AstraZeneca, GSK and Pfizer CEOs among nine to sign Covid-19 vaccine pledge
The CEOS of nine biopharmaceutical companies, including Cambridge-based AstraZeneca, have signed a pledge that commits them to upholding the integrity of the scientific process in the race to produce the first approved Covid-19 vaccines.
Pascal Soriot, CEO of AstraZeneca, joined the leaders of BioNTech, GlaxoSmithKline, Johnson & Johnson, MSD (known as Merck in the US and Canada), Moderna, Novavax, Pfizer and Sanofi in signing the commitment to ensuring the safety and well-being of vaccinated individuals remains the top priority in developing a vaccine.
The move comes after safety concerns were expressed internationally over the speed with which Russia approved a vaccine known as Sputnik 5.
Russia became the first country in the world to approve a SARS-CoV-2 vaccine on August 11, despite the fact that phase III trials had not begun and no results on earlier stage trials had been published at the time.President Vladimir Putin said his daughter was among those who had been given the vaccine.
The biopharmaceutical CEOs’ pledge said: “We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for Covid-19 in accordance with high ethical standards and sound scientific principles.
“The safety and efficacy of vaccines, including any potential vaccine for Covid-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA).
“FDA has established clear guidance for the development of Covid-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential Covid-19 vaccines.
“More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomised and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.
“Following guidance from expert regulatory authorities such as FDA regarding the development of Covid-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
- Always make the safety and well-being of vaccinated individuals our top priority.
- Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
- Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
- Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved.”
The nine companies have developed more than 70 novel vaccines between them for a wide range of diseases.
AstraZeneca is working on clinical trials of a potential Covid-19 vaccine with the University of Oxford. The trials have expanded into phase III in the US, where 30,000 individuals are being enrolled to test the safety, efficacy andsafety, efficacy and ability to provoke an immune response.
Late-stage phase II/III trials are also ongoing in the UK and Brazil, while a phase I/II trial is under way in South Africa and there are planned trials in Japan and Russia.
In total, 50,000 participants will be involved around the world.
Interim results from the phase I/II COV001 trial , published in The Lancet in July, showed the Oxford vaccine - named AZD1222 - was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
Results from the late-stage trials are due later this year, depending on the rate of infection within the communities where they are carried out.
The UK government has already signed a deal for 100 million doses of the vaccine, should it prove effective.
In August, it concluded an agreement with the European Commission to supply up to 400 million doses of the AZD1222 vaccine, at no profit to AstraZeneca.
AstraZeneca said recent announcements with Japan, China, Latin America and Brazil take its global supply capacity towards three billion doses.
Mr Soriot said: “In recent weeks we have seen an increasing number of questions around the safety and availability of vaccines to fight this terrible Covid-19 pandemic and I want to reiterate my commitment that we are putting science and the interest of society at the heart of our work.
“We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential Covid-19 vaccine.
“We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around the world.”