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Industry Leaders Provide an Update on COVID-19 Vaccine Progress

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"We are deeply aware that nobody can fight COVID-19 alone." – Thomas Cueni, Director General, IFPMA.

"The industry has responded in an unprecedented way," said Thomas Cueni, Director General of
The International Federation of Pharmaceutical Manufacturers & Associations in a virtual press conference held today.

Despite it being only two and a half months since COVID-19 was declared a global pandemic,
over 100 vaccine candidates are at various stages in the biopharmaceutical development pipeline.

Numerous industry collaborations have been implemented to bolster these efforts and substantial funding has been allocated, on a scale that has perhaps not been seen before. There is no guarantee that a safe and efficacious vaccine will be found, but it's safe to say no resources are being spared in the pursuit of one.

So, what progress has been made thus far?

This was the theme of the virtual conference, and as such, a number of representatives from the biopharmaceutical industry were on hand to share their updates, insights and to highlight challenges that still remain. Speakers included:

To kick off the event, Walmsley is asked what GSK are currently doing and how far down the road the company is in supporting projects to find a safe and effective vaccine.

"A vaccine is going to be key for the world's exit from this very challenging situation," Walmsley said before outlining three key factors that all industry members need to be focused on:

1. That it works

2. That it is safe

3. That it can be produced at scale

"Clearly the world is going to need several vaccines, and so we decided that the best path forward was to offer our unique pandemic adjuvant technology to multiple partners and candidates," she stated.

"In terms of actual progress on specific candidates, we announced our first collaboration at the beginning of February, and we now have partners in North America, Europe and China who are all using our adjuvant technology," Walmsley added. This includes former business competitors
Sanofi, whom GSK announced a partnership with on April 14. "We're hoping to make some further announcements in due course. We will be seeing data in the coming months, and we are working with our publicly announced partners and others on opportunities to accelerate. Today we announced our commitment to supply 1 billion doses of this adjuvant in 2021, and that is on top of 750 million doses of vaccines that we supply for other diseases that need them to keep people protected."

When asked about progress in terms of clinical trials, Walmsley referred to the earlier point that data will be coming in the next few months.

"We need a lot of options as soon as possible"

The spotlight next turned to Bourla of Pfizer, who
announced a five point plan to battle COVID-19 in March.

When asked to discuss the novelty of the technology that Pfizer are advancing (referring to the companies' first-in-class, mRNA-based
coronavirus vaccine program), Bourla said: "There are multiple technologies that are now being implemented, from very old ones to very new ones. I hope that they will all be successful as we need a lot of options as soon as possible." He continued: "We have chosen the mRNA technology – despite this not being used in vaccine technology so far – because we already have a two year collaboration with BioNTech who are mastering this technology." This collaboration has been focused on developing a flu vaccine. Why have Pfizer chosen this approach? "We felt that we had enough expertise, enough scale, and that the technology was offering speed. With mRNA technology you can achieve in weeks what might take months using other technologies." Bourla added.

"I think – and I hope – that the technology will be effective. We will only know at the end of the trials. We have collected a lot of data, and so far, so good."

When queried about specific timeline expectations for having such data on effectiveness and safety, Bourla said: "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 Food and Drug Administration to feel comfortable, and for the European Medicines Agency to feel comfortable, to have a vaccine around the end of October."

Clinical trial progress and human challenge trials

is currently working in partnership with the University of Oxford on a trial which has received a large amount of media attention over recent weeks.

The potential vaccine candidate, ChAdOx1 nCoV-19, was developed at the University of Oxford's Jenner Institute. It uses a viral vector based on a weakened version of the common cold containing genetic material of the SARS-CoV-2 spike protein. Post-vaccination, the surface spike protein is produced in the body which primes the immune system to attack COVID-19 if, at a later date, it infects the body. "We finished the Phase I trial and we should receive the results very soon. We have announced that the Phase II/III trial will be starting in the UK with 10,000 volunteers. We are also launching a clinical trial in the US that will recruit 30,000 volunteers."

Soriot was questioned on whether
human challenge trials, whereby an individual is deliberately infected with SARS-CoV-2, are something that AstraZeneca have considered. He noted that there were internal discussions, but the answer was no: "The ethical issues around this are yet to be resolved, and the protocol surrounding these studies has to be defined. We feel that it is too early. We still have a chance to show efficacy [of the vaccine] in a "normal" way, so to speak."

"There are no rivals, we are competitors. The only rivals are the virus and time." – Albert Bourla, Chairman and Chief Executive of Pfizer.

However, should disease cases fall to the point where testing a vaccine becomes challenging, will this still apply? Perhaps not. "We have to move quickly. If the disease gets to a very low level, challenge studies will have to be considered," Soriot added.

The development of valid animal models

Next, to Stoffels update on Jonhson & Johnson's progress, where it appears time investments have been made in the development of animal models for the testing of vaccine candidates.

"We first spent some time on selecting the right vaccine based on the right part of the spike. We selected the DNA piece with the most immunogenicity. We have published in parallel validated animal models – one was a disease model and the other was a challenge model – and now we are on the way to do real challenge studies in validated models to identify what doses [will be required]." Deciphering how manufacturing can be upscaled quickly has been a priority of Johnson & Johnson, Stoffels discussed, before stating: "I can proudly say that we are in place to deliver 1 billion vaccine doses next year."

To that end, when can we expect to see a transition from preclinical studies to human clinical trials? "[With regards to clinical studies] We are planning to start in September, but we are very much working in collaboration to go through Phase I, II and III very quickly," Stoffels added.

"We are making progress, and we see it every day." – Thomas Cueni, Director General, IFPMA.

Only time will tell

It's clear to see that, at present, there are no definitive answers as to whether the world will see a safe and efficacious vaccine for COVID-19 – only time, and human clinical trial data, will tell.

Collaboration and communication within the biopharmaceutical industry must continue, as Cueni explains: “The only way to deliver on our promise of safe, equitable, affordable coronavirus vaccines is for science and collaboration on a global scale to prevail."

As we wait for trial data, Cueni emphasizes that we must not be deterred away from ongoing immunization projects and also the risk of future infectious diseases: “While we should give our undevoted attention to ending the COVID-19 pandemic, we must not fall into the trap of forgetting the need for ongoing immunization efforts to continue as well as being very vigilant in tracking any future virus.” The full press conference footage is available
here, accompanied by a press release.

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