[ad_1]
DESPITE global efforts to develop and deploy a successful Covid-19 vaccine to end the current pandemic, analysis of vaccine development and upscaling of manufacturing point to a Covid-19 vaccine reaching global coverage. by the end of 2023. While vaccine efforts continue, it is recommended that other mechanisms should be employed to help manage the crisis.
These findings were highlighted by two recent reports, contributed to by members of IChemE, that investigated the delivery of a successful vaccine. A report, published by the Center for Global Development (CGD), uses models and expert opinion to estimate the timelines and odds of developing and producing a successful vaccine. The second other report, published by the DELVE (Data Assessment and Learning for Viral Epidemics) group convened by the Royal Society, focuses on the challenges of vaccine delivery, from development to implementation.
Highlighting challenges
Efforts to develop a Covid-19 vaccine are happening at unprecedented speed. According to DELVE, there are more than 200 vaccine candidates in development and initial results from large-scale trials are expected soon. DELVE report, Development and implementation of the SARS-CoV-2 vaccine; Scenarios, options, key decisions, highlights the key challenges involved, the impact of those challenges, and future strategies to mitigate them.
The multidisciplinary group DELVE was convened to support data-driven learning of the approaches different countries are using to manage the pandemic.
Capacity challenge
In general, the challenges facing manufacturing are caused by the urgency and scale of demand for a new vaccine for a previously unknown disease, the report says. A “huge” challenge facing the manufacture of the Covid-19 vaccine is achieving the scale necessary to meet the demand for a global immunization program.
Once an effective vaccine is identified, it will have to be manufactured with a high enough capacity to combat the pandemic while manufacturing of existing vaccines continues. Additionally, the nature of the vaccine could have implications for capacity requirements. For example, if immunity is short-lived and boosters are needed, the ability to extend coverage while maintaining immunity in existing recipients will be needed.
The report highlights that while substantial amounts of global manufacturing capacity can be reused in vaccines, this is not possible in all cases. In the UK, where capacity is limited, short-term disposable technology has been used to start production in existing reused facilities.
DELVE also recognizes the importance of financial incentives to accelerate vaccine development and achieve manufacturing capacity. Financial incentives such as “fund extraction” have been used as advanced market commitments (AMC). AMCs are purchase agreements that can be used to guarantee the price and quantity of vaccines purchased before trial results are known and before licensing is granted. The UK, for example, has made advance purchase agreements for more than 300 million doses of vaccine, which is potentially enough for nearly five doses per person, according to the report. The United States, the EU and Japan have also secured hundreds of millions of doses.
Fixed price purchase guarantees incentivize and reduce the risk of vaccine development and investment in manufacturing capacity.
There has also been direct investment in capacity. The UK Government has worked to increase capacity, for example by investing in the Vaccine Manufacturing and Innovation Center (VMIC), the UK’s first strategic vaccine development and advanced manufacturing facility. It also bought a facility in Essex, UK, from Benchmark Vaccines, a contract manufacturing company focused on vaccines for animal health, which it will upgrade for the production of Covid-19 vaccines.
To manage future outbreaks, DELVE recommends maintaining emergency vaccine manufacturing capacity to allow for accelerated deployment. Scalability refers to increasing available capacity during high-casualty and disaster situations. Maintaining emergency vaccine manufacturing capacity is “crucial” for rapid-response vaccine production, the report says.
It should be noted that these investments have been made based on assumptions about the type of vaccine most likely to be developed.
According to DELVE, the health crisis has prompted governments, non-governmental organizations (NGOs) and industry to make unprecedented investments to accelerate the development and manufacture of vaccines. Beyond individual efforts, it encourages coordinated high-level manufacturing to ensure sufficient capacity, as well as to reduce the likelihood of “vaccine nationalism” and ensure the availability of affordable global vaccine supplies, thereby reducing the likelihood of future outbreaks. worldwide.
DELVE notes that the investments and scientific innovations made during the pandemic will benefit the development of future vaccines.
Timothy Clayton, an IChemE member who contributed to the DELVE report, said: “The vaccine requirement is beyond any single disease attempt and we need a truly international effort to control Covid-19. This will require significant effort and investment to build an unprecedented pharmaceutical supply chain with additional manufacturing capacity from glass supply to vaccine manufacturing, with adequate storage and distribution infrastructure. We also have to continue to manufacture all the necessary pharmaceutical products in parallel. “
The UK affiliate team of IChemE and the International Society for Pharmaceutical Engineering (ISPE) contributed to the DELVE report. ISPE is an organization that works to lead advancement throughout the pharmaceutical life cycle. IChemE’s participation was through its Covid-19 Response Team.
Projecting success
Entitled COVID-19 Vaccine Predictions: Using Mathematical Models and Expert Opinions to Estimate Covid-19 Vaccines Timing and Chances of Success, The CGD report seeks to offer projections that can inform public and private sector decision-making.
According to Adrian La Porta, a co-author of the CGD report and a member of IChemE’s Covid-19 Response Team, CGD set out to model vaccine research and manufacturing because it recognized that announcements from individual research groups about progress could not give a holistic picture of when a vaccine might be available.
He added: “The biochemical engineers’ knowledge of vaccine processing supports predictions of the time from vaccine approval to sufficient doses for target populations.”
La Porta has been a member of the Response Team since its inception, and has contributed to the Personal Protective Equipment (PPE) decontamination working group and the therapeutic working group.
Based on information provided by experts, the report’s model projects that the probability that a strict regulator will approve at least one vaccine in 2020 is less than 2%. This increases to 50% by April 2021, 85% by the end of 2021 and 98% by the end of 2022. The model predicts a <1% probability that no vaccine will be approved from the current global portfolio, although opinion pessimistic drives this to 20%.
CGD says scalability and capacity models indicate that sufficient doses may not be available to vaccinate the entire world population until September 2023. However, sufficient production for healthcare workers is anticipated by the end of 2021 and early 2022, and for vulnerable or at-risk groups 2–3 months after that.
The report highlights that first-generation vaccines are unlikely to be effective enough to end the pandemic, and experts project a disease prevention per vaccine of around 61%, too low to fully contain the virus.
Recognizing that it will likely take more than 12 months before fully effective vaccines are developed, licensed and manufactured at scale to meet the needs of the entire population, the CGD recommends using other public health measures to control the outbreak. This includes continued investment in non-drug measures such as social distancing, expanding testing and contact tracing, and promoting innovations in diagnosis and treatment that could help accelerate the availability of vaccines.
