Novavax COVID-19 Vaccine Gaining Regulatory Ground

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

Novavax’s COVID-19 vaccine (Nuvaxovid) received a conditional marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) on Feb 3, 2022. The approval permits use of the vaccine in individuals 18 years and older in Great Britain.

"We are proud that Nuvaxovid will be the first protein-based vaccine option authorized by MHRA as the United Kingdom tackles this next phase of the pandemic," said Stanley C. Erck, president and CEO, Novavax, in a company press release. "We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the UK, as well as the Vaccines Taskforce, for their ongoing support and vital contributions to this program."

On the same day, Novavax also announced that they had received provisional approval from New Zealand’s Medsafe. Like MHRA’s conditional marketing authorization, Medsafe’s provisional approval allows the vaccine to be used in individuals 18 years or older.

Novavax is a recombinant, adjuvanted, protein-based vaccine designed to prevent SARS-CoV-2. According to a company press release, two pivotal Phase III clinical trials found that the vaccine demonstrated efficacy and had a reassuring safety profile. One of the trials totaled 30,000 participants, while the other had 15,000.

In addition to these approvals, Novavax announced that they had also applied for an Emergency Use Authorization from FDA on Jan. 31, 2021.

Source: Novavax 1, 2, 3