USA – Novavax Inc. has announced that it had finished its rolling regulatory submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for approval of its Covid-19 vaccine candidate, with the company stating that other global regulatory submissions would follow in due course.
The application is based on clinical data from a 15,000-volunteer phase 3 trial in the United Kingdom, in which the vaccine “demonstrated efficacy of 96.4 percent against the original virus strain, 86.3 percent against the Alpha variant, and 89.7 percent efficacy overall.”
The move brings the US biotech “significantly closer” to delivering a vaccine based on a “proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus,” according to Novavax CEO Stanley Erck.
Erck stated that he expects a “positive decision” from the UK’s Medicines and Healthcare products Regulatory Agency and that the company will be ready to roll out its vaccines once approved.
The submission, according to Novavax, was crucial because it included data on chemistry and manufacturing control.
Earlier this year, the drugmaker delayed submitting data to the US Food and Drug Administration because it was unable to compile consistent manufacturing data.
The prolonged wait for the company’s first regulatory approval for any vaccine made by the company, which has been in business for more than three decades, sent its shares soaring for the majority of this year.
However, Novavax stated that it expected to complete additional regulatory filings in Europe, Canada, Australia, and the World Health Organization “shortly after the UK submission.” It plans to file for US regulatory approval by the end of this year.
Global health officials, including the head of the European Medicines Agency, Emer Cooke, have stated that maintaining a diverse portfolio of vaccines that use different technologies is the best way to protect against new coronavirus variants and unexpected pandemic developments.
However, the protein-based shot is unlikely to play a significant role in the near future in countries where primary vaccination programs have been completed and booster campaigns are underway.
The United Kingdom, where messenger RNA shots like those from BioNTech/Pfizer have been used in a booster campaign, has a deal for up to 60 million Novavax shots.
In the EU, where authorities have purchased a total of 2.1 billion doses of the Pfizer and Moderna vaccines, an agreement has been reached for up to 200 million shots to be donated to poorer countries. The United States has so far purchased 100 million doses.
The Novavax shot could be crucial for low-income countries and Covax, the WHO-backed vaccine access program that has struggled to deliver doses.
According to a Financial Times analysis, rich countries have received more than 16 times the number of shots as poorer countries that rely on the program, but the facility has a deal in place for 350 million doses of the shot.
If wealthier countries redirect the Novavax vaccines to which they are entitled, this figure could skyrocket