Monoclonal antibody therapies, Pfizer’s Paxlovid, and Merck’s molnupiravir are also available only under EUAs.
#VACCINE PRODUCTION CAPACITY US FULL#
While the base two-dose series of the Pfizer and Moderna vaccines for adults now have full FDA approval, booster doses and vaccines for children are only available under EUAs.
This means that developing and manufacturing new vaccines and therapeutics-and ensuring continued easy access to existing ones-remains an urgent need. Moreover, the emergence of the Omicron variant showed that changes in the virus pose a serious threat to the effectiveness of existing vaccines and therapeutics: existing vaccines are less effective against Omicron, and some monoclonal antibody therapies are entirely ineffective. Existing vaccines, while highly effective, wane in effectiveness over time, so periodic booster doses will likely be needed for the foreseeable future indeed, older US adults are now being encouraged to receive a fourth dose. It is now clear that will not be the case. There may once have been hopes that a one-time vaccine rollout would produce durable herd immunity against COVID-19 in the United States, causing COVID-19 to fade into the background or disappear completely. African manufacturers should focus on strategic and realistic priorities, such as supply-constrained products with less complex end-to-end manufacturing processes.A second lesson is that pandemic is dynamic, and what works today will not necessarily work tomorrow.Continental organisations must coordinate information sharing, provide market intelligence, and revisit strategic ambitions and priorities.Donors need to offer sustained support to manufacturers, to help them overcome the obstacles to strengthening capabilities and scaling up capacity.Global health organisations must introduce supportive procurement and financial mechanisms to create conditions for a sustainable vaccine manufacturing ecosystem.African governments are expected to prioritise continental supply (even if more expensive) and put a supportive economic and regulatory environment in place.Support risk: As the Covid-19 pandemic recedes, the attention and efforts being offered by national, continental and global stakeholders could also decrease.Īfrican vaccine manufacturers have made a clear call to action to overcome existing concerns and accelerate change:.They would have to consider the manufacturing complexity of a product, and the current and future global supply and demand. Strategic risk: African manufacturers need to identify which vaccines and technology platforms to prioritise in the short- and mid-term. Manufacturing initiatives also remain uncoordinated, creating a risk of overcapacity.
Sustainability risk: The historic dynamic, described by Gavi, the Vaccine Alliance, as the “high-price and low-volume trap”, persists, and measures are required to change it. But African manufacturers say that economic viability is crucial and still needs to be demonstrated, with significant risks to overcome for the strategy to be successful in the long term.Īfrican manufacturers identify three major risks to the desired economic viability: The past 18 months have produced many promising announcements and initiatives to develop vaccine manufacturing capacity in Africa. In March 2022, PAVM shared a bold goal in its continental strategy: by 2040, the African vaccine manufacturing industry would develop, produce and supply over 60% of the continent’s total vaccine doses – from a base of less than 1% today. In 2021, the African Union and Africa Centres for Disease Control and Prevention (CDC) established Partnerships for African Vaccine Manufacturing (PAVM).
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