IFPMA Covid-19 Günlük Bülteni – 4 Mayıs
- The European Commission virtual global pledging event has reached a target of $8bn/ €7.4 billion in its first day – the pledging marathon will last until end of May
- WHO’s Dr Tedros calls for equal distribution of COVID-19 medical products at European Commission pledging event & NGOs likewise call on governments to take action to make sure COVID-19 tools are accessible for all
- European Commission to launch three partnerships focusing on vaccines (led by CEPI & GAVI), treatments (led by the COVID-19 Therapeutics Accelerator) and diagnostics (led by FIND) respectively
- FDA authorizes emergency use of remdesivir, while Gilead pledges to donate the first 1.5 million doses in the US
- Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization & company ramps up manufacturing in Germany
GLOBAL PLEDGING CONFERENCE
- EU Commission: Coronavirus Global Response: €7.4 billion raised for universal access to vaccines. Today, the Commission registered €7.4 billion, equivalent to $8 billion, in pledges from donors worldwide during the Coronavirus Global Response pledging event. This includes a pledge of €1.4 billion by the Commission. An overview of all the pledges per respective country can be found here. The Global Vaccines Summit that Gavi will organise on 4 June will mobilise additional funding to protect the next generation with vaccines.
- IFPMA: Pharma Joins Global Pledge Committing to Work Together to Beat COVID-19. Today, the industry recommitted at the Coronavirus Global Response Pledging Marathon, to channel its innovation, mobilize its knowhow, pool its expertise and share its manufacturing capacity to help deliver new vaccines and different types of therapeutics to stop the spread of pandemic.
- Reuters: U.N. calls for COVID vaccine, treatment available for all at affordable prices at European Commission pledging conference. WHO DG, Dr Tedros stated that “the ultimate measure of success will not be how fast we can develop tools. It will be how equally we can distribute them.” Dr Tedros’ statement (via video) to the EU Commission’s pledging event can be found here.
- UNITAID: Marison Touraine, Executive Board Chair, UNITAID, reiterated the support for the WHO/ Costa Rica COVID-19 proposal.
- Health Gap: Funding Raised at Coronavirus Global Response Summit Must Come with “Strings Attached” to Ensure Access for All. They request that: biopharmaceutical industry and medical device companies provide comprehensive technology transfer to mobilize and expand worldwide manufacturing capacity; governments commit to exercising emergency powers and IP flexibilities if the private sector does not cooperate; pledges to the ACT Accelerator must be additional to pre-COVID-19 global health investments and must not come from ongoing disease response spending for other pandemics.
- European Alliance for Responsible R&D and Affordable Medicines: Concrete actions needed for global pledges to result in access for all. They request that all initiatives supported with public funding in the context of COVID-19 have a global mandate. They call upon participating governments, donors and partners to set up a plan on global equitable access, affordability and availability including detailed conditions under which partners are expected to contribute to fulfilling these ambitions in return for funding.
- Politico: The Trump administration’s apparent lack of interest in cooperation has alarmed health officials and diplomats. They fear Trump will be content with allowing the race to develop and distribute a vaccine to devolve into a global contest where poorer countries will likely be left behind in the rush to procure doses.
- DW: Coronavirus vaccine: where profit and public health collide. The article starts stating that “while the industry vows to make a vaccine globally accessible, not all are on board with that idea”. Jürgen Wasem, Professor for healthcare management at the University of Duisburg-Essen, states that despite obvious issues with private interests in drugs research and development, he still strongly believes in a market-driven approach.
- G20: Extraordinary G20 Digital Economy Ministerial Meeting – COVID-19 Response Statement. G20 ministers responsible for digital economy emphasized the promising role of digital technologies and relevant digital policies to strengthen and accelerate the collective response to the COVID-19 pandemic.
- German Federal Foreign Office: Germany’s Presidency of the Council of the EU, which is due to begin on 1 July, has revised its strategy in the light of the current COVID-19 crisis to include rebuilding of Europe’s economy while fighting the virus. Alongside these new commitments it states it will not lose sight of climate change, digital transformation, the EU budget and Brexit negotiations.
SUPPLY & MANUFACTURING
- Fierce Pharma: With the world waiting, Roche socks $459M into COVID-19 antibody test production. Roche will plow $459 million into its manufacturing facility in Penzberg, Germany, to boost production of the antibody test that won an emergency use authorization from the FDA last week
- UN News: Vaccine bottlenecks from COVID lockdown put children’s lives at stake. UNICEF warned that young people’s lives “are at stake” owing to the dramatic decline in commercial flights and limited availability of charters to distribute vaccines worldwide.
GLOBAL ECONOMIC IMPACT
- Financial Times: Global stocks drop as US-China tension flares. The falls came after Mike Pompeo, US secretary of state, on Sunday reiterated US government claims linking the coronavirus outbreak to a laboratory in Wuhan, China, without providing any evidence. China has denied the allegations.
VACCINE/ TREATMENT DEVELOPMENT & DONATIONS
- Politico: EMA begins evaluation of potential coronavirus treatment remdesivir. The purpose of the exceptional practice is to speed up the regulatory process compared with a regular evaluation procedure. The EMA stated that the decision to go ahead with the review is based on preliminary data from a U.S. clinical trial and added it will also look at a previous Chinese study.
- Politico: FDA authorizes emergency use of coronavirus drug remdesivir. The authorization allows doctors to use remdesivir outside of clinical trials, while the drug undergoes further review. Gilead said it will donate the first 1.5 million doses of remdesivir, which should be enough for about 140,000 COVID-19 patients.
- Fierce Pharma: Lilly-partnered AbCellera gets COVID-19 boost from Canadian government. AbCellera said it will get up to $175.6 million in support from the government of Canada. This money will be used to “expand efforts related to the discovery of antibodies for use in drugs to treat COVID-19” as well as to build out new tech and manufacturing infrastructure for antibody therapies “against future pandemic threats.”
- 7 News Australia: Stem cell treatment for virus patients to be trialled in Sydney. Executive Director Professor Jason Kovacic of Sydney’s Victor Chang Cardiac Research Institute, says the institute will work on a local clinical trial of the treatment being explored by New York’s Mount Sinai Hospital after 9 out of 12 patients in the US administered with stem cells were able to come off a ventilator in 10 days.
- Roche: Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark. Roche will provide high double-digit millions of tests already in May, further ramping up capacities thereafter.
- Wall Street Journal: FDA Sets Standards for Coronavirus Antibody Tests in Crackdown on Fraud. More than 200 antibody tests for Covid-19 entered the U.S. without previous FDA scrutiny on March 16, because the agency felt then that it was most important to get them to the public quickly.
- Al Jazeera: Senegal trials begin for $1 COVID-19 test kit. The blood/saliva test, originally developed for Dengue fever provides results in 10 minutes. The idea is now to rapidly produce 2-4 million kits for African countries.
- BBC: Which African countries are ahead on testing? The Africa CDC, which co-ordinates pandemic responses across the continent, says there is a large gap in testing rates between nations.
WHO – COVID-19 UPDATE, 4 May
Statement at the media briefing by Dr Tedros here.
- Today, leaders from 40 countries all over the world came together to support the ACT Accelerator through the COVID-19 Global Response International Pledging Event, hosted by the European Commission.
- During today’s event, some €7.4 billion was pledged for research and development for vaccines, diagnostics and therapeutics.
- WHO remains committed to working with all countries and partners to accelerate the development and production of vaccines, diagnostics and therapeutics, and to ensure their equitable distribution.
- This is an opportunity for the world to come together to confront a common threat, but also to forge a common future; a future in which all people enjoy the right to the highest attainable standard of health – and the products that deliver that right.
- Later this week, WHO will launch its updated Strategic Preparedness and Response Plan, which will provide an update of the resources WHO needs to support the international response and national action plans to the end of 2020.
Dr Tedros’ statement (video) to the EU Commission’s pledging event here.