IFPMA Covid-19 Günlük Bülteni – 6 Mayıs
- CEPI calls for another round of proposals inviting organizations around the world to apply for funding to speed up development, scale-up manufacturing capacity, and expand the geographical footprint of production of COVID-19 vaccine candidates.
- New draft landscape of COVID-19 candidate vaccines published by WHO: 8 candidate vaccines in clinical evaluation & 100 candidate vaccines in preclinical evaluation
- Novartis & partner Incyte will take Jakafi into a second late-stage trial for COVID-19 patients with acute respiratory distress syndrome (ARDS).
- Eli Lilly and Chinese drug maker Shanghai Junshi Biosciences Co. collaborate on new antibody therapies for COVID-19 & Pfizer and New York University are partnering on a vaccine.
- Sanofi said it plans to enrol thousands of subjects globally for trials of its vaccine candidate with GSK and that it has started to discuss advanced purchases with several countries.
- Millions are predicted to develop and die of tuberculosis as result of COVID-19, setting off global efforts to end TB by 5-8 years.
ACCESS & IP
- Business Insider: A coronavirus vaccine may be available in record time, but experts predict pandemonium during the rollout. Without a solid plan for distribution, bioethicist Arthur Caplan says “there will be fights about who gets priority.”
- De Tijd: Will Covid patents save us. Opinion by Geertrui Van Overwalle, a professor in Intellectual Property Law at KU Leuven University. He suggested that companies and universities working on a vaccine should already now declare that they will allow other companies to produce it at a reasonable price.
MANUFACTURING & SUPPLY
COVID-19 vaccines & treatments
- Pipeline Review: CEPI seeks to expand COVID-19 vaccine portfolio, focusing on speed and global manufacturing.CEPI calls for Proposals inviting organizations around the world to apply for funding to speed up development, scale-up manufacturing capacity, and expand the geographical footprint of production of COVID-19 vaccine candidates.
- FT Health: We’re not all in this together. Three questions to Seth Berkley, head of Gavi, on the impact of COVID-19 and vaccine R&D. “In developing countries, we need some type of global access agreement, which will be tough in this political environment. Plus we need to be prepared to manufacture “at risk”. If we can get a prioritised list of approaches, we can begin to ensure adequate production.” Several references to the articles from the special report on Combatting Coronavirus are made.
- BioPharma: Lonza and Moderna shoot for billion COVID-19 vaccine doses. Moderna announced it has partnered with Lonza with the aim of producing one billion doses annually.
- Bloomberg: Gilead Under Gun to Mass-Produce Virus Drug or Risk Exclusivity. Gilead has patent exclusivity on its potential COVID-19 treatment remdesivir for the next 15 years, but the company could be forced to license its patents if the drug is approved and it can’t keep up with production demand.
- STAT News: As coronavirus pandemic worsens, health officials fear nationalization of drugs and supplies.Health officials are concerned that countries worldwide might move to nationalize key supplies to respond to the growing pandemic.
- Pink Sheet: PhRMA And AAM Urge New Approaches In Dealing With COVID-19 Supply Chain Disruptions. AAM continues to press for federal contracts, and PhRMA wants the Department of Transportation to use its enforcement discretion under CARES Act to mandate international flights. AAM survey finds pandemic has caused 224% spike in the cost of transporting drugs.
GLOBAL ECONOMIC IMPACT
- Al Jazeera: Europe’s ‘historic’ recession threatens eurozone survival. The EU forecast that the eurozone economy would contract by a staggering 7.7% in 2020, warning the wreckage from the coronavirus outbreak could endanger the single currency.
- EURACTIV: Commission expects Spanish economy to shrink 9.4% this year. The European Commission expects the Spanish economy to contract by as much as 9.4% this year due to the impact of the coronavirus.
- The Guardian: Global report: nations in Asia-Pacific pass Covid-19 peak and plot return to work. Countries across the Asia-Pacific region have announced plans to cautiously reopen for business as governments around the world race to reboot economies.
- BBC News: Most Africans ‘will go hungry in 14-day lockdown’. More than two-thirds of people surveyed in 20 African countries said they would run out of food and water if they had to stay at home for 14 days.
GLOBAL HEALTH IMPACT
- The Guardian: Millions predicted to develop tuberculosis as result of COVID-19 lockdown. Up to 6.3 million more people are predicted to develop TB between now and 2025 and 1.4 million more people are expected to die as cases go undiagnosed and untreated during lockdown. This will set back global efforts to end TB by five to eight years.
VACCINE/ TREATMENT DEVELOPMENT
- Fierce Pharma: Novartis, Incyte will take Jakafi into 2nd trial for COVID-19 patients on ventilators. The partners plan to test Jakafi in a second phase 3 trial for COVID-19 patients with acute respiratory distress syndrome (ARDS).
- Caixin: Eli Lilly Ties Up With Shanghai Junshi to Pursue Covid-19 Therapies. Eli Lilly set up a partnership with Chinese drug maker Shanghai Junshi Biosciences Co. to jointly develop new antibody therapies for COVID-19.
- NBC News: Pfizer, NYU working on innovative coronavirus vaccine that could be ready by end of summer. Researchers at Pfizer Inc. and New York University are working on a vaccine which attempts to reprogram the deadly pathogen rather than manipulate the live virus.
- Reuters: Gilead in talks to expand global supply of COVID-19 drug remdesivir. Gilead Sciences is in discussions with chemical and drug manufacturers to produce its experimental COVID-19 drug remdesivir for Europe, Asia and the developing world through at least 2022.
- Live Mint: Bangladesh’s Beximco to start COVID-19 drug remdesivir production this month. One of Bangladesh’s largest drug makers, Beximco Pharmaceuticals, will start production this month of the experimental antiviral drug remdesivir.
- NHK: Japan to approve remdesivir and Avigan as coronavirus treatment. The Japanese government will fast-track its approval of remdesivir and Avigan as treatment for coronavirus patients.
- STAT News: Mounting promises on Covid-19 vaccines are fueling false expectations, experts say. Regardless of who gets vaccines when, it’s believed that most if not all of the new vaccines will require at least two doses to be effective, so any estimates of numbers of doses available in the autumn will need to be divided by two to find out how many people could expect to be vaccinated.
- North Africa Post: Clinical trial to test effects of BCG vaccine on coronavirus. A clinical trial conducted in South Africa, has recruited 500 caregivers. One half will receive the BCG vaccine and the other half a placebo.
- Bloomberg: Regeneron Covid-19 Antibody Treatment Could Be Available by Fall. Regeneron said an experimental antibody treatment for COVID-19 could be available as soon as this fall, an expedited timeline for a drug that’s scheduled to be studied in humans for the first time in June.
- J&J: Alveo Technologies Announces Research Collaboration with Janssen Pharmaceuticals, Inc. to Advance At-Home Testing Platform for Viral Infectious Diseases. Johnson & Johnson entered into a research collaboration with Alveo Technologies to advance Alveo’s be.well™ platform of analyzers, nasal swabs and cartridges for the detection of viral infectious diseases, including potentially SARS-CoV-2. J&J will provide Alveo with financial support as well as technical and regulatory counsel.
- Reuters: Sanofi to enrol thousands for its coronavirus vaccine trials. Sanofi said it plans to enrol thousands of subjects globally for trials of an experimental vaccine for the coronavirus it is developing with GSK and that it has started to discuss advanced purchases with several countries.
- Fierce Pharma: Regeneron eyes human tests of COVID-19 antibody cocktail in June. Regeneron’s planning to test the antibody cocktail in three different clinical programs, R&D chief George Yancopoulos explained. First, it will study the drug as a prophylactic measure to prevent infection in individuals at high risk. Second, it plans to use it in mild patients who are sent home after diagnosis, to see whether the therapy can cut the risk of their being hospitalized. Thirdly, it wants to evaluate whether the antibody cocktail can improve clinical outcomes in hospitalized patients.
- Business Wire: Merck Commits Additional $10 Million to COVID-19 Relief Efforts to Help Disparately Impacted Patients and Communities. Merck Foundation announced the company will make an additional commitment of $10 million in support of COVID-19 relief efforts to help address health disparities and inequality among patients and communities.
COVID-19 & EARNINGS
- The New York Times: Novo Nordisk’s Drug Sales Boosted by Virus-Related Stockpiling. Novo Nordisk beat profit and sales forecasts in the first quarter and kept its full-year outlook as diabetics stocking up during the coronavirus pandemic led to a surge in demand for its medicines
WHO – COVID-19 UPDATE, 6 May
Statement at the media briefing of Dr Tedros here.
- Today, WHO, UNICEF and the International Federation of the Red Cross have published guidance for countries on how to maintain community-based health care in the context of COVID-19.
- As more and more countries consider how to ease so-called lockdown restrictions, I want to reiterate the six criteria that WHO recommends countries consider:
- First, that surveillance is strong, cases are declining and transmission is controlled;
- Second, that health system capacities are in place to detect, isolate, test and treat every case and trace every contact;
- Third, that outbreak risks are minimized in special settings like health facilities and nursing homes;
- Fourth, that preventive measures are in place in workplaces, schools and other places where it’s essential for people to go;
- Fifth, that importation risks can be managed;
- And sixth, that communities are fully educated, engaged and empowered to adjust to the “new norm”.
- The risk of returning to lockdown remains very real if countries do not manage the transition extremely carefully, and in a phased approach.
- 8 candidate vaccines in clinical evaluation
- 100 candidate vaccines in preclinical evaluation
WHO: Community-based health care, including outreach and campaigns,in the context of the COVID-19 pandemic. The guide includes practical recommendations for countries on sustaining essential services at the community level, leveraging community health workers for the response to COVID-19 while keeping them safe, and advice for how to adapt services for specific diseases and age groups.