Following the withdrawal of Curevac, the European Medicines Agency EMA currently has four vaccine candidates in the rolling approval process.
(Photo: Reuters)
Frankfurt The end of the Covid vaccine from Curevac not only highlights the specific weaknesses of the Tübingen biotech company. It also reminds of the growing challenges that other laggards in Covid vaccine development could face. Regardless of the clinical test results, the approval process is apparently taking longer and longer. And this increases the gap between these companies and the pioneers even further.
The number of vaccine projects is still huge. According to an overview by the World Health Organization (WHO), there are currently 126 Covid vaccines in clinical development, a good two dozen of them in phase 3 of the tests. But no further vaccines have been approved in either the US or Europe since March.
Following the withdrawal of Curevac, the European Medicines Agency EMA currently has four vaccine candidates in the rolling approval process. These include the protein-based vaccines from Novavax and Sanofi, the Sputnik-V vector vaccine from the Russian Gamaleya Institute, which is based on a modified virus, and a vaccine from the Chinese company Sinovac, which consists of inactivated Sars-Cov viruses. The processes for Novavax and Sputnik products started in March and April. Novavax published data from key clinical studies in March and June.
The EMA continues to provide no information on the possible timeline for regulatory decisions on these products. The progress of the rolling approval process depends on the available data and on the time it takes developer companies to submit additional data, which is requested by the medical committee of the authority (CHMP), said a spokeswoman on request.
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The EMA continues to regard Covid-19 as a public health emergency and continues to signal its readiness to test vaccines and therapies in accordance with the regulations for conditional approvals, which allow faster processing. “The assessment of both Covid vaccines and drugs remains a priority for the EMA,” the agency emphasized. At the same time, however, it also makes it clear that no gaps or ambiguities in the data situation are accepted.
More focus on drugs than vaccines
In the case of Curevac, the head of the EMA vaccine department, Marco Cavaleri, announced at the end of September that important clinical data had been obtained. But that you only look at it as a starting point to see where you stand with the approval process. Expect to be in a better position by the end of the year “to really understand what the next step for this vaccine could be.” Summer 2022.
In the case of the Tübingen-based company, the weak and in some cases unclear data situation may have played an important role. In the decisive study, the vaccine had only shown an overall effectiveness of 48 percent; in older people, there were even more cases of infection in the vaccine group than in the comparison group.
Regardless of this, in view of the high vaccination rates and the good availability of effective vaccines, it should also generally make sense for the regulatory authorities to shift their resources more into the evaluation of Covid drugs.
In the USA, the FDA amended its guidelines for potential emergency approvals in the area of Covid-19 as early as May. It stipulates, among other things, that the corresponding products must demonstrate a positive risk-benefit balance and that no adequate active ingredients have yet been available for treatment or prevention.
The last criterion in particular is now practically no longer given, given the three vaccines available in the USA. In addition, the vaccine from Biontech and Pfizer was the first Covid vaccine to receive regular approval in addition to emergency approval. Against this background, new registrations in the fast-track process hardly appear possible in the USA either.
More: You can find all current developments on the subject of Corona in our news blog