Novavax vaccine nearing approval in the EU

NETHERLANDS – The European Union’s drug regulator has said that it could make a decision on Novavax’s COVID-19 vaccine approval “within weeks” if the data it has received from the drugmaker is sufficient to demonstrate the shot’s efficacy.

The protein-based vaccine, Nuvaxovid, has been subject to a rolling review since February, according to the European Medicines Agency (EMA).

The Novavax vaccine is a protein subunit vaccine, which distinguishes it from mRNA vaccines developed by Moderna and Pfizer, viral-vectored vaccines developed by AstraZeneca and Johnson & Johnson, and inactivated-virus vaccines developed by Sinovac and Sinopharm.

Protein subunit vaccines contain a critical component of whatever they are designed to protect against. In this case, to protect against the coronavirus, they contain spike proteins that cover the virus’s surface and are easily recognized by the immune system.

When the real virus is encountered in the future, the immune system has defenses that are trained to attack and quickly destroy the virus’s outer parts.

The Novavax COVID vaccine appears to be effective as well. In phase 3 trials, which is the final stage of human testing, it was found to be 90% protective against developing symptomatic COVID, with no severe cases reported among those who received the vaccine.

Its safety profile appears to be comparable, if not superior, to that of the Pfizer and Moderna vaccines.

Significance of Novavax approval

Novavax’s vaccine appears to be a very exciting product, but its future is dependent on it being approved by some of the world’s most important regulators.

In the short term, most richer countries have substantial stocks of existing vaccines, implying that their immediate rollouts and booster programs are likely covered. The longer-term need for additional doses in these countries is unknown.

However, if the vaccine became available in developed countries, it could be a useful tool for reaching vaccine-hesitant people. Some people who have avoided the newly developed mRNA and viral-vectored products due to safety concerns have stated that they would take a vaccine based on a more traditional method, such as Novavax’s.

However, the most appropriate use of Novavax in the coming year or two would be to help reduce the widespread COVID vaccine inequity. Only 6% of Sub-Saharan Africa’s population has received two doses of any COVID vaccine. Less than 5% of people in low-income countries have received even one dose.

The Novavax vaccine also does not need to be frozen for storage, making it an appealing product for low-income countries.

However, in order to reach these countries, the vaccine would most likely need to be distributed through the global vaccine-sharing scheme, Covax, and getting the vaccine approved by the WHO is a prerequisite.

Production constraints

A further issue is that the company has reportedly struggled with the manufacturing process, with doubts raised about its ability to produce the vaccine in large quantities.

The major approval could come much sooner than the approval in the US, where Novavax had to resolve manufacturing issues and expects to file for approval by the end of the year.

India, though, may come to the rescue here. The Serum Institute of India will make the Novavax doses that will be supplied to Indonesia, and it has already ramped up production of other vaccines licensed to it for production – in particular the AstraZeneca vaccine.

The institute is reportedly producing 240 million doses of COVID vaccines each month, and has resumed supply of Covid vaccines to Covax.

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