Biotechnology company Novavax has announced the long-awaited results from its large Phase 3 COVID-19 vaccine trial, revealing over 90 percent protection from symptomatic infection and 100 percent protection from moderate to severe disease. The vaccine utilizes a very different technology to previously approved COVID-19 vaccines and is hoped to be a vital new weapon in the pandemic.
The Phase 3 trial recruited nearly 30,000 subjects across the US and Mexico. In total there were 77 cases of COVID-19 reported, 14 in the vaccine group and 63 in the placebo group. This means the vaccine has an overall efficacy of 90.4 percent.
But most importantly, all 14 COVID-19 cases in the vaccine group were defined as mild, whereas a number of cases in the placebo group were moderate or severe. So in terms of protection from severe disease, hospitalization, and death, the vaccine is 100 percent effective.
The vaccine requires two doses, delivered four weeks apart. Unlike the mRNA COVID-19 vaccines, Novavax's candidate is stable at normal refrigerator temperatures, making it substantially easier to deliver to remote communities.
As the vaccine was trialed in the early months of 2021 when variants of SARS-CoV-2 were spreading, the data offers promising evidence of efficacy against B.1.1.7, the variant that originally appeared in the UK and is now known as the Alpha variant. Although there is no data on efficacy against the newer Delta variant, Peter English, former chair of the British Medical Association’s Public Health Medicine Committee, says the Novavax technology should be easily adaptable to coronavirus variants as they appear.
“The good news is that, now the platform exists for producing this vaccine, Novavax (like other manufacturers) may soon have variant-adapted vaccines that will be as effective against the Variants of Concern as the existing vaccines are against the original strain of the SARS-CoV-2 virus,” says English.
The Novavax COVID-19 vaccine works quite differently to the other vaccines currently being utilized around the world. It’s a protein subunit vaccine. This technology essentially cultivates the infamous coronavirus spike proteins in a lab before assembling those proteins into nanoparticles designed to mimic the structure of a virus. These nanoparticles are then paired with adjuvants, molecules that help boost the body’s immune response.
Novavax has been working on this protein subunit technology for several years but no previous vaccine candidate has yet progressed to market approval. A major Phase 3 trial for Novavax’s protein subunit influenza vaccine commenced in 2019, and early data published just as the pandemic commenced suggested extremely promising efficacy.
The new data presented by Novavax is yet to be peer-reviewed and published in a journal but the company claims full trial data will be published over the coming months, alongside filings for regulatory authorizations around the world.
It’s estimated manufacturing capacity should reach 150 million doses per month by the end of 2021, and although the vaccine may not ultimately be needed in the United States, it will surely become an important part of the greater global vaccination strategy. GAVI, an international organization dedicated to the equitable distribution of vaccines, recently agreed on a deal with Novavax for 1.1 billion doses of its COVID-19 vaccine for lower-income countries.
"Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines,” says Stanley Erck, CEO of Novavax. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection. Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines."
Source: Novavax