Pharma firms move to reassure public


Major pharma companies joint pledge aims to boost public confidence in Covid-19 vaccines process

Nine major biopharmaceutical companies came together to issue a joint pledge on Tuesday (September 8) that they would not put forward a Covid-19 vaccine until it had been thoroughly vetted for safety and efficacy.

At the same time, they added, they would only submit for approval or emergency use authorisation, after demonstrating safety and efficacy based on a Phase III clinical study, designed and conducted to meet requirements of expert regulatory authorities, such as the US Food and Drug Administration (US FDA).

They pledged to always make the safety and well-being of vaccinated individuals their top priority; to continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigour of manufacturing processes, and to 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,” added the statement.

Together, these nine companies had collectively developed more than 70 novel vaccines that had helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigour, as well as their longstanding commitments to patient safety and public health.

The pledge “outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first Covid-19 vaccines”, was signed by CEOs of AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson & Johnson, Merck, known as MSD outside the United States and Canada, Moderna Inc, Novavax Inc, and Sanofi.

European Union (EU) member state health ministers heard last Friday that the EU Vaccine Strategy for Covid-19, had almost completed a portfolio with six promising vaccine candidates.

The EU signed an Advance Purchase Agreement signed with AstraZeneca on August 27.

It had also concluded exploratory talks with Sanofi-GSK, Johnson & Johnson, CureVac and Moderna; and were also very close to concluding talks with BioNTech.

Meanwhile, the World Health Organization is pursuing a global Covid-19 shared vaccine procurement plan and is seeking support from member countries.

Nine candidate vaccines are currently being supported by one of the groups acting as co-leads on the global approach to procurement, the Coalition for Epidemic Preparedness Innovations (CEPI). Seven of the CEPI-supported candidate vaccines are currently in clinical trials.

The nine candidate vaccines are: Inovio, USA (in Phase I/II trials); Moderna, USA (Phase III trials); CureVac, Germany (Phase I); Institut Pasteur/Merck/Themis, France/USA/Austria (at Preclinical stage); AstraZeneca/University of Oxford, UK (Phase III); University of Hong Kong, China (Preclinical); Novavax, USA (Phase I/II); Clover Biopharmaceuticals, China (Phase I), and University of Queensland/CSL, Australia (Phase I).

A further nine are under evaluation and conversations are underway with other major producers.

It has recently emerged that the Oxford vaccine trial , seen as one of the front runners in the global race to find a jab, has been suspended but is not doomed after a UK woman was hit by a rare neurological disorder; which some experts said demonstrated patient safety was paramount and that the complex system of regulatory checks and balances was working as it should.

valerie.ryan@imt.ie



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