Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.
Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.
Last week, Novavax shared interim data from a Phase III study in the United Kingdom that shows its vaccine candidate demonstrated 89.3% efficacy against the virus. The results include the most common strain of the novel coronavirus, as well as some viral variants. Breaking it down, Novavax said efficacy of its NVX-CoV2373 vaccine was 95.6% against the original strain and 85.6% against the U.K. variant that has swept across that nation. Results from a Phase IIb study in South Africa, where a highly virulent strain is running amok, were not as high. Overall for that study, the results showed a 60% efficacy. However, the Phase IIb study included patients who were HIV-positive. Among those immuno-compromised patients included in the study, the efficacy against the South African strain dropped to 49%.
Gregory M. Glenn, president of Novavax’s Research and Development unit, said the rolling review of the company’s submission for emergency use authorization of its vaccine will help “expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide.” As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.
Novavax’s recombinant protein-based vaccine candidate is currently in Phase III clinical development in both the U.K. and U.S. for the prevention of COVID-19. NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant. Phase I data from a Phase I/II study showed that NVX‑CoV2373 produced antibodies in healthy patients, a sign the vaccine is working as intended. The vaccine was also well-tolerated in those patients, the company said.
Elsewhere in the fight against the ongoing pandemic:
CureVac Forges Alliance with the UK
Germany’s CureVac, which earlier this week forged a vaccine partnership with GlaxoSmithKline, announced this morning it entered into a collaboration with the U.K. Government to develop and manufacture potential vaccine candidates against SARS-CoV-2 variants. Any resulting vaccine candidates will be manufactured and distributed in the U.K. CureVac said the objective of its collaboration with that government is to mitigate the effects of the current pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.
As part of the collaboration, the U.K. government’s Vaccine Task Force and CureVac will assess multiple SARS-CoV-2 variants and generate vaccine candidates against them. Clinical studies will be expedited in order to secure emergency or conditional marketing authorizations for selected vaccine candidates against the most threatening variant viruses, CureVac said.
“One of the biggest challenges we continue to face in combating COVID-19 is the emergence of multiple variants, each of which poses a potentially significant threat to public health,” Antony Blanc, chief business officer and chief commercial officer of CureVac said in a statement. “At CureVac, we believe we have the ability to quickly adapt our mRNA technology to address current variants and prepare for the emergence of new strains. This collaboration is expected to bring to bear our significant combined forces to ensure vaccines keep winning against COVID-19.”
New FDA Guidance Planned
With increased concerns about viral variants, the FDA is developing guidance to help vaccine, drug and testing manufacturers adapt, USA Today reported. Janet Woodcock, acting FDA Commissioner, noted that current treatments and testing methods work, but the regulatory agency wants to prepare for eventual shifts with the virus, even as vaccination efforts are underway across the country. Over the next few weeks, the FDA will provide draft guidance to manufacturers on how to adapt their products as needed, according to the report.
Some vaccines, such as the one in development from Novavax, as well as AstraZeneca’s, which has not yet been authorized in the United States, are showing some limited efficacy against these more virulent strains. However, there is a concern that as these new strains become more widespread in the U.S., current vaccines from Moderna and Pfizer and BioNTech, as well as monoclonal antibodies developed by Eli Lilly and Regeneron, may become less effective.
