IFPMA Covid-19 Günlük Bülteni – 11 Mayıs

11.05.2020

Top news:

  • WHO’s dedicated webpage for the 73rd World Health Assembly is online & Announcement of virtual side event (May 14)  hosted by KEI, Health Action International and more on access to COVID-19 medical tools featuring Dr Mariângela Simão, Costa Rica’s Health Minister Dr. Daniel Salas Peraza, Charles Gore (MPP), and others
  • A modelling study by WHO & UNAIDS shows that a six-month disruption of antiretroviral therapy (due to lock downs/ COVID-19) could lead to more than 500 000 extra deaths from AIDS-related illnesses, including from TB, in sub-Saharan Africa in 2020–2021.
  • Dr Tedros announced tomorrow’s launch of the Tech Access Partnership which aims to increase local production of essential health technologies – like masks and ventilators – in developing countries.
  • Pfizer eyes to shift more of its medicine production to outside contractors as it prepares for large-scale production of its experimental vaccine candidate
  • Hydroxychloroquine failed to show benefits in a large clinical trial conducted in the U.S.
  • Study in Hong Kong found that remdesivir alone would not be able to treat the virus and cannot help to reduce mortality rates.

WORLD HEALTH ASSEMBLY

  • WHO: WHA73 dedicated webpage. The World Health organisation has launched their official WHA73 page with additional documents related to the provisional agenda.
  • KEI: The WHO Covid-19 Technology Pool: The solution to ensure global access to Covid-19 health technologies.  Health Action International, Knowledge Ecology International, Medicines Law & Policy, Pharmaceutical Accountability Foundation, and Wemos will convene a virtual side event ahead of the WHA on May 14 titled: “The WHO Covid-19 Technology Pool: The solution to ensure global access to Covid-19 health technologies”. Speakers includeDr Mariângela Simão, Costa Rica’s Health Minister Dr. Daniel Salas Peraza, Charles Gore (MPP), and others.

ACCESS & PRICING

  • The Guardian: Soaring drug prices could bar access to future coronavirus treatments. Existing drugs may help us get through the coronavirus pandemic while we wait for a vaccine, but high pricing by pharmaceutical companies will probably mean that, even if these drugs are proven to be effective, many sick people will still be prevented from getting treatment.
  • Global News Canada: Looming war over a possible COVID-19 vaccine. If a vaccine is discovered for COVID-19, the reality is not everyone will get it at the same time. There will be many dilemmas in the process including, who should get it first? This is discussed in an interview with Dr. Seth Berkley.

INTELLECTUAL PROPERTY

EU RESPONSE

  • EurActiv: Call for Action: Time to strengthen the EU’s public health policy powers. Former Health Commissioner Vytenis Andriukaitis was joined by former Transport Commissioner Violeta Bulc and former Parliament President Klaus Hänsch to pen an op-ed calling for boosting the EU’s health powers, arguing the EU’s role in coordinating health policies has “been watered down over time, often for political reasons.”

GLOBAL ECONOMIC IMPACT

MANUFACTURING

IFPMA members

Others

SHORTAGES

  • EMA: EU actions to support availability of medicines during COVID-19 pandemic.  The EMA’s shortages committee wrote that shortages of ICU drugs have been caused by the “unexpected surge in demand and by changes in prescribing behaviours.” National competent authorities agreed then to look into various data models that could be used to predict these shortages, which we wrote about last month.

VACCINE/ TREATMENT DEVELOPMENT

IFPMA Members:

  • Financial Express: New drug combination to speed up recovery for patients.  After studying 1,000 people, the study showed that the remdesivir alone would not be able to treat the virus and cannot help to reduce mortality rates. The study explaining trials at Hong Kong University said that using three drugs, including interferon beta-1b, lopinavir-ritonavir, and ribavirin have been positive.
  • Clinical Trials Arena: Hydroxychloroquine fails to show benefit in Covid-19 study. Overall, 346 patients went on to develop respiratory failure, 180 were intubated and 166 died without intubation. The findings revealed that patients on hydroxychloroquine had the same risk of intubation or death as those who were not treated with the drug.

Other

  • Times of India: Government picks IIT, Bennett University proposals in war on COVID-19.  In order to urgently develop “safe and effective biomedical solutions” against COVID-19, the department of biotechnology has recommended 70 proposals from different institutions including Bennett University for funding.
  • Medical News: Italy develops vaccine candidate that neutralizes SARS-CoV-2 in mice.  A team from Takis Biotech, carried out tests and the results of this initial study in mice were extremely positive. After a single dose, the five candidate DNA-based vaccines were able to induce a strong antibody response against the SARS-CoV-2 spike protein in just 14 days.
  • Anadolu Agency: Llama antibodies may help coronavirus treatment.  Researchers from Ghent’s VIB-UGent biotechnology centre and from the University of Texas at Austin announced that antibodies from a 4-year old llama, named Winter, have neutralized coronavirus in lab experiments.

Ethics

CLINICAL TRIALS

  • Politico (paywall)/ France Info (original source): A European Trial That Macron Placed Hope In Is Stalling. A clinical trial meant to enroll some 3,000 Europeans has stalled — despite Emmanuel Macron’s announcement that the first results will be available on May 14. The trial initially set out to test three drug (combinations): Gilead’s remdesivir; the combination of lopinavir and ritonavir, which are; and the combination of the two drugs, plus beta interferon. Due to the buzz surrounding hydroxychloroquine, the researchers then added it to the list, further decreasing the patient pool each drug would be tested on.
  • STAT News: Inside the NIH’s controversial decision to stop its big remdesivir study.  The National Institute of Allergy and Infectious Diseases has described to STAT in new detail how it made its fateful decision: to start giving remdesivir to patients who had been assigned to receive a placebo in the study, essentially limiting researchers’ ability to collect more data about whether the drug saves lives — something the study, called ACTT-1, suggests but does not prove.
  • Triangle Business Journal: Raleigh pharma to study coronavirus treatment on patients in U.S.  RedHill Biopharma has received approval from the U.S. FDA for clinical trial testing with its drug opaganib. The company will move forward with a randomized, double-blind, placebo-controlled study that plans to enrol 40 patients with moderate to severe COVID-19 infections.
  • SCS: Stanford’s new coronavirus treatment approach: Hit hard — and early.  A new clinical trial at Stanford University is part of an emerging movement to find COVID-19 medicines that can be given almost immediately after infection, before the virus gains a firm foothold in the body.
  • Financial Review: Mesoblast seeks $100m for COVID-19 treatment trial.  The company has started a 300-patient randomised placebo-controlled “Phase 2/3” trial in the US. To help fund it, Mesoblast is seeking to issue new shares worth $100 million.

DIAGNOSTICS

AID & DONATIONS

GLOBAL HEALTH IMPACT

COVID-19 & AFRICA

  • The Nation: Africa Is Not Waiting to Be Saved From the Coronavirus.  As Covid-19 races its way across Africa, there are two stories happening at once. The first is of governments using their armies and militarized police to beat, threaten, and shoot their way to public health. The second is of communities knitting together their meagre resources to fill the gap of failed services and absent states.
  • KRCR News: African nations seek their own solutions in virus crisis.  Many hope that these efforts to develop ventilators, personal protective equipment, sanitizers and quick-result antibody tests will lead to more independent solutions for future health crises.

WHO – COVID-19 UPDATE, 11 May

Statement by Dr Tedros during today’s media briefing here.

  • Early serological studies reflect that a relatively low percentage of the population has antibodies to COVID-19, which means most of the population is still susceptible to the virus.
  • WHO is working closely with governments to ensure that key public health measures remain in place to deal with the challenge of lifting lockdowns.
  • Over the weekend, WHO issued detailed new workplace guidelines, which recommend all places of work carry out a risk assessment for workers potential exposure to COVID-19. This includes the implementation of measures to prevent the spread of the virus.
  • COVID-19 has exposed the uneven distribution of life-saving medical equipment across the world.
    • Tomorrow, the Tech Access Partnership will be launched to increase local production of essential health technologies – like masks and ventilators – in developing countries.
    • This new partnership is another great example of solidarity that builds on the solidarity flights, solidarity trials and Access to COVID-19 Tools Accelerator, which all aim to ensure the latest health innovations are reaching those communities that need them most.

NEW FEATURE STORIES

WHO: How WHO is re-imagining and fixing the links in the supply chains during COVID-19. Article lays out details how the UN COVID-19 Supply Chain Task Force operates, who participates with what roles and responsibilities.

WHO: Countering misinformation about COVID-19.  WHO has joined forces with the communications teams at the Government of the UK and the Prime Minister’s office for an awareness campaign about the risks of incorrect and false information regarding the pandemic. “Stop The Spread” is a global campaign, rolled out on BBC World television, website and apps during May and June 2020.

NEW RESOURCES

WHO: Informal consultation on the dose of chloroquine and hydroxychloroquine for the SOLIDARITY Clinical Trial – 8 April 2020. The dose of CQ or HCQ employed in the SOLIDARITY protocol was intended to exploit the maximum chance of therapeutic efficacy. Some participants noted that the SOLIDARITY protocol is using the highest dose of CQ of any recent COVID 19 study or expanded access protocol. Hence, it is crucial to proceed with caution and take safety concerns seriously. It was suggested that safety monitoring, especially cardiac monitoring, be considered in the SOLIDARITY protocol.

WHO: Draft landscape of COVID 19 candidate vaccines – 11 May. 8 candidate vaccines in clinical evaluation. 102 candidate vaccines in preclinical evaluation.

WHO: Considerations for public health and social measures in the workplace in the context of COVID-19. This document provides guidance on how to ensure a safe workplace amid the COVID-19 pandemic.