While existing vaccines are being rolled out worldwide, Novavax’s is demonstrating effectiveness in late-stage trials and the partnership of Sanofi and Translate Bio is beginning early-stage trials for their mRNA vaccine. Here’s a look.
Novavax Vaccine Highly Effective Against Wuhan, UK and South African Strains
Novavax, based in Gaithersburg, Maryland, announced that its COVID-19 vaccine had final efficacy of 96.4% against mild, moderate and severe COVID-19 caused by the original Wuhan wildtype strain in its U.K. pivotal Phase III trial. And after completing analysis of its Phase IIb trial in South Africa, it reported 55.4% efficacy among the HIV-negative trial volunteers in an area where the majority of strains were the South African B1.351 variants.
Perhaps most importantly, across both trials, the Novavax vaccine was 100% protective against severe disease, including hospitalizations and death. At this time Novavax has not submitted to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA).
The U.K. trial enrolled more than 15,000 volunteers between the ages of 18 and 84, including 27% over the age of 65. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic disease with onset at least 7 days after the second study vaccination in serologically negative participants. Efficacy was 96.4% against the original Wuhan strain, 86.3% against the B.1.1.7/501Y.V1 UK variant. The overall vaccine efficacy was 89.7%.
In the South Africa trial, one cohort was 2,665 healthy adults, the second cohort 240 medically stable, HIV-positive adults. The trial demonstrated an overall efficacy of 48.6% against mostly variant strains, mostly the South African strains. In the HIV-negative group, efficacy was 55.4%.
“We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials,” said Stanley C. Erck, president and chief executive officer of Novavax. “Importantly, both studies confirmed efficacy against the variant strains. Today marks one year since the WHO officially declared the COVID-19 pandemic, and with this data in hand, we are even more motivated to advance our vaccine as a potential weapon in the fight to end the suffering caused by COVID-19.”
Sanofi and Translate Bio Launch Phase I/II Trial of their mRNA COVID-19 Vaccine
Paris-based Sanofi Pasteur and Lexington, Massachusetts-based Translate Bio initiated their Phase I/II clinical trial of MRT5500, a messenger RNA (mRNA) vaccine candidate against COVID-19. Translate Bio receives a $25 million milestone payment for this step. They expect interim data in the third quarter of 2021.
Part of their development program is to improve the temperature stability of the vaccine candidate. Both the Pfizer-BioNTech and Moderna COVID-19 vaccines are mRNA vaccines, and require very cold temperatures, particularly the Pfizer-BioNTech vaccine. The Pfizer-BioNTech requires storage at about -94 degrees F, which requires specialized freezers and transport containers. The Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F.
Sanofi and Translate are targeting a -20 degree C (-4 degrees F) storage temperature. They also hope to enable the vaccine to be stable at 2-8 degrees C (35.6-46.4 degrees F).
The Phase I/II trial will include a total of 415 healthy adults 18 years of age and older and be enrolled across 13 sites. It requires two doses, 21 days apart. They will evaluate three different dose levels, 15 micrograms, 45 micrograms and 135 micrograms.
“Our mRNA vaccine candidate is the result of our expertise in infectious diseases coupled with the innovative technologies of our partner,” said Thomas Triomphe, executive vice president and global head of Sanofi Pasteur. “Initiating the Phase I/II trial represents an important step forward in our goal of bringing another effective vaccine to the ongoing fight against the COVID-19 pandemic.”
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