Week's news analysis

who is in the race for a vaccine?

PHARMAnetwork studies - 18 June 2020

In the race to develop a Covid-19 vaccine, which laboratory will win the competition? Which one will first launch a product allowing protection for populations as the pandemic has already killed over 420 000 people and put worldwide economies down?

Currently, more than 100 coronavirus vaccine candidates are in development throughout the planet, rising concerns over potential geopolitical troubles. "Fears are growing that the hunt for a coronavirus vaccine will spark geopolitical clashes if countries act according to narrow self- interest", write Joe Miller and Clive Cookson in The Financial Times (June 17th). Governments are eager to offer hope to citizens and reactivate their economies. Global health bodies estimate that the cost to vaccine people around the world against COVID-19 is likely to surpass $20 billion.

Still in the Financial Times (June 15th), Isao Teshirogi, the head of Japanese drug makerShionogi called "for a longer-term international strategy to develop and distribute coronavirus vaccines", warning that political hopes for a quick solution may be disappointed.

According to the World Health Organization, Chinese companies are behind five of the 10 vaccine candidates being tested on people worldwide, while authorities commit millions of dollars in research. But the US and the EU have agreed to spend billions to finance the development of several of the vaccines in an effort to shorten the usual years -long testing process. In Europe, the European Commission plans to pump billions of euros into advance purchase deals with pharmaceuticals companies, to secure supplies of future treatments. The funds would be targeted primarily at drugs that will enter clinical trials this year, with a view to mass production in 2021.

Meanwhile, the US federal government plans to fund and conduct the decisive studies of three experimental coronavirus vaccines (Moderna, AstraZeneca and Johnson & Johnson's), starting this summer.

Here are some of the main projects underway throughout the world.

o In April, Boston-based biotech company, Moderna, unveiled early positive results for its potential vaccine, which is using a "messenger RNA" platform. The Phase 1 study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The FDA has granted a fast-track designation for the company's mRNA-1273 vaccine candidate in April. Moderna has also submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its mRNA-1273. And a Phase 3 study could begin in the fall of 2020.

Moderna hopes to be able to produce up to 1 billion doses per year, after signing a manufacturing deal with Lonza. The companies plan to establish manufacturing suites at Lonza's facilities in the US and Switzerland, with technology transfer beginning this month. The biotech reached an agreement with the US Biomedical Advanced Research and Development Authority (BARDA) to get a funding of $483 million to accelerate development of its vaccine candidate. The US agency will fund the advancement of mRNA-1273 up to FDA licensure, with Phases I, II and III underway, in order to have vaccine available as quickly as possible.

Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S. and is expected to be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Based on the results of the Phase 1 study, the 100 ?g dose level was chosen as the optimal dose level to maximize the immune response while minimizing adverse reactions. Moderna has completed manufacture of vaccine required to start the Phase 3 study. The Company expects dosing in the Phase 3 study to begin in July.

o Pfizer has concluded an extended partnership with BioNTech to co-develop the mRNA-based COVID-19 vaccine candidate BNT162. The partners plan to jointly conduct clinical trials initially in the US and Europe, with potential to supply 10 to 20 millions of vaccine doses by the end of 2020 (for emergency use) and hundreds of millions of doses in 2021. End of April, the companies got the approval of the german Paul-Ehrlich-Institut for a Phase I/II trial of the BNT162 vaccine programme, while actively preparing for the potential start of this clinical study programme in the US in the near future.

oIn May, AstraZeneca entered into an agreement for the global development and distribution of the University of Oxford's potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.The UK drugmaker would also be responsible for worldwide manufacturing of the vaccine, AZD1222 (formerly ChAdOx1 nCoV-19).

AstraZeneca CEO, Pascal Soriot, indicated that the partnership is looking to produce 100 million doses by the end of the year and prioritise supply in the UK. AstraZeneca has also received support of up to $1.2 billion from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of at least 300 million doses of the University of Oxford's COVID-19 vaccine starting as early as October. The executive explained that AstraZeneca plans to rely on contract manufacturing organisations and other partners, while boosting its own production capacity. Cobra Biologics, has signed a supply agreement with AstraZeneca UK Ltd. to provide GMP manufacture of the adenovirus vector-based COVID-19 vaccine candidate AZD1222. Catalent Biologics will provide vial filling and packaging capacity to AstraZeneca PLC at Catalent's manufacturing facility in Anagni, Italy, and prepare for large-scale commercial supply of the University of Oxford's adenovirus vector based COVID-19 vaccine candidate, AZD1222.

AstraZeneca has reached an agreement with Europe's Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford's COVID-19 vaccine, with deliveries starting by the end of 2020.

The Company has recently completed similar agreements with the UK, US, the Coalition for Epidemic Preparedness Innovations and Gavi the Vaccine Alliance for 700 million doses, and it agreed a licence with the Serum Institute of India for the supply of an additional one billion doses, principally for low- and middle-income countries. Total manufacturing capacity currently stands at two billion doses.

o J&J stated it would have 600 to 800 million coronavirus vaccines by 202, when it expects the US government to approve the drug it plans to start testing in humans this September. The company has selected a lead COVID-19 vaccine candidate from constructs it has been working on since January, with plans to initiate a Phase I study at the latest by September. The technology relies on the production of adenoviral vectors to deliver an immunogenic protein, and had been previously deployed against Ebola. J&J and the federal Biomedical Advanced Research and Development Authority (BARDA) announced in April a $1 billion investment to help achieve that goal. J&J plans to set up a new manufacturing facility in the US to supplement the company's plant in the Netherlands that can produce up to 300 million doses.

Edition 45 - page 60 | Read: "COVID-19: The race for production resources"...
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