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IFPMA industry association conference: ‘no-one left behind’ on coronavirus vaccine

CEOs of vaccine giants AZ, GSK, J&J and Pfizer pledge to pull out all the stops

Coronavirus vaccine

Pharma industry leaders pledged to pull out all the stops to get a vaccine for coronavirus available as soon as possible – perhaps as early as October this year – and make sure that it is available to everyone who needs it around the world.

The CEOs of vaccine giants AstraZeneca, GlaxoSmithKline, Johnson & Johnson and Pfizer made the promise at a virtual media briefing convened by the IFPMA industry association yesterday.

IFPMA director general Thomas Cueni said the industry had come together in an unprecedented way to tackle the public health challenge of COVID-19 though collaborations on vaccine development with other companies, academia and government.

“We have a deep sense of responsibility in that we need to ensure no-one is left behind,” he told the briefing. “The notion of an equitable and affordable vaccine is a truly important one.”

Vaccine developers are racing against time to get their candidates through the late-stage testing needed to make sure they are safe and effective, as the pandemic continues to advance around the globe with new hot spots in Latin America and Africa.

The sheer scale of the pandemic means that several vaccines will be needed, said Emma Walmsley, CEO of GSK, which is contributing its vaccine adjuvant technology – which boost the immune response to antigens – to a number of the candidates coming through the collective pipeline, including one from Sanofi.

Using adjuvants means that limited supplies of vaccine can be spread further, which could be an important factor while supplies are still in the scale-up phase, she added. This week, GSK committed to producing a billion doses of its adjuvant in 2021.

At the moment there are already ten vaccines in clinical development for SARS-CoV-2, according to the World Health Organization’s latest update, with another 114 candidates in preclinical testing.

Among those, one of the furtherest ahead in development is an adenovirus-based vaccine being developed by the University of Oxford and AZ, which according to the drugmaker’s CEO Pascal Soriot completed phase 1/2 trials last week, with data expected imminently.

Oxford’s Jenner Institute has now started dosing patients in a 10,000-patient phase 2/3 trial, while AZ is planning a 30,000-volunteer study in the US that should start in July.

“We’re moving at full speed, like everybody else,” he told the briefing. “We don’t know which vaccine is going to work, but the good thing is we’re testing different technologies. We have to give it several shots.”

Albert Bourla, CEO of Pfizer, said the company and its partner BioNTech expect to enrol up to 30,000 people in the phase 3 programme for their mRNA-based candidate, which uses a similar mRNA base that Moderna’s vaccine does, which is due to start phase 3 in July.

Bourla thinks Pfizer and BioNTech could potentially have enough safety and efficacy data needed around the end of October - “if the stars are aligned” – to support approval by the FDA, EMA and other regulators.

Soriot discussed the challenge posed by declining infection rates in Europe as well as the US, which  could make it hard to show that the vaccines work using healthy volunteer studies. If that becomes a challenge, studies based on individuals who agree to be deliberately infected with SARS-CoV-2 may have to be considered.

Speaking on behalf of J&J, chief scientific officer Paul Stoffels said its adenovirus-based vaccine is based on a technology that has already been used to generate immunisations for Ebola, RSV, HIV and Zika, allowing the SARS-CoV-2 project to get underway rapidly.

“We are also in place to deliver a billion doses of the vaccine next year,” Stoffels told the briefing. J&J wants to start human testing in September and is planning two phase 3 trials – possibly in the Northern Hemisphere but possibly in the Southern Hemisphere as the pandemic epicentre shifts to other countries like South Africa and Brazil.

A key part of J&J’s programme is to make sure it has a vaccine that works at ambient temperatures, avoiding refrigeration that could make it challenging to deliver to some parts of the world. It expects efficacy data “early next year”, according to Stoffels.

Article by
Phil Taylor

29th May 2020

From: Research, Healthcare



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