IVI in the Media

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Bloomberg | Consequences of ‘Huge’ Global Gap in Vaccinations

EIU Perspectives | What does Denmark’s permanent suspension of both the AstraZeneca and Janssen covid-19 vaccines mean for other countries?

Asia Times | Vaccinations in a race against viral variants

Nature | Why COVID vaccines are so difficult to compare

DEVEX | Opinion: COVAX — too big, and too important, to fail

CNN | “Our response needs to be clear, strong, and unified”

South China Morning Post | Coronavirus vaccines will save 2021? Not so fast, here’s what the experts think

Bloomberg | Will the Covid-19 Vaccines Be Effective and Safe?

Asian Boss | Update On COVID-19 Vaccine Price & Schedule From A Leading Vaccine Expert

The Telegraph | ‘If you are not prepared, the virus has found every weakness’: How countries in Asia tamed Covid-19

CGTN | ‘The vaccine itself is not the silver bullet,’ says International Vaccine Institute

Devex | Q&A: Why Jerome Kim is ‘hopeful’ but cautious about distributing a COVID-19 vaccine

Maeil Business Newspaper | IVI Director General Jerome Kim Shares His Thoughts on Resurgence of COVID-19 Outbreaks in S. Korea

Chosun Ilbo | IVI Director General Jerome Kim Shares His Thoughts on Equitable Access of COVID-19 Vaccines

Channel News Asia | On a fast track like never before: The COVID-19 vaccine effort and 5 vital questions

The Economist’s Future of Healthcare Insight Hour | Vaccine development: A race to the finish line

Devex | Q&A: Is COVID-19 helping or hindering progress toward an HIV vaccine?

TED | The trials, tribulations and timeline of a COVID-19 vaccine

Wired Korea | The End of World War C: Peace without Victory?

Asian Boss | World’s Leading Vaccine Expert Fact-Checks COVID-19 Vaccine Conspiracy

Development Today | Why Sweden funds a vaccine institute in Korea and not Oslo-based CEPI

CNBC | Parts of Asia that relaxed restrictions without a resurgence in coronavirus cases did these three things

The Korea Herald | [Herald Interview] ‘Making vaccines accessible is biggest COVID-19 challenge’

CGTN: The Agenda with Stephen Cole | Speed of vaccine trials is ‘unprecedented’

Asian Boss | We Asked The World’s Leading Vaccine Expert About COVID-19 Vaccine

The Guardian | Test, trace, contain: how South Korea flattened its coronavirus curve

BBC World Service: The Inquiry | How do we come out of the lockdown? (13:00)

ANC 24/7 | Int’l Vaccine Institute: 12-18 months reasonable timetable for development of Covid-19 vaccine

Seeker | How Fast Can We Make a Coronavirus Vaccine?

Education City Speaker Series: Flattening the Curve – Global Responses to COVID-19

Wion News | About 70% of vaccines used around the world are made in India: S Korean expert Dr Jerome Kim

South China Morning Post | How long will a coronavirus vaccine take? A Q&A with Jerome Kim, head of the International Vaccine Institute

BBC World News | Jerome Kim: Vaccines are the long-term solution to the pandemic

The Korea Times | Developing vaccine against COVID-19

TRT: Bigger than Five | COVID-19: The World Reacts

South Korea’s fight against coronavirus (CBS News)

NDTV | Top South Korea Doctor On Why He Thinks Coronavirus Is Not A ‘Chinese Virus’

RTE | What South Korea can teach Ireland about fighting Covid-19

Physical distancing should last months, not weeks, says epidemiologist (Yahoo News Canada)

Development of vaccine requires massive investment… international cooperation is needed (Korea Economic Daily)

COVID-19 Pandemic (Arirang TV, 22:50~46:00)

By then, we’ll have a vaccine on our side (Hankyoreh—Korean)

Coronavirus Pandemic: International Vaccine Institute director on how long it will take to develop vaccine (CGTN)

Testing times: Why South Korea’s COVID-19 strategy is working (Al Jazeera English)

Genexine seeks to compress the vaccine timeline

Genexine, Binex to develop COVID-19 vaccine (Korea Biomedical Review)

Genexine, Binex to co-develop coronavirus vaccine GX-19 (Korea Herald)

How close are we to a COVID-19 vaccine? Jerome H. Kim from International Vaccine Institute (Arirang News)

COVID-19 vaccine, drugs on fast track for development: IVI chief (Yonhap News)

Inside the race to find a coronavirus vaccine (Devex)

Chinese students keen for turnaround (China Daily)

China Daily | S. Korea can try out makeshift hospitals, experts say

Director General Jerome Kim for Phoenix TV

Speed and accuracy vital for COVID-19 test kits (Arirang News)

2020 COVID-19 Live Updates: Jerome Kim for tbs eFM

Jerome Kim for KBS WORLD Radio, Korea24 on the COVID-19 outbreak in South Korea

Korea should join efforts in vaccine development to prevent pandemics (JoongAng Ilbo)

Future global health threats

IVI: COVID-19 could linger (Korean)

Jerome Kim for Korea, Factual: “Hong Kong’s handling of COVID-19 outbreak & Prospects of vaccine development”

Concerns about the spread of COVID-19: When will a vaccine be developed? When can we expect the “Super Vaccine”?

Al Jazeera English | Scientists call for global cooperation over coronavirus

When will COVID-19 vaccine be commercialized…And “super vaccine”? (Korean)

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Neglected Victims of Neglected Diseases

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World must join forces to prevent infectious diseases

IVI editorial in The Korea Herald advocates for Korean leadership for global health

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Challenges in MenB vaccine development

Author
ivi
Date
2016-10-10 07:26
Views
4154

In an editorial published in The New England Journal of Medicine, IVI Director General Jerome Kim looks at the challenges and possible solutions


 


In a recent issue of The New England Journal of Medicine, IVI Director General Jerome Kim considers an accelerated pathway for vaccine approval. Dr. Kim’s editorial follows the publication of a research article in the same journal regarding the immunogenicity study of a meningococcal B vaccine (4CMenB) used during an outbreak of Neisseria meningitides serogroup B at a U.S. university.


Regulatory approval and clinical use of vaccines for pathogens causing outbreaks has always been challenging. In the case of MenB vaccines, proving clinical efficacy has been difficult due to the substantial genetic diversity of the pathogen and the decline of meningococcal disease in countries where the burden is well understood. Yet there have been several outbreaks at U.S. universities from 2009-’15 resulting in 43 cases and 3 deaths. Since no MenB vaccine was approved at the time of the outbreaks, chemoprophylaxis was the main intervention. Therefore, a U.S. university outbreak of serogroup B meningococcal disease presented an opportunity to test a multicomponent meningococcal serogroup B vaccine (4CMenB) that had been approved in Europe and Canada on the basis of laboratory biomarkers of efficacy. There was also evidence that the vaccine could provide protection against the outbreak strain.


The study showed that 4CMenB induced a response to certain MenB strains but induced a lower response rate against the outbreak strain in the vaccinated students. While it is difficult to conclude if vaccination had a positive effect on the outbreak, the vaccine did induce bactericidal antibodies against the outbreak strain and was safe.


Based on these findings, 4CMenB and another MenB vaccine (MenB-FHbp) were approved by the U.S. FDA in 2015 through an accelerated approval process intended for treatments for serious or life-threatening diseases. The vaccines were approved for use in persons 10-25 years old with the caveat that post-marketing studies be conducted to confirm effectiveness against MenB strains endemic in the U.S..


With this case study in mind, Dr. Kim’s editorial points out that for a relatively uncommon but life-threatening disease such as MenB, the regulatory approval of a vaccine in the absence of ideal data may be necessary and appropriate if the vaccine is used in the context of a public health response and if there is commitment to generating additional data for its use. More importantly, he argues the accelerated pathway for product approval should extend to vaccines against pandemic threats and limited outbreaks (e.g., Zika virus, MERS-CoV). By doing so, this could help accelerate emergency R&D to prevent or mitigate the impact of infectious disease outbreaks, ultimately saving lives and minimizing socioeconomic disruption.


Read it here:http://www.nejm.org/doi/pdf/10.1056/NEJMe1606015

 

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