IFPMA Covid-19 Günlük Bülteni – 14 Nisan

14.04.2020

Top news:

  • Scientists, physicians, funders and manufacturers have come together as part of an international collaboration, coordinated by the WHO, to help speed the availability of a vaccine against COVID-19.  WHO published a draft landscape document of all COVID-19 vaccines under development – currently there are 3 candidates in clinical evaluation and 67 in preclinical evaluation.
  • Dr Tedros, DG WHO, voiced confidence on Monday that the United States would continue funding his U.N. agency, despite President Donald Trump’s criticism of WHO’s handling of the COVID-19 pandemic.
  • IMF board approves immediate debt relief for 25 poorest countries & announces that the global economy is expected to shrink by 3% during 2020
  • GSK and Sanofi team up on accelerating the development of a COVID-19 vaccine; AstraZeneca initiated a global clinical trial to assess the potential of Calquence (acalabrutinib; blood cancer drug) for treating severely ill COVID-19 patients & Eli Lilly begins clinical trial testing the safety and efficiency of its rheumatoid arthritis drug baricitinib for COVID-19.  Meanwhile, European Commission plans joint purchasing of experimental drugs against COVID-19, incl drugs by Gilead, AbbVie, Sanofi and Roche.
  • An academic study (released on Friday) found that repurposed drugs demonstrating efficacy against COVID-19, could be manufactured at very low costs (between $1 and $29 per course of treatment). Yet, demand for these medicines could swiftly outstrip supply, necessitating new industry alliances, parallel manufacturing by multiple companies, and shared intellectual property.
  • EU finance ministers agreed on a €500bn package of palliative economic measures but they did not decide on how to pay for the longer-term economic reconstruction effort post-COVID19.

PRICING & ACCESS

  • Reuters: Coronavirus drug hopefuls are cheap to make but may be in short supply. A study examined the cost of manufacturing medicines in recent or ongoing COVID-19 trials. “Should repurposed drugs demonstrate efficacy against COVID-19, they could be manufactured profitably at very low costs,” the authors wrote, giving range of between $1 and $29 per course of treatment. Demand for medicines that prove their mettle could swiftly outstrip supply, necessitating new industry alliances, parallel manufacturing by multiple companies, and shared intellectual property.

INTELLECTUAL PROPERTY

  • InfoJustice: Patent Holders Urged To Take “Open COVID Pledge” For Quicker End To Pandemic. An international coalition of legal experts, engineers and scientists are calling on companies, universities and other organizations to take a pledge to make their intellectual property temporarily available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.
  • KEI: KEI letter to Brazil Congress, regarding a compulsory licensing bill. A group of legislators last week proposed a bill to permit the government to temporarily suspend any patents for medical products that could be used to fight COVID-19, as well as any future public health emergency declared by Brazilian authorities or the WHO. In this article, James Love, Director of KEI, commented on several objections raised by many drug companies against the compulsory licensing bill. 

MANUFACTURING & SUPPLY OF MEDICINES

  • Nature: If a coronavirus vaccine arrives, can the world make enough?. Some optimistic forecasts suggest that one could be available in 12-18 months – but researchers are already warning that it might not be physically possible to make enough vaccine for everyone, and that rich countries might hoard supplies. CEPI says that there is no agreement yet on the principles or rules for a fair allocation system incorporated into contracts that can be consistently applied and enforced. There is also no global entity responsible for ordering the manufacturing of vaccines on a global scale and paying for it.

GLOBAL ECONOMIC & SOCIAL IMPACT

GLOBAL RESPONSE

  • IMF: IMF executive Board approves immediate debt relief for 25 countries. The fund together with the World Bank have called for rich nations to stop collecting debt payments from poor countries from May 1 2020 through June 2021. The debt relief will be funded by the IMF’s Catastrophe Containment and Relief Trust (CCRT), the fund currently has $500 million, with Japan, Britain, China and the Netherlands among its main contributors.
  • Bloomberg: Deadly Virus Fails to Trigger World Bank’s Pandemic Bonds. The outbreak of coronavirus failed to trigger payouts from bonds that the World Bank issued to provide emergency pandemic resources, even after almost 100,000 global deaths from Covid-19. AIR Worldwide Corporation published its so-called eligible event report, determining that the outbreak hadn’t met the “exponential growth rate” criterion in eligible countries. The determinations are final and binding on the World Bank and the investors.
  • Gavi: Gavi steps up response to pandemic. Gavi will provide $29 million in urgent initial funding to 13 low-income countries to support their COVID-19 response, helping them to protect health care workers with personal protective equipment (PPE), perform vital surveillance and training, and fund diagnostic tests. More support from a total of up to $200 million is likely to be approved in the coming days and weeks.
  • ASEAN: Declaration of the Special ASEAN Summit on Coronavirus Disease 2019 (COVID-19). The Heads of State/Government of the Member States of the Association of Southeast Asian Nations (ASEAN) held the special summit via video conference on 14 April 2020. They declared to build upon existing efforts by individual ASEAN Member State and that of the ASEAN Community to “share experiences and best practices in epidemiological research and development, clinical treatment, joint research and development of vaccines and anti-viral medicines, enhancing capacity for the public health systems of ASEAN Member States while protecting and ensuring the safety of public health workers”.
  • Financial Times: Eurozone countries strike emergency deal on coronavirus rescue. Eurogroup finance ministers have agreed an €500bn emergency rescue package aimed at responding to the coronavirus crisis. But ministers did nothing to lay to rest the festering dispute over how to pay for the longer-term economic reconstruction effort that will follow the crisis. 

COVID-19: FOCUS ON AFRICA

  • WHO: First UN solidarity flight departs Addis Ababa carrying vital COVID-19 medical supplies to all African nations. WHO cargo is being  transported by the UN World Food Programme (WFP), and includes personal protective equipment as well as thermometers and ventilators. The cargo also includes a large quantity of medical supplies donated by the Prime Minister of Ethiopia Abiy Ahmed and the Jack Ma Foundation Initiative. The African Union, through the Africa CDC is providing technical support and coordination for the distribution of the supplies.
  • Financial Times: China-Africa relations rocked by alleged racism over COVID-19. Africans in the South-Chinese city of Guangzhou have been evicted from hotels and had passports confiscated, officials say. Sino-African relations have been plunged into crisis after African officials reacted furiously to allegations that their nationals were being routinely discriminated against, as alleged potential “carriers” of coronavirus.

VACCINE/ TREATMENT DEVELOPMENT

IFPMA members

  • Financial Times: GSK and Sanofi team up on COVID-19 vaccine. The two companies said in a joint statement on Tuesday that they plan to start phase 1 trials in the second half of this year, and if successful they aim to have it available by the second half of 2021. Sanofi’s vaccine candidate, which is an S-protein Covid-19 antigen based on recombinant DNA technology, needs what is known as an adjuvant to function. GSK already has a “proven pandemic adjuvant technology” that it used during the H1N1 swine flu outbreak in 2009. Calling the partnership of former rivals “unprecedented”, Sanofi’s head of vaccines David Loew stated that teaming up made sense because each company held “a piece of the puzzle”.
  • Sanofi: Sanofi has committed to donating 100 million doses of hydroxychloroquine to 50 countries around the world, and has begun to progressively deliver the medicine to authorities that have requested it (statement from Friday).
  • Fierce Pharma: Lilly partners with NIH to test Olumiant in patients hospitalised with COVID-19. National Institute of Allergy and Infectious Diseases, Eli Lilly is planning to. The study to test  is starting this month in the U.S., and investigators eventually plan to expand testing to Europe and Asia. The New York Times: Despite Qualms, Arthritis Drug to Be Tested in Coronavirus Study.
  • AstraZeneca: AstraZeneca initiates CALAVI clinical trial with Calquence against COVID-19. It will initiate a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients. Calquence is a drug used to treat some blood cancers.
  • CNN: Heart risk concerns mount around use of chloroquine and hydroxychloroquine for COVID-19 treatment. The medications haven’t endured the due diligence of extensive clinical trials and there have been growing concerns about the impact chloroquine and the closely related hydroxychloroquine can have specifically on the heart. A chloroquine trial in Brazil has been cut short, hospitals in Sweden have been cautioned against using the drugs for Covid-19 and American cardiology groups have urged doctors to be aware of “potential serious implications” when used for people with existing cardiovascular disease.
  • AA: Russia expands list of drugs for coronavirus treatment. In addition to antimalarial drug Mefloquine and anti-AIDS Lopinavir/ritonavir, found effective against coronavirus earlier, the Russian Health Ministry has added in the list Hydroxychloroquine and Chloroquine, Azithromycin, Nadroparin, Tocilizumab, recombinant interferon alpha and recombinant interferon beta-1b.

Others

  • Medical Device Network: BD secures approval for second Covid-19 molecular diagnostic test. This new test that received emergency use authorization from the US FDA and is similar to the previous COVID-19 test released by the company. It runs on the BD MAX System and also secured CE Mark in Europe. It is expected to scale up the testing capacity for the pandemic in the US and in other countries that accept CE Mark as regulatory approval.

DISEASE CHARACTERISTICS

  • Bloomberg: Coronavirus May ‘Reactivate’ in Cured Patients, Korean CDC Says. About 51 patients classed as having been cured in South Korea have tested positive again, the CDC said. Rather than being infected again, the virus may have been reactivated in these people, given they tested positive again shortly after being released from quarantine, said Jeong Eun-kyeong, director-general of the Korean CDC.

WHO – Daily COVID-19 update, 14 April   – No briefing today (14 April 2020)

Yesterday’s (13/04/2020) statement by Dr Tedros:

  • Early case-finding, testing, isolating caring for every case and tracing every contact is essential for stopping transmission is important.
  • Control measures must be lifted slowly, and with control. It cannot happen all at once.
  • Focus on LMICs having limited resources, especially in countries with large poor populations where stay-at-home orders and other restrictions used in high-income countries are not practical.
  • Development and delivery of a safe and effective vaccine will be needed to fully interrupt transmission.
  • Thanks the UK for its contribution of £200 million to the global response to COVID-19.
  • Refers to development ministers from the UK, Denmark, Iceland, Finland, Germany, Norway and Sweden calling on all countries to join this common endeavour and requests more solidarity at national and global level.

WHO: Public statement for collaboration on COVID-19 vaccine development. “Under WHO’s coordination, a group of experts with diverse backgrounds is working towards the development of vaccines against COVID-19”: the declaration is signed by scientists, physicians, funders and manufacturers have come together as part of an international collaboration, to help speed the availability of a vaccine against COVID-19. The group makes a call to everyone to follow recommendations to prevent the transmission of the COVID-19 virus and protect the health of individuals. The group also thanks everyone for putting their trust in the scientific community.