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Vaccine development: it's a race - but with common standards
Photo: Mikael Sjoberg / Bloomberg / Getty Images
Nine leading western pharmaceutical companies want to ensure careful corona vaccine development according to scientific standards despite the immense time pressure.
In an unusual move, the competitors AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Moderna, Novavax, Sanofi, the Mainz-based company Biontech and its US partner Pfizer joined forces and promised in a statement on Tuesday that security and Effectiveness in the development of a corona vaccine is the top priority.
Approval or emergency approval will only be applied for if the safety and efficacy has been proven in a crucial phase III study that meets the usual regulatory requirements, it said.
Often it is the pharmaceutical companies who want rapid approval, after all, every month that a drug is not yet on the market costs the company a lot of money.
But in the case of the corona vaccination, it is they who step on the brakes - with a public impact.
The merger is also noteworthy because there is a race going on in vaccine development: Those who are the first to receive approval can expect high sales.
That in turn enables this company to collect more data and improve the vaccine - the gap to the competition would continue to grow.
If an inadequately tested vaccine were to prove in retrospect to be ineffective or, in the worst case, even to be harmful to health, the consequences would be catastrophic and could range from damage to those affected to damage to the company's image to a loss of confidence in vaccinations among the population.
Accordingly, the global research-based pharmaceutical industry has a great interest in ensuring that an effective and safe vaccine against Sars-CoV-2 is ultimately available.
The development in record time and the approval of a first vaccine in Russia without the usual large efficacy study are fueling safety concerns.
Last week, the US Food and Drug Administration (FDA) brought a flash approval into play in October.
As a result, concerns arose that vaccine development in the US may have been campaign-driven.
The Paul Ehrlich Institute responsible in Germany considers approval at the end of the year to be realistic.
With their promise, the pharmaceutical companies want to dispel such concerns.
"In addition to the pressure and the hope for a vaccine that is available as quickly as possible, there is also a lot of uncertainty among the people that steps in the development could be omitted here," said Biontech CEO Ugur Sahin of the Reuters news agency.
"We want to speed up vaccine development as much as possible, but we're not going to take short cuts and omit important steps."
The pandemic can only be stopped with an effective vaccine.
In the press release, which was sent out by the German company Biontech, among others, it said, for example, that four principles were adhered to during development:
The safety and well-being of the vaccinated subjects are paramount.
High scientific and ethical standards with regard to conducting clinical studies and strict manufacturing processes are adhered to.
Approvals or emergency approvals are only applied for after evidence of the safety and efficacy of a vaccine candidate through a clinical phase III study.
This should be designed and carried out in such a way that it meets the requirements of the responsible supervisory authority.
Work is being done to produce a sufficient range of vaccine options - including for global use.
As the communication shows, the pharmaceutical companies hope that this will increase the public's confidence in vaccine development.
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kry / Reuters