State-backed vaccine manufacturer Biovac has entered into a partnership with California-based ImmunityBio for local production of its candidate Covid-19 vaccine, it announced on Thursday.
The agreement is strategically important because it paves the way for Biovac to develop the expertise to manufacture active pharmaceutical ingredients (APIs), said CEO Morena Makhoana.
There is currently no vaccine API production in SA, and local pharmaceutical manufacturers, such as Biovac and Aspen Pharmacare, fill and package vaccines formulated by other firms.
“Strategically, if we want to make a long-term impact, we have to look at API manufacturing,” said Makhoana. Biovac anticipated building the capacity to produce vaccine APIs for both the domestic and export market, he said.
“Biovac has also recently collaborated with Wits University’ antiviral gene therapy unity where Biovac’s staff are being trained to handle viral vaccines. These collaborations are a significant stepping stone to addressing the gap in Africa of self-reliance and pandemic response capability,” he said.
Nasdaq-listed ImmunityBio is running a phase 1 safety trial of its experimental hAd5 T-cell vaccine in the US and SA. The vaccine is a second-generation Covid-19 vaccine that uses the Ad5 adenovirus to carry two genes from the coronavirus — one for the spike protein and another for the more stable, inner nucleocapsid protein. Researchers hope it will protect people against current and future variants of Sars-CoV-2, the virus that causes Covid-19.
“Pursuing a vaccine that does not rely solely on targeting the S [spike] protein where the mutations are occurring is of critical importance as multiple variants of the SARS-CoV-2 virus have appeared globally, with concentrated outbreaks being detected in SA,” said ImmunityBio chair Patrick Soon-Shiong, who is also the owner of the Los Angeles Times.
The highly transmissible 501Y.V2 variant that has swiftly come to dominate transmission in SA has several mutations in the spike protein, which the virus uses to enter human cells.
Researchers hope the ImmunityBio’s vaccine will not only trigger antibody production, but also provide long-term immunity by eliciting a response from the body’s killer T-cells.
“T-cell-based vaccines kill the infected cell, preventing virus replication, and could provide long-term memory [protection] to recipients,” said Soon-Shiong.
The US trial is investigating both an injectable and oral formulation of the vaccine, said Makhoana. If the phase 1 trial demonstrates the vaccine is safe and elicits a response from the immune system, larger phase 2 and 3 trials will be conducted during the course of the year, he said.
Biovac has the potential to make up to 100-million doses of the shot, Soon-Shiong said.
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