CAN: Companies seek approval for C-19 vaccine, using plants to express proteins needed

Canadian biotech Medicago and GlaxoSmithKline are pushing for regulatory approval of the world’s first plant-based vaccine after positive results against a number of coronavirus variants in a late-stage trial. In a phase 3 randomized study in more than 24,000 adults across six countries, including the UK and the US, two doses of the Medicago vaccine, given in combination with GSK’s adjuvant, were 75.6 percent effective against all variants in people without previous exposure to Covid-19. Omicron was not circulating during the study.

Medicago and GSK said they would seek regulatory approval from Canada’s drug regulator, Health Canada. Medicago has also initiated submissions with the US Food and Drug Administration and the UK’s MHRA, and it will also apply for World Health Organization approval, which paves the way for rollout through the Covax access scheme. A “small number” of severe cases occurred in the study, and none was registered in the vaccinated group. No cases of the Alpha, Lambda, or Mu viral variants were observed in those immunized.

Efficacy was as high as 88.6 percent against the Gamma variant. Takashi Nagao, Medicago’s chief executive, told the Financial Times that a “key differentiator” of the study was that it took place at a time when variants were in circulation, in contrast with most large studies that read out late last year, when the ancestral coronavirus was dominant. The vaccine uses plants to express the protein needed — if approved, it would be the world’s first plant-based vaccine.

The vaccine could “make a huge difference and provide variable options to the people who need to be vaccinated,” he said. Medicago has a contract with Canada to supply up to 76 million doses, Nagao said, declining to comment on pricing. Manufacturing was already underway, he added. Brian Ward, Medicago’s medical officer, said the results were “a really big deal.”

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