Four bottlenecks of Covid-19 vaccine development

Updated: Aug 25, 2020

Who on the planet is developing a vaccine against the corona pandemic? The best overview is provided by the Washington Post:

Since January, shortly after scientists in China put the genome of the SARS-Cov-II virus online, numerous research groups have started developing a vaccine. It should be noted that so far the mumps vaccination was the fastest developed vaccination in history of science from 1963-1967. It took four years before it could be used. In just seven months, seven vaccines against Covid-19 have entered Phase III clinical trials in humans. Firstly, this is due to new biotechnological methods that shorten the development process. Second, because governments are covering the financial risk, even if the development fails. In the case of the USA, this means $ 9.5 billion of government investment in mainly proprietary companies, which are also recipients of funds from other countries outside the USA that purchase vaccines in subscription. Among these countries are Germany and Switzerland.

How likely is it that one of the vaccines will be launched on the market soon, i.e. in 2021? Will it be available on a large scale? Let us openly share our thoughts about four bottlenecks. This seen from our research management point of view, and our work in the bio sector in the past decades.

An important first bottleneck here are the National regulatory authorities (NRAs)*. The American FDA enjoys the greatest credibility and political power in this respect. Based on European companies such as Roche with the approval of Avastin© by the FDA, or our Swiss experience with the approval of a medtech process developed in Zurich (corneal cross-linking), we can see that you have to be financially strong, politically assertive and based in the USA if you want to have the slightest chance of approval. In Europe, the EMA (European Medical Agency) is new since Brexit is located in Amsterdam and in China the China Food and Drug Administration, or CFDA. The study published in the journal " Nature Reviews Drug Discovery" analyzed the regulatory authorities in Europe, the USA, Japan, China, India, Brazil, Singapore, Russia, Great Britain, Canada, Switzerland and Australia. There are major differences in the approval process for new drugs in terms of regulatory resources, speed and cost for manufacturers, as the study results show.

The processing time varies from 110 days in Russia to 33 months in China. The costs of approval in Europe amount to around 282,000 euros plus 100,000 euros annually recurring fees; in the USA, an application including the review of clinical data is already worth around 2 million euros.

In Russia, a drug approval costs the equivalent of 6000 Euro. While in the USA and Canada a granted marketing authorization is valid until market withdrawal, in Europe, China, Brazil, Russia and Great Britain it must be renewed after five years, in Singapore and Australia even annually.

The varying length of the drug's journey to the patient also determines where a Covid-19 vaccination has the greatest chance of ever reaching humans.

A second important bottleneck is the clinical trials. Who likes to be a guinea pig? In Europe, with its very active patient organizations, this is impossible. The studies are usually conducted in certified CROs (Contract Research Organisations) in South America or Southeast Asia, operated by Europeans. In the post-Corona era, this is not as smooth as it used to be. In the USA, the spirit of the study is to include minorities, because they are particularly affected by Ovid-19. It will be similar in China and Russia. But at least; they manage to recruit volunteers.

A third important bottleneck is industrial production. The vaccine, if available, must be produced industrially according to the highest (GMP/GCP/ISO/...) quality standards, which are not uniform all over the world. This as numerous and cheap as possible. There is currently some evidence that in order to achieve sufficient immunity against the virus it may be necessary to vaccinate several times at intervals of a few weeks/months.

A fourth bottleneck is the opening up of the market and the associated liability. To serve the market in the USA, for example, requires the registration of subsidiaries in each individual state. Internationally, depending on the legal situation, the liability does not always go back to the company. But if a state propagates the vaccination and officially recommends it to its citizens, it is possible that the citizens sue the state and not the company that caused the side effects. This in turn gives a vaccine producer and its always economically viable business partners the opportunity to take legal action. This in turn gives a vaccine producer and his always economic-political control of the drug regulatory authorities a certain freedom. After all, apart from all the blessings that an effective vaccination can bring and the welcome acceleration and investment in research and development; vaccine development is a huge business. For the US company Moderna at the forefront, this has already paid off. Mission vaccine developed or not. One must add: the company so far in 10 years has never brought any product on the market.

*Learn more about National regulatory authorities (NRAs) and universal health coverage in the latest article of Frontiers in Medecine POLICY AND PRACTICE REVIEWS ARTICLE: