Berlin – The football professional Joshua Kimmich caused a stir with his statement that he wanted to be vaccinated against corona with a dead vaccine first. Novavax has now announced that the vaccine has received its first approval in one of the most populous countries in the world: In Indonesia, millions of people have not yet been vaccinated against the virus. The Indonesian health authority has now granted the US company Novavax and its partner, the Serum Institute of India, emergency approval for its Covid-19 vaccine. The vaccine is marketed under the name Covovax. In addition to Novavax, the Austro-French company Valneva also expects a good chance of an early approval. The German company Curevac, into which the federal government had invested millions in funding, on the other hand, canceled its vaccine development.
In a Phase III clinical trial of nearly 30,000 adults in the United States and Mexico, the vaccine, named NVX-CoV2373, had 100 percent protection against moderate and severe disease and an overall effectiveness of 90.4 percent, according to the company. In a Phase III clinical trial conducted in the UK in around 15,000 adults, NVX-CoV2373 showed an overall effectiveness of 89.7 percent and an effectiveness of more than 96 percent against the original strain of the virus.
Novavax called the Indonesian approval a milestone. The company expects many more approvals worldwide in the next few weeks and months, reports the Pharmazeutische Zeitung. The documents had been submitted to the relevant regulatory authorities in the EU, Canada, Australia and the UK. In the European Union, the vaccine has been in the so-called rolling review process since February. At the beginning of November, Novavax applied for approval from the EMA and in Canada.
The company originally hoped to complete the review in the third quarter, an expectation that has not materialized. According to experts, the biggest problem in manufacturing is the purity of the substances. If Novavax can be successfully manufactured, the vaccine will be of particular interest to populous countries that cannot ensure large-scale deep-frozen storage due to climatic conditions. As with other protein-based vaccines, cooling of two to eight degrees Celsius is sufficient, according to the company. In addition to Indonesia, India is also planning to use Novavax.