With world still in sore need of doses, Clover says its Covid-19 vaccine is 67% effective in Phase III
With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.
Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.
The candidate, known as SCB-2019, met both the primary and secondary efficacy endpoints in a study in which all of the strains were variants from the original virus. The study showed 92% vaccine efficacy against the Gamma variant, but just 59% efficacy against Mu. The 30,000 participants were all over the age of 18, and were in five countries: Philippines, Brazil, Colombia, South Africa and Belgium.
The vaccine showed 83% efficacy against moderate-to-severe Covid-19. There were no causes of hospitalization or death in the group, Clover said, and all three deaths in the trial were from the placebo group.
Clover now plans to file for authorization in China, Europe and with the World Health Organization.
In a press release, Clover CEO Joshua Liang said:
Spectra enrolled participants during a time when the world encountered the rapid spread of increasingly transmissible SARS-CoV-2 variants and a takeover by Delta. Amidst this backdrop, we are pleased that SCB-2019 has successfully demonstrated efficacy against the globally dominant Delta strain and other concerning variants. Based on our pioneering data, we believe that SCB-2019 could be utilized as an important tool to combat this pandemic, and we remain dedicated to expediting the availability and equitable access of our Covid-19 vaccine candidate for global distribution.
Clover’s platform is dubbed Trimer-Tag and produces covalently-trimerized fusion proteins. Its candidate, Covid-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.
Though those figures are below the efficacy numbers for mRNA shots or the Novavax vaccine, biotech investor Brad Loncar noted it comes at a time when much of the world still desperately needs vaccine doses.
Some seem to be yawning at the Clover result, especially the 67% overall number, but it’s not bad and hits the target of a vaccine that will be widely used in a world that needs doses.
— Brad Loncar (@bradloncar) September 22, 2021
The trial also found that the vaccine significantly reduced the risk of Covid-19 in people who have previously been infected with Covid-19. Nearly 50% of participants in the trial had previously been infected. The vaccine showed a 64% reduction in risk of symptomatic infection and a 79% reduction in symptomatic reinfection from the Delta variant.
Earlier this month, Clover got the OK to manufacture its candidate at a Changxing facility. The company says the facility has the capability to produce a billion doses of antigens for the jab, which if granted emergency use approval, will be one of the first protein-based Covid-19 vaccines.
If all goes according to plan, Clover anticipates launch by the end of 2021. The company will supply up to 414 million doses of the jab to Covax to distribute throughout countries in need of doses.
Clover has gotten $328 million from CEPI to develop its vaccine. GlaxoSmithKline put its trust in the company in February 2020, when it lent the company its adjuvant system in fear of a pandemic that proved to be valid. The company boasts of one of the largest in-house commercial cGMP manufacturing capabilities in China, which puts itself in a position to quickly scale up production when needed.
The company has six vaccine candidates that in its pipeline that use Trimer-Tag technology, which includes an HIV/AIDS vaccine and a flu vaccine, and two oncology candidates.
About 18% of trial participants had co-morbidities for Covid-19, the company said.