Leaders from four of the biggest drugmakers in the world spoke about rising to the challenge of defeating the global pandemic as scaled-up trials and a potential approval peek over the horizon.
COVID-19 pharma vaccine executives took to the (virtual) stage of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) event Thursday, speaking specifically on the “status of collaboration and risk-sharing to speed up the research, development and manufacturing of vaccines against COVID-19” as well as where we are in the vaccine timeline.
Speakers included AstraZeneca CEO Pascal Soriot, GlaxoSmithKline chief Emma Walmsley, Johnson & Johnson Chief Scientific Officer Paul Stoffels and Pfizer leader Albert Bourla. Each company is working internally and with partners to seek out a new inoculation to stop the pandemic in its tracks.
One of the biggest points made from the outset is the need for partners. No one company will create a vaccine for this pandemic on their own: GSK has teamed up with Sanofi, while AstraZeneca is backing the University of Oxford by being on the hook for millions of doses for its leading candidate. Pfizer has teamed up with German mRNA company BioNTech, and J&J recently pledged $1 billion in partnership with the U.S. Biomedical Advanced Research and Development Authority to develop its vaccine.
This is just a snapshot: There are more than 100 vaccines now in the works for COVID-19 (10 clinical, 115 preclinical), with Merck the most recent (and late to the party) with its Themis tie-up.
This might seem like overkill, but, as Merck CEO Ken Frazier said this week (in what turned out to be a splash of cold water to the face), most vaccine R&D developments don’t work, so the more you have in the pipeline, the more you increase the likelihood something will stick.
Stoffels says there will be the need for around five to 10 vaccines to serve everyone around the world. The massive undertaking of manufacturing and delivering these is unprecedented, and because the majority of the world’s 7.8 billion people will likely require inoculation, no one company can be expected to get a vaccine through development, made up and shipped out in the shortest period of time it has ever taken to make a new vaccine from scratch.
In terms of timelines, Walmsley said they expect initial data out “in the coming months,” and Soriot says AZ is planning to start a phase 3 made up of about 30,000 volunteers in the U.S. by July. The Oxford-discovered candidate, ChAdOx1 nCoV-19, uses a viral vector based on a weakened version of the common cold containing genetic material of the SARS-CoV-2 spike protein
“We finished the phase 1 trial and we should receive the results very soon,” Soriot said. “We have announced that the phase 2/3 trial will be starting in the U.K. with 10,000 volunteers. We are also launching a clinical trial in the U.S. that will recruit 30,000 volunteers.”
Pfizer and BioNTech have recently said they are looking to ramp up trials of their vaccine hopefuls, with a major scaled-up test plotted for the fall.
Bourla added: “If things go well and the stars are aligned, we will have enough evidence of safety and efficacy for us to feel comfortable, for the FDA to feel comfortable, and for the EMA to feel comfortable, to have a vaccine around the end of October.”
But Soriot said that there could be an issue with development: “We’re running against time,” he warned, because the virus is now in the decline across most of the world amid strict lockdown measure that have significantly lowered its so-called R rate. (It was around a very worrying 3-4 , meaning one person could infect three to four others, but is now under 1 across many regions, making it much harder for the virus to find hosts.) He said that this also means the intensity of the virus will be low, so “we have to move quickly” to create a vaccine from it.
“If the disease gets to a very low level, challenge studies will have to be considered,” he added. This is where participants are intentionally “challenged” with the virus.
The new strategy these four companies are undertaking is against the “business as usual” model, IFPMA explained, and the need for collaborations and speed was paramount, with normal fears about intellectual property put aside. “There are no rivals, we are competitors. The only rivals are the virus and time,” Bourla concluded.