scholarly journals Pre-market development times for innovative vaccines – to what extent are the COVID-19 vaccines outliers?

Author(s):  
Reed F Beall ◽  
Aaron S Kesselheim ◽  
Aidan Hollis

Abstract One reason expressed in surveys of people reporting COVID-19 vaccine hesitancy is how rapidly these vaccines have reached the market. To estimate the length of time the COVID-19 vaccine spent in research and development as compared to other novel vaccines, we apply previously-established methods for estimating medical product development times, using the earliest associated patent filings cited by the manufacturer as the marker of when commercial development activity began. Applying these methods to a cohort of recently approved innovative vaccines and comparing them to the development time of the first-approved COVID-19 vaccine (BioNTech/Pfizer), we found patent filings for the technology in this COVID-19 vaccine occurred 10.0 years prior to regulatory authorization. Furthermore, the development timelines for innovative vaccines have been shortening since the 1980s and the COVID-19 vaccine comfortably fits within this pattern. Vaccine development timelines have now even drawn to parity with many of the most commonly-used drugs.

2020 ◽  
Vol 185 (Supplement_1) ◽  
pp. 617-623
Author(s):  
Victor E Zottig ◽  
Katherine A Carr ◽  
John G Clarke ◽  
Moshe J Shmuklarsky ◽  
Mara Kreishman-Deitrick

Abstract Malaria is classified as a top-tier infectious disease threat associated with a high risk for mortality among U.S. service members deployed overseas. As malarial drug resistance degrades the efficacy of current gold standard drugs for malarial prophylaxis and treatment, it is vitally important to maintain a robust drug pipeline to discover and develop improved, next-generation antimalarial prevention and treatment tools. The U.S. Army Medical Materiel Development Activity (USAMMDA) manages the medical product development of the malarial drug tafenoquine for malarial prophylaxis to address the threat to U.S. service members. Tafenoquine is an effective prophylactic drug against all parasite life cycle stages and all malaria species that infect humans. Thus, it provides broad capabilities in a single drug for malarial prophylaxis and treatment. Partnerships with industry are a crucial part of USAMMDA’s medical product development strategy, by leveraging their drug development experience and manufacturing capabilities to achieve licensure and commercial availability. Additionally, these partnerships capitalize on expertise in the commercial market and help ensure that USAMMDA successfully translates a Department of Defense capability gap into a commercially available product. This article will highlight the strategies used to move this critical antimalarial drug through the development pipeline.


2021 ◽  
pp. 101053952110181
Author(s):  
Lu Chen ◽  
Xinfa Zhou ◽  
Xiao Han ◽  
Anqichen Shi ◽  
Zhe Cheng ◽  
...  

The latest news about global vaccine research and development shows that we have made great progress in vaccine development. However, in China, a large population of people are hesitant to get vaccinated due to various reasons. In this article, we focus on how to address people’s hesitancy on the coronavirus disease 2019 (COVID-19) vaccine. It is important that governments fully prepare for both pre-risk prevention and post-event relief to promote the vaccination program’s smooth implementation. In particular, the government should establish and improve a national vaccine injury compensation program in response to COVID-19’s adverse events following immunization. Only through multilateral efforts and comprehensive measures can the people’s confidence in vaccination improve and their worries about the future be relatively eased.


Author(s):  
Rajesh Kumar ◽  
Seetha Harilal ◽  
Abdullah G. Al-Sehemi ◽  
Githa Elizabeth Mathew ◽  
Simone Carradori ◽  
...  

: COVID-19, an epidemic that emerged in Wuhan, has become a pandemic affecting worldwide and is in a rapidly evolving condition. Day by day, the confirmed cases and deaths are increasing many folds. SARS-CoV-2 is a novel virus; therefore, limited data are available to curb the disease. Epidemiological approaches, isolation, quarantine, social distancing, lockdown, and curfew are being employed to halt the spread of the disease. Individual and joint efforts all over the world are producing a wealth of data and information which are expected to produce therapeutic strategies against COVID-19. Current research focuses on the utilization of antiviral drugs, repurposing strategies, vaccine development as well as basic to advanced research about the organism and the infection. The review focuses on the life cycle, targets, and possible therapeutic strategies, which can lead to further research and development of COVID-19 therapy.


Author(s):  
Seth C Kalichman ◽  
Lisa A Eaton ◽  
Valerie A Earnshaw ◽  
Natalie Brousseau

Abstract Background The unprecedented rapid development of COVID-19 vaccines has faced SARS-CoV- (COVID-19) vaccine hesitancy, which is partially fueled by the misinformation and conspiracy theories propagated by anti-vaccine groups on social media. Research is needed to better understand the early COVID-19 anti-vaccine activities on social media. Methods This study chronicles the social media posts concerning COVID-19 and COVID-19 vaccines by leading anti-vaccine groups (Dr Tenpenny on Vaccines, the National Vaccine Information Center [NVIC] the Vaccination Information Network [VINE]) and Vaccine Machine in the early months of the COVID-19 pandemic (February–May 2020). Results Analysis of 2060 Facebook posts showed that anti-vaccine groups were discussing COVID-19 in the first week of February 2020 and were specifically discussing COVID-19 vaccines by mid-February 2020. COVID-19 posts by NVIC were more widely disseminated and showed greater influence than non-COVID-19 posts. Early COVID-19 posts concerned mistrust of vaccine safety and conspiracy theories. Conclusion Major anti-vaccine groups were sowing seeds of doubt on Facebook weeks before the US government launched its vaccine development program ‘Operation Warp Speed’. Early anti-vaccine misinformation campaigns outpaced public health messaging and hampered the rollout of COVID-19 vaccines.


Vaccines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 500
Author(s):  
Marco Trabucco Aurilio ◽  
Francesco Saverio Mennini ◽  
Simone Gazzillo ◽  
Laura Massini ◽  
Matteo Bolcato ◽  
...  

Background: While the COVID-19 pandemic has spread globally, health systems are overwhelmed by both direct and indirect mortality from other treatable conditions. COVID-19 vaccination was crucial to preventing and eliminating the disease, so vaccine development for COVID-19 was fast-tracked worldwide. Despite the fact that vaccination is commonly recognized as the most effective approach, according to the World Health Organization (WHO), vaccine hesitancy is a global health issue. Methods: We conducted a cross-sectional online survey of nurses in four different regions in Italy between 20 and 28 December 2020 to obtain data on the acceptance of the upcoming COVID-19 vaccination in order to plan specific interventions to increase the rate of vaccine coverage. Results: A total of 531 out of the 5000 nurses invited completed the online questionnaire. Most of the nurses enrolled in the study (73.4%) were female. Among the nurses, 91.5% intended to accept vaccination, whereas 2.3% were opposed and 6.2% were undecided. Female sex and confidence in vaccine efficacy represent the main predictors of vaccine intention among the study population using a logistic regression model, while other factors including vaccine safety concerns (side effects) were non-significant. Conclusions: Despite the availability of a safe and effective vaccine, intention to be vaccinated was suboptimal among nurses in our sample. We also found a significant number of people undecided as to whether to accept the vaccine. Contrary to expectations, concerns about the safety of the vaccine were not found to affect the acceptance rate; nurses’ perception of vaccine efficacy and female sex were the main influencing factors on attitudes toward vaccination in our sample. Since the success of the COVID-19 immunization plan depends on the uptake rate, these findings are of great interest for public health policies. Interventions aimed at increasing employee awareness of vaccination efficacy should be promoted among nurses in order to increase the number of vaccinated people.


2021 ◽  
pp. 0961463X2110322
Author(s):  
Mia Harrison ◽  
Kari Lancaster ◽  
Tim Rhodes

This article investigates how evidence of the safety and efficacy of COVID-19 vaccines is enacted in news media via a focus on the temporality of vaccine development. We argue that time constitutes a crucial object of and mechanism for knowledge production in such media and investigate how time comes to matter in vaccine evidence-making communication practices. In science communication on vaccine development, the vaccine object (along with the practices through which it is produced) undergoes a material-discursive shift from an imagined “rushed” product to being many years in the making and uninhibited by unnecessarily lengthy processes. In both these enactments of vaccine development, time itself is constituted as evidence of vaccine efficacy and safety. This article traces how time (performed as both calendar time and as a series of relational events) is materialized as an affective and epistemic object of evidence within public science communication by analyzing the material-discursive techniques through which temporality is enacted within news media focused on the timeline of COVID-19 vaccine development. We contend that time (as evidence) is remade through these techniques as an ontopolitical concern within the COVID-19 vaccine assemblage. We furthermore argue that science communication itself is an important actor in the hinterland of public health practices with performative effects and vital evidence-making capacities.


Author(s):  
Kamil M. Kraj

As discussed in the literaturę, more and more transnational corporations (TNCs) were attaching importance to research and development (R&D) activity from the 1970s through the 2000s. This growing involvement of TNCs in R&D resulted in their dominant role in global R&D expenditure. Indeed, a comparative analysis of financial data collected for the group of the 102 largest corporate R&D spenders worldwide in 2007 showed that this group of TNCs accounted for a significant share of the worlds R&D expenditure not only in 2007 alone but also in the period of 2000-2011. Moreover, a similarity between their home countries and the countries being top R&D spenders was found; however, most of these corporations were conducting their R&D at international level. Furthermore, the analysed TNCs operated mostly in technology-intensive industries, for which the foun- dations were provided by a multidisciplinary science and technology basis.


Vaccine ◽  
2016 ◽  
Vol 34 (26) ◽  
pp. 2863-2864 ◽  
Author(s):  
Birgitte K. Giersing ◽  
Kayvon Modjarrad ◽  
David C. Kaslow ◽  
Jean-Marie Okwo-Bele ◽  
Vasee S. Moorthy

2014 ◽  
Vol 68 (3) ◽  
Author(s):  
Tan Owee Kowang ◽  
Amran Rasli ◽  
Choi Sang Long

New Product Development (NPD) is vital in assisting Research and Development (R&D) based organizations to adapt to the changes in markets and technology for competitive advantage. Ensuring the success of new products and optimization of new product performance is critical and essential for Research and Development based organizations.  Hence, this study is carried out to explore does organizational background in term of company’s ownership (i.e. local or multinational companies) and operational scales (i.e. number of Research and Development staffs) affect NPD performance of Research and Development companies in Malaysia. In line with this, 8 New Product Development performance attributes were identified from literature review. These attributes were subsequently formulated into a survey questionnaire and responded by 186 respondents. Thereafter, the effect of organizational ownership and operational scale toward NPD performance are examined separately via Independent Sample t-test and Analysis of Variance (ANOVA). Finding from the study revealed that the level of NPD performance in multinational R&D companies is higher than local R&D companies. Findings from this research also implied that NPD performance can be further improved by increasing number of R&D staffs.  


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