Does the World Still Need New Covid-19 Vaccines?

By Dr Frank Yap, M.D. -
New England Journal of Medicine - Although there was a global shortage of Covid-19 vaccines in 2021, by mid 2022, the vaccine supply will no longer be a limiting factor in efforts to provide more equitable coverage. As of April 19, 2022, approximately 11.5 billion Covid-19 vaccine doses have been administered globally (R). Scaling up manufacturing capacity for currently available vaccines at the speed promised by vaccine producers through the COVAX (Covid-19 Vaccines Global Access) program and beyond should secure the coverage target projected by the World Health Organization (WHO) for 70% of the world population by mid 2022 (R). So why do we still need new Covid-19 vaccines?

A total of 344 Covid-19 vaccine candidates have been developed or are still in development.3 Of these, 31 vaccine products are already in large-scale use after conditional approval by national regulatory authorities or under the WHO Emergency Use Listing. At least five different technology platforms have been used (i.e., messenger RNA [mRNA], viral-vectored, inactivated whole-virus, protein subunit, and plasmid DNA approaches). Several of the inactivated whole-virus and protein subunit vaccines need adjuvants to potentiate the immune response.

Many reasons dictate a need for the development of a range of Covid-19 vaccines available for use across the world with the aim of bringing the pandemic under control. Each vaccine product has different attributes and advantages and disadvantages, and multiple factors must be considered to guide policy decisions. Different countries and health care settings, as well as different subpopulations and age groups, may benefit from different vaccine products developed on different platforms. Efficacy and safety, as evaluated in phase 3 trials, are not the sole outcomes to be assessed in a country’s decision to procure and introduce new Covid-19 vaccines. Ease of schedules, vaccine effectiveness when used in routine programs, need and frequency of boosters, cost, considerations regarding cold-chain logistics, manufacturing scalability, acceptability by communities, and scope for local or regional production are additional important factors.

To this end, we commend the development of two new vaccines, as now described in two articles in the Journal, one by Hager et al.4 and one by Dai et al.5 Both of these Covid-19 vaccines are produced on new technology platforms: Hager et al. describe a plant-based coronavirus-like particle vaccine, and Dai et al., a receptor-binding domain (RBD)–dimer–based vaccine. Both vaccines have the advantage of not requiring extreme cold-chain procedures for storage, which makes them user-friendly in primary health care settings as well as in low- and middle-income countries, and it is important that such countries were included in the phase 3 trials of these vaccines. The time period of both trials covered the circulation of several SARS-CoV-2 variants, but the trials were completed before the emergence of the B.1.1.529 (omicron) variant and subvariants.

In the phase 3 trial by Hager et al., which was conducted in Argentina, Brazil, Canada, Mexico, the United Kingdom, and the United States, the recombinant plant-based vaccine displaying the prefusion spike glycoprotein of ancestral SARS-CoV-2 combined with Adjuvant System 03 (AS03) was evaluated as a two-dose regimen. The vaccine efficacy against polymerase-chain-reaction–confirmed symptomatic infection was 69.5% (95% confidence interval [CI], 56.7 to 78.8). In a post hoc analysis, the overall vaccine efficacy against preventing moderate-to-severe disease was 78.8% (95% CI, 55.8 to 90.8), and among participants who were seronegative at baseline, vaccine efficacy against any severity of disease was 74.0% (95% CI, 62.1 to 82.5). It is interesting to note that the median viral load among vaccinated participants with breakthrough cases was more than 100 times as low as that among the placebo recipients with incident cases of Covid-19.

In the phase 3 trial by Dai et al., which was conducted in Ecuador, Indonesia, Uzbekistan, and Pakistan (efficacy and safety assessments) and in China (safety assessment only), the RBD-dimer–based Covid-19 vaccine was evaluated as a three-dose regimen. During the 6-month follow-up period, vaccine efficacy against PCR-confirmed symptomatic disease with an onset of at least 7 days after the third dose was 75.7% (95% CI, 71.0 to 79.8), and against severe to critical Covid-19, vaccine efficacy was 87.6% (95% CI, 70.6 to 95.7). Most of the incident cases occurred during period in which B.1.617.2 (delta) was the dominant variant.

Both trials included mostly working-age adults; hence, no vaccine efficacy data are available for older persons who belong to the highest priority-use group according to the WHO Prioritization Roadmap.6 As in the efficacy trials of the vaccines already in use, estimates of omicron-specific vaccine efficacy are lacking, as well data on durability of protection and safety in subpopulations such as older persons, pregnant women, and persons with immunosuppression. Postintroduction surveillance will be of paramount importance in the monitoring of vaccine effectiveness over time and against different virus variants and in various subpopulations and health care settings. The WHO has published guidance on how best to conduct studies of postintroduction vaccine effectiveness.7 Findings from such studies will determine whether the two new vaccines described by Hager et al. and by Dai et al. will indeed play a bigger role in our armamentarium against Covid-19.

The first Covid-19 vaccines used during the pandemic may not be the best long-term solution. The next generation of Covid-19 vaccines will need to have broader epitope coverage to provide cross-immunity against SARS-CoV-2 variants, confer a longer duration of protection, and be easy to update in a timely manner for protection against any new variants. We should remain agile in fine-tuning the best use of Covid-19 vaccines for the greatest effect on global public health by acknowledging trade-offs. With more vaccine platforms available, we can possibly improve decision making regarding the selection of a vaccine, since different vaccine platforms may be more suitable for certain age groups, certain subpopulations (e.g., those with underlying immune-compromising or other medical conditions), and pregnant women. We may increasingly need to mix and match vaccines to leverage the benefits of each of these platforms.8 Finally, currently available vaccines have only modest effectiveness against mild infection and transmission, which is further reduced in the context of the newly emerging omicron subvariants. Hence, to slow down the circulation of the virus and to limit the speed at which further variants emerge, new vaccines that have a substantial effect on reducing mild infection and transmission are needed, even as the world attempts to learn how to live with SARS-CoV-2.9

These are tall orders for vaccine developers and manufacturers, but our mandate remains to develop the best tools to prevent the emergence of new variants of concern and control the health and socioeconomic fallout from new surges. The decision by representatives of the African region to establish a network of six mRNA technology hubs10 is a sign that countries and regions are motivated to build local and regional capacity and expand self-sufficiency not only in planning and participating in key clinical trials but also in designing and manufacturing vaccines to better meet the needs of their populations during pandemic threats. Such technology hubs will need to embrace technologies beyond the mRNA approach.


References (10)

1.Our World In Data. Coronavirus (COVID-19) vaccinations (https://ourworldindata.org/covid-vaccinations. opens in new tab).Google Scholar. opens in new tab

2.World Health Organization. Strategy to achieve global Covid-19 vaccination by mid 2022 (https://cdn.who.int/media/docs/default-source/immunization/covid-19/strategy-to-achieve-global-covid-19-vaccination-by-mid-2022.pdf?sfvrsn=5a68433c_5. opens in new tab).Google Scholar. opens in new tab

3.London School of Hygiene and Tropical Medicine. Covid-19 vaccine tracker (https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/. opens in new tab).Google Scholar. opens in new tab

4.Hager KJ, Pérez Marc G, Gobeil P, et al. Efficacy and safety of a recombinant plant-based adjuvanted Covid-19 vaccine. N Engl J Med. DOI: 10.1056/NEJMoa2201300.Free Full TextGoogle Scholar. opens in new tab

5.Dai L, Gao L, Tao L, et al. Efficacy and safety of the RBD-dimer–based Covid-19 vaccine ZF2001 in adults. N Engl J Med. DOI: 10.1056/NEJMoa2202261.Free Full TextGoogle Scholar. opens in new tab

6.World Health Organization. WHO SAGE Roadmap for prioritizing uses of COVID-19 vaccines. January 21, 2022 (https://www.who.int/publications/i/item/WHO-2019-nCoV-Vaccines-SAGE-Prioritization-2022.1. opens in new tab).Google Scholar. opens in new tab

7.Patel MK, Bergeri I, Bresee JS, et al. Evaluation of post-introduction COVID-19 vaccine effectiveness: summary of interim guidance of the World Health Organization. Vaccine 2021;39:4013-4024.Crossref. opens in new tab
Web of Science. opens in new tab
Medline. opens in new tabGoogle Scholar. opens in new tab

8.Parker EPK, Desai S, Marti M, et al. Emerging evidence on heterologous COVID-19 vaccine schedules — to mix or not to mix? Lancet Infect Dis 2022;22:438-440.Crossref. opens in new tab
Medline. opens in new tabGoogle Scholar. opens in new tab

9.Morens DM, Folkers GK, Fauci AS. The concept of classical herd immunity may not apply to COVID-19. J Infect Dis 2022 March 31 (Epub ahead of print).Crossref. opens in new tab
Medline. opens in new tabGoogle Scholar. opens in new tab

10.World Health Organization. The mRNA vaccine technology transfer hub (https://www.who.int/initiatives/the-mrna-vaccine-technology-transfer-hub. opens in new tab).Google Scholar


Comments

Post a Comment

Popular posts from this blog

Dr Peter McCullough: How to Detox Spike Protein from Body

By Dr Frank Yap, M.D. -
Image
Base Spike Detox According to Dr Peter McCullough (in a Twitter post): Base Spike Detox is what I am currently using in my practice for those who have had COVID-19 multiple times, one or more of the COVID-19 vaccines, or both and believe persistent SARS-CoV-2 Spike protein could be causing problems in their body.  I have arrived, based on the emerging scientific literature (1) and my clinical observation, that three OTC products are essential as a triple base combination: Nattokinase 2000 FU (100 mg) twice a day Bromelain 500 mg once a day Nano/Liposomal Curcumin 500 mg twice a day Related: Nattokinase, Bromelain and Curcumin from The Wellness Company Additional products can be added, including NAC, IVM (Ivermectin), HCQ (Hydroxychloroquine), fluvoxamine, low-dose naltrexone, and blood thinners, depending on the clinical evaluation and the syndrome. The therapeutic...
Read more

Dr Peter McCullough: Povidone Iodine, Oral and Nasal Hygiene (2024)

By Dr Frank Yap, M.D. -
Image
Dr. Peter McCullough is an internist, cardiologist, epidemiologist, a full professor of medicine at Texas A&M College of Medicine in Dallas, USA. He also has a master's degree in public health and is known for being one of the top five most-published medical researchers in the United States and is the editor of two medical journals. McCullough Protocol 2022 Updates:  Double blind randomized controlled trial of saline solution gargling and nasal rinsing in COVID infection (Nov 2023) What really killed COVID-19 patients: It wasn't a cytokine storm, suggests study  (2023) Everyone is familiar with nasal and oral swab testing for COVID-19. It should be obvious the virus is replicating in the nose, and with Omicron, the speed of replication has become much greater than the pr...
Read more

How to Make Povidone Iodine 1% Nasal Spray (2024)

By Dr Frank Yap, M.D. -
Image
Is povidone iodine the next ivermectin or hydroxychloroquine? Is there any evidence that povidone iodine can treat COVID-19? Iodine 1% Nasal Spray is part of the FLCCC I-CARE early treatment protocol :  Nasal spray with 1% povidone-iodine: 2-3 times a day. Do not use for more than 5 days in pregnancy. If 1% product is not available, dilute the more widely available 10% solution and apply 4-5 drops to each nostril every 4 hours. Use 1 % povidone iodine commercial product as per instructions 2–3 x daily. If 1 %-product not available, must first dilute the more widely available 10 %-solution. To make 1% povidone iodine concentrated solution from 10% povidone iodine solution, one dilution method is as follows: – First pour 1½ tablespoons (25ml) of 10% povidone/ iodine solution into a nasal irrigation bottle...
Read more

Dr Peter McCullough Early Treatment Protocol

By Dr Frank Yap, M.D. -
Image
Well-respected North Texas cardiologist, Dr. Peter McCullough has impeccable academic credentials. He's an internist, cardiologist, epidemiologist, a full professor of medicine at Texas A&M College of Medicine in Dallas. He also has a master's degree in public health and is known for being one of the top five most-published medical researchers in the United States and is the editor of two medical journals. McCullough et al. Reviews in Cardiovascular Medicine, 2020 McCullough Protocol 2022 Updates:  How to Detox Spike Protein from Body  (November 2023) Use of hydroxychloroquine in multidrug protocols for SARS-CoV-2 (October 2024) Paxlovid for Vaccinated or Unvaccinated Adult Outpatients with ...
Read more

Find a Doctor to prescribe Hydroxychloroquine, Ivermectin and Early Outpatient Treatments (2024)

By Dr Frank Yap, M.D. -
Image
Treatment should start based on clinical suspicion as soon as possible, preferably within the first 3 days of symptoms. Perform PCR testing, but do not withhold treatment pending results. 'Early' treatment will make significant difference in outcome as opposed to late treatment.  Related: How can I get Ivermectin? See the directory of professionals in US below. Directory of Doctors (by State) Prescribing Effective Outpatient COVID-19 Therapy USA ​ MULTIPLE STATES (Telemedicine or online consultation) The Wellness Company ( twc.health ) Medical Specialty: Family Medicine, Functional Medicine Supported Protocols: I-PREVENT (COVID Protection), I-CARE (Early at-home treatment), I-RECOVER (Long COVID and Post-Vaccine treatment) Dr. Miguel Antonatos (IVM) (855) 767-8559  https://text2md.com (States: AL, AZ, CO, FL, GA, IA, ID, IL, KS, KY, MD, ME, MI, MN, MS, ND, NE, NJ, NV, OK, SC, SD, TN, UT, VT, WA, WI, WV) ...
Read more

FLCCC I-Recover Protocol: Post Vaccine Treatment Protocol (2024)

By Dr Frank Yap, M.D. -
Image
Over the last three years, the COVID-19 pandemic has transformed almost every aspect of our lives before we've had time to stop and question it. Although no official definition exists for post-COVID-vaccine syndrome, a temporal correlation between a patient receiving a COVID-19 vaccine and beginning or worsening of clinical manifestations is sufficient to diagnose as a COVID-19 vaccine-induced injury, when the symptoms are unexplained by other concurrent causes. Dr. Paul Marik and Dr. Pierre Kory are pleased to introduce the I-RECOVER: Post-Vaccine Treatment protocol, designed to help people who have experienced adverse symptoms after a COVID vaccine. Kory and Marik are both part of the FLCCC, which was founded in 2020 to share early treatment protocols for COVID-19. Kory is an ICU specialist, triple board certified in internal medicine, critical care and pulmonary medicine. He now runs a private tele-health practice specializing in the treatment ...
Read more

Front Line Doctors Ivermectin Protocol for Prevention and Treatment of COVID-19 (2024)

By Dr Frank Yap, M.D. -
Image
The Front Line COVID-19 Critical Care (FLCCC) Alliance was initially formed as a working group during the early COVID-19 pandemic days in response to multiple early reports of COVID patients with an inexplicably high need for prolonged mechanical ventilation and an excessive death rate.  Based on rapidly emerging clinical trials evidence, the FLCCC team has developed the   I-MASK+ protocol   ( is now divided into I-Prevent and I-Care protocols ) for prophylaxis and at home treatment of early stage COVID-19. Quercetin, zinc and a number of nutrients and drugs are part of this protocol, not only for critical care but also for prophylaxis and mild disease being treated at home. This article, we will dive deeper to provide the scientific background, related references and rationale of the FLCCC protocols. FLCCC ( Front Line COVID-19 Critical Care)  Protocols I-MASK+ Prevention & Early Outpatient Treatment Protocol for COVID-19 was designed for use as a prevention and...
Read more

How to Remove Spike Protein from Body: FLCCC I-Recover Protocol

By Dr Frank Yap, M.D. -
Image
Over the last three years, the COVID-19 pandemic has transformed almost every aspect of our lives before we've had time to stop and question it. Although no official definition exists for post-COVID-vaccine syndrome, a temporal correlation between a patient receiving a COVID-19 vaccine and beginning or worsening of clinical manifestations is sufficient to diagnose as a COVID-19 vaccine-induced injury, when the symptoms are unexplained by other concurrent causes. Dr. Paul Marik and Dr. Pierre Kory are pleased to introduce the I-RECOVER: Post-Vaccine Treatment protocol, designed to help people who have experienced adverse symptoms after a COVID vaccine. Kory and Marik are both part of the FLCCC, which was founded in 2020 to share early treatment protocols for COVID-19. Kory is an ICU specialist, triple board certified in internal medicine, critical care and pulmonary medicine. He now runs a private tele-health practice specializing in the treatment of COVID-19, so-called "long-C...
Read more

Quercetin and Zinc: Zelenko Treatment Protocol

By Dr Frank Yap, M.D. -
Image
As of July 2024, more than 35 studies on the topic of zinc and COVID-19  ( c19zinc.com )  (constantly updated) and more than 10 studies on quercetin and COVID-19 have been published  ( c19quercetin.com ).  Dr. Zelenko’s main hypothesis based on the data showing that early intervention and treatment of high-risk patients with COVID-19 results in significantly few hospitalizations and deaths. This treatment regimen involving zinc, low-dose hydroxychloroquine, and azithromycin (published in the International Journal of Antimicrobial Agents ) is also apparently known as, “The Zelenko Protocol.” Quercetin and Zinc The Zelenko Covid-19 Protocols was developed by Dr Vladimir Zelenko. The protocol has as its centerpiece, but not exclusive piece, the combined use of  Hydroxychloroquine  (HCQ) and Zinc as a means by which a person can both help to prevent or mitigate the contraction of COVID-19, or can actually treat the disease once it has been diagno...
Read more

Dr Peter McCullough: Fact Check and Debunked Theories

By Dr Frank Yap, M.D. -
Image
Biography Well-respected North Texas cardiologist, Dr. Peter McCullough has impeccable academic credentials. He's an internist, cardiologist, epidemiologist, a full professor of medicine at Texas A&M College of Medicine in Dallas. He also has a master's degree in public health and is known for being one of the top five most-published medical researchers in the United States and is the editor of two medical journals. Personal History Dr. Peter A. McCullough was born in Buffalo, New York, on the 29th of December 1962. During high school, he and his family moved to Wichita Falls in Texas and later settled in Grapevine. He has lived and worked in various parts of the United States, including Washington and Michigan, and he now resides in Dallas, Texas. McCullough Protocol 2022 Dr Peter McCullough Early Treatment Protocol ...
Read more

Labels

Show more