Review is a weekly digest summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date
.– Request anEmail Summary:Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
– pdf version: A pdf of the current issue is available here:
– blog edition: comprised of the approx. 35+ entries posted below.
– Twitter:Readers can also follow developments on twitter: @vaxethicspolicy. . – Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
Support this knowledge-sharing service:Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.
. David R. Curry, MS Executive Director Center for Vaccine Ethics and Policy
Editor’s Note:
As is obvious to all, the sheer volume of strategic announcements, regulatory actions, country program decisions, commentary, and, indeed, misinformation around COVID response continues at extraordinary levels. Our weekly digest strives to present a coherent and comprehensive snapshot, but cannot be exhaustive, If you recognize a missed strategic development, a new source of rigorous analysis, or an insight/commentary that would benefit our common understanding, please advise me…we will review all suggestions and consider for inclusion in a subsequent edition: david.r.curry@ge2p2global.org
We are seeking access to modelling which engages scenarios and articulates imperatives around a pandemic end-game through at least a 2025 horizon. We assess that WHO must be conducting or contracting for such modeling – or should recognize an imperative to be doing so in its global health governance role. If we have missed such modeling in progress, we would be delighted to be advised of it and will include it in our coverage.
ACT-Accelerator launches urgent US$ 7.7 billion appeal to stem surge of dangerous variants and save lives everywhere
16 August 2021 WHO News release
Delta variant on path to become dominant strain worldwide as surge in the highly transmissible variant increases urgency for vaccinating large numbers of vulnerable people
Rising infection rates resulting in increased hospitalizations are overwhelming health systems and leaving many countries in urgent need of life-saving oxygen
Testing rates in much of the world is too low, especially low- and lower-middle-income countries [1] – leaving much of the world blind to how the disease is evolving and vulnerable to new variants
Funding the Rapid ACT-Accelerator Delta Response (RADAR) urgent appeal for US $7.7 billion would enable: significantly increased testing and better surveillance to detect and protect against new variants; more oxygen to treat the seriously ill and save lives; vital personal protective equipment (PPE) to protect health workers; the rolling out of emergency response and delivery support for the effective delivery and deployment of COVID-19 tools, including in humanitarian contexts; and continued research and development (R&D) so that tools remain effective
The US$ 7.7 billion is not an additional funding need but is part of the ACT-Accelerator’s overall 2021 budget, which is needed urgently within the next four months
With more COVID-19 cases reported in the first five months of 2021 than in the whole of 2020, the world is still in the acute phase of the pandemic – despite high vaccination rates in some countries protecting populations from severe disease and death. Inadequate testing and low vaccination rates are exacerbating disease transmission and overwhelming local health systems, while leaving the whole world vulnerable to new variants.
Many countries are experiencing new waves of infections – and while many high-income countries and some upper-middle-income countries have implemented widespread vaccinations, put more robust testing systems in place, and made treatments increasingly available – many low- and lower-middle-income countries are struggling to access these vital tools due to a lack of funds and supplies. Investing in the ACT-Accelerator to make tools available to everyone, everywhere, will benefit all countries through a more globally inclusive and coordinated response.
While four variants of concern currently dominate the epidemiology, there are fears that new, and possibly more dangerous, variants of concern may emerge.
With hard-won gains of the last three months at risk, the ACT-Accelerator has mounted a US$ 7.7 billion appeal, the Rapid ACT-Accelerator Delta Response (RADAR), to urgently: Scale up testing: US$2.4 billion to put all low- and lower-middle-income countries on track towards a ten-fold increase in COVID-19 testing and ensure all countries get up to satisfactory testing levels. This will significantly enhance local and global understanding of the changing disease epidemiology and emerging variants of concern, inform the appropriate application of public health and social measures and break chains of transmission.
Maintain R&D efforts to stay ahead of the virus: US$ 1 billion for ongoing R&D, enable further market shaping and manufacturing, technical assistance and demand generation to ensure that tests, treatments and vaccines remain effective against the Delta variant and other emerging variants, and that they are accessible and affordable where they are needed.
Address acute oxygen needs to save lives: US$ 1.2 billion to rapidly address acute oxygen needs to treat the seriously ill and control the exponential death surges caused by the Delta variant.
Rollout of tools: US$ 1.4 billion to help countries identify and address key bottlenecks for the effective deployment and use of all COVID-19 tools. As supply of COVID-19 vaccines ramps up in the coming months, flexible funding will be essential to help fill on-the-ground delivery gaps.
Protect frontline healthcare workers: US$ 1.7 billion to provide two million essential healthcare workers with enough basic PPE to keep them safe while they care for the sick, prevent the collapse of health systems where the health workforce is already understaffed and overstretched, and prevent further spread of COVID-19.
In addition to the US$ 7.7 billion appeal, there is an opportunity to reserve the supply of vaccines through exercising options in the fourth quarter of 2021 for 760 million doses of vaccine to be available in mid-2022 beyond the fully subsidised doses that COVAX will deliver up to the end of Q1 2022. Commitments to reserve these vaccine options in the last quarter of the year for delivery in the middle of 2022 can be made to Gavi/COVAX, as part of the ACT-A network of agencies.
Reserve vaccines: Reserve supply of 760 million doses of vaccine by exercising options in the final quarter this year to ensure there is continued supply available to make deliveries into 2022. Reserving doses requires contingent capital; on delivery these 760m doses will cost an additional US$ 3.8 billion…
Multilateral Leaders Task Force on COVID-19 [IMF, World Bank Group, WHO, WTO] A joint initiative from the International Monetary Fund, World Bank Group, World Health Organization, and World Trade Organization to accelerate access to COVID-19 vaccines, therapeutics and diagnostics by leveraging multilateral finance and trade solutions, particularly in low- and middle-income countries. Data to help track, coordinate, and advance delivery of COVID-19 health tools to developing countries and to mobilize relevant stakeholders and national leaders to remove critical roadblocks – in support of the priorities set out by the WBG, IMF, WHO, and WTO.
Global COVID-19 Figures: 210M total confirmed cases; 4.4M total confirmed deaths Global vaccines administered: 4.88B
Number of Countries: 26 [26]
COVAX Allocations (Number of Doses): 73M [73M week ago]
COVAX Delivered (Number of Doses): 53M [46M week ago]
Other Delivered (Number of Doses): 93M [61M week ago]
Total Delivered (Number of Doses): 150M [110M week ago]
Total Administered (Number of Doses): 110M [110M week ago]
19 August 2021 Speech WHO Director-General’s opening remarks at the Member State Information Session on COVID-19 – 19 August 2021
18 August 2021Speech WHO Director-General’s opening remarks at the media briefing on COVID-19 – 18 August 2021 In Haiti, where the earthquake has killed more than 1,900 people, we are continuing to support the government and the people by all means possible during this difficult moment. The people of Afghanistan are facing an enormous challenge. We are particularly concerned about the health and wellbeing of women and girls. Our staff remain in the country and committed to delivering health services to the most vulnerable. This week, a new case of Ebola was identified in Côte d’Ivoire. Thousands of doses of Ebola vaccines were sent from Guinea to Cote d’Ivoire and ring vaccination of high-risk contacts has started. Just 10 countries have administered 75 per cent of all vaccine supply and low-income countries have vaccinated barely 2 per cent of their people. I called for a temporary moratorium on boosters to help shift supply to those countries that that have not even been able to vaccinate their health workers and at-risk communities and are now experiencing major spikes. Vaccine injustice is a shame on all humanity and if we don’t tackle it together, we will prolong the acute stage of this pandemic for years when it could be over in a matter of months. When G20 health ministers meet on the 5th and 6th of September in Rome, I will call on them to consider the fragility of this historic moment and make a clear defining commitment to solidarity. …At present, just 10 countries have administered 75 per cent of all vaccine supply and low-income countries have vaccinated barely 2 per cent of their people.
I called for a temporary moratorium on boosters to help shift supply to those countries that that have not even been able to vaccinate their health workers and at-risk communities and are now experiencing major spikes.
Last week, WHO brought together 2,000 experts from all around the world and debated the available data on boosters. What is clear is that it’s critical to get first shots into arms and protect the most vulnerable before boosters are rolled out.
The divide between the haves and have nots will only grow larger if manufacturers and leaders prioritise booster shots over supply to low- and middle-income countries. The virus is evolving and it is not in the best interests of leaders just to focus on narrow nationalistic goals when we live in an interconnected world and the virus is mutating quickly.
In fact, strong national leadership would be to fully commit to vaccine equity and global solidarity, which would save lives and slow variants down.
In this context, I was stunned by the news that J&J vaccines fill and finished in South Africa are leaving the continent and going to Europe, where virtually all adults have been offered vaccines at this point.
We urge J&J to urgently prioritize distribution of their vaccines to Africa before considering supplies to rich countries that already have sufficient access…
Weekly operational update on COVID-19 – 16 August 2021 Overview n this edition of the COVID-19 Weekly Operational Update, highlights of country-level actions and WHO support to countries include: Facilitating procurement of 1.6 million antigen-detecting rapid diagnostic tests to strengthen COVID-19 diagnostic in Indonesia The roll-out of Go.Data contact tracing tool in Ukraine Donated COVID-19 vaccine doses by France arrive in Somalia Community health at the center of COVID-19 vaccination in indigenous communities in Paraguay Online learning opportunities to support hospital infection prevention and control committees in Azerbaijan Progress on a subset of indicators from the SPRP 2021 Monitoring and Evaluation Framework Updates on WHO’s financing to support countries in SPRP 2021 implementation and provision of critical supplies.
Weekly epidemiological update on COVID-19 – 17 August 2021 Overview The global number of new cases has been increasing for the last 2 months with over 4.4 million cases reported in the past week (9 – 15 August 2021), bringing the cumulative number of globally to cases to over 206 million. This increasing trend is largely attributed to increases in the Western Pacific Region and the Region of the Americas which reported 14% and 8% increases respectively as compared to the previous week. Overall, the number of deaths reported remained similar with over 66 000 deaths this week, as compared to the previous week. While the African Region reported the largest percentage decrease in case and death incidence, 23% and 18% respectively, data from the weekend is incomplete which might lead to an overestimation of the percentage change. The Western Pacific and the Eastern Mediterranean Regions reported the highest proportionate increases in death incidence of 23% and 15% respectively over the last seven days.
In this edition, a special focus updates are provided on: SARS-CoV-2 Variants of Concern (VOCs) Alpha, Beta, Gamma and Delta which includes updates on the geographic distribution of VOCs. COVID-19 in Prisons
The SAGO will advise WHO on technical and scientific considerations regarding the origins of emerging and re-emerging pathogens of epidemic and pandemic potential, and will be composed of a wide range of experts acting in their personal capacity. SAGO will also guide WHO on next steps for understanding the SARS-CoV-2 origins.
There have been an increasing number of high threat pathogens emerging and re-emerging in recent years with, for example, SARS-CoV, MERS-CoV, Lassa, Marburg, Ebola, Nipah, avian influenza, the latest being SARS-CoV-2. There is a clear need for robust surveillance and early actions for rapid detection and mitigation efforts, as well as systematic processes to study the emergence of these pathogens and routes of transmission from their natural reservoirs to humans. This is critical to helping WHO, Member States and partner institutions to prepare for future spillover threats and to minimize the risk of a disease outbreak growing into a pandemic.
From SARS-CoV-2, which continues to wreak havoc around the world, to the next “Disease X”, this global framework to study the emergence of new and known high threat pathogens needs to be comprehensive and coordinated based on a One Health approach. It should also encompass biosafety and biosecurity. And it needs to be scientific, transparent, comprehensive, rapid and inclusive…
Functions of SAGO
…4. In the context of SARS-CoV-2 origins:
:: To provide the WHO Secretariat with an independent evaluation of all available scientific and
technical findings from global studies on the origins of SARS-CoV-2;
:: To advise the WHO Secretariat regarding developing, monitoring and supporting the next series of studies into the origins of SARS-CoV-2, including rapid advice on WHO’s operational plans to implement the next series of global studies into the origins of SARS-CoV-2, as outlined in the ‘Joint WHO-China Global Study of Origins of SARS- CoV-2: China Part’ report published on 30 March 2021 and advise on additional studies as
needed; and
5. To provide additional advice and support to WHO, as requested by the WHO SAGO Secretariat,
which may include participation in future WHO-international missions to study the origins of SARS-
CoV-2 or for other emerging pathogens.
…More information can be found on the Terms of Reference of the SAGO The SAGO will be multidisciplinary, with members who have a range of technical knowledge, field experience, skills and experience relevant to emerging and re-emerging pathogens. Up to 25 experts may be selected…
Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021 For 22 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date [See full scale graphics at link above]
COVID Vaccine Developer/Manufacturer Announcements [relevant press releases/announcement from organizations from WHO EUL/PQ listing above]
AstraZeneca Press Releases AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19
20 August 2021 :: 77% reduced risk of developing symptomatic COVID-19 :: First long-acting antibody combination to prevent COVID-19
Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca’s AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial’s primary endpoint.
AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis…
BioCubaFarma – Cuba Últimas Noticias– [Website not responding at inquiry; receiving 403=Forbidden message]
CanSinoBIO News– [Website not responding at inquiry]
Clover Biopharmaceuticals – China News – No new digest announcements identified
Curevac [Bayer Ag – Germany] News
August 16, 2021 Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study
:: Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone
:: Data demonstrate high protective efficacy of second-generation lead candidate, CV2CoV, in animal model during SARS-CoV-2 challenge study
:: Neutralizing capacity of induced antibodies tested against a range of variants, including the Beta, Delta and Lambda variant
Gamaleya National Center Latest News and Events – No new digest announcements identified [See Russia/RFID below]
IMBCAMS, China Home– – [Website not responding at inquiry; receiving 502 Bad Gateway]
Janssen/JNJ Press Releases Statement on Boosting with the Johnson & Johnson COVID-19 Vaccine
NEW BRUNSWICK, N.J., August 18, 2021 — We are engaging with the U.S. FDA, CDC and other health authorities and will share new data shortly regarding boosting with the Johnson & Johnson COVID-19 vaccine. In July, Johnson & Johnson shared data demonstrating that our single-shot COVID-19 vaccine generated strong, persistent immune activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. Interim results from a Phase 1/2a study published in the New England Journal of Medicine also showed that the durability of the immune response was strong, with no waning for at least eight months, the length of time that had been evaluated to date.
Ensuring long-term and durable protection against hospitalization and death are critical in curbing the COVID-19 pandemic.
Pfizer Recent Press Releases
08.16.2021 Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine
:: Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust immune responses
:: The booster dose elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), and the Beta and Delta variants, compared to the levels observed after the two-dose primary series
:: After the booster dose, neutralizing titers for variants were similar to wild type
:: Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19
Sanofi Pasteur Press Releases – No new digest announcements identified
GSK Press releases for media
16 August 2021 Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study
:: Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone
:: Data demonstrates high protective efficacy of second-generation lead candidate, CV2CoV, in animal model during SARS-CoV-2 challenge study
:: Neutralizing capacity of induced antibodies tested against a range of variants, including the Beta, Delta and Lambda variant
SK Biosciences Press releases– No new digest announcements identified
The Race for Global COVID-19 Vaccine Equity
A flurry of nearly 200 COVID-19 vaccine candidates are moving forward through the development and clinical trials processes at unprecedented speed; more than ten candidates are already in Phase 3 large-scale trials and several have received emergency or limited authorization. Our team has aggregated and analyzed publicly available data to track the flow of procurement and manufacturing and better understand global equity challenges. We developed a data framework of relevant variables and conducted desk research of publicly available information to identify COVID vaccine candidates and status, deals and ongoing negotiations for procurement and manufacturing, COVID burden by country, and allocation and distribution plans. We have also conducted interviews with public officials in key countries to better understand the context and challenges facing vaccine allocation and distribution [accessed 24 July 2021] See our COVID Vaccine Purchases research See our COVID Vaccine Manufacturing research See our COVID Vaccine Donations & Exports research
Global Dashboard on COVID-19 Vaccine Equity The Dashboard is a joint initiative of UNDP, WHO and the University of Oxford with cooperation across the UN system, anchored in the SDG 3 Global Action Plan for Healthy Lives and Well-being for All.
Our World in Data Coronavirus (COVID-19) Vaccinations[Accessed 21 Aug 21] 32.3% of the world population has received at least one dose of a COVID-19 vaccine, and 24.3% is fully vaccinated. 4.91 billion doses have been administered globally, and 34.96 million are now administered each day. Only 1.4% of people in low-income countries have received at least one dose.
The statement is attributable to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC); Dr. Janet Woodcock, Acting Commissioner, Food and Drug Administration (FDA); Dr. Vivek Murthy, U.S. Surgeon General; Dr. Francis Collins, Director of the National Institutes of Health (NIH); Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Rachel Levine, Assistant Secretary for Health; Dr. David Kessler, Chief Science Officer for the COVID-19 Response; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force:
“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maximize this protection. The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.
“We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.
“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.
“Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape. We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it.
“We also want to emphasize the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all. We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trusted sources. We will also continue to expand our efforts to increase the supply of vaccines for other countries, building further on the more than 600 million doses we have already committed to donate globally.”
::::::
Editor’s Note:
We assess [1] the announcement of a plan as above to provide booster doses of COVID vaccines with an established start date ̶ before FDA action and before a CDC decision to accept a supporting recommendation from an ACIP meeting not yet held, and [2] concluding the announcement of such a plan by referencing continuing but unspecified efforts “to increase the supply of vacancies for other countries” to be incongruous.
FACT SHEET: President Biden to Announce New Actions to Protect Americans from COVID-19 and Help State and Local Leaders Fight the Virus
August 18, 2021 • Statements and Releases …Today the President will highlight the following actions: Planning to Offer COVID-19 Booster Shots Starting the Week of September 20:
Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) announced a plan for administering booster shots later this fall, pending final Food and Drug Administration (FDA) evaluation and recommendations from the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP). Under this plan, a booster would be administered, eight months after an individual’s second dose, beginning the week of September 20—at which point those individuals who were fully vaccinated earliest in the vaccination rollout will be eligible, including many health care providers, nursing home residents, and other seniors…We will also continue to expand our efforts to send vaccines to other countries, building on the more than 600 million doses we have already committed to donate globally…
Press release 16 August 2021 Coronavirus: 13 European countries provide urgent assistance to Tunisia To help Tunisia cope with the impact of the COVID-19 pandemic and the worrying health situation within the country, the European Union and its member states continue to mobilise emergency aid via the EU Civil Protection Mechanism.
Latest Updates
17.08.2021 Genomic Surveillance for SARS-CoV-2 In India: Indian SARS-CoV-2 Genomics Consortium (INSACOG) (Updated guidelines and SOPs)
… Indian SARS-CoV-2 Genomics Consortium (INSACOG) was established to expand Whole
Genome Sequencing of SARS-CoV-2 across the nation, aiding our understanding of how the virus
spreads and evolves. The Consortium had initially started with a network of ten regional genome
sequencing laboratories spread across the country and has now been expanded to currently include
28 INSACOG Genome Sequencing Laboratories (IGSLs) that are mapped to the States and UTs
for facilitating smooth flow of samples. The viral genome sequencing data generated by these
IGSLs is analysed by the respective centres and sent to the National Centre for Disease Control
(NCDC), Delhi for collation and integration…
The approval for world’s first DNA based ‘ZyCov-D’ vaccine of Zydus Universe is a testimony to the innovative zeal of India’s scientists: PM
Posted on: 20 Aug 2021
The Prime Minister, Shri Narendra Modi has said that the approval for world’s first DNA based ‘ZyCov-D’ vaccine of is a testimony to the innovative zeal of India’s scientists.
In response to a tweet by CDSCO India Info, the Prime Minister said; “India is fighting COVID-19 with full vigour. The approval for world’s first DNA based ‘ZyCov-D’ vaccine of @ZydusUniverse is a testimony to the innovative zeal of India’s scientists. A momentous feat indeed.” CDSCO_INDIA_INFO @CDSCO_INDIA_INF Aug 20 After evaluation of interim Phase III clinical trial results in consultation with Subject Expert Committee, CDSCO has approved DNA COVID-19 vaccine (ZyCoV-D) of M/s Cadila Healthcare for restricted use in emergency situation in India for 12 years and above.
::::::
Zydus receives EUA from DCGI for ZyCoV-D, the only needle-free COVID vaccine in the world :: World’s first Plasmid DNA Vaccine for COVID-19, ZyCoV-D will be administered in three
doses.
:: Apart from adults, for the first time adolescents in the age group of 12-18 years will take the
vaccine shot in India.
:: Safety, efficacy and immunogenicity of the vaccine is well established.
:: Company begins stockpiling of the vaccine.
Ahmedabad, August 20, 2021,
Zydus Cadila today announced that the company has received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D the world’s first Plasmid DNA Vaccine for COVID-19. ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day. With this approval, India now has its first COVID-19 vaccine for the adolescents in the 12-18 age group, besides the adult population. ZyCoV-D, is a needle-free vaccine administered using The PharmaJet® a needle free applicator, which ensures painless intradermal vaccine delivery.
This is for the first time that a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use. The platform because of its rapid plug and play technology can be easily adapted to deal with mutations in the virus, such as those already occurring. The company plans to manufacture 10-12 crore doses of ZyCoV-D annually.
Speaking on this development, Mr. Pankaj R. Patel, Chairman, Cadila Healthcare Ltd., said “This is a historic milestone with ZyCoV-D, a product of Indian innovation becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunization drive. We are particularly happy that our vaccine will contribute to this fight against COVID-19 and enable the country to vaccinate a larger population especially in the age group of 12-18 years. I would like to thank all the researchers, clinical trial investigators, volunteers and the regulators who have supported this endeavour.”
The company also plans to seek approval for the two dose regimen of the vaccine. The main advantage of DNA vaccines is their ability to stimulate both the humoral and cellular arms of the adaptive immune system. They are a valuable form of antigen-specific immunotherapy, as they are safe, stable and can be easily produced. Zydus acknowledges the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India, National Institute of Virology, Indian Council of Medical Research and PharmaJet® in the development of ZyCoV-D vaccine…
vaccines and global health :: ethics and policy 