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KAPI Weekly Brief: 8TH – 12TH MARCH 2021

12th March 2021

Executive Summary

The Kenya Association of Pharmaceutical Industry (KAPI) is a membership organization, established in the late 1960s, representing biopharmaceutical manufacturers (or their local representatives) that through research invent and develop medicines and technologies (e.g., Biopharmaceuticals, Vaccine Healthcare, Medical devices, Diagnostics) that significantly improve people’s lives. KAPI represents the industry voice and promotes efficiency in the pharmaceutical industry to ensure that medical products and healthcare technologies of the highest quality can be readily available for diagnosis, prevention and treatment of diseases.

Weekly Brief:

This is a roundup of news allied to the biopharmaceutical industry with a bearing on our mission to improve access to lifesaving health products and technologies for positive health outcomes.

  • After several deaths from clotting, health authorities have stressed there’s no indication of a link to vaccination. Still, Austria, Denmark, Estonia, Lithuania, Luxembourg, Latvia and Italy, as well as non-EU Norway and Iceland, have all suspended the rollout of at least some Oxford/AstraZeneca batches as a precautionary measure. (Politico)
  • Novavax reported Thursday that its experimental Covid-19 vaccine is more than 96 percent effective in preventing mild and severe illness. The results are from the company’s Phase 3 clinical trial, which was conducted in the U.K. Novavax’s trials in the U.S. and South Africa continue, and the company cannot apply for emergency use authorization in the U.S. until the American trials are complete. (NBC News)
  • Pfizer Inc and German partner BioNTech SE will exceed their original global production target for COVID-19 vaccines by as much as 20% this year, as they ramp up production a year into the global pandemic, Pfizer Chief Executive Albert Bourla said on Thursday. (Reuters)
  • Europe’s vaccination push was dealt another severe blow when Brussels warned supplies from AstraZeneca threatened to fall short in the first quarter and hopes faded that the US would provide extra jabs. (Financial Times)
  • Sanofi will start human trials for the second Covid-19 vaccine it has in development as it races to try to catch up with rival groups that have beaten it to market during the pandemic. French group has fallen behind newcomers despite being one of the biggest jab makers in world. (Financial Times)
  • Europe’s drug regulator said on Thursday it had initiated a rolling review of U.S.-based Eli Lilly’s antibodies to treat COVID-19, days after saying their combination could be used in patients at high risk of progressing to severe illness. (Reuters)
  • In response to calls for a waiver of TRIPS for COVID-19 vaccines, Oxfam’s Health Policy Manager Anna Marriott referred to it as massive missed opportunity to speed up and scale up the production of lifesaving vaccines worldwide. (Oxfam)
  • In response to the WTO TRIPS discussions, MSF said that the continued delays on the waiver negotiations are considered disappointing for global public health. (MSF)
  • The UN on Thursday launched a new global campaign, Only Together, aiming to advance fair and equitable access to COVID-19 vaccines worldwide. UN Deputy Secretary-General, Amina J Mohammed highlighted that “an unprecedented global scientific effort for vaccines has given us hope to defeat the virus,” Ms Mohammed stressed that new momentum and hope will emerge “only if we work together to ensure everyone, everywhere has access to COVID-19 vaccines. Only together can we end the pandemic and transform a new era of hope.” (UN)
  • Dr John Nkengasong, Director of the Africa CDC, said Thursday that the continent must develop its capacity to produce COVID-19 vaccines, considering that at least five African countries appear to have the capacity to produce vaccines, citing South Africa, Senegal, Tunisia, Morocco, and Egypt. A meeting is planned for April 12 between the African Union and external partners to create a “roadmap” for boosting African capacity to eventually produce COVID-19 vaccines, Nkengasong said. (AP)
  • During the final day of the Africa Health Agenda International Conference (AHAIC), a session convened by IAPO and IFPMA saw experts gathering to discuss the prospects for near-term ratification of the African Union treaty to create an African Medicines Agency (AMA), a single centralizing regulatory body for pharmaceuticals in Africa. The creation of the AMA was approved two years ago at the 32nd African Union Assembly, but the start of its operations has fallen victim to slow bureaucratic. As of today, the treaty has been signed by 19 countries but only ratified by 8 out of a required 15 countries. During the online session, experts emphasized the critical role a body like AMA could play in helping pave the way for more efficient bulk procurement of medicines and vaccines, while also assisting in the “identification, prevention, detection and response strategies” in delivering quality medication across Africa. (Health Policy Watch)
  • Kenya is yet to ratify the African Medicines Agency Treaty (AMA) – but a senior official in the Ministry of Health has said that the move should come soon. The AMA could pave the way for more efficient bulk procurement of medicines and vaccines, through the African Union or regional blocs of countries, as well as more local production. “AMA is critical now more than ever and ties into the WHO’s Patient Safety Plan directly,” observed Oksana Pyzik, Global Engagement Lead and founder of the University College London Fight the Fakes initiative. (Health Policy Watch)
  • The ICC released new guidelines called ICC Innovation Principles for Policymakers “Creating and nurturing innovation ecosystems” to highlight that a supportive policy environment is necessary to create and nurture innovation ecosystems, and to build the confidence necessary for investments in innovative activity. It provides 4 principles to guide policymakers in creating policy frameworks that enable the emergence of productive, resilient, and sustainable innovation ecosystems. These guidelines are building investor confidence in a trustworthy business environment, promoting education and training for a robust innovation ecosystem, encouraging open trade and investment, and ensuring intellectual property systems incentivize both innovation and dissemination. (ICC)
  • During the Global COVID-19 Vaccine Supply Chain & Manufacturing Summit convened by Chatham House, WTO Director-General Ngozi Okonjo-Iweala called on COVID-19 vaccine manufacturers to do more to ramp up production in emerging markets and developing countries to combat the vaccine supply shortage that is excluding many lower-income nations from access. Okonjo-Iweala also said that pandemic-related export restrictions had fallen in recent months, urging countries to drop or reduce the remaining ones or set timelines for their phase-out to help minimize problems in the vaccine supply chain. (WTO)

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KAPI WEEKLY BRIEF: 18TH – 22ND JAN. 2021

Executive Summary

The Kenya Association of Pharmaceutical Industry (KAPI) is a membership organization, established in the late 1960s, representing biopharmaceutical manufacturers (or their local representatives) that through research invent and develop medicines and technologies (e.g., Biopharmaceuticals, Vaccine Healthcare, Medical devices, Diagnostics) that significantly improve people’s lives. KAPI represents the industry voice and promotes efficiency in the pharmaceutical industry to ensure that medical products and healthcare technologies of the highest quality can be readily available for diagnosis, prevention and treatment of diseases.

Weekly Brief:

This is a roundup of news allied to the biopharmaceutical industry with a bearing on our mission to improve access to lifesaving health products and technologies for positive health outcomes.

  • Larger trials needed to assess efficacy of tocilizumab in managing COVID-19. This follows conflicting findings from a study done in Brazil on the same drug published in the British Medical Journal (BMJ). (Reuters)
  • The US Government under President Biden and VP Kamala Harris recommits to WHO and plans to engage in supporting COVAX platform to support access to COVID-19 vaccines by poor countries. (AP News | AP News)
  • The World Health Organization (WHO) welcomes proposal by the European Commission to establish a treaty on Pandemic Preparedness keen on mobilizing political commitment at such critical times. (Reuters)
  • Three COVID-19 vaccines under final review by WHO for emergency use approval (Reuters)
  • “Equal access” to coronavirus vaccines is failing poor countries (POLITICO)
  • With emergence of new COVID-19 variants, vaccine efficacy against the new variants have been a concern. A study by Pfizer/BioNTech confirms efficacy of their vaccine against the UK variant of the virus. (Financial Times | STAT)
  • Global leaders make calls to rethink global public health governance for research and development on the backdrop of a raging pandemic. (South Center)
  • African children are consistently excluded from cancer clinical trials leading to high burden of cancer with no established therapies for this population. They are the unseen and the unheard. (BMJ Global Health)
  • WHO Executive Board discusses for the first time the importance of implementing mental health and psychosocial support services and activities. This will be expedited by endorsing the updated mental health action plan 2013 – 2030. (Relief Web)
  • Antibiotics overuse among pediatric patients which is rampant is driving the spike in antibiotic-resistant ‘superbugs’ in children’s hospitals. (Business Insider | Infectious Disease Society of America)
  • Drop in vaccination causes surge in global measles cases and deaths (JAMA)
  • Monthly Malaria Prophylaxis cuts child deaths in Sub-Saharan Africa (JAMA)
  • Progress towards ending TB at risk (Development Policy Center)
  • Gritstone Oncology a biotech company working on cancer vaccines adds COVID-19 vaccine to its pipeline with the hope of developing a vaccine effective against the entire family of viruses. (Fierce Biotech)
  • Single COVID-19 vaccine doses not as effective as earlier hoped. Study in Israel finds out. (Guardian)
  • COVID-19 vaccine shots to cost $3 to $ 10 under the African Union vaccine plan (Reuters)
  • COVAX is ready to deliver vaccines, WHO officials tell WHO Executive Board – but Regulatory Approvals still lagging for key COVAX products (Health Policy Watch)
  • Independent panel on pandemic preparedness and response presented a report on WHO with findings showing the agency is powerless with need for more funding and reforms. (France 24 | WSJ)
  • Executive Board members of the WHO call for diversification and reform of the agencies funding mechanisms to avoid budget crisis as was witnessed when US withdrew. (Health Policy Watch)
  • Nations propose strengthening of local manufacture of medicines and other health technologies to improve access to medicines during 148th Session of the WHO Executive Board Meeting. (WHO)
  • Africa CDC opens up COVID-19 vaccines pre-order programme for 55 AU countries (CGTN)
  • FDA approves first monthly injectable to treat HIV infection (STAT)

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